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WO2024259730A1 - Anti-oil and anti-acne shower gel and production method therefor - Google Patents

Anti-oil and anti-acne shower gel and production method therefor Download PDF

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Publication number
WO2024259730A1
WO2024259730A1 PCT/CN2023/102162 CN2023102162W WO2024259730A1 WO 2024259730 A1 WO2024259730 A1 WO 2024259730A1 CN 2023102162 W CN2023102162 W CN 2023102162W WO 2024259730 A1 WO2024259730 A1 WO 2024259730A1
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WO
WIPO (PCT)
Prior art keywords
acne
extract
oil
shower gel
skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
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PCT/CN2023/102162
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French (fr)
Chinese (zh)
Inventor
周干文
潘康奕
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guo Zanhui
Original Assignee
Guo Zanhui
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Publication of WO2024259730A1 publication Critical patent/WO2024259730A1/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9789Magnoliopsida [dicotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34Alcohols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34Alcohols
    • A61K8/345Alcohols containing more than one hydroxy group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36Carboxylic acids; Salts or anhydrides thereof
    • A61K8/362Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/44Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67Vitamins
    • A61K8/676Ascorbic acid, i.e. vitamin C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9728Fungi, e.g. yeasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-acne agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/14Ectoparasiticides, e.g. scabicides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005Antimicrobial preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/02Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings containing insect repellants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/008Preparations for oily skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/10Washing or bathing preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59Mixtures
    • A61K2800/592Mixtures of compounds complementing their respective functions
    • A61K2800/5922At least two compounds being classified in the same subclass of A61K8/18
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to the field of daily cosmetics, and in particular to an oil-controlling and acne-removing shower gel and a preparation method thereof.
  • the present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention provides an oil-controlling acne-removing shower gel and a preparation method thereof.
  • An oil-controlling and acne-removing shower gel comprises the following raw materials in percentage by weight: 10-18% of a surfactant, 0.3-1% of a thickener, 0.5-2% of sodium chloride, 0.05-0.2% of a pH regulator, 0.1-0.6% of azelaic acid, 0.1-0.5% of capryloyl glycine, 0.1-0.6% of a plant mite remover, 0.2-2% of a sophora flavescens extract, 0.01-0.1% of an epilobium fleischerii extract, 0.1-0.5% of a sugar isomer mixture, 0.1-0.5% of sodium ascorbyl phosphate, 0.5-1.5% of a tremella extract, 0.01-0.2% of a gentian extract, 0.6% of a preservative and the remainder of water.
  • the surfactant is composed of sodium laureth sulfate, sodium methyl cocoyl taurate, cocamidopropyl betaine, sodium lauroamphoacetate, and cocamide methyl MEA.
  • the plant acaricide is composed of thyme extract, rosemary water, 1,3-propylene glycol, dichlorobenzyl alcohol and phenoxyethanol.
  • the thickener consists of tocopherol and PEG-120 methyl glucose dioleate.
  • the sugar isomer mixture comprises sugar isomers, water, citric acid and sodium citrate.
  • the pH adjuster is potassium hydroxide.
  • the above-mentioned oil-controlling and acne-removing shower gel is prepared by a preparation method comprising the following steps:
  • Azelaic acid also known as azelaic acid
  • azelaic acid is currently mainly used to treat melanoma, chloasma, rosacea, hyperpigmentation, acne, etc.
  • Mechanism of action of azelaic acid inhibiting skin oil secretion.
  • Androgen especially dihydrotestosterone, induces the activity of sebaceous glands, which is one of the causes of acne.
  • 5a-reductase in sebaceous glands can increase the bioconversion of testosterone into dihydrotestosterone, and azelaic acid can produce a competitive concentration inhibitory effect on this reductase, thereby reducing oil secretion of the skin; it has an anti-keratinization effect on normal skin and acne-infected skin, reduces the synthesis of filamentous keratin, prevents excessive keratinization of hair follicles, and unclogs pores.
  • the epilobium yaker extract added to the formula also has a strong inhibitory effect on 5a-reductase.
  • capryloyl glycine For acne/pimples caused by excessive growth of Propionibacterium acnes, capryloyl glycine has good skin affinity and is mild to the skin. At the same time, it can achieve a good inhibitory effect on Propionibacterium acnes and Staphylococcus aureus in a relatively short time (2min-5min), and has a significant effect on the prevention and treatment of acne and pimples. Therefore, this formula selects capryloyl glycine as the active ingredient to inhibit Propionibacterium acnes, which fully considers its characteristics of short action time and high action efficiency, and also considers its mildness to the skin.
  • Sophora flavescens extract has a broad-spectrum antibacterial property, which can not only inhibit the biosynthesis of bacteria, but also affect the biological oxidation process of bacteria.
  • the anti-inflammatory mechanism of Sophora flavescens extract is due to the stabilization of the red blood cell membrane, and it has a strong immunomodulatory effect. It can exert its anti-inflammatory effect through the changes in immune cells, cytokines and other inflammatory regulatory factors. It has a good effect on eczema and dermatitis, can relieve skin itching caused by inflammation, and accelerate the repair of acne skin.
  • a plant-based mite remover is added to the formula.
  • the main active ingredients of the mite remover are: thyme extract, rosemary, water and dichlorobenzyl alcohol. It has a strong killing and repelling effect on various types of mites. It can effectively prevent or relieve acne caused by mites.
  • the compatibility mechanism of the acne-removing and oil-controlling ingredients in this formula covers various pathogenesis of acne/pimples, and can achieve more significant acne-removing and oil-controlling effects. At the same time, it also takes into account the mildness and safety of the overall formula, and is suitable for a wider range of people. It can not only be used for acne removal on acne-prone skin, but also for daily cleansing to prevent acne.
  • FIG1 is a schematic diagram of the effect of use by subject 1;
  • FIG2 is a schematic diagram of the effect of use by subject 2;
  • the preparation method is as follows:
  • the plant mite remover used in this application is produced and provided by Guangdong Dimei New Material Technology Co., Ltd.
  • Test substance original cosmetic final product (diluted to 1% aqueous solution).
  • Control blank filter paper control.
  • Subjects A total of 30 subjects, including 1 male and 29 females, aged 21 to 59 years old, with an average age of 39.77 ⁇ 12.14 years old, met the voluntary inclusion criteria.
  • Test method Select qualified patch test equipment and use closed patch test method. Place about 0.020mL-0.025mL (liquid) of diluted test substance in the patch tester and apply it to the back of the subject with low-allergenic tape. Remove the test substance after 24 hours and observe the skin reaction at 0.5, 24 and 48 hours after removal. Record the results according to the skin reaction grading standard in the "Technical Specification for Safety of Cosmetics" (2015 edition).
  • Test substance original cosmetic final product
  • Subjects A total of 30 subjects (33 subjects were enrolled and 3 subjects dropped out), including 14 females and 16 males, aged 18 to 40 years old, with an average age of 29.50 ⁇ 6.31 years old, who met the subject inclusion criteria.
  • Test environment temperature: 20°C ⁇ 22°C, humidity: 40% ⁇ 60%, and real-time dynamic monitoring.
  • At least 30 subjects were recruited to use the test samples for 28 consecutive days.
  • the improvement level of acne lesions was evaluated subjectively and by doctors.
  • Antera 3D was used to collect and analyze the corresponding parameters of acne on the subjects' backs.
  • the test probe SM815 was used to measure the oil content on the skin surface. The changes in various indicators before and after use were compared to determine the acne removal and oil control effects of the product.
  • Acute inflammation or other skin diseases on the back such as eczema, lupus erythematosus, seborrheic dermatitis, psoriasis, severe epidermal exfoliation, etc.
  • Any medications taken orally or topically in the past month that may affect skin condition or reaction such as antihistamines, antibiotics, insulin, anti-inflammatory drugs, vitamin A, steroid drugs, aspirin, thyroid drugs, etc.
  • Humidity 40% to 60% Sit quietly for 30 minutes without drinking water or beverages. Keep the subject relaxed and avoid touching the back.
  • the test area was the back.
  • the subjects When bathing, take an appropriate amount of the test product to replace the usual bath products, rub the whole body gently and then wash. Use once a day for 28 consecutive days.
  • the subjects are prohibited from using acne-removing, oil-controlling, anti-inflammatory and antibacterial preparations; the subjects are prohibited from dripping, injecting, orally or taking other forms of preparations that affect acne-removing and oil-control tests; the subjects are mainly indoor activities and avoid long-term exposure to outdoor light.
  • the subjects filled out a questionnaire in the human efficacy laboratory to evaluate the back condition and record the score.
  • the 7-point scoring method was used to score the product in four aspects: skin feel, use effect, mildness and use satisfaction, and then make a judgment, and record it once for each follow-up visit.
  • the dermatologists evaluated the acne lesions on the subjects' backs in the photos before using the product (D0) and 28 days after using the product (D28).
  • the improvement of the lesion symptoms before and after use of the subjects was scored using the ISGA scale (Table 2), and the percentage of lesion reduction was calculated.
  • the subjects After resting for 30 minutes in the human efficacy evaluation room, the subjects were photographed with the Antera 3D skin image analyzer at the back acne site. The average volume of acne in the test area was obtained through software analysis. The SM815 was used to detect the skin oil value at the test site. The measured value was used as the baseline value (D0). The product was then distributed and the use method was instructed. The subjects were required to return for a visit 28 days (D28) after using the product and undergo the same indicator test.
  • test of the same subject should be completed by the same instrument and the same tester.
  • the test site should be kept consistent between the two test time points.
  • the 7-point scoring method (Table 5) was used to score the product's use effect, mildness, and use satisfaction in the questionnaire.
  • the subjects' evaluation and satisfaction with the product's use experience and efficacy were analyzed.
  • Dermatologists evaluated the acne lesions on the subjects' backs before and after using the product.
  • the ISGA scale was used to score the improvement of the lesion symptoms before and after use, and the percentage of lesion reduction was calculated.
  • the percentage of lesion reduction was calculated using Formula 1.
  • the ISGA skin lesion score showed a downward trend after using the product.
  • the percentage of skin lesion reduction was 36.51%, and there was a very significant difference between the two (p ⁇ 0.01).
  • the acne area images taken by Antera3D can be analyzed by software to measure the average volume change of acne in the AOI selected area at different time points. By comparing the average volume change of acne before and after use, the acne removal effect of the product can be reflected.
  • Average acne volume reduction rate (average acne volume before using the product - average acne volume after using the product) / Average volume of acne before using the product ⁇ 100%
  • test results are shown in Table 12 and Figure 4 (paired t-test was used to analyze the difference between the baseline value and the return visit time point value of the average volume of acne. Significant differences are marked with *p ⁇ 0.05, **p ⁇ 0.01):
  • the average volume of acne showed a downward trend after using the product, and decreased by 74.17% after 28 days of use (D28), which was significantly different from the baseline value (p ⁇ 0.01).
  • the average volume of acne after using the product was lower than the baseline value.
  • the oil control effect of the product can be reflected.
  • Skin oil content reduction rate (oil content before using the product - oil content after using the product) / oil content before using the product ⁇ 100%
  • the oil content on the skin surface showed a downward trend after using the product. After 28 days of use (D28), it decreased by 45.39%, which was significantly different from the baseline value (p ⁇ 0.01). After using the product, the oil content on the skin surface was lower than the baseline value.
  • the ISGA score can be reduced, the overall acne lesions on the back can be improved, the average volume of acne on the back can be reduced, the oil content on the back can be reduced, and the acne and oil control effects can be achieved.
  • more than 50% of the subjects gave positive comments on the product's skin feel, acne removal, oil control effects, mildness and satisfaction, indicating that the product has acne removal and oil control effects.

