External traditional Chinese medicine compound preparation as well as preparation method and application thereof

Abstract

The invention relates to an external traditional Chinese medicine compound preparation as well as a preparation method and application thereof, and the traditional Chinese medicine compound preparation is prepared from the following raw materials in parts by weight: 5-15 parts of duckweed, 5-15 parts of herba ecliptae, 5-15 parts of folium mori, 3-10 parts of angelica sinensis, 5-15 parts of glossy privet fruit, 5-15 parts of soapberry peel, 5-15 parts of tea bran, 3-10 parts of gynostemma pentaphylla, 2-8 parts of loofah sponge and 2-8 parts of black bean peel. According to compatibility of the traditional Chinese medicine compound preparation, the effects of reducing alopecia, promoting hair growth and promoting hair weight increment are remarkable, clinical tests prove that the effect on the cure rate is remarkable, the number of invalid people is small, and the traditional Chinese medicine compound preparation is simple in preparation mode, convenient to produce and very convenient to use.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to an externally applied traditional Chinese medicine compound preparation, a preparation method thereof, and an application thereof. Background Art

[0002] Hair loss is a common hair disease that seriously affects the appearance and mental health of patients. Modern medical research shows that the causes of hair loss are diverse, including genetic factors, endocrine disorders, malnutrition, mental stress, drug side effects, etc. At present, the clinical treatment methods for hair loss mainly include drug treatment, laser treatment, hair transplantation surgery, etc. Laser treatment is costly and the effect is unstable. Hair transplantation surgery has large trauma, high cost and certain risks. Therefore, more people choose drug treatment. Drug treatment mainly uses minoxidil, finasteride, spironolactone, etc., and has relatively large side effects.

[0003] With the renewed understanding and in-depth research of traditional Chinese medicine, traditional Chinese medicine has gradually attracted attention in the treatment of hair loss. Traditional Chinese medicine has the advantages of being natural, mild, and having small side effects, and has unique advantages in promoting hair growth and improving the scalp environment. In the prior art, an externally applied traditional Chinese medicine compound preparation such as an anti-hair loss externally applied traditional Chinese medicine composition disclosed in Patent No. CN115120698A still needs to be soaked in alcohol during preparation, and alcohol may cause irritation to the scalp. Therefore, the present invention provides an externally applied traditional Chinese medicine compound preparation with pure traditional Chinese medicine ingredients, a simple preparation method, and good medicinal effects to solve the above technical problems. Summary of the Invention

[0004] The purpose of the present invention is to provide an externally applied traditional Chinese medicine compound preparation, a preparation method thereof, and an application thereof in order to solve the above problems.

[0005] The present invention achieves the above purpose through the following technical solutions: The present invention provides an externally applied traditional Chinese medicine compound preparation. The preparation raw materials of the traditional Chinese medicine compound preparation are calculated by weight and include 5-15 parts of duckweed, 5-15 parts of eclipta prostrata, 5-15 parts of mulberry leaves, 3-10 parts of angelica sinensis, 5-15 parts of glossy privet fruit, 5-15 parts of sapindus peel, 5-15 parts of tea bran, 3-10 parts of gynostemma pentaphyllum, 2-8 parts of luffa cylindrica, and 2-8 parts of black soybean peel.

[0006] As a further optimized scheme of the present invention, the preparation raw materials of the traditional Chinese medicine compound preparation are calculated by weight, The parts of duckweed, eclipta prostrata, and mulberry leaves are the same, all being 5-8 parts; The parts of angelica sinensis, glossy privet fruit, sapindus peel, and tea bran are the same, all being 5-6 parts; The gynostemma pentaphyllum is 3-4 parts; The parts of luffa cylindrica and black soybean peel are the same, all being 2-3 parts.

[0007] As a further optimized solution of the present invention, the raw materials for preparing the traditional Chinese medicine compound preparation include, by weight, 6 parts of duckweed, 6 parts of Eclipta prostrata, 6 parts of mulberry leaves, 5 parts of Angelica sinensis, 5 parts of Glossy Privet Fruit, 5 parts of Sapindus peel, 5 parts of tea bran, 3 parts of Gynostemma pentaphyllum, 2 parts of Luffa cylindrica vascular bundles, and 2 parts of black soybean peel.

