WO2004089388A1

WO2004089388A1 - The ready-prepared chinese medicine for treatment of hair loss and process of manufacturing thereof

Info

Publication number: WO2004089388A1
Application number: PCT/CN2003/000257
Authority: WO
Inventors: Hai Yin; Yanming Zeng; Jilin Sun
Original assignee: Sichuan Dikang Industry Holdings Group Co., Ltd.
Priority date: 2003-04-11
Filing date: 2003-04-11
Publication date: 2004-10-21
Also published as: CN1720057A; AU2003236119A1

Abstract

The invention discloses the ready-prepared Chinese medicine for treatment of hair loss, which comprises the following Chinese materia medica materials: Polygoni Multiflori Radix, Biota seed, Rehmanniae Radix Exsiccata seu Recens, Angelicae Sinensis Radix, Glycyrrhizae Radix, Ginseng Radix, Corni Fructus, Dioscoreae Rhizoma, Epimedii Herba, Eucommiae Cortex. Ginseng Radix and Dioscoreae Rhizoma were ground into fine powder; Angelicae Sinensis Radix was triturated into coarse powder, volatile oil was extracted, and volatile oil was encapsulated with for use; then dregs of Angelicae Sinensis Radix was soaked for 4-6 hours and decocted for 2-4 times with Polygoni Multiflori Radix, Biota seed, Rehmanniae Radix Exsiccata seu Recens, Glycyrrhizae Radix, Corni Fructus, Epimedii Herba, and Eucommiae Cortex, the result decoction was combined, filtered, the filtrate was concentrated into extractum of relative density 1.20-1.40; and the fine powder of Ginseng Radix and Dioscoreae Rhizoma was combined, dried and ground, and the β-cyclodextrin encapsulation of Angelicae Sinensis Radix was added, combined, and prepared according to conventional pharmaceutical methods.

Description

Chinese patent medicine for treating hair loss and preparation method thereof

The invention relates to a Chinese patent medicine for treating hair loss, in particular to a Chinese patent medicine for treating hair loss prepared by using Chinese herbal medicines as raw materials, and the invention also relates to a method for preparing the drug. Background technique

Hair loss is a common dermatological disorder. Although the disease will not endanger the patient's life, it will affect the patient's appearance, 'bringing heavy mental stress to the patient and reducing the quality of life of the patient.

Chinese medicine believes that: The nutrition of hair comes from camp blood, and its vitality comes from the essence of kidney. If you are overworked, or have an inadequate diet, abnormal living habits, overworked labor, or atrioventricular attrition, you can make your heart and kidneys deficient, have less essence and blood, have visceral organ dysfunction, and have insufficient blood and energy. "When the hair is blood, the kidney is the main bone and the pith is growing." Today, the heart and kidney are deficient, the essence and blood are insufficient, and the muscles, sacral and internal organs are nourished, and the hair loses nutrition and vitality, leading to empty hair roots. While shedding. Therefore, its treatment should nourish the heart and kidney, nourish blood and dryness.

At present, western medicine lacks specific medicines for this disease. Although the proprietary Chinese medicines for treating this disease are on the market, the varieties and indication types cannot meet the clinical needs. Therefore, the development and research of this proprietary Chinese medicine for treating hair loss will have better social and economic benefits. Disclosure of invention

The purpose of the present invention is to provide a Chinese patent medicine for treating hair loss, which is safe and effective, nourishing blood and generating hair, strengthening the body and resisting the formation of free radicals.

Another object of the present invention is to provide a method for preparing the proprietary Chinese medicine for treating hair loss.

The technical solution of the present invention is based on the principle of traditional Chinese medicine. Traditional Chinese medicine believes that although hair loss is caused by blood stasis, blood heat, wind dryness, liver stagnation, etc., it is based on heart and kidney deficiency and blood deficiency and dryness. And the majority of patients meet this pathogenesis. The theory of nourishing the heart and kidneys, nourishing the blood and moisturizing dryness has captured the main pathogenesis of hair loss. In the selection of medicine, follow the ancient teachings, with Shouwu, Baiziren, Shengdi, Ginseng, Angelica, Licorice, etc. to nourish the heart and kidney, nourish blood and dryness.