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Abstract

An anti-oil and anti-acne shower gel, comprising the following raw material components in percentage by weight: 10-18% of a surfactant, 0.3-1% of a thickening agent, 0.5-2% of sodium chloride, 0.05-0.2% of a pH regulator, 0.1-0.6% of azelaic acid, 0.1-0.5% of caprylylglycine, 0.1-0.6% of a plant acaricide, 0.2-2% of a radix sophorae flavescentis extract, 0.01-0.1% of an Epilobium fleischeri extract, 0.1-0.5% of a saccharide isomeride mixture, 0.1-0.5% of sodium ascorbyl phosphate, 0.5-1.5% of a Tremella extract, 0.01-0.2% of a gentian extract, 0.3-0.7% of a preservative, and the balance of water.

Description

一种控油祛痘沐浴露及其制备方法Oil-controlling and acne-removing shower gel and preparation method thereof 技术领域Technical Field

本发明涉及日用化妆品领域,尤其涉及一种控油祛痘沐浴露及其制备方法。The invention relates to the field of daily cosmetics, and in particular to an oil-controlling and acne-removing shower gel and a preparation method thereof.

背景技术Background Art

沐浴露已逐渐成为人们日常生活中最常用、消耗量最大的一类日用品,随着人们生活水平的提高,人们对于沐浴露的要求也越来越高,目前,市面上常见的沐浴露,大多数含有较多化学成分,频繁使用,会破坏皮肤水分和油脂的平衡,容易引起皮肤干燥、出油、起痘的问题,长期使用,不利于人们的皮肤健康。Shower gel has gradually become the most commonly used and consumed daily necessity in people's daily life. With the improvement of people's living standards, people's requirements for shower gel are getting higher and higher. At present, most of the common shower gels on the market contain more chemical ingredients. Frequent use will destroy the balance of skin moisture and oil, easily causing problems such as dry skin, oily skin, and acne. Long-term use is not good for people's skin health.

发明内容Summary of the invention

本发明旨在至少解决现有技术中存在的技术问题之一。为此,本发明提出一种控油祛痘沐浴露及其制备方法。The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention provides an oil-controlling acne-removing shower gel and a preparation method thereof.

本发明的一种实施例解决其技术问题所采用的技术方案是:The technical solution adopted by an embodiment of the present invention to solve the technical problem is:

一种控油祛痘沐浴露,按重量百分比计,包括以下原料成分:10-18%表面活性剂、0.3-1%增稠剂、0.5-2%氯化钠、0.05-0.2%pH调节剂、0.1-0.6%壬二酸、0.1-0.5%辛酰甘氨酸、0.1-0.6%植物除螨剂、0.2-2%苦参提取物、0.01-0.1%弗来歇氏柳叶菜提取物、0.1-0.5%糖类同分异构体混合物、0.1-0.5%抗坏血酸磷酸酯钠、0.5-1.5%银耳提取物、0.01-0.2%龙胆提取物、0.6%防腐剂以及余量水。An oil-controlling and acne-removing shower gel comprises the following raw materials in percentage by weight: 10-18% of a surfactant, 0.3-1% of a thickener, 0.5-2% of sodium chloride, 0.05-0.2% of a pH regulator, 0.1-0.6% of azelaic acid, 0.1-0.5% of capryloyl glycine, 0.1-0.6% of a plant mite remover, 0.2-2% of a sophora flavescens extract, 0.01-0.1% of an epilobium fleischerii extract, 0.1-0.5% of a sugar isomer mixture, 0.1-0.5% of sodium ascorbyl phosphate, 0.5-1.5% of a tremella extract, 0.01-0.2% of a gentian extract, 0.6% of a preservative and the remainder of water.