[0008] The present invention also provides a method for preparing an external traditional Chinese medicine compound preparation, specifically by mixing duckweed, Eclipta prostrata, mulberry leaves, Angelica sinensis, Glossy Privet Fruit, Sapindus peel, tea bran, Gynostemma pentaphyllum, Luffa cylindrica vascular bundles, and black soybean peel in proportion and then pulverizing them into powder.

[0009] As a further optimized solution of the present invention, the powder is 100 - 150 mesh powder.

[0010] The present invention also provides an application of the above - mentioned external traditional Chinese medicine compound preparation in the preparation of drugs for preventing hair loss.

[0011] As a further optimized solution of the present invention, when in use, the traditional Chinese medicine compound preparation is stirred into a paste with a liquid at 70 - 100 °C.

[0012] Duckweed: Pungent in taste, cold in nature. It belongs to the lung and bladder meridians; it has the functions of inducing sweating and relieving exterior syndrome, promoting eruption and relieving itching, and promoting diuresis and detumescence.

[0013] Eclipta prostrata: Sweet, sour in taste, cold in nature; it belongs to the liver and kidney meridians; its efficacy is to nourish the liver and kidney and cool the blood to stop bleeding.

[0014] Mulberry leaves: Sweet, bitter in taste, cold in nature; it belongs to the lung and liver meridians; it has the functions of dispersing wind - heat, moistening the lung and relieving dryness, and clearing the liver and improving eyesight.

[0015] Angelica sinensis: Sweet, pungent in taste, warm in nature; it belongs to the liver, heart, and spleen meridians; its main efficacy is to enrich blood and promote blood circulation, regulate menstruation and relieve pain, and moisten the intestines and relieve constipation.

[0016] Glossy Privet Fruit: Sweet, bitter in taste, cool in nature; it belongs to the liver and kidney meridians; its main efficacy is to nourish the liver and kidney and remove deficiency - heat.

[0017] Sapindus: Bitter, sweet in taste, neutral in nature; it belongs to the lung, spleen, and large intestine meridians; it has the functions of clearing heat and detoxifying, reducing phlegm and relieving cough, and killing insects and relieving itching; its pericarp can also be used externally, with the efficacy of detumescence and dissipating nodules; Sapindus peel is the outer peel of Sapindus.

[0018] Tea bran: Bitter, astringent in taste, warm in nature; it belongs to the lung and spleen meridians; it has the functions of expelling wind and dampness and relieving itching.

[0019] Gynostemma pentaphyllum: Bitter, slightly sweet in taste, cold in nature; it belongs to the lung, spleen, and kidney meridians; it has the functions of tonifying qi and strengthening the spleen, resolving phlegm and relieving cough, and clearing heat and detoxifying.

[0020] Luffa cylindrica vascular bundles: Sweet in taste, cold in nature; it belongs to the lung, liver, and stomach meridians; it has the functions of dredging channels and collaterals, clearing heat and resolving phlegm, and cooling the blood and detoxifying.

[0021] Black soybeans: Belong to the seeds of Glycine max in the legume family, with black outer skin; sweet in taste, neutral in nature. It belongs to the spleen and kidney meridians; has the functions of strengthening the spleen and promoting diuresis, nourishing the kidney yin, and detoxifying.

[0022] Mulberry twigs: Slightly bitter in taste, neutral in nature; belong to the liver meridian; have the functions of dredging the meridians and activating collaterals, dispelling wind-dampness, promoting joint movement, and promoting the flow of water qi.

[0023] Green soybeans: Belong to the seeds of Glycine max in the legume family, with green outer skin, sweet in taste, neutral in nature; belong to the spleen and large intestine meridians; have the effects of strengthening the spleen and promoting diuresis, clearing heat and detoxifying.