The Chinese patent medicine for treating hair loss according to the present invention is a medicament made of the following raw materials by weight: Shouwu 80—110 Bai Ziren 90—120 Habitat 90—120

Angelica 90—120 Licorice 80—120 Ginseng 40—60

Dogwood 40—70 Yam 50—70 Epimedium 100—130 Replacement page (Article 26) Eucommia 40—60

The preferred weight ratio range of the Chinese patent medicine for treating hair loss according to the present invention is:

Shouwu 90—100 Boziren 100—110 Habitat 100—110

Angelica 100—110 Licorice 90—110 Ginseng 45—50

Dogwood 50-60 Yam 55-65 Epimedium 110-120

Eucommia 45--55

The optimal weight ratio range of the Chinese patent medicine for treating hair loss according to the present invention is:

Shouwu 100 Baiziren 100 Habitat 100 Angelica 100 Licorice 100 Ginseng 50 Dogwood 50 Yam 50 Epimedium 100 Eucommia 50 The above components are prepared into the traditional Chinese medicine for treating hair loss according to the present invention. The preparation method includes: ginseng and yam are pulverized into fine powder Angelica sinensis is pulverized into coarse powder, and volatile oil is extracted, and the volatile oil is packaged with β-cyclodextrin for use; Angelica sinensis dregs are mixed with Shouwu, Baiziren, raw land, licorice, dogwood, Epimedium and Eucommia for 4 to 6 hours, Cook for 2 to 4 times, 1 to 2 hours each time. Combine the decoction, filter, and concentrate the filtrate to extracts with a relative density of 1. 20-1. 40. Mix the ginseng and yam fine powder with the extract and dry. Crush, add angelica β-cyclodextrin embedded material, mix well, and prepare according to the conventional preparation method.

The advantages of the present invention are: The Chinese patent medicine for treating hair loss is safe and effective, nourishes hair, strengthens the body, improves the body's immunity and resists the formation of free radicals, without any toxic and side effects, and its quality is stable and reliable.

In order to further understand the essence of the present invention, the present invention and its beneficial effects are further described below in combination with specific embodiments and experimental results.

Best way to implement the invention

Example 1

Weigh the raw materials according to the following ratio (kg)

Shouwu 100 Baiziren 100 Habitat 100 Angelica 100 Licorice 100 Ginseng 50 Dogwood 50 Yam 50 Epimedium 100 Eucommia 50

Ginseng and yam are pulverized into fine powder; Angelica sinensis is pulverized into coarse powder, and volatile oil is extracted, and the volatile oil is packaged with β-cyclodextrin for use; Angelica sinensis residue and Shouwu, Baiziren, raw land, licorice, mountain

Replacement page (Article 26) Fructus corni, Epimedium and Eucommia were immersed in water for 5 hours, and cooked 3 times for 1.5 hours each time. The decoction was combined, filtered, and the filtrate was concentrated to an extract with a relative density of 1. 30. Ginseng and yam Powder and extract are mixed uniformly, dried and pulverized, added with angelica β-cyclodextrin embedded material, mixed uniformly, and manufactured according to the conventional method for manufacturing tablets. The specifications are based on ginsenosides (C ₃₄ H ₉₂ 0 ₂₃ ). In a tablet of 0.06 mg / tablet.

Example 2

Weigh the raw materials according to the following ratio (kg)

Shouwu 80 Bai Ziren 90 Habitat 90 Angelica 90 Licorice 80

Ginseng 40 Dogwood 40 Yam 50 Epimedium 100 Eucommia 40

Ginseng and yam are pulverized into fine powder; Angelica sinensis is pulverized into coarse powder, and volatile oil is extracted, and the volatile oil is packaged with e-cyclodextrin for use; Angelica sinensis residue is combined with Shouwu, Baiziren, habitat, licorice, dogwood, Epimedium and Eucommia Add water for 4 hours, cook twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to extracts with a relative density of 1. 20; mix the ginseng and yam fine powder with the extract, dry and crush, add Angelica beta-cyclodextrin embedded matter, mixed uniformly, according to the conventional method of manufacturing capsules, the specifications are based on ginsenosides (C _{34 2} 0 ₂₃ ), not less than 0.06mg / capsules.