优选的,所述表面活性剂由月桂醇聚醚硫酸酯钠、甲基椰油酰基牛磺酸钠、椰油酰胺丙基甜菜碱、月桂酰两性基乙酸钠、椰油酰胺甲基MEA组成。Preferably, the surfactant is composed of sodium laureth sulfate, sodium methyl cocoyl taurate, cocamidopropyl betaine, sodium lauroamphoacetate, and cocamide methyl MEA.

优选的,所述植物除螨剂由百里香提取物、迷迭香水、1,3-丙二醇、二氯苯甲醇、苯氧乙醇组成。Preferably, the plant acaricide is composed of thyme extract, rosemary water, 1,3-propylene glycol, dichlorobenzyl alcohol and phenoxyethanol.

优选的,所述增稠剂由生育酚和PEG-120甲基葡糖二油酸酯组成。Preferably, the thickener consists of tocopherol and PEG-120 methyl glucose dioleate.

优选的,所述糖类同分异构体混合物包括有糖类同分异构体、水、柠檬酸以及柠檬酸钠。Preferably, the sugar isomer mixture comprises sugar isomers, water, citric acid and sodium citrate.

优选的,所述pH调节剂为氢氧化钾。Preferably, the pH adjuster is potassium hydroxide.

制备上述一种控油祛痘沐浴露,制备方法包括如下步骤:The above-mentioned oil-controlling and acne-removing shower gel is prepared by a preparation method comprising the following steps:

S1:将水分成两部分,将第一部分水投入生产锅中,升温至80-85℃,加入表面活性剂搅拌至溶解均匀;S1: Divide the water into two parts, put the first part of water into the production pot, heat it to 80-85℃, add surfactant and stir until it is evenly dissolved;

S2:在生产锅中继续加入增稠剂、壬二酸、辛酰甘氨酸搅拌至溶解均匀; S2: Continue to add thickener, azelaic acid, and capryloyl glycine into the production pot and stir until they are evenly dissolved;

S3:降温至45℃,加入植物除螨剂、苦参提取物、pH调节剂、糖类同分异构体混合物、抗坏血酸磷酸酯钠、银耳提取物、龙胆提取物、弗来歇氏柳叶菜提取物搅拌溶解均匀;S3: Cool down to 45°C, add plant acaricide, Sophora flavescens extract, pH adjuster, sugar isomer mixture, sodium ascorbyl phosphate, Tremella fuciformis extract, Gentiana scabra extract, and Epilobium freiherb extract, and stir to dissolve evenly;

S4:氯化钠先用第二部分水溶解完全后投入生产锅中搅拌均匀,调节PH以及粘度、出料。S4: Sodium chloride is first completely dissolved with the second part of water and then put into the production pot and stirred evenly, and the pH and viscosity are adjusted and the material is discharged.

本发明的有益效果:Beneficial effects of the present invention:

1、针对雄激素对皮脂腺调控异常和皮脂腺导管角质化异常引起的痤疮/痘痘,本申请利用壬二酸和弗来歇氏柳叶菜提取物的协同作用达到祛痘控油的效果。壬二酸别名杜鹃花酸,目前其主要用于治疗黑色素瘤、黄褐斑、酒糟鼻、色素过度沉着、痤疮等方面。壬二酸作用机制:抑制皮肤油脂分泌。雄性激素特别是二氢睾酮诱发皮脂腺的活性是痤疮的成因之一。皮脂腺中5a-还原酶能增加睾酮生物转化为二氢睾酮,而壬二酸对此还原酶能产生竞争性浓度抑制作用,从而使皮肤减少油脂分泌;对正常皮肤和痤疮感染的皮肤有抗角质化作用,减少丝状角蛋白的合成,防止毛囊角化过度,疏通毛孔。同时配方中添加的弗来歇氏柳叶菜提取物对5a-还原酶也具有很强的抑制作用。通过将歇氏柳叶菜提取物与壬二酸进行复配,减少壬二酸的使用量和皮肤刺激,同时达到显著的祛痘控油效果。1. In view of acne/pimples caused by abnormal regulation of sebaceous glands by androgens and abnormal keratinization of sebaceous gland ducts, this application uses the synergistic effect of azelaic acid and epilobium fleischer extract to achieve the effect of removing acne and controlling oil. Azelaic acid, also known as azelaic acid, is currently mainly used to treat melanoma, chloasma, rosacea, hyperpigmentation, acne, etc. Mechanism of action of azelaic acid: inhibiting skin oil secretion. Androgen, especially dihydrotestosterone, induces the activity of sebaceous glands, which is one of the causes of acne. 5a-reductase in sebaceous glands can increase the bioconversion of testosterone into dihydrotestosterone, and azelaic acid can produce a competitive concentration inhibitory effect on this reductase, thereby reducing oil secretion of the skin; it has an anti-keratinization effect on normal skin and acne-infected skin, reduces the synthesis of filamentous keratin, prevents excessive keratinization of hair follicles, and unclogs pores. At the same time, the epilobium fleischer extract added to the formula also has a strong inhibitory effect on 5a-reductase. By combining Epilobium schreberi extract with azelaic acid, the amount of azelaic acid used and skin irritation can be reduced, while achieving significant acne-removing and oil-controlling effects.

2、针对痤疮丙酸杆菌过度繁殖引起的痤疮/痘痘,辛酰甘氨酸具有良好的皮肤亲和性,对皮肤温和,同时它对痤疮丙酸杆菌、金黄色葡萄球菌在较短时间内(2min-5min)即可达到很好的抑制作用,对粉刺、痘痘的预防和治疗具有显著的效果。因此,本配方选择以辛酰甘氨酸作为抑制痤疮丙酸杆菌的活性物,一方面充分考虑了其作用时间短,作用效率高的特点,同时也考虑了其对皮肤的温和性。2. For acne/pimples caused by excessive growth of Propionibacterium acnes, capryloyl glycine has good skin affinity and is mild to the skin. At the same time, it can achieve a good inhibitory effect on Propionibacterium acnes and Staphylococcus aureus in a relatively short time (2min-5min), and has a significant effect on the prevention and treatment of acne and pimples. Therefore, this formula selects capryloyl glycine as the active ingredient to inhibit Propionibacterium acnes, which fully considers its characteristics of short action time and high action efficiency, and also considers its mildness to the skin.

3、针对炎症免疫反应引发的痤疮/痘痘,主要通过苦参提取物来实现。苦参提取物具有广谱抗菌性,不仅能抑制菌体的生物合成,又能影响菌体的生物氧化过程。苦参提取物的抗炎机理是通过对红细胞膜的稳定作用所致,而且具有较强的免疫调节作用,可通过对免疫细胞的变化、细胞因子及其他炎性调节因子的影响发挥其抗炎作用,对湿疹、皮炎具有很好的疗效,能够缓解炎症引起的皮肤瘙痒,加速痘痘皮肤的修复。3. For acne/pimples caused by inflammatory immune response, it is mainly achieved through Sophora flavescens extract. Sophora flavescens extract has a broad-spectrum antibacterial property, which can not only inhibit the biosynthesis of bacteria, but also affect the biological oxidation process of bacteria. The anti-inflammatory mechanism of Sophora flavescens extract is due to the stabilization of the red blood cell membrane, and it has a strong immunomodulatory effect. It can exert its anti-inflammatory effect through the changes in immune cells, cytokines and other inflammatory regulatory factors. It has a good effect on eczema and dermatitis, can relieve skin itching caused by inflammation, and accelerate the repair of acne skin.

