Traditional Chinese medicine composition for treating spleen and kidney deficiency type alopecia

Abstract

The invention relates to a traditional Chinese medicine composition for treating spleen and kidney deficiency type alopecia, the medicine composition comprises active ingredients and medically acceptable auxiliary materials, and the active ingredients are prepared from the following raw material medicines in percentage by weight: 8-10% of radix rehmanniae preparata, 6-8% of semen cuscutae, 6-8% of glossy privet fruit, 16-20% of radix astragali, 8-10% of fructus lycii, 8-10% of herba taxilli, 6-8% of roasted rhizoma atractylodis macrocephalae and 8-10% of radix salviae miltiorrhizae. , 8-10% of mulberry, 5-7% of dahurian angelica root, and 8-10 The pharmaceutical composition disclosed by the invention has a remarkable effect of treating spleen and kidney deficiency type alopecia.

Description

Technical Field

[0001] The present invention relates to a medical preparation, in particular to a pharmaceutical preparation containing an undetermined structure from traditional Chinese medicine. The pharmaceutical preparation is particularly suitable for treating alopecia caused by deficiency of spleen and kidney. Background Art

[0002] Alopecia is a common hair follicle atrophy disease, which is usually manifested as thinning hair, hair loss, or even complete baldness. The occurrence of hair loss is closely related to many factors, including genetics, endocrine, nutrition, lifestyle habits, stress, etc. There are various types of hair loss. The most common is androgenic alopecia, which is more common in male patients and manifests as gradual hair loss on the top and forehead; women often show diffuse hair loss, especially during menopause or hormonal changes. The degree of hair loss can be mild or severe. Mild hair loss may not have much impact on life, but severe hair loss may cause serious appearance problems and even cause psychological stress and inferiority.

[0003] Western medicine believes that the causes of hair loss are primarily related to factors such as genetics, elevated androgen levels, and increased sensitivity of hair follicles to androgens. Among these, the most common form of androgenic alopecia is caused by androgens affecting the hair follicle cycle, leading to gradual thinning, shortening, and eventual cessation of hair growth. Malnutrition, excessive stress, medication use, certain medical conditions (such as thyroid disease and anemia), and unhealthy lifestyle habits (such as smoking and alcohol) are also contributing factors. Western medicine primarily treats hair loss with topical medications such as minoxidil and finasteride, which stimulate hair regrowth by promoting blood circulation to the hair follicles and inhibiting the effects of androgens. Minoxidil promotes hair growth by dilating blood vessels in the hair follicles, while finasteride inhibits the action of 5α-reductase, reducing the inhibitory effects of androgens on hair follicles and thereby slowing the progression of hair loss. Furthermore, physical therapies such as laser therapy and hair transplantation are also commonly used clinically to achieve certain therapeutic benefits by stimulating hair follicle activity and promoting hair growth.

[0004] Traditional Chinese Medicine (TCM) refers to this condition as "hair rot and hair loss." The "Guidelines for the Diagnosis and Treatment of Androgenic Alopecia in China" (2023 edition) states that TCM syndrome differentiation and treatment is also a treatment option for androgenic alopecia, while the "Guidelines for the Diagnosis and Treatment of Alopecia Areata in China" (2019) emphasizes TCM as an alternative treatment. TCM believes that hair loss is often closely related to internal factors such as organ dysfunction, insufficient Qi and blood, and liver and kidney deficiency. Liver and kidney deficiency is a common internal cause of hair loss, especially under conditions such as long-term stress, excessive fatigue, and emotional distress. Liver Qi stagnation and kidney Qi deficiency lead to a lack of Qi and blood production, thus impairing hair growth. TCM also believes that hair loss is often closely related to external environmental factors. For example, the invasion of external pathogens such as damp heat and wind-cold can also cause hair loss. TCM treatment of hair loss focuses on syndrome differentiation and treatment, using Chinese herbal medicine based on different syndrome types. Common prescriptions include Liuwei Dihuang Wan and Zuogui Wan, which aim to regulate the liver and kidneys, nourish Qi and blood, and promote hair growth. Traditional Chinese medicine treatment can also be combined with external treatments such as acupuncture and cupping to soothe the liver and regulate qi, promote blood circulation and remove blood stasis, and help restore hair growth.