[0024] The beneficial effects of the present invention are as follows: The components of the traditional Chinese medicine compound preparation of the present invention are duckweed, Eclipta prostrata, mulberry leaves, angelica, Glossy Privet Fruit, Sapindus peel, tea bran, Gynostemma pentaphyllum, loofah sponge, and black soybean peel. According to the compatibility of the present invention, it has a significant effect in reducing hair loss, promoting hair growth, and increasing hair weight; The traditional Chinese medicine compound preparation of the present invention has been verified in clinical trials and has a significant effect on the cure rate, and the number of ineffective people is small. Therefore, it shows that the compatibility of the traditional Chinese medicine compound preparation of the present invention has the effects of promoting hair growth, preventing hair loss, and promoting hair growth; The preparation of the traditional Chinese medicine compound preparation of the present invention only needs to grind various traditional Chinese medicine drugs into powder and can be directly used. The production, processing, and use are all very convenient, and it is composed of pure traditional Chinese medicine ingredients without chemical components such as silicone oil, preservatives, and artificial fragrances, which can reduce the irritation and potential harm to the scalp, and is natural, mild, and safer. Brief Description of the Drawings

[0025] Figure 1 It is the product state diagram (powder, paste) of the traditional Chinese medicine compound preparation of the present invention.

[0026] Figure 2 It is the hair volume state diagram before and after the treatment of the cases of the present invention (a is before treatment; b is after 9 months of treatment). Detailed Embodiments

[0027] The following further describes the present application in detail with reference to the drawings. It is necessary to point out here that the following detailed embodiments are only used to further illustrate the present application and cannot be understood as a limitation on the protection scope of the present application. Those skilled in the art can make some non-essential improvements and adjustments to the present application according to the above application content.

[0028] Materials Duckweed, Eclipta prostrata, mulberry leaves, angelica, Glossy Privet Fruit, Sapindus peel, tea bran, Gynostemma pentaphyllum, loofah sponge, and black soybean peel are all purchased from Anhui Chengfeng Pharmaceutical Co., Ltd.

[0029] Unless otherwise specified, the methods used in the present invention are conventional methods known to those skilled in the art, and the raw materials, reagents and other materials used for preparation are commercially available products unless otherwise specified.

[0030] Method 2.1 Preparation of the external-use traditional Chinese medicine compound preparation.

[0031] Example 1

[0032] In this example, the raw materials for preparing the traditional Chinese medicine compound preparation include, by weight: 8 parts of duckweed, 8 parts of Eclipta prostrata, 8 parts of mulberry leaves; 6 parts of Angelica sinensis, 6 parts of Glossy Privet Fruit, 6 parts of Sapindus peel, 6 parts of tea bran; 4 parts of Gynostemma pentaphyllum; 3 parts of Luffa cylindrica, 3 parts of black soybean peel; Preparation method: Mix duckweed, Eclipta prostrata, mulberry leaves, Angelica sinensis, Glossy Privet Fruit, Sapindus peel, tea bran, Gynostemma pentaphyllum, Luffa cylindrica and black soybean peel in proportion and then crush them into powder (120-mesh powder).

[0033] Example 2

[0034] The difference from Example 1 is that in this example, the raw materials for preparing the traditional Chinese medicine compound preparation include, by weight: 6 parts of duckweed, 6 parts of Eclipta prostrata, 6 parts of mulberry leaves; 5 parts of Angelica sinensis, 5 parts of Glossy Privet Fruit, 5 parts of Sapindus peel, 5 parts of tea bran; 3 parts of Gynostemma pentaphyllum; 2 parts of Luffa cylindrica, 2 parts of black soybean peel; The preparation method is the same as that of Example 1.

[0035] Example 3

[0036] The difference from Example 1 is that in this example, the raw materials for preparing the traditional Chinese medicine compound preparation include, by weight: 5 parts of duckweed, 5 parts of Eclipta prostrata, 5 parts of mulberry leaves; 6 parts of Angelica sinensis, 6 parts of Glossy Privet Fruit, 6 parts of Sapindus peel, 6 parts of tea bran; 3 parts of Gynostemma pentaphyllum; 2 parts of Luffa cylindrica, 2 parts of black soybean peel; The preparation method is the same as that of Example 1.

