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CN117695236A - Ascorbyl palmitate tablet and its production process - Google Patents

Ascorbyl palmitate tablet and its production process Download PDF

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Publication number
CN117695236A
CN117695236A CN202311719847.0A CN202311719847A CN117695236A CN 117695236 A CN117695236 A CN 117695236A CN 202311719847 A CN202311719847 A CN 202311719847A CN 117695236 A CN117695236 A CN 117695236A
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CN
China
Prior art keywords
ascorbyl palmitate
parts
tablet
tablets
ethanol
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
Application number
CN202311719847.0A
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Chinese (zh)
Inventor
王建业
张立明
孟祥安
孙海南
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.)
Shandong Xinquan Pharmaceutical Co ltd
Original Assignee
Shandong Xinquan Pharmaceutical Co ltd
Priority date (The priority date 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 date listed.)
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Publication date
Application filed by Shandong Xinquan Pharmaceutical Co ltd filed Critical Shandong Xinquan Pharmaceutical Co ltd
Priority to CN202311719847.0A priority Critical patent/CN117695236A/en
Publication of CN117695236A publication Critical patent/CN117695236A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/06Free radical scavengers or antioxidants
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses an ascorbyl palmitate tablet and a production process thereof, belonging to the technical field of pharmaceutical preparations. The technical proposal is as follows: the coating comprises the following components in parts by weight: 12-16 parts of ascorbyl palmitate, 1-3 parts of dextrin, 1-3 parts of lactose, 0.5-2 parts of 50% ethanol, 0.02-0.04 part of tartaric acid and 0.03-0.08 part of magnesium stearate. The dissolution rate and bioavailability of the ascorbyl palmitate tablets prepared by the invention are much better than those of other dosage forms prepared by vitamin C; since ascorbyl palmitate itself has a good oxidation resistance, the quality of the ascorbyl palmitate tablets is very stable, and the effect of light, air, moisture and the like on the ascorbyl palmitate tablets in production or in transportation is small. Ascorbyl palmitate tablets are capable of providing lipid-soluble protection against oxidative free radicals to areas of tissue not reached by ascorbic acid.

Description

Ascorbyl palmitate tablet and its production process
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to an ascorbyl palmitate tablet and a production process thereof.
Background
Ascorbyl Palmitate (AP) is white or yellowish powdery crystal esterified by ascorbic acid (vitamin C) and palmitic acid (C16:0), has slight orange smell, has a melting point of 107-117 ℃, is extremely insoluble in water and is easily dissolved in ethanol, diethyl ether and animal and vegetable oil, and has extremely stable properties in a concentrated or crystalline state, and is commonly used as an oil antioxidant.
Vitamin C, also known as ascorbic acid, is used in foods as an antioxidant and a nutritional supplement, but ascorbic acid is water-soluble and is poorly effective as an antioxidant in oils and fats. The ascorbyl palmitate which is a derivative produced by esterifying water-soluble ascorbic acid and palmitoyl is soluble in grease, and has not only all physiological functions of vitamin C, but also many characteristics which are not possessed by vitamin C. Such as ascorbyl palmitate, can penetrate biological barriers to reach tissues and organs not accessible to vitamin C, and are good carriers for delivery of vitamin C to nerve tissues. The ascorbyl palmitate can protect lipid parts such as cell membranes from being oxidized, has the nutrition and health care functions of scavenging free radicals, resisting oxidation, resisting aging and the like, and is far superior to vitamin C. Ascorbyl palmitate has the following structural formula:
therefore, there is a need to develop an ascorbyl palmitate tablet to solve the problem that the existing vitamin C tablet is not fat soluble.
Disclosure of Invention
The invention aims to solve the technical problems that: overcomes the defects of the prior art, and provides an ascorbyl palmitate tablet and a production process thereof, wherein the dissolution and bioavailability of the prepared ascorbyl palmitate tablet are much better than those of other dosage forms prepared from vitamin C.
The technical scheme of the invention is as follows:
in one aspect, the invention provides an ascorbyl palmitate tablet, which comprises the following components in parts by weight: 12-16 parts of ascorbyl palmitate, 1-3 parts of dextrin, 1-3 parts of lactose, 0.5-2 parts of 50% ethanol, 0.02-0.04 part of tartaric acid and 0.03-0.08 part of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight: 12 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight: 13 parts of ascorbyl palmitate, 2 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate.
Preferably, the composition comprises the following components in parts by weight: 16 parts of ascorbyl palmitate, 3 parts of dextrin, 2 parts of lactose, 1 part of 50% ethanol, 0.04 part of tartaric acid and 0.08 part of magnesium stearate.
In another aspect, the invention provides a process for producing the ascorbyl palmitate tablets, which comprises the following steps:
s1, weighing all the components;
s2, uniformly mixing the components to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
Compared with the prior art, the invention has the following beneficial effects:
1. the dissolution rate and bioavailability of the ascorbyl palmitate tablet prepared by the invention are much better than those of other formulations prepared by vitamin C. Since ascorbyl palmitate itself has a good oxidation resistance, the quality of the ascorbyl palmitate tablets is very stable, and the effect of light, air, moisture and the like on the ascorbyl palmitate tablets in production or in transportation is small. Ascorbyl palmitate tablets are capable of providing lipid-soluble protection against oxidative free radicals to areas of tissue not reached by ascorbic acid.
2. The ascorbyl palmitate tablet prepared by the invention not only has all physiological functions of vitamin C, but also has the characteristics that many vitamin C does not have, such as that the ascorbyl palmitate can penetrate biological barriers, so that tissues and organs which cannot be reached by the vitamin C are reached, the ascorbyl palmitate tablet is a good carrier for conveying the vitamin C to nerve tissues, the absorption of components is promoted, and the immunity of a human body is enhanced.
Detailed Description
In order to make the technical solution of the present invention better understood by those skilled in the art, the technical solution of the present invention will be clearly and completely described in the following in conjunction with the embodiments of the present invention.
Example 1
The production process of the ascorbyl palmitate tablet of the embodiment comprises the following steps:
s1, respectively weighing 12 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate according to parts by weight for subsequent use;
s2, uniformly mixing 12 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
Example 2
The production process of the ascorbyl palmitate tablet of the embodiment comprises the following steps:
s1, respectively weighing 13 parts of ascorbyl palmitate, 2 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate according to parts by weight for subsequent use;
s2, uniformly mixing 13 parts of ascorbyl palmitate, 2 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
Example 3
The production process of the ascorbyl palmitate tablet of the embodiment comprises the following steps:
s1, respectively weighing 16 parts of ascorbyl palmitate, 3 parts of dextrin, 2 parts of lactose, 1 part of 50% ethanol, 0.04 part of tartaric acid and 0.08 part of magnesium stearate according to parts by weight for subsequent use;
s2, uniformly mixing 16 parts of ascorbyl palmitate, 3 parts of dextrin, 2 parts of lactose, 1 part of 50% ethanol, 0.04 part of tartaric acid and 0.08 part of magnesium stearate to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
Comparative example 1
The production process of the ascorbyl palmitate tablet of the comparative example comprises the following steps:
s1, respectively weighing 20 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of calcium hydrophosphate, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate according to parts by weight for subsequent use;
s2, uniformly mixing 20 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of calcium hydrophosphate, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate to obtain a mixed raw material;
s3, tabletting the mixed raw materials by a tablet press, wherein the tablet is not easy to form.
Comparative example 2
The production process of the ascorbyl palmitate tablet of the comparative example comprises the following steps:
s1, respectively weighing 1 part of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of calcium hydrophosphate, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate according to parts by weight for later use;
s2, uniformly mixing 1 part of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of calcium hydrophosphate, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
However, the tablet of comparative example 2 had too little ascorbyl palmitate to achieve the effect.