4、针对受皮肤螨虫的影响引起的痤疮/痘痘,配方中添加了植物除螨剂,该除螨剂的主要活性成分是:百里香提取物、迷迭香、水和二氯苯甲醇。其对各类螨虫具有很强的杀灭和驱避效果。能够有效预防或缓解皮肤因螨虫引起的痘痘情况。 4. For acne/pimples caused by skin mites, a plant-based mite remover is added to the formula. The main active ingredients of the mite remover are: thyme extract, rosemary, water and dichlorobenzyl alcohol. It has a strong killing and repelling effect on various types of mites. It can effectively prevent or relieve acne caused by mites.

综上所述,本配方祛痘控油成分的配伍机理涵盖了痤疮/痘痘的各种发病机理,可以达到更加显著的祛痘控油效果,同时还考虑了整体配方的温和性和安全性,适用群体更加广泛,不仅可以作为痘痘肌肤的祛痘用途,也可以作为日常清洁的预防痘痘用途。To sum up, the compatibility mechanism of the acne-removing and oil-controlling ingredients in this formula covers various pathogenesis of acne/pimples, and can achieve more significant acne-removing and oil-controlling effects. At the same time, it also takes into account the mildness and safety of the overall formula, and is suitable for a wider range of people. It can not only be used for acne removal on acne-prone skin, but also for daily cleansing to prevent acne.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

本发明的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解,其中:The above and/or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

图1为受试者1使用的效果示意图;FIG1 is a schematic diagram of the effect of use by subject 1;

图2为受试者2使用的效果示意图;FIG2 is a schematic diagram of the effect of use by subject 2;

图3为不同时间点ISGA评分比较(x±s,n=30);Figure 3 is a comparison of ISGA scores at different time points (x±s, n=30);

图4为痤疮平均体积变化(mm,x±s,n=30);Figure 4 shows the average volume change of acne (mm, x±s, n=30);

图5为皮肤油脂含量变化(μg/cm,x±s,n=30)。FIG5 shows the changes in skin oil content (μg/cm, x±s, n=30).

具体实施方式DETAILED DESCRIPTION

具体实施方式对于充分公开、理解和再现发明创造,支持和解释权利要求是十分重要的。实施方式的描述应当与解决技术问题所采用的技术方案相一致,对于简单的技术方案,可以只给出一个实施例,对于保护范围较宽的技术方案,应当给出一个以上的实施例,以支持要求保护的范围。Specific implementation methods are very important for fully disclosing, understanding and reproducing the invention, supporting and explaining the claims. The description of the implementation method should be consistent with the technical solution adopted to solve the technical problem. For simple technical solutions, only one embodiment can be given. For technical solutions with a wider protection scope, more than one embodiment should be given to support the scope of the protection required.

实施例的配方示例

Example of recipe of embodiment

制备方法如下:The preparation method is as follows:

1.准确称量配方成分中的各组分物料,同时将生产设备清洁干净;1. Accurately weigh the ingredients in the formula and clean the production equipment;

2.搅拌锅中加入1号原料(预留5%水),升温至80~85℃,加入2、3号原料,搅拌至完全溶解;2. Add raw material No. 1 (reserve 5% water) to the stirring pot, heat to 80-85°C, add raw materials No. 2 and 3, and stir until completely dissolved;

3.依次加入4、5、6号原料,搅拌20分钟至溶解均匀;3. Add raw materials 4, 5 and 6 in sequence and stir for 20 minutes until they are evenly dissolved;

4.依次加入7、8、9号原料,搅拌至完全溶解后降温; 4. Add raw materials 7, 8, and 9 in sequence, stir until completely dissolved and then cool down;

5.降温至45℃,加入10、11、12、13、14、15、16、17、18号原料,每加一个原料必须搅拌均匀后再加下一个物料;5. Cool down to 45℃, add raw materials 10, 11, 12, 13, 14, 15, 16, 17, and 18. Stir each raw material evenly before adding the next one;

6.加入剩余水溶解的19号原料,调好pH、粘度后抽样检验;6. Add the remaining water-dissolved raw material No. 19, adjust the pH and viscosity, and then conduct sampling inspection;

7.经检验合格后,半成品出料、储存;7. After passing the inspection, the semi-finished products are discharged and stored;

8.灌装、包装、喷码;8. Filling, packaging and coding;

9.抽检合格后入库。9. Products will be put into storage after passing random inspection.

本申请用的植物除螨剂由广东迪美新材料科技有限公司生产并提供。The plant mite remover used in this application is produced and provided by Guangdong Dimei New Material Technology Co., Ltd.

皮肤封闭型斑贴试验皮肤反应测试Skin occlusive patch test Skin reaction test

一、材料和方法1. Materials and Methods

1.受试物:化妆品终产品原物(稀释为l%的水溶液).1. Test substance: original cosmetic final product (diluted to 1% aqueous solution).

2.对照:空白滤纸对照。2. Control: blank filter paper control.

3.受试者:共30人,男l人,女29人,年龄21至59岁,平均年龄39.77±12.14岁,符合受试者志愿入选标准。3. Subjects: A total of 30 subjects, including 1 male and 29 females, aged 21 to 59 years old, with an average age of 39.77±12.14 years old, met the voluntary inclusion criteria.

4.试验方法:选用合格的斑试器材,以封闭性斑贴试验方法.将稀释后的受试物约0.020mL-0.025mL(液体)置于斑试器内,外用低致敏胶带贴敷于受试者背部,24小时后去除受试物,分别于去除后0.5、24、48小时观察皮肤反应,按《化妆品安全技术规范》(2015年版)中皮肤反应分级标准记录其结果。4. Test method: Select qualified patch test equipment and use closed patch test method. Place about 0.020mL-0.025mL (liquid) of diluted test substance in the patch tester and apply it to the back of the subject with low-allergenic tape. Remove the test substance after 24 hours and observe the skin reaction at 0.5, 24 and 48 hours after removal. Record the results according to the skin reaction grading standard in the "Technical Specification for Safety of Cosmetics" (2015 edition).

皮肤封闭型斑贴试验皮肤反应分级标准
Skin occlusive patch test skin reaction grading standard

二、试验结果2. Test results

化妆品人体皮肤斑贴试验结果汇总
Summary of cosmetics human skin patch test results

结果显示:人体皮肤斑贴试验结果显示,30人中出现6例1级皮肤不良反应。The results showed that: the human skin patch test results showed that 6 cases of grade 1 adverse skin reactions occurred among 30 people.

祛痘和控油效果实验Acne removal and oil control effect experiment

一、材料和方法1. Materials and Methods

1.受试物:化妆品终产品原物1. Test substance: original cosmetic final product

2.对照:自身前后对照2. Comparison: Compare yourself before and after

3.受试者:共30人(33例受试者入组,3例脱落),其中女性14人,男性16人,年龄18至40岁,平均年龄29.50±6.31岁,符合受试者入选标准。3. Subjects: A total of 30 subjects (33 subjects were enrolled and 3 subjects dropped out), including 14 females and 16 males, aged 18 to 40 years old, with an average age of 29.50±6.31 years old, who met the subject inclusion criteria.

4.仪器测量参数及相关设备:
4. Instrument measurement parameters and related equipment:

5.试验环境:温度:20℃~22℃,湿度:40%~60%,并且进行实时动态监测。5. Test environment: temperature: 20℃~22℃, humidity: 40%~60%, and real-time dynamic monitoring.