Example 3

Weigh the raw materials according to the following ratio (kg)

Shouwu 110 Bai Ziren 120 Habitat 120 Angelica 120 Licorice 120 Ginseng 60 Dogwood 70 Yam 70 Epimedium 130 Eucommia 60

Ginseng and yam are pulverized into fine powder; Angelica is pulverized into coarse powder, and volatile oil is extracted, and the volatile oil is packaged with β-cyclodextrin for use; Angelica dregs is combined with Shouwu, Baiziren, Habitat, Licorice, Dogwood, Epimedium and Eucommia Add water for 6 hours, cook 4 times, 2 hours each time. Combine the decoction, filter, and concentrate the filtrate to extracts with a relative density of 1.40. Mix the ginseng and yam fine powder with the extract, dry and crush, add Angelica β-cyclodextrin embedded matter, mixed uniformly, according to the conventional method of manufacturing granules, the granules are formulated to be ginsenoside (C ₃₄ H ₉₂ 0 ₂₃ ), not less than 0.3 mg / bag of granules.

Experiment 1 The pharmacodynamics of the traditional Chinese medicine for treating hair loss prepared by the present invention:

Replacement page (Article 26) 1. The Chinese patent medicine for treating hair loss of the present invention can promote the growth of body hair of normal rats and bone marrow suppression model rats caused by cyclophosphamide. Histopathology also shows that the Chinese patent medicine for treating hair loss of the present invention can protect the skin hair follicles and sebaceous glands of rats caused by cyclophosphamide. experimental method

A batch of 220-300 g male and female rats were split in half, and the hair was clipped 4 x 4 cm at the center of the spine on the back. After 20 days, the hair of the same part and area was cut again and weighed. Thirty-two animals with similar body hair growth were selected and randomly divided into 4 groups: (1) blank control group: 0.5% CMC-Na 15ml / Kg was administered by gavage; (2) positive control group: the invention was administered by gavage 5g / kg The prepared capsule was 2. 4g / kg, with a concentration of 0. 183g / ml (equivalent to 20 times the clinical dosage); , Concentration 0. 10g / ml (equivalent to 20 times the clinical amount); (4) test low-dose group: intragastric administration of the traditional Chinese medicine for the treatment of hair loss of the present invention 0.75g / kg, a concentration of 0.05g / ml (equivalent 10 times the clinical dosage). Each group was administered for 20 days, and the hairs were sheared in the same area at 4 X 4CM, weighed, and the difference in body hair growth before and after administration was compared. The t test was used to compare differences between groups.

After 20 days of administration, the hair growth of the animals in each group increased compared to the 20 days before administration. However, compared with the blank control group, the high-dose group of Chinese patent medicine for treating hair loss increased body hair weight in the same area (p <0.05). It shows that it can promote the growth of body hair.

Table 1 _1 Effect on normal animal body hair (mg, X ± SD)

Compared with the blank group, P <0.05. experimental method

48 rats were randomly divided into (1) 8 normal control groups; (2) 10 model control groups

Replacement page (Article 26) ig0.5 CMC-Na 15ml / kg; (3) 10 positive control groups, ig Yangxue Shengfa capsules 2.4g / kg, concentration 0.183g / ml (equivalent to 20 times the clinical dosage); (4) test high dose Group 10: ig Chinese patent medicine for treating hair loss according to the present invention 1.5g / kg, concentration 0.10g / ml (equivalent to 20 times the clinical dosage); (5) Test low-dose group 10: ig Chinese patent medicine for treating hair loss according to the present invention 0.75g / kg, 5 concentration of 0.05g / ml (equivalent to 10 times the clinical dosage); except for the normal control group, the other groups were injected intraperitoneally with cyclophosphamide at a dose of 30mg / kg once a day for 3 consecutive days. From the first day of injection, the drug is administered orally. On the fourth day of the test, the hair was cut in the middle of the spine of the rat's back, and on the 10th day, the body hair at the same site was cut again and weighed. The test compares the differences between groups. On the 10th day, the skin in the cut area was taken, fixed with 10% formaldehyde, and routinely embedded, dehydrated, and HE stained to observe the skin hair follicle histology.

Experimental results: After cyclophosphamide injection in rats, the animals showed reduced activity and standing hair. Compared with the normal group, the body hair growth of the model group was inhibited (P <0.01). The high- and low-dose Chinese patent medicine for treating hair loss and the Yangxue Shengfa capsule can obviously correct the poor hair growth caused by cyclophosphamide. Compared with the model group, the body hair increases (P <0.01).

5 Table 1-2 Effect on Cyclophosphamide-induced Poor Hair Growth (mg, X ± SD)

Notes: 1. Each group is compared with the model group.

2. Some animals died of failure, so the number of animals was less than the number of groups.

2. The Chinese patent medicine for treating hair loss according to the present invention can protect the rat bone marrow erythrocytic inhibition caused by cyclophosphamide, which can increase the total number of reticulocytes in peripheral blood, and increase the classification of middle and young erythrocytes in the red line in the bone marrow. This shows that the Chinese patent medicine for treating hair loss of the present invention has a certain corrective effect on the "blood deficiency" state of rats caused by cyclophosphamide. experimental method:

: ⁵ 48 rats were randomly divided into 5 groups, (1) 8 normal control groups; (2) model control group 10

Replacement page (Article 26) Only, ig0.5% CMC-Na 15ml / kg; (3) 10 positive control groups, ig Yangxue Shengfa capsules 2.4g / kg, concentration 0.183g / ml (equivalent to 20 times the clinical dosage); (4) Ten high-dose groups: 1.5g / kg of the proprietary Chinese medicine for treating hair loss according to the present invention, with a concentration of 0.10g / ml (equivalent to 20 times the clinical dosage); (5) Ten low-dose groups: ig, the present invention for treatment of hair loss Chinese patent medicine 0.75g / kg, with a concentration of 0.05g / ml (corresponding to 10 times the clinical dosage); except for the normal control group, the other groups were injected intraperitoneally with cyclophosphamide at a dose of 30mg / kg once a day for 3 days. From the first day of injection, the drug is administered orally. After 1 hour of re-administration at the end of the 10th day of administration, urethane 1.0 g kg, ip anesthesia, bleeding from the common carotid artery, blood routine and reticulocyte count were measured. The sternum of the rat was separated, and the sternum stem at the level of the second rib was cut open to squeeze out the sternum bone marrow. The total number and classification of bone marrow nucleated cells were determined. Each group of data was subjected to an inter-group t test. Experimental results

After intraperitoneal injection of cyclophosphamide in rats, it significantly inhibited reticulocytes and peripheral blood, showing a decrease in reticulocyte and white blood cell counts and an increase in lymphocyte classification. The high-dose reticulocyte count of the Chinese patent medicine for treating hair loss of the present invention is significantly higher than that of the model control group (P <0.05).

Table 2-1 Effects on reticulocytes and blood routine in blood deficiency rats

Notes: 1. Compared with the normal group: # # 是？ <0.05, ### is P <0.01.

2. Compared with the model group: * * is P <0.05, * * * is P <0.01.

3. Because some animals died in each group, the number of animals was less than the number of groups.

3. The Chinese patent medicine for treating hair loss of the present invention, 1.13g / kg / d, 2.25g / kg / d, for 7 consecutive days, can enhance the phagocytic function of mouse macrophages.

Replacement page (Article 26) Oil microscope observation showed that the percentage of phagocytosis in each group was higher than that in the blank control group, and had significant significance.

Table 3-1 Effect on phagocytosis of mouse peritoneal macrophages (X ± SD)

Note: Compared with the blank control group: * * is P <0.05, * * * is P <0.01.

4. The Chinese patent medicine for treating hair loss according to the present invention can increase the ability of mice to respond to stress such as cold, hypoxia and fatigue.

Mice were tested for their ability to withstand cold, hypoxia, and fatigue using routine methods. Table 4-1 Effect on cold tolerance in mice (X soil SD)

Note: Compared with the blank control group: * * is P <0.05, * * * is P <0.01. Table 4-2 Effect on Hypoxia Tolerance in Mice (X ± SD)

Replacement page (Article 26) Trial low dose 1.13 12 15. 22 ± 3. 17 ** group

Note: Compared with the blank control group: * * is P <0.05, * * * is P <0.01. Table 4-13 Effect on the abdominal fatigue resistance of mice (X ± SD)

Note: Compared with the blank control group: * * is P <0.05, * * * is P <0.01.

The above experimental results prove that the Chinese patent medicine for treating hair loss of the present invention has the functions of nourishing hair and strengthening hair, strengthening the body, improving the body's immunity, and resisting the formation of free radicals. 2. Study on the toxicology of the drug of the present invention

1. Acute toxicity test:

experiment method:

Twenty healthy mice were weighed, weighing 18-20 g, male and female, fasted for 14 hours before the experiment, and freely drank water. Each mouse was orally administered at the maximum capacity, with an orally administered dose of 0.2 g / 10 g, a volume of 0.4 ml / 10 g, two intragastric administrations at intervals of 6 h, and a total amount of 40 g / kg. General condition and mortality of mice.

Results:

No abnormalities were found in mice after gavage, coat color, food intake, water consumption, stool, etc., and no case died within 7 days. The weight of the mice was 18. 7 g ± 1. 32, 8. 2 g ± 0.42 before the experiment. Early as early as 20. 9g ± 2.13, 24. 8g ± 3. 67.