Claims (5)

1. The ascorbyl palmitate tablet is characterized by comprising the following components in parts by weight: 12-16 parts of ascorbyl palmitate, 1-3 parts of dextrin, 1-3 parts of lactose, 0.5-2 parts of 50% ethanol, 0.02-0.04 part of tartaric acid and 0.03-0.08 part of magnesium stearate.
2. The ascorbyl palmitate tablet according to claim 1, comprising the following components in parts by weight: 12 parts of ascorbyl palmitate, 1.5 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate.
3. The ascorbyl palmitate tablet according to claim 1, comprising the following components in parts by weight: 13 parts of ascorbyl palmitate, 2 parts of dextrin, 1 part of lactose, 1 part of 50% ethanol, 0.025 part of tartaric acid and 0.06 part of magnesium stearate.
4. The ascorbyl palmitate tablet according to claim 1, comprising the following components in parts by weight: 16 parts of ascorbyl palmitate, 3 parts of dextrin, 2 parts of lactose, 1 part of 50% ethanol, 0.04 part of tartaric acid and 0.08 part of magnesium stearate.
5. The process for producing ascorbyl palmitate tablets according to any of claims 1-4, comprising the steps of:
s1, weighing all the components;
s2, uniformly mixing the components to obtain a mixed raw material;
and S3, tabletting the mixed raw materials by a tablet press to obtain the ascorbyl palmitate tablets.
CN202311719847.0A 2023-12-14 2023-12-14 Ascorbyl palmitate tablet and its production process Pending CN117695236A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202311719847.0A CN117695236A (en) 2023-12-14 2023-12-14 Ascorbyl palmitate tablet and its production process

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Application Number Priority Date Filing Date Title
CN202311719847.0A CN117695236A (en) 2023-12-14 2023-12-14 Ascorbyl palmitate tablet and its production process

Publications (1)

Publication Number Publication Date
CN117695236A true CN117695236A (en) 2024-03-15

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120514678A (en) * 2025-07-23 2025-08-22 烟台泰燊生物技术有限公司 A selenized carrageenan vitamin complex and its preparation method and application

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120514678A (en) * 2025-07-23 2025-08-22 烟台泰燊生物技术有限公司 A selenized carrageenan vitamin complex and its preparation method and application

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