6.试验方法:6. Test methods:

6.1试验目的及原理6.1 Test Purpose and Principle

招募至少30名受试者连续使用测试样品28天,通过主观评价及医生评价痤疮皮损改善等级,利用Antera 3D采集及分析受试者背部痤疮相应参数,并通过测试探头SM815进行皮肤表面油脂含量测量,比较使用前后各指标变化,判断产品的祛痘、控油效果。 At least 30 subjects were recruited to use the test samples for 28 consecutive days. The improvement level of acne lesions was evaluated subjectively and by doctors. Antera 3D was used to collect and analyze the corresponding parameters of acne on the subjects' backs. The test probe SM815 was used to measure the oil content on the skin surface. The changes in various indicators before and after use were compared to determine the acne removal and oil control effects of the product.

6.2试验设计原则6.2 Experimental design principles

双盲,随机,自身前后对照Double-blind, randomized, self-controlled

6.3受试者筛选6.3 Subject Screening

6.3.1受试者人数:最低有效例数30例6.3.1 Number of subjects: minimum valid number of 30 subjects

6.3.2受试者条件:6.3.2 Subject conditions:

6.3.2.1入选标准:6.3.2.1 Inclusion criteria:

(1)年龄为18~45岁,健康男性或女性。(1) Applicants should be healthy male or female and aged between 18 and 45 years.

(2)全身健康状况良好、无重要的全身系统性疾病。(2) The patient is in good general health and has no major systemic diseases.

(3)背部有2颗以上痤疮。(3) There are two or more acne spots on the back.

(4)能严格按照研究方案的要求和时间安排,并签署知情同意书和保密协议。(4) Able to strictly follow the requirements and time schedule of the research plan and sign the informed consent form and confidentiality agreement.

6.3.2.2排除标准:6.3.2.2 Exclusion criteria:

(1)目前处于孕期、哺乳期或者在接下来的两个月计划怀孕的女性。(1) Women who are currently pregnant, breastfeeding, or planning to become pregnant in the next two months.

(2)背部有急性炎症或其他皮肤疾病(如湿疹、红斑狼疮、脂溢性皮炎、银屑病、严重的表皮脱落等)。(2) Acute inflammation or other skin diseases on the back (such as eczema, lupus erythematosus, seborrheic dermatitis, psoriasis, severe epidermal exfoliation, etc.).

(3)有高度敏感体质或化妆品过敏。(3) Those with a highly sensitive constitution or allergy to cosmetics.

(4)背部具有明显晒伤、瘢痕及多毛或其他可能影响试验测量结果者。(4) Those with obvious sunburn, scars, excessive hair on the back or other conditions that may affect the test results.

(5)近一个月内服或外用任何可能会影响皮肤状态或反应的药物,如抗组胺药、抗生素、胰岛素、抗炎药物、维生素A、类固醇类药物、阿司匹林、甲状腺药物等。(5) Any medications taken orally or topically in the past month that may affect skin condition or reaction, such as antihistamines, antibiotics, insulin, anti-inflammatory drugs, vitamin A, steroid drugs, aspirin, thyroid drugs, etc.

(6)近一月内曾使用激素类药物及免疫抑制剂者。(6) Those who have used hormone drugs or immunosuppressants in the past month.

(7)现在或近一个月受试部位参加其他临床实验者。(7) Those who are currently or have participated in other clinical trials within the past month.

(8)三个月内背部进行过化学剥脱(果酸治疗)、微晶焕肤术、激光磨皮等美容治疗。(8) Have had cosmetic treatments on the back such as chemical peel (fruit acid treatment), microdermabrasion, laser resurfacing, etc. within the past three months.

(9)参照国际改良痤疮分级法及Pillsbury分类法属于IV级的痤疮。(9) Acne classified as grade IV according to the International Modified Acne Scale and Pillsbury classification.

6.3.2.3剔除标准:试验过程中出现严重不良反应以及不遵守研发方案(如测试期间使用其它化妆品、药物以及其它原因要求退出者)6.3.2.3 Exclusion criteria: serious adverse reactions during the test and non-compliance with the R&D plan (such as using other cosmetics or drugs during the test and requesting to withdraw for other reasons)

表1国际改良痤疮分级法

Table 1 International modified acne grading system

6.4试验前的准备6.4 Preparation before the test

受试部位试验当天不能使用任何产品。试验前,受试者需要在人体功效评价室(温度:20℃~22℃,No product can be used on the test site on the day of the test. Before the test, the subjects need to be in the human efficacy evaluation room (temperature: 20℃~22℃,

湿度:40%~60%)静坐30min,期间不能喝水和饮料。受试者保持放松,背部避免触碰。Humidity: 40% to 60%) Sit quietly for 30 minutes without drinking water or beverages. Keep the subject relaxed and avoid touching the back.

试验前对受试者进行试验说明,并签署知情同意书。Before the trial, the subjects were given an explanation of the experiment and signed an informed consent form.

测试区域为背部。The test area was the back.

6.5产品使用方法6.5 Product Usage

洗澡时,取适量试验产品替代惯用的沐浴产品使用,轻揉全身后洗净。每天1次,连续使用28天。在试验期间,受试者禁止使用祛痘、控油、抗炎抑菌的制剂;受试者禁止点滴、注射、口服或其他形式摄入影响祛痘、控油测试的制剂;受试者以室内活动为主,避免长期暴露在室外光照下。When bathing, take an appropriate amount of the test product to replace the usual bath products, rub the whole body gently and then wash. Use once a day for 28 consecutive days. During the trial, the subjects are prohibited from using acne-removing, oil-controlling, anti-inflammatory and antibacterial preparations; the subjects are prohibited from dripping, injecting, orally or taking other forms of preparations that affect acne-removing and oil-control tests; the subjects are mainly indoor activities and avoid long-term exposure to outdoor light.

6.6受试者主观评价6.6 Subjective evaluation

受试者在使用产品后28天(D28)回访时在人体功效实验室填写问卷评价背部情况,并记录评分。使用7分评分法,分别从产品的肤感、使用效果、温和度及使用满意度这4个方面对产品进行评分,然后进行判断,每次回访进行一次记录。During the follow-up visit 28 days after using the product (D28), the subjects filled out a questionnaire in the human efficacy laboratory to evaluate the back condition and record the score. The 7-point scoring method was used to score the product in four aspects: skin feel, use effect, mildness and use satisfaction, and then make a judgment, and record it once for each follow-up visit.

6.7半定量评价(医生评估)6.7 Semi-quantitative evaluation (doctor's evaluation)

皮肤科医生在受试者使用产品前(D0)及使用产品后28天(D28)回访时就照片中受试者背部痤疮皮损情况进行评价。通过ISGA量表(表2)对受试者使用前后皮损症状改善进行评分,并计算皮损减少百分率。The dermatologists evaluated the acne lesions on the subjects' backs in the photos before using the product (D0) and 28 days after using the product (D28). The improvement of the lesion symptoms before and after use of the subjects was scored using the ISGA scale (Table 2), and the percentage of lesion reduction was calculated.

表2 ISGA量表
Table 2 ISGA scale

6.8客观定量评价6.8 Objective and quantitative evaluation

在人体功效评价室休息30min后,使用Antera 3D皮肤图像分析仪进行背部痤疮位置拍摄,通过软件分析得到待测区域内痤疮平均体积,并SM815于试验部位检测皮肤油脂值,其测量值作为基线值(D0),然后进行产品发放并指导使用方法。受试者使用产品后28天(D28)需回访并进行同样的指标检测。After resting for 30 minutes in the human efficacy evaluation room, the subjects were photographed with the Antera 3D skin image analyzer at the back acne site. The average volume of acne in the test area was obtained through software analysis. The SM815 was used to detect the skin oil value at the test site. The measured value was used as the baseline value (D0). The product was then distributed and the use method was instructed. The subjects were required to return for a visit 28 days (D28) after using the product and undergo the same indicator test.

同一个受试者的测试使用同一仪器、同一测试人员完成。两个测试时间点之间应保持测试部位前后一致。The test of the same subject should be completed by the same instrument and the same tester. The test site should be kept consistent between the two test time points.

6.9统计分析6.9 Statistical analysis

对各测试区域的测量值进行统计,包括数量、均值、标准差、标准误、最小值、中位数、最大值等。如测试数据为正态分布,则采用配对t检验方法进行统计分析;如测试数据为非正态分布,则采用秩和检验方法进行统计分析。统计方法均采用双尾检验,检验水准α=0.05。数据统计采用SPSS 25.0软件进行统计分析。当结果出现显著性差异时,分别用*p<0.05和**p<0.01进行标注。*p<0.05表示呈显著性差异,**p<0.01表示呈极显著性差异。测试区域各项指标数值若有显著性差异,表示该产品具有祛痘、控油效果。The measured values of each test area were statistically analyzed, including quantity, mean, standard deviation, standard error, minimum value, median, maximum value, etc. If the test data is normally distributed, the paired t-test method is used for statistical analysis; if the test data is non-normally distributed, the rank sum test method is used for statistical analysis. The statistical methods all use two-tailed tests, and the test level α=0.05. SPSS 25.0 software was used for statistical analysis of data statistics. When the results show significant differences, they are marked with *p<0.05 and **p<0.01 respectively. *p<0.05 indicates a significant difference, and **p<0.01 indicates an extremely significant difference. If there are significant differences in the values of the various indicators in the test area, it means that the product has acne removal and oil control effects.

二、试验结果2. Test results

试验过程中,33例受试者入组,3例脱落(因个人原因自动退出),最终30例受试者符合方案,为有效案例。其中,女性14人,男性16人,平均年龄29.50±6.31岁;本研究以此人群做统计分析During the trial, 33 subjects were enrolled, 3 dropped out (automatically withdrew due to personal reasons), and finally 30 subjects met the protocol and were effective cases. Among them, there were 14 females and 16 males, with an average age of 29.50±6.31 years old; this study used this population for statistical analysis

1.安全性和不良反应评价1. Safety and adverse reaction evaluation

试验过程中,由专业皮肤科医生询问受试者在使用被测试产品过程中是否出现干燥、油腻、脱屑、发红、刺痛等症状,并观察记录背部是否有皮疹、红肿及脱屑的现象。而后根据表3的评分标准进行评分,得分记入事件报告表,并根据表4所列的标准进行关联性评估。在试验期间,没有受试者出现不良反应。 表3不良反应的评分标准
During the trial, professional dermatologists asked the subjects whether they experienced dryness, oiliness, scaling, redness, stinging and other symptoms while using the tested products, and observed and recorded whether there were rashes, redness, swelling and scaling on the back. Then the scores were scored according to the scoring criteria in Table 3, and the scores were recorded in the event report form, and the correlation was evaluated according to the criteria listed in Table 4. During the trial, no subjects experienced adverse reactions. Table 3 Scoring criteria for adverse reactions

表4被测试产品的评估
Table 4 Evaluation of the tested products

2.受试者主观评价2. Subjective evaluation

使用7级评分法(表5),对调查问卷中的关于产品的使用效果、温和度及使用满意度评分,受试者在试用产品后4周(D28)填写问卷。由此分析受试者对产品使用感受及功效的评价和满意度。The 7-point scoring method (Table 5) was used to score the product's use effect, mildness, and use satisfaction in the questionnaire. The subjects filled in the questionnaire 4 weeks after trying the product (D28). The subjects' evaluation and satisfaction with the product's use experience and efficacy were analyzed.

表5自评分值标准(7级评分法)
Table 5 Self-assessment scoring standards (7-level scoring method)

以下是根据受试者填写的问卷调查进行统计的图表,由表格和图中的数据得出结论。The following are charts based on the statistics of the questionnaires filled out by the subjects, and conclusions are drawn from the data in the tables and charts.

2.1产品肤感评价2.1 Product skin feel evaluation

表6产品肤感评价结果(n=30)
Table 6 Product skin feel evaluation results (n=30)

从产品肤感上来看,评分均值在6.1分以上,统计学上超过50%的受试者对产品肤感评分给予积极评价。其中在D28时,“使用后感觉背部皮肤不紧绷”均值为6.17分,有96.67%受试者认同;在D28时,“温和无刺激”均值为6.30分,有100.00%受试者认同。From the perspective of product skin feel, the average score was above 6.1 points, and statistically more than 50% of the subjects gave positive comments on the product skin feel. On D28, the average score of "the back skin does not feel tight after use" was 6.17 points, and 96.67% of the subjects agreed; on D28, the average score of "gentle and non-irritating" was 6.30 points, and 100.00% of the subjects agreed.

2.2产品的使用效果评价2.2 Product use effect evaluation

在使用4周(D28)时,受试者分别对产品的祛痘和控油效果进行评价。问卷数据统计如下所示:After 4 weeks of use (D28), the subjects evaluated the acne removal and oil control effects of the product. The questionnaire data statistics are as follows:

2.2.1祛痘效果 2.2.1 Acne-removing effect

表7产品祛痘效果评价结果(n=30)
Table 7 Evaluation results of product anti-acne effect (n=30)

从祛痘方面来看,使用28天(D28)后所有评分均值均在5.8分以上,统计学上超过50%的受试者对产品的祛痘效果评分给予积极评价。其中“使用后对痘痘区域红肿有舒缓的作用”和“使用后感觉皮肤变平滑了”在D28时均有93.33%受试者认同;“使用后感觉背部突起痘痘体积变小了”在D28时有96.67%受试者认同;“使用后感觉易长痘肤质有改善,痘痘数量减少了”在D28时有90.00%受试者认同。In terms of acne removal, after 28 days of use (D28), all average scores were above 5.8 points, and more than 50% of the subjects gave positive comments on the acne removal effect of the product. Among them, "it has a soothing effect on the redness and swelling of the acne area after use" and "the skin feels smoother after use" were both recognized by 93.33% of the subjects at D28; "the size of the raised acne on the back has become smaller after use" was recognized by 96.67% of the subjects at D28; "after use, the acne-prone skin quality has improved and the number of acne has decreased" was recognized by 90.00% of the subjects at D28.

2.2.2控油效果2.2.2 Oil control effect

表8产品控油效果评价结果(n=30)
Table 8 Evaluation results of product oil control effect (n=30)

从控油方面来看,使用28天(D28)后所有评分均值均在5.9分以上,统计学上超过50%的受试者对产品控油效果评分给予积极评价。其中“使用后感觉背部肌肤出油减少了”在D28时有100.00%受试者认同;“使用感觉后背部皮肤清爽”在D28时有90.00%受试者认同。 In terms of oil control, after 28 days of use (D28), all average scores were above 5.9 points, and more than 50% of the subjects gave positive comments on the oil control effect of the product. Among them, "I feel that the oiliness of the back skin has decreased after use" was recognized by 100.00% of the subjects at D28; "The back skin feels refreshed after use" was recognized by 90.00% of the subjects at D28.

2.3产品满意度评价2.3 Product Satisfaction Evaluation

表9产品满意度评价结果(n=30)
Table 9 Product satisfaction evaluation results (n=30)

从产品的整体满意度上来看,使用28天(D28)后统计学上超过50%的受试者对产品满意度调查结果给予积极评价。在D28时有93.33%受试者对产品表示满意。In terms of overall product satisfaction, after 28 days of use (D28), more than 50% of the subjects gave positive comments on the product satisfaction survey results. At D28, 93.33% of the subjects were satisfied with the product.

3.半定量评价(医生评估)3. Semi-quantitative evaluation (doctor evaluation)

皮肤科医生在受试者使用产品前后对受试者背部痤疮皮损情况进行评价。通过ISGA量表对受试者使用前后皮损症状改善进行评分,并计算皮损减少百分率。皮损减少百分率以公式1计算。通过比较使用前后的ISGA评分,可反映产品的祛痘功效。Dermatologists evaluated the acne lesions on the subjects' backs before and after using the product. The ISGA scale was used to score the improvement of the lesion symptoms before and after use, and the percentage of lesion reduction was calculated. The percentage of lesion reduction was calculated using Formula 1. By comparing the ISGA scores before and after use, the acne removal efficacy of the product can be reflected.

皮损减少百分率=(使用产品前ISGA评分-使用产品后ISGA评分)/使用产品前ISGA评分×100%Skin lesion reduction percentage = (ISGA score before using the product - ISGA score after using the product) / ISGA score before using the product × 100%

表10使用前后ISGA评分值比较(x±s,n=30)
Table 10 Comparison of ISGA scores before and after use (x±s, n=30)

评估结果如表10,图3所示(利用秩和检验分析对ISGA评分的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):The evaluation results are shown in Table 10 and Figure 3 (the baseline values and the values at the time of the follow-up visit were analyzed using the rank sum test. Significant differences are marked with *p<0.05, **p<0.01):

与使用前基线值(D0)相比,ISGA皮损评分在使用产品后呈现下降趋势,在使用28天(D28)后皮损减少百分率为36.51%,两者具有极显著性差异(p<0.01)。Compared with the baseline value before use (D0), the ISGA skin lesion score showed a downward trend after using the product. After 28 days of use (D28), the percentage of skin lesion reduction was 36.51%, and there was a very significant difference between the two (p<0.01).

4.痤疮平均体积分析4. Analysis of average volume of acne

Antera3D拍摄的痤疮区域图像经软件分析,可衡量不同时间点AOI选区中的痤疮平均体积变化。通过比较使用前后的痤疮平均体积变化,可反映产品的祛痘功效。The acne area images taken by Antera3D can be analyzed by software to measure the average volume change of acne in the AOI selected area at different time points. By comparing the average volume change of acne before and after use, the acne removal effect of the product can be reflected.

痤疮平均体积在不同回访时间点的数值与使用前基线值(D0)相比下降越多,痤疮皮损的改善效果越好,提示产品的祛痘效果越好。
痤疮平均体积下降率=(使用产品前痤疮平均体积-使用产品后痤疮平均体积)/
使用产品前痤疮平均体积×100%
The more the average volume of acne at different follow-up time points decreases compared with the baseline value before use (D0), the better the improvement effect of acne lesions is, indicating that the acne removal effect of the product is better.
Average acne volume reduction rate = (average acne volume before using the product - average acne volume after using the product) /
Average volume of acne before using the product × 100%

表11痤疮平均体积描述性统计(mm,n=30)
Table 11 Descriptive statistics of average volume of acne (mm, n = 30)

表12痤疮平均体积差异性分析(mm,x±s,n=30)
Table 12 Analysis of differences in average volume of acne (mm, x±s, n=30)

试验结果如表12,图4所示(利用配对t检验分析对痤疮平均体积的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):The test results are shown in Table 12 and Figure 4 (paired t-test was used to analyze the difference between the baseline value and the return visit time point value of the average volume of acne. Significant differences are marked with *p<0.05, **p<0.01):

与使用前基线值(D0)相比,痤疮平均体积在使用产品后呈现下降趋势,在使用28天(D28)后下降了74.17%,与基线值相比具有极显著性差异(p<0.01),使用产品后痤疮平均体积低于基线值。Compared with the baseline value before use (D0), the average volume of acne showed a downward trend after using the product, and decreased by 74.17% after 28 days of use (D28), which was significantly different from the baseline value (p<0.01). The average volume of acne after using the product was lower than the baseline value.

5.皮肤表面油脂含量分析5. Analysis of skin surface oil content

由Sebumeter SM815测得的皮肤表面皮脂含量数值越大,代表皮肤表面油脂含量越高。通过比较使用前后皮肤特定区域内的油脂含量变化,可反映产品的控油效果。皮脂量在不同回访时间点的数值与使用前基线值(D0)相比下降越多,测试区域内表面油脂含量的改善效果越好,提示产品的减少皮肤表面油脂含量的效果越好。The larger the value of the skin surface sebum content measured by Sebumeter SM815, the higher the skin surface oil content. By comparing the changes in oil content in a specific area of the skin before and after use, the oil control effect of the product can be reflected. The more the sebum content at different return visit time points decreases compared to the baseline value before use (D0), the better the improvement effect of the surface oil content in the test area, indicating that the product is more effective in reducing the oil content on the skin surface.

皮肤油脂含量下降率=(使用产品前油脂含量-使用产品后油脂含量)/使用产品前油脂含量×100%Skin oil content reduction rate = (oil content before using the product - oil content after using the product) / oil content before using the product × 100%

表13皮肤油脂含量描述性统计(μg/cm,n=30)
Table 13 Descriptive statistics of skin oil content (μg/cm, n=30)

表14皮肤油脂含量差异性分析(μg/cm,x±s,n=30)
Table 14 Analysis of differences in skin oil content (μg/cm, x±s, n=30)

试验结果如表14,图5所示(利用秩和检验分析对皮肤油脂含量的基线值和回访时间点数值进行差异性分析。显著性差异结果以*p<0.05,**p<0.01标注):The test results are shown in Table 14 and Figure 5 (the baseline values and the values at the time of the return visit were analyzed for differences using the rank sum test. Significant differences are marked with *p<0.05, **p<0.01):

与使用前基线值(DO)相比,皮肤表面油脂含量在使用产品后呈现下降趋势,在使用28天(D28)后下降了45.39%,与基线值相比具有极显著性差异(p<0.01),使用产品后皮肤表面油脂含量低于基线值。Compared with the baseline value before use (DO), the oil content on the skin surface showed a downward trend after using the product. After 28 days of use (D28), it decreased by 45.39%, which was significantly different from the baseline value (p<0.01). After using the product, the oil content on the skin surface was lower than the baseline value.

三、试验结论3. Test Conclusion

通过30例受试者多次使用由中山市长兴实业有限公司提供的柏缇控油祛痘沐浴露,进行化妆品祛痘、控油功效评价,结果表明:The acne removal and oil control effects of cosmetics were evaluated by using the Beti Oil Control Anti-acne Shower Gel provided by Zhongshan Changxing Industrial Co., Ltd. for multiple times on 30 subjects. The results showed that:

1、本试验未发生不良反应案例,试验产品具有较高安全性。1. No adverse reactions occurred in this trial, and the trial product has high safety.