[0037] 2.2 Adjustment and replacement of the component compatibility of the external-use traditional Chinese medicine compound preparation 2.2.1 Adjustment of the component ratio of the external-use traditional Chinese medicine compound preparation Based on the component formulations of the above Examples 1-2, the following adjustments were made, specifically: Group S1-T1: In this group, based on the group allocation formula in Example 1, adjustments were made. The raw materials for preparing the traditional Chinese medicine compound preparation after adjustment, by weight, include: 8 parts of duckweed, 6 parts of eclipta prostrata, and 8 parts of mulberry leaves; 6 parts of angelica sinensis, 6 parts of glossy privet fruit, 6 parts of sapindus peel, and 5 parts of tea seed cake; 4 parts of gynostemma pentaphyllum; 3 parts of luffa cylindrica vascular bundles and 3 parts of black soybean peel; The preparation method is the same as that in Example 1.

[0038] Group S2-T1: In this group, based on the group allocation formula in Example 2, adjustments were made. The raw materials for preparing the traditional Chinese medicine compound preparation after adjustment, by weight, include: 6 parts of duckweed, 8 parts of eclipta prostrata, and 6 parts of mulberry leaves; 5 parts of angelica sinensis, 5 parts of glossy privet fruit, 5 parts of sapindus peel, and 6 parts of tea seed cake; 3 parts of gynostemma pentaphyllum; 2 parts of luffa cylindrica vascular bundles and 2 parts of black soybean peel; The preparation method is the same as that in Example 1.

[0039] 2.2.2. Replacement of components of the externally applied traditional Chinese medicine compound preparation Group S2-G1: In this group, based on the group allocation formula in Example 2, replacements were made. Black soybean kernels (peeled black soybeans) with equal mass were used to replace the black soybean peel, and the rest were the same as in Example 2; Group S2-G2: In this group, based on the group allocation formula in Example 2, replacements were made. Black soybeans (black soybeans with skins) with equal mass were used to replace the black soybean peel, and the rest were the same as in Example 2; Group S2-G3: In this group, based on the group allocation formula in Example 2, replacements were made. Green soybean peels with equal mass were used to replace the black soybean peel, and the rest were the same as in Example 2; Group S-2G4: In this group, based on the group allocation formula in Example 2, replacements were made. Mulberry twigs with equal mass were used to replace the luffa cylindrica vascular bundles, and the rest were the same as in Example 2; Group S2-G5: In this group, based on the group allocation formula in Example 2, replacements were made. Mulberry twigs with equal mass were used to replace the luffa cylindrica vascular bundles, and green soybean peels with equal mass were used to replace the black soybean peel, and the rest were the same as in Example 2.

[0040] III. Experiments 3.1. Study on the effect of the externally applied traditional Chinese medicine compound preparation on the neonatal hair of mice Model establishment: 240 mice (C57BL / 6J male mice) were randomly divided into 12 groups, namely blank control group, positive control group, experimental groups (Example 1-3 groups, S1-T1 group, S2-T1 group, and S2-G1 to 5 groups of the present invention), with 20 mice in each group. The hair on the back of the mice was cut short. After applying 10% Na2S to the back of the mice for about 2-3 minutes, it was washed with warm water. The back of the mice was smooth, without injury or remaining hair. The depilation area was about 3×5 cm 2 , and care was taken to avoid skin damage.

[0041] Drug administration: The drug was applied to the depilated areas of the mice in each group once a day for 20 consecutive days. The blank control group was applied with 0.2 ml of physiological saline per mouse each time, the positive control group was applied with 0.2 ml of 0.05% testosterone solution per mouse each time, and the experimental groups were applied with 0.2 g of the traditional Chinese medicine compound preparation of Example 1-3 groups, S1-T1 group, S2-T1 group, and S2-T1 to 5 groups of the present invention per mouse (mixed and stirred with 100°C hot water at a mass ratio of 1:1 until it became a paste, cooled, and then evenly applied. After applying for 30-60 minutes, it was washed with clean water).