[0005] Regarding the common TCM syndrome types of hair loss, although the "Expert Consensus on the Diagnosis and Treatment of Androgenic Alopecia with Integrated Traditional Chinese and Western Medicine" (2021 edition) does not mention specific syndrome types, the "Consensus" points out that hair loss is commonly caused by two major conditions: blood heat and wind dryness, and liver and kidney deficiency. In the "Expert Consensus on the Diagnosis and Treatment of Androgenic Alopecia in Men with Integrated Traditional Chinese and Western Medicine" (2024 edition), several major syndrome types are listed, including internal accumulation of damp heat, blood heat and wind dryness, liver depression and spleen deficiency, spleen deficiency and damp accumulation, and liver and kidney deficiency. Recommended prescriptions include Shenling Baizhu San and Liuwei Dihuang Wan. The "Consensus" also proposes that androgenic alopecia "is mainly characterized by spleen deficiency and dampness accumulation or liver depression and spleen deficiency in the middle stage, and liver and kidney deficiency or qi and blood deficiency in the later stage", which clearly points out the importance of the spleen and kidney in the onset of hair loss, but does not mention the prescriptions that should be recommended for those with spleen and kidney deficiency. Based on clinical findings, the applicant found that patients with hair loss often suffer from spleen and kidney deficiency, and treatment through strengthening the kidneys and spleen can have a good effect on hair growth. However, patented prescriptions for hair loss caused by spleen and kidney deficiency are still rare.

[0006] The inventors have published an article on the experience of treating postpartum hair loss in women (Zheng Xuwei, Luo Ya, Yao Danni, Lu Chuanjian, etc. Lu Chuanjian's experience in treating postpartum hair loss from the perspective of spleen and kidney [J]. Journal of Traditional Chinese Medicine and Pharmacy, Vol. 27, No. 9, September 2021: 197-199.), which discloses a prescription for treating postpartum hair loss in women: "20g Astragalus, 15g Atractylodes, 15g Rehmannia, 15g Salt Ligustrum lucidum, 15g Salt Cuscuta, 15g Morus alba, 30g Salvia miltiorrhiza, 10g Red Peony Root, 15g Vinegar Cyperus, 15g Curcuma, 15g Albizia Julibrissin, 15g Taraxacum, 15g Angelica dahurica, 15g Dictamni, 15g Pine Needle". The article also discloses the following content: "Traditional Chinese medicine diagnosis: Postpartum hair loss is due to deficiency of both spleen and kidney. The treatment is to strengthen the spleen, replenish qi and tonify the kidney."

[0007] In subsequent clinical practice, the inventors discovered that the aforementioned prescription for treating postpartum hair loss in women was not ideal for treating patients with general hair loss. In-depth analysis revealed that while the treatment described in the aforementioned literature aligns with the core pathogenesis of hair loss, its composition and compatibility suffer from the following significant flaws: the six herbs included in the prescription—red peony root, cyperus rotundus, turmeric, dandelion, white peony root bark, and albistylum bark—clash with the core therapeutic approach of "strengthening the spleen, replenishing qi, and tonifying the kidneys" described in the literature, severely weakening the overall therapeutic effect. Among them, red peony root is bitter and cold in nature, and has strong heat-clearing and blood-cooling effects, but it can easily harm spleen yang; cyperus rotundus is pungent and aromatic, which can easily dissipate vital energy, and is even more harmful to those with qi deficiency; turmeric is pungent and cold in nature, which can stir up qi and activate blood circulation, and is not conducive to the storage of kidney essence; dandelion is cold in nature and enters the middle burner, and can easily damage spleen yang when used by those with spleen deficiency; white peony root is cold and drying, which can easily damage the spleen, and its excessive drying effect can also deplete kidney essence, making it unsuitable for those with spleen and kidney deficiency; and elixir bark has neither spleen-strengthening nor kidney-tonifying effects, and its blood-activating and swelling-reducing effects can actually hinder qi-tonifying. In short, the above six herbs have cold properties that damage spleen yang, stir up blood and deplete kidney essence, and promote qi without tonifying it, which is contrary to the treatment method for hair loss caused by "spleen and kidney deficiency." Summary of the Invention

[0008] The technical problem to be solved by the present invention is to provide a pharmaceutical composition for treating spleen and kidney deficiency type hair loss. The pharmaceutical composition is simple in dosage and has a significant effect in treating spleen and kidney deficiency type hