WO2014056413A1 - Topical kidney and fertility reinforcing patch - Google Patents

Description

 Solid kidney breeding external application medicine patch

 [0001] The present invention relates to a medicament for treating infertility, and in particular to a medicament for treating infertility using Chinese herbal medicine as a raw material.

Background technique

 [0002] Infertility is one of the problems that plagues couples of childbearing age in modern life. The degree of infertility in modern male women has risen to an unprecedented level, and it has become a modern disease. There are many reasons for infertility in men and women, such as sexually transmitted diseases, reproductive immunity and other disease factors, personal psychological factors; environmental and industrial poisons increase, damage to multiple organs of the human body, thus affecting the fertility of men and women, in addition, life The rhythm is accelerating, the pressure of life is increasing, affecting people's emotions and endocrine, which can cause infertility when people are in high intensity for a long time. If a couple is cohabiting for one year without getting pregnant, they should be given sufficient attention and necessary and reasonable counseling and examination should be conducted to understand the fertility of both men and women as soon as possible.

 [0003] The Chinese medicine has a long history of thousands of years, and Chinese medicine has accumulated rich experience in treating infertility. Chinese medicine believes that the infertility of women is based on kidney deficiency, or the deficiency of the body, lack of endowment; or inadvertent sexual intercourse, damage to the kidney essence; or prolonged disease and prolific kidney injury. The spleen is the foundation of the day after tomorrow, the source of blood and biochemistry, and the spleen is biochemically passive and infertile. Women with the liver as the congenital, liver and blood, the main venting, liver qi stagnation is also a common pathogenesis of female infertility. On the rule of law, the five internal organs, ventilate blood, regulate the seeds, and gestation. There are three major factors in female infertility caused by Chinese medicine: First, the palace is cold and kidney deficiency: Chinese medicine says that the woman is yin, the uterus is susceptible to cold, the yin is cold, and the kidney is weak, the kidney is insufficient, and the rush is guilty. No period, can not be pregnant; Second, liver spleen and dampness: If the emotion is not smooth, liver qi stagnation, spleen deficiency, wet, then blood flow is not smooth, blood and blood are not, phlegm and dampness, menstrual disorders, resulting in infertility; Qi stagnation: Women are blood-based, qi-shun, blood and gas are interdependent and affect each other. Qi and blood are not harmonious, qi stagnation and blood stasis, all diseases are born, infertility is thus formed.

Summary of the invention

 [0004] The object of the present invention is to provide a traditional Chinese medicine external application patch for solidifying the kidney, regulating the liver and strengthening the spleen, and promoting pregnancy. The traditional Chinese medicine has less toxic effects and can be pregnant during the treatment.

 [0005] The technology of the present invention is realized as follows: A solid kidney breeding medicine, an external patch composed of the following weight ratio raw materials:

7-8 parts of dodder, 4-6 parts, 4 to 4 mulberry, 2-4 parts of psoralen,

2-4 portions of dog ridges, 2-3 parts of medlar, 1-3 parts of white peony, 2-4 parts of rehmannia glutinosa.

2-4 parts of Hawthorn, 2-3 parts of Atractylodes, 3-4 parts of Astragalus, 2-3 parts of Codonopsis 1-3 parts of Chinese yam, 1-2 parts of bamboo ru, 1-2 parts of sage, 1-2 parts of Amomum villosum L.

Woody 1-2 parts, Eclipta 1-2 parts, palm charcoal 1-2 parts, Ai Ye charcoal 1-2 parts,

Astragalus 1-2 servings, Uncaria 1-2 servings, licorice 1-2 servings.

[0006] The fertility medicine of the present invention, the optimum ratio of the raw materials of the raw materials is:

7.5 parts of dodder, 5 parts, 3 parts of mulberry, 3 parts of psoralen,

3 parts of dog ridge, 2.5 parts of medlar, 2 parts of white peony, 3 parts of rehmannia glutinosa,

Hawthorn 3 copies Atractylodes 2.5, Astragalus 3.5, Codonopsis 2.5,

2 yam, 1.5 parts of bamboo ru, 1.5 parts of sage, 1 part of Amomum villosum,

1 part of woody, 1.5 parts of Eclipta, 1.5 parts of palm charcoal, 1 part of Ai Ye charcoal,

1.5 parts of Astragalus, 1 part of Uncaria, 1.5 parts of licorice.

[0007] The invention has the effects of solidifying the kidney, regulating the liver and strengthening the spleen, and has significant effects on infertility and fetal leakage.

detailed description

 The invention is further described in detail below.

 [0009] Traditional Chinese medicine believes that the theory of "congenital nature", "the kidney is sealed, the dirty of Tibetan essence" and "the essence of kidney accumulation", the strength of human endowment, the quality of health, the coefficient of life are Determined by the kidneys. Kidney essence, the main human reproductive development, whether it is the essence of reproduction or the vitality of life activities, are all from the kidney. Insufficient function of the kidney essence, not only developmental delay, soft bones, tooth loss, fetal leakage, fetal movement, slippery, infertility, less menstruation, late menstruation or pre-menstrual, amenorrhea, uterine bleeding, dysmenorrhea , with the following symptoms before and after menstruation, all kinds of symptoms before and after menopause, impotence and premature ejaculation, etc., but also lead to premature aging of the body, shortening the life course of the human; the kidney is also the main water, regulating the metabolism of human body water, Balance, restraint, management and other functions, the dysfunction, there will be edema, palpitations and other symptoms; the function of the kidney in the motherland medicine includes not only the concept of modern anatomy, but also far beyond this range, The mastery of the power is mastered by the kidneys:

[0010] According to the above TCM theory, the drug is used, and 23 kinds of traditional Chinese medicines with warming kidney qi, nourishing liver and kidney, spleen and spleen, qi and vomiting, and hemostasis are selected, refined into powder, coated with meridian points, and finally Gushen, spleen, liver, qi, fetus, vomiting.

 [0011] (1) The kidney is the innate foundation, the root of vitality, the main essence, is the driving force for growth and development. Fangzhong scorpion, sequelae, mulberry parasitic three have liver and kidney, Yishenxue, blood circulation, Antaiyuangong; psoralen, dog ridge kidney to help Yang, liver and kidney, strong waist and knee. The combination of five medicines will help the Yin and Guyang, and the strength of the fetus.

[0012] (2) liver blood, kidney essence, liver and kidney homologous, blood can be alternate; liver main venting, liver gas regulation, liver blood is sufficient, not only can breed kidney essence, but also make the air machine smooth, Breathing with qi and blood, coordinating with the kidneys, complementing the encapsulation of the kidneys, balancing and maintaining the normal function of the human reproductive system. The combination of Fangzhongyu, Baiji and Hawthorn can nourish the liver and kidney. Nourishing blood and softening the liver, relieve pain and relieve the pain.

 [0013] (3) The spleen is transported, and the spleen is absorbed and transferred. The water valley is constantly replenishing the congenital essence, so that the kidney essence is kept full, which is conducive to the generation of reproductive essence. At the same time, the water and blood of the water valley can make the blood flow sufficient, which helps the woman to develop normal reproductive ability. Fangzhongbaizhu, Astragalus, Dangshen, and Yam are combined to play the role of Buzhongyiqi and spleen and lung. Among them, Atractylodes has the effect of having a fetus.

 [0014] (4) If the woman's stomach is weak or the liver is hot and gas, after the pregnancy, the pulse of the pulse is reversed, it is easy to cause stomach loss and fall, or induce liver heat and fire, and there is a pregnancy resistance, fetal gas resistance Equivalent. Fangzhong Zhuru and Su Ye combined with qi and qi, clearing away heat and vomiting; Amomum vulgaris L. and fragrant spleen and spleen appetite; In addition, Amomum has the power to regulate qi and fetus.

 [0015] (5) Eclipta prostrata, ramie root, and astragalus three drugs cool blood to stop bleeding, clearing heat and fetus; Ai Ye charcoal temperature manager, stop bleeding and fetus; palm charcoal convergence hemostasis; five medicines combined, with cooling blood to stop bleeding, The effect of qi and fetus. Licorice reconcile the medicinal taste.

[0016] The formula of the invention has a total of solid kidney and fetus, liver and spleen, nourishing blood and stopping bleeding, and the effect of qi and vomiting is used for treating infertility after treatment; pregnant vaginal irregular vaginal bleeding (fetal leakage) .

 [0017] Aiye charcoal in this formula: Ai is a perennial herb, which is the raw leaves after drying, and the vinegar is made into charcoal.

Palm charcoal: The palm petiole has a long slat shape with one end that is narrow and thick, and the other end that is wider and thiner and of different sizes. Main ingredients: Containing tannin, cellulose, calcined into charcoal, so get. Mainly used for vomiting blood, blood stasis, blood in the stool, uterine bleeding and other evidence.