[0042] (1) Detection of the effect on hair growth: The mice were sacrificed on the day when the experiment ended. The fur on the depilated areas of the mice's backs was cut off. A circular skin piece was taken from the same position of the depilated area of each mouse with a puncher with a diameter of 0.5 cm. Using a magnifying glass and forceps, 10 longest hairs were selected, and the length was measured with a vernier caliper. The average length of the 10 hairs was used as the length of the newly grown hair of each mouse, and the data was recorded in Table 1: Table 1 Effect of the traditional Chinese medicine compound preparation on the length of newly grown hair in mice ; Experimental conclusion: Based on the data analysis in Table 1, it can be known that the traditional Chinese medicine compound preparations of Example 1-3 groups of the present invention all have the effect of promoting hair growth. Among them, the traditional Chinese medicine compound preparation of Example 2 group has a significant effect in promoting hair growth and increasing length. By comparing the component formulas, it can be known that Ecliptae Herba and tea bran can play a synergistic role only when their proportions in the mixture with other traditional Chinese medicines are the same. Specifically, the proportions of Lemnae Herba, Ecliptae Herba, and Mori Folium are the same; the proportions of Angelicae Sinensis Radix, Ligustri Lucidi Fructus, Sapindi Mukorossi Cortex, and tea bran are the same; the proportions of Luffae Fructus Retinervus and Phaseoli Radiati Semen Nigrum are the same, and the drug effect is the best; In addition, through experimental comparison, it can be known that the combination of Luffae Fructus Retinervus and Phaseoli Radiati Semen Nigrum added to the traditional Chinese medicine mixture system has a synergistic effect, can promote hair growth, and the length of the hair growth is longer.

[0043] (2) Detection of the effect on hair weight: On the day when the experiment ended, the mice were sacrificed. The fur on the depilated area of the back of the mice was cut off. A circular skin piece was taken from the same position of the depilated area of each mouse with a hole puncher with a diameter of 15 mm. Then, all the body hairs on the skin piece were scraped off with a scalpel. Body hairs of the same length and the same quantity were taken and weighed on a balance, which was used as the weight of the newly grown hair of the mice. The data was recorded in Table 2: Table 2 Effects of the traditional Chinese medicine compound preparation on the length and weight of newly grown hair of mice ; Experimental conclusion: Based on the data in Table 2, it is known that the traditional Chinese medicine compound preparations formulated in Examples 1-3 of the present invention have a significant effect on increasing the weight of the hair of mice. Among them, the effect of Example 2 is significant. However, after adjusting or replacing the components in the traditional Chinese medicine compound preparation of the present invention, the drug effect decreases significantly, indicating that the compatibility of the traditional Chinese medicine compound preparation of the present invention has a synergistic effect and conforms to the principle of syndrome differentiation and treatment in traditional Chinese medicine.

[0044] 3.2 Clinical application test Clinical case data: 225 patients with alopecia (without hypertension, diabetic aldosteronism, hypokalemia, hepatic and renal insufficiency, pregnant women, lactating patients). All patients met the diagnostic criteria in "Chinese Clinical Dermatology": The onset was sudden, with round or oval patchy alopecia on the head, clear boundaries, normal skin in the alopecia area, no obvious subjective symptoms, no obvious atrophy and scars in the alopecia area, hair follicle openings clearly visible, and mild itching may occur locally, without systemic symptoms.

[0045] Usage method: The traditional Chinese medicine compound preparation is mixed and stirred with hot water (70-100 °C, preferably 100 °C) at a mass ratio of 1:1-5 (preferably 1:2) until it becomes a paste (as shown in Figure 1 ) and after cooling, it is evenly applied to the scalp and hair. After heat preservation and hot compress at 35-45 °C (preferably 40 °C) for 30-60 min (preferably 35 min), it is washed with clean water. The dosage is 15-25 g / day, once every 2 days, and the usage period is 9 months.

[0046] Efficacy evaluation criteria: The efficacy criteria refer to the relevant efficacy criteria in "Efficacy Criteria for Judging Traditional Chinese Medicine Diseases and Syndromes", which are specifically as follows: Cure: All new hairs have grown, and the hair color, thickness and density have returned to normal; Marked effect: More than 70% of new hairs have grown, and the hair thickness and color are close to normal; Effective: 10%-70% of new hairs have grown, and hair loss no longer occurs; Ineffective: After 2 courses of treatment, no new hairs have grown, or the hairs do not grow but fall out instead.