2、受试者主观评价显示,使用28天(D28)后,评分均值均在5分以上,统计学上超过50%的受试者对产品肤感、祛痘、控油效果、温和度和满意度给予积极评价。在D28时,100%的受试者对“使用后感觉背部肌肤出油减少了”和“产品温和无刺激”表示认同;90%以上的受试者对“使用后对痘痘区域红肿有舒缓的作用”、“使用后感觉背部突起痘痘体积变小了”、“使用后感觉皮肤变平滑了”、“使用后感觉易长痘肤质有改善,痘痘数量减少了”、“使用感觉后背部皮肤清爽”和“使用后感觉背部皮肤不紧绷”表示认同。以及90%以上的受试者对产品满意度给予积极评价。2. Subjective evaluations by the subjects showed that after 28 days of use (D28), the mean scores were all above 5 points. Statistically, more than 50% of the subjects gave positive comments on the product's skin feel, acne removal, oil control effect, mildness and satisfaction. At D28, 100% of the subjects agreed with "I feel that the oiliness of the back skin has decreased after use" and "The product is mild and non-irritating"; more than 90% of the subjects agreed with "It has a soothing effect on the redness and swelling of the acne area after use", "I feel that the size of the raised acne on the back has become smaller after use", "I feel that the skin has become smoother after use", "I feel that the acne-prone skin has improved after use, and the number of acne has decreased", "I feel that the back skin feels refreshed after use" and "I feel that the back skin is not tight after use". More than 90% of the subjects gave positive comments on product satisfaction.

3、半定量评价(医生评价)显示,受试者使用产品后,ISGA评分在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。3. Semi-quantitative evaluation (doctor's evaluation) showed that after the subjects used the product, the ISGA score showed a downward trend at the follow-up time point D28, which was significantly different from the baseline value.

4、痤疮平均体积分析显示,受试者使用产品后,痤疮平均体积在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。4. Analysis of the average volume of acne showed that after the subjects used the product, the average volume of acne showed a downward trend at the follow-up time point D28, which was significantly different from the baseline value.

5、皮肤表面油脂含量分析显示,受试者使用产品后,皮肤表面油脂含量在回访时间点D28有下降趋势,与基线值相比具有极显著性差异。5. Analysis of the oil content on the skin surface showed that after the subjects used the product, the oil content on the skin surface showed a downward trend at the follow-up time point D28, which was significantly different from the baseline value.

综上所述,使用柏缇控油祛痘沐浴露28天后,能降低ISGA评分,改善背部整体痤疮皮损情况,降低背部痤疮平均体积,减少背部油脂含量,达到祛痘、控油的作用,并且在主观评价中统计学上超过50%的受试者对产品肤感、祛痘、控油效果、温和度和满意度给予积极评价,说明产品具有祛痘、控油功效。In summary, after using the Beauti Oil Control Anti-Acne Shower Gel for 28 days, the ISGA score can be reduced, the overall acne lesions on the back can be improved, the average volume of acne on the back can be reduced, the oil content on the back can be reduced, and the acne and oil control effects can be achieved. In the subjective evaluation, more than 50% of the subjects gave positive comments on the product's skin feel, acne removal, oil control effects, mildness and satisfaction, indicating that the product has acne removal and oil control effects.

尽管参照上面实施例详细说明了本发明,但是通过本公开对于本领域技术人员显而易见的是,而在不脱离所述的权利要求限定的本发明的原理及精神范围的情况下,可对本发明做出各种变化或修改。因此,本公开实施例的详细描述仅用来解释,而不是用来限制本发明,而是由权利要求的内容限定保护的范围。 Although the present invention is described in detail with reference to the above embodiments, it is obvious to those skilled in the art through this disclosure that various changes or modifications may be made to the present invention without departing from the principle and spirit of the present invention as defined by the claims. Therefore, the detailed description of the embodiments of the present disclosure is only used to explain, not to limit the present invention, but the scope of protection is limited by the content of the claims.

Claims (7)

一种控油祛痘沐浴露,其特征在于,按重量百分比计,包括以下原料成分:10-18%表面活性剂、0.3-1%增稠剂、0.5-2%氯化钠、0.05-0.2%pH调节剂、0.1-0.6%壬二酸、0.1-0.5%辛酰甘氨酸、0.1-0.6%植物除螨剂、0.2-2%苦参提取物、0.01-0.1%弗来歇氏柳叶菜提取物、0.1-0.5%糖类同分异构体混合物、0.1-0.5%抗坏血酸磷酸酯钠、0.5-1.5%银耳提取物、0.01-0.2%龙胆提取物、0.3-0.7%防腐剂以及余量水。An oil-controlling and acne-removing shower gel is characterized in that it comprises the following raw material components by weight percentage: 10-18% surfactant, 0.3-1% thickener, 0.5-2% sodium chloride, 0.05-0.2% pH regulator, 0.1-0.6% azelaic acid, 0.1-0.5% capryloyl glycine, 0.1-0.6% plant acaricide, 0.2-2% sophora flavescens extract, 0.01-0.1% epilobium fleischer extract, 0.1-0.5% carbohydrate isomer mixture, 0.1-0.5% sodium ascorbyl phosphate, 0.5-1.5% tremella extract, 0.01-0.2% gentian extract, 0.3-0.7% preservative and balance water. 根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述表面活性剂由月桂醇聚醚硫酸酯钠、甲基椰油酰基牛磺酸钠、椰油酰胺丙基甜菜碱、月桂酰两性基乙酸钠、椰油酰胺甲基MEA组成。The oil-control and acne-removing shower gel according to claim 1, characterized in that the surfactant is composed of sodium laureth sulfate, sodium methyl cocoyl taurate, cocamidopropyl betaine, sodium lauroamphoacetate, and cocamide methyl MEA. 根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述植物除螨剂由百里香提取物、迷迭香水、1,3-丙二醇、二氯苯甲醇、苯氧乙醇组成。The oil-control and acne-removing shower gel according to claim 1 is characterized in that the plant mite remover consists of thyme extract, rosemary water, 1,3-propylene glycol, dichlorobenzyl alcohol, and phenoxyethanol. 根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述增稠剂由生育酚和PEG-120甲基葡糖二油酸酯组成。The oil-control and acne-removing shower gel according to claim 1, characterized in that the thickener consists of tocopherol and PEG-120 methyl glucose dioleate. 根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述糖类同分异构体混合物包括有糖类同分异构体、水、柠檬酸以及柠檬酸钠。The oil-controlling and anti-acne shower gel according to claim 1 is characterized in that the carbohydrate isomer mixture comprises carbohydrate isomers, water, citric acid and sodium citrate. 根据权利要求1所述的一种控油祛痘沐浴露,其特征在于,所述pH调节剂为氢氧化钾。The oil-controlling and anti-acne shower gel according to claim 1, characterized in that the pH regulator is potassium hydroxide. 制备如权利要求1所述的一种控油祛痘沐浴露,其特征在于,制备方法包括如下步骤:The preparation method of the oil-controlling and acne-removing shower gel according to claim 1 comprises the following steps: S1:将水分成两部分,将第一部分水投入生产锅中,升温至80-85℃,加入表面活性剂搅拌至溶解均匀;S1: Divide the water into two parts, put the first part of water into the production pot, heat it to 80-85℃, add surfactant and stir until it is evenly dissolved; S2:在生产锅中继续加入增稠剂、壬二酸、辛酰甘氨酸搅拌至溶解均匀;S2: Continue to add thickener, azelaic acid, and capryloyl glycine into the production pot and stir until they are evenly dissolved; S3:降温至45℃,加入植物除螨剂、苦参提取物、pH调节剂、糖类同分异构体混合物、抗坏血酸磷酸酯钠、银耳提取物、龙胆提取物、弗来歇氏柳叶菜提取物搅拌溶解均匀;S3: Cool down to 45°C, add plant acaricide, Sophora flavescens extract, pH adjuster, sugar isomer mixture, sodium ascorbyl phosphate, Tremella fuciformis extract, Gentiana scabra extract, and Epilobium freiherb extract, and stir to dissolve evenly; S4:氯化钠先用第二部分水溶解完全后投入生产锅中搅拌均匀,调节PH以及粘度、出料。 S4: Sodium chloride is first completely dissolved with the second part of water and then put into the production pot and stirred evenly, and the pH and viscosity are adjusted and the material is discharged.
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