[0018] psoralen: psoralen is a dry and mature fruit of leguminous psoralen. Fruits and seeds contain coumarins, flavonoids, monoterpenoids, volatile oils, soaps, polysaccharides, lipids, etc. .

 [0019] Dog ridges: There are two types of dog ridges, one is black as a dog's spine, and the other is a golden hair such as a dog. This product is the dried rhizome of the golden-haired dog ridge of the genus Fernaceae. For fine roots, petiole and golden pilose for the original medicinal herbs, dip for one day, steam on the basket, and then slice and dry for medicine.

 [0020] The dosage form of the present invention is an external application patch.

 [0021] The preparation method adopted by the invention refines and purifies the components of the raw material medicine, and the system conforms to the Chinese Pharmacopoeia regulations, and the prepared medicine has no side effects and has high curative effect.

 [0022] The external application patch of the present invention is inspected by the Shantou City Drug Inspection Institute, and the results meet the requirements.

 [0023] The clinical use of the invention shows that it has the functions and effects of tonifying kidney and filling essence, promoting blood circulation and nourishing blood, adapting to amenorrhea, irregular menstruation, uterine bleeding, and syndrome of kidney deficiency and qi deficiency.

[0024] In order to prove the curative effect of the medicament of the present invention, the present invention is gradually extended to all sub-health populations requiring fertility for clinical trials in the infertility patients of the hospital in Shantou City, Guangdong Province. [0025] The clinical treatment test is carried out, and the invention drug is applied to the acupuncture point, and the treatment is performed every three days, and the treatment is re-evaluated after one course of treatment. Efficacy criteria:

 (1) Cure: Smooth pregnancy, symptoms disappear; or physical fitness assessment conversion score <30 points, and peace conversion conversion score of 80 points.

[0026] (2) markedly effective: smooth pregnancy, physical fitness assessment: 30 points conversion score <40 points, 60 points of flat quality conversion points < 80 points; or although not pregnant, but the symptoms disappeared, physical fitness conversion score <30 points, peace The quality conversion is divided into 80 points.

[0027] (3) Effective: Symptoms improve or disappear, physical fitness assessment: 30 points conversion score <40 points, peace conversion score 60 points or physical fitness evaluation conversion points <30 points, peace and quality conversion points 60 points.

 [0028] (4) Invalid: Failure to successfully conceive, biased physical symptoms still exist, symptoms still exist or physical fitness assessment score > 40 points.

 [0029] Since June 2011, a total of 1,200 patients have been evaluated, including 1021 cases, 72 cases, 49 cases, and 58 cases.

 [0030] Comparative observation: The results of the study on functional infertility using the combination of solid kidney breeding and ecological therapy combined with syndrome differentiation showed statistical significance compared with the simple treatment of syndrome differentiation (P<0.01).

 [0031] As can be seen from the above clinical trial results, the medicament of the present invention has good curative effect, and is not only used alone, but also can be used in combination with other Chinese medicines to produce better effects. The invention is easy to absorb and is easy for the patient to accept.

[0032] This embodiment will be further described below in conjunction with the embodiments.

Embodiment 1

Take: 5 g of dodder, 50 g of stalk, 30 g of mulberry, 30 g of psoralen, 30 g of dog ridge, 25 g of medlar, 20 g of white peony, 30 g of rehmannia, 30 g of Hawthorn, 25 g of Atractylodes, 35 g of Astragalus, 25 g of Radix Ginseng, 20 g of Chinese yam, bamboo Ru 15g, Su Ye 15g, Amomum 10g, Muxiang 10g, Eclipta 15g, Palm Charcoal 15g, Ai Ye Charcoal 10g, Astragalus 15g, Uncaria 10g, Licorice 15g processed into powder powder, 150 mesh sieve, made Powder powder spare;

Preparation of application: The application consists of a heating element and a powder of the above steps. The heating element comprises: activated carbon, iron powder, sodium chloride, acetic acid.

 [0034] The activated carbon is first ground into a coarse powder, uniformly mixed with the powder and the salt, and then placed in a bag. Iron powder: Active Carbon: Sodium chloride: The ratio of powder is by mass ratio = 15 : 3: 3: 4.

 [0035] taking 250g of mixed activated carbon, iron powder, sodium chloride powder, adding rice vinegar 15g (0.3mol / L, not excessive) ratio, mix and mix, so that the powder maintains a certain humidity, into the bag, Serve Apply. After the application of fever, apply acupuncture points, that is, Guanyuan or Sanyinjiao (this point is used for pregnancy, the temperature must be suitable), and take off after the medicine is cool. When using it again, use the previous method to mix vinegar, which can be used several times. Apply Guanyuan or Sanyinjiao 1 to 3 times a day.