[0047] The treatment conditions of the patients were statistically analyzed with reference to the above-mentioned efficacy evaluation criteria and recorded in Table 3: Table 3 Statistical Table of the Efficacy of the Traditional Chinese Medicine Compound Preparation ; Experimental Conclusion: It can be seen from the data in Table 3 that the efficacy of the traditional Chinese medicine compound preparation of the embodiment of the present invention is obvious. For the compatibility of the traditional Chinese medicine compound preparation of the embodiment of the present invention, the cure rate of patients is as high as 73.3%-77.8%. Compared with the component adjustment group (the cure rate of the S2-T1 group is 53.3%) and the component replacement group (the cure rate of the S2-G2 group is 33.3%; the cure rate of the S2-G5 group is 24.4%), the compatibility of the traditional Chinese medicine compound preparation of the embodiment of the present invention has a significant effect and the number of ineffective people is small. Therefore, it can be shown that the compatibility of the traditional Chinese medicine compound preparation of the present invention has the effects of preventing hair loss and promoting hair growth.

[0048] Clinical Case (One of 225 Alopecia Patients): Sun, female, 37 years old, visited the doctor due to progressive reduction of scalp hair for 10 months (as Figure 2 shown in a), and was diagnosed with "seborrheic alopecia". After visiting the doctor, the traditional Chinese medicine compound preparation of Example 2 of the present invention was used according to the usage method in Step 3.2, and the treatment period was 9 months; the treatment efficacy was that the scalp greasiness was significantly relieved, the hair loss amount was significantly reduced, and the amount of newly grown hair was significantly increased (as Figure 2 shown in b).

[0049] The above embodiments only represent several implementation manners of the present invention, and the description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. An external traditional Chinese medicine compound preparation, characterized in that: The raw materials for preparing the traditional Chinese medicine compound preparation, by weight, include 5-15 parts of duckweed, 5-15 parts of Eclipta prostrata, 5-15 parts of mulberry leaves, 3-10 parts of Angelica sinensis, 5-15 parts of Glossy Privet Fruit, 5-15 parts of Sapindus peel, 5-15 parts of tea seed cake, 3-10 parts of Gynostemma pentaphyllum, 2-8 parts of Luffa cylindrica, and 2-8 parts of black soybean peel.

2. The external-use traditional Chinese medicine compound preparation according to claim 1, wherein: The raw materials for preparing the traditional Chinese medicine compound preparation, by weight, The parts of the duckweed, Eclipta prostrata, and mulberry leaves are the same, all being 5-8 parts; The parts of the Angelica sinensis, Glossy Privet Fruit, Sapindus peel, and tea seed cake are the same, all being 5-6 parts; The Gynostemma pentaphyllum is 3-4 parts; The parts of the Luffa cylindrica and black soybean peel are the same, all being 2-3 parts.

3. The external-use traditional Chinese medicine compound preparation according to claim 2, characterized in that: The raw materials for preparing the traditional Chinese medicine compound preparation, by weight, include 6 parts of duckweed, 6 parts of Eclipta prostrata, 6 parts of mulberry leaves, 5 parts of Angelica sinensis, 5 parts of Glossy Privet Fruit, 5 parts of Sapindus peel, 5 parts of tea seed cake, 3 parts of Gynostemma pentaphyllum, 2 parts of Luffa cylindrica, and 2 parts of black soybean peel.

4. A preparation method of an external traditional Chinese medicine compound preparation according to any one of claims 1-3, characterized in that: Specifically, the duckweed, Eclipta prostrata, mulberry leaves, Angelica sinensis, Glossy Privet Fruit, Sapindus peel, tea seed cake, Gynostemma pentaphyllum, Luffa cylindrica, and black soybean peel are mixed in proportion and then pulverized into powder.

5. The preparation method of an external-use traditional Chinese medicine compound preparation according to claim 4, characterized in that: The powder is 100-150 mesh powder.

6. Use of an external traditional Chinese medicine compound preparation according to any one of claims 1-3 in the preparation of a drug for preventing hair loss.

7. The application according to claim 6, characterized in that: When in use, the traditional Chinese medicine compound preparation is stirred into a paste with a liquid at 70-100 °C.

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