CONCLUSION: The maximum tolerated amount of the Chinese patent medicine powder for the treatment of hair loss in a day is 40g I 40Kg (including crude drug 114 · 29g / Kg) in mice, which is 571 times the daily oral dose of an adult. No case died. Animal diet, coat color, weight, and fecal activity were not abnormally found, suggesting that the Chinese patent medicine for treating hair loss of the present invention has no acute toxic and side effects within this dosage range.

2. Long-term toxicity test: Wistar rats were orally administered the Chinese patent medicine for treating hair loss according to the present invention as 1.05 g / Kg. D, 2. lg / Kg. D, 4.2 g / Kg. D. 15 times, 30 times, 60 times, 180 consecutive days. For animal diet, coat color, weight, stool

Replacement page (Article 26) The condition has no significant effect. There was no significant difference between the rats in each group at 90 days and 180 days of the test. Blood biochemical tests showed that GLU, ALP, AST, ALT, TP, ALB, and T-CH0 in each group were all within the normal range. Animals in each group There was no significant difference in the organ index, and no pathological changes were found in the rat organs as a result of pathological examination. After 15 days of discontinuation, no delayed toxicity was detected in the above indicators. It is suggested that the Chinese patent medicine for treating hair loss of the present invention does not have any toxic or side effect on rats within this dosage range.

Clinical research

According to the diagnostic criteria, 102 cases of hair loss were selected, of which 46 were alopecia areata, 26 were bald, and alopecia areata

In 30 cases, the Chinese patent medicine for treating hair loss of the present invention was taken 5 tablets each time, three times a day, and one month was a course of treatment. Medication 1-2 courses. The results showed that the total effective rate was 92, 16%, of which alopecia areata was 93. 48%, overall baldness was 92.3%, and general baldness was 90. 0%.

The analysis results of the above studies indicate that the prescription of this proprietary Chinese medicine for treating hair loss is in accordance with the theory of traditional Chinese medicine, and is applicable to a variety of clinical symptoms of hair loss caused by heart and kidney deficiency, blood deficiency and dryness, and dryness of the heart and kidney deficiency syndrome. It is a safe, effective, stable and controllable medicine for treating hair loss.

Replacement page (Article 26)

Claims

Chinese patent medicine for treating hair loss according to claim, characterized in that it is a medicine made of the following raw materials by weight _:

Shouwu 80-110 Bai Ziren 90- 120 Habitat 90- 120

Angelica 90—120 Licorice 80—120 Ginseng 40—60

Dogwood 40—70 Yam 50—70 Epimedium 100—130

Eucommia 40-60.

The Chinese patent medicine for treating hair loss according to claim 1, characterized in that the weight ratio of each raw material is-Shouwu 90_ 100 Bai Ziren 100—110 Health Land 100—110

Angelica 100—110 Licorice 90—110 Ginseng 45—50

Dogwood 50-60 Yam 55-65 Epimedium 110-120

Eucommia 45-55.

2. The Chinese patent medicine for treating hair loss according to claim 2, characterized in that the weight ratio of each raw material is: Shouwu 100 Baiziren 100 Habitat 100 Angelica 100 Licorice 100 Ginseng 50 Dogwood 50 Yam 50 Epimedium 100 Eucommia 50.

The Chinese patent medicine for treating hair loss according to any one of claims 1, 2 or 3, characterized in that said agent may be any of said dosage forms in pharmacy.

2. The Chinese patent medicine for treating hair loss according to claim 4, characterized in that said agent is a tablet, capsule or granule.

A method for preparing Chinese patent medicine for treating hair loss, which is characterized in that the raw material ginseng and yam are pulverized into fine powder; angelica is pulverized into coarse powder, and volatile oil is extracted, and the volatile oil is packaged with P-cyclodextrin for use; Angelica slag and Shouwu, Baiziren, raw land, licorice, dogwood, Epimedium and eucommia were immersed in water for 4 to 6 hours, and cooked for 2 to 4 times, each for 1 to 2 hours. Combine the decoction, filter, and concentrate the filtrate to a relative density of 1 20— 1. 40 extracts; ginseng and yam fine powder are mixed with the extracts, dried and crushed, and the angelica β-cyclodextrin embedded substance is added and mixed, and prepared according to the conventional preparation method.

Replacement page (Article 26)