Embodiment 2 Take: 5 g of dodder, 50 g of stalk, 30 g of mulberry, 30 g of psoralen, 30 g of dog ridge, 25 g of medlar, 20 g of white peony, 30 g of rehmannia, 30 g of Hawthorn, 25 g of Atractylodes, 35 g of Astragalus, 25 g of Radix Ginseng, 20 g of Chinese yam, bamboo Ru 15g, Su Ye 15g, Amomum 10g, Muxiang 10g, Eclipta 15g, Palm Charcoal 15g, Ai Ye Charcoal 10g, Astragalus 15g, Uncaria 10g, Licorice 15g, crushed, sieved with 20 mesh sieve, removed more than In the 20-part part, the part below 20 mesh is reserved.

 [0037] Preparation of Applicator: The application consists of a heating element and a powder of the above steps, and the heating element comprises: ferric chloride, iron powder, and hydrochloric acid.

 [0038] The iron powder is sieved with a mesh of 20 mesh, and the portion larger than 20 mesh is removed, and the portion below 20 mesh is mixed, and the iron powder and the powder are mixed in proportion and stirred uniformly. Then add the ferric chloride solution, stir it evenly, then place it to cool and pack it. Iron powder: Ferric chloride: The proportion of powder is: 30: 9= 10, the temperature of the heating system can last for 8 hours.

[0039] When applied, the application is applied to an appropriate temperature, and then applied to Guanyuan or Sanyinjiao (the point is used for pregnancy, the temperature must be suitable)

 [0040] The present embodiment 2, 3 is based on the principle of kelification, adopts a heat conduction administration method, and has the triple effect of far-infrared physiotherapy, hyperthermia and medicine, and the external application of solid kidney and fetus has a smooth meridian effect. Self-heating, heat to the medicine, immediate penetration, rapid pain relief. When used, the drug sticks self-heating, and the volatile components contained in it constantly ooze out from the drug patch. A "medical mist" with a certain temperature and humidity is formed at Guanyuan or Sanyinjiao. Under the action of heat, the acupuncture points are directly penetrated. Meridians, promote drug absorption.

[0041] The mechanism of heat generation of the two systems is due to the formation of micro-batteries, so that a redox reaction occurs, and a large amount of heat is generated. By controlling the ratio of different components and the speed of air entering, the length of the control temperature and the length of the constant temperature can be achieved. This kind of heating system packaging is very important, and the temperature and duration of the heating temperature can be completely controlled by the packaging bag. The package is divided into two layers, inner and outer. The inner bag is directly used for packaging the heat generating agent, and a small hole of a certain size and quantity is formed on the surface to control the speed of the air entering, thereby controlling the progress of the reaction and achieving the purpose of controlling the heating temperature. The outer bag is a plastic bag for isolating the air, and the sealing property is particularly good.

 [0042] When the external application of solid kidney breeding is used, it will self-heat when exposed to air. The average temperature of the paste is constant at 53 °C, and has a far-infrared radiance corresponding to the wavelength of human body radiation absorption. After contact with the human body, the far-infrared radiation is radiated. In the human body, it generates resonance absorption and penetrates the cortical tissue, which improves the human microcirculation, activates human cells, improves the activity of biological macromolecules such as proteins, contributes to the growth of biological enzymes, strengthens the regeneration function of human tissues, and promotes metabolism. Enhances immune function, regulates autonomic disorders; improves microcirculation through hyperthermia, promotes blood circulation, prevents tissue hypoxia, relieves pain in local organs and tissues, simultaneously expands blood vessels, accelerates blood flow, improves blood circulation, and promotes drug penetration Skin absorption.

[0043] When using the solid kidney parenteral application, the first confirmation is whether the external application of Guanyuan or Sanyinjiao is not applied to the Guanyuan point, and the pregnant is applied to the Sanyinjiao acupoint. After the sealed bag is opened, the kidney will be fixed. The extra-fetal application is gently shaken to self-heat and then attached to the acupuncture point. Embodiment 3

Take: 5 g of dodder, 50 g of stalk, 30 g of mulberry, 30 g of psoralen, 30 g of dog ridge, 25 g of medlar, 20 g of white peony, 30 g of rehmannia, 30 g of Hawthorn, 25 g of Atractylodes, 35 g of Astragalus, 25 g of Radix Ginseng, 20 g of Chinese yam, bamboo Ru 15g, Su Ye 15g, Amomum 10g, Muxiang 10g, Eclipta 15g, Palm Charcoal 15g, Ai Ye Charcoal 10g, Astragalus 15g, Uncaria 10g, Licorice 15g processed into powdered powder, 165g powder was made into external coating Stick, use the rice wine soaked in the medicine bag, steam for 20 minutes, and then cool to 45 degrees, then apply acupuncture points. Those who are not pregnant are applied to the Guanyuan point. They are pregnant and applied to the Sanyinjiao acupoint. Cover the towel to make the medicine penetrate. Direct to the meridian viscera; 1 pack per day, 3 times per pack, 30 minutes each time.

[0045] In this embodiment: hot application is to place a hot object in a diseased part of the body, or a specific position of the body (such as acupuncture points), to expand local capillaries, accelerate blood circulation, local muscles Relaxation, a treatment for anti-inflammatory, swelling, cold and dampness, pain relief, and fatigue relief. The hot compress can accelerate the metabolism of the body, and the absorption of exudates in the tissue is also accelerated, which promotes the healing of inflammation. After the heat is applied, the waste in the muscles is also accelerated to reduce fatigue, stiffness and spasm, making the muscles slack and comfortable. Heat also increases the secretion of sweat glands, promotes heat dissipation, and makes the skin moist, warm and flushed. Moreover, due to the reflection effect, the surface heating can also affect the visceral activity. For example, heating the abdomen can stimulate the peristalsis of the intestine and adjust the gastrointestinal function. Traditional Chinese medicine, hot pack method, hot liquid method, etc., due to heat, moisture and skin contact, can improve microcirculation, promote blood circulation, prevent tissue hypoxia, relieve local organ and tissue pain, and at the same time expand blood vessels Accelerate blood flow, so that the active ingredients of the drug can quickly penetrate into the tissue, promote the transdermal absorption of the drug, and thus play the role of skin administration and treatment.

[0046] Case introduction:

Huang X Fan, female, 29 years old, Shantou (living in Guangzhou), visited in April 2012, physique assessment: peace and quality: 63.5 points, qi deficiency: 21.4 points, yang deficiency: 10.7 points, yin deficiency: 7.6 Points, phlegm: 50 points, damp heat: 40.9 points, blood sputum: 22.8 points, gas stagnation: 50.6 points, special enamel: 0 points. It is rated as phlegm, moist heat, and qi stagnation. Give ecological therapy to the kidney and fetus, once every three days, seven times for a course of treatment. After two courses of treatment, the patient was reassessed. The results showed: peace and quality: 80.5 points, qi deficiency quality: 15.2 points, yang deficiency quality: 10.7 points, yin deficiency quality: 7.6 points, phlegm-dampness quality: 21.6 points, moist heat quality: 28.4 points, Blood sputum: 7.6 points, qi stagnation: 22.5 points, special enamel: 0 points. The pregnancy was diagnosed in September 2012 and cured.

Claims

1. A solid kidney parenting external application patch consisting of the following weight ratio raw materials: 7-8 parts of dodder, 4-6 parts, 4 to 4 mulberry, 2-4 parts of psoralen, 2-4 portions of dog ridges, 2-3 parts of medlar, 1-3 parts of white peony, 2-4 parts of rehmannia glutinosa. Hawthorn 2-4 parts Atractylodes 2-3, Astragalus 3-4, Codonopsis 2-3, 1-3 copies of yam, 1-2 parts of bamboo ru, 1-2 parts of sage, 1-2 parts of Amomum villosum L. Woody 1-2 parts, Eclipta 1-2 parts, palm charcoal 1-2 parts, Ai Ye charcoal 1-2 parts, Astragalus 1-2 servings, Uncaria 1-2 servings, licorice 1-2 servings.  2 . The solid kidney parenting external application patch according to claim 1 , wherein the raw material ratio composition is: 7.5 parts of dodder, 5 parts of continuous, 3 parts of mulberry, 3 parts of psoralen, 3 parts of dog ridge, 2.5 parts of medlar, 2 parts of white peony, 3 parts of rehmannia glutinosa, 3 copies of Hawthorn, 2.5 copies of Atractylodes, 3.5 copies of Astragalus, 2.5 copies of Codonopsis. 2 yam, 1.5 parts of bamboo ru, 1.5 parts of sage, 1 part of Amomum villosum, 1 part of woody, 1.5 parts of Eclipta, 1.5 parts of palm charcoal, 1 part of Ai Ye charcoal, 1.5 parts of Astragalus, 1 part of Uncaria, 1.5 parts of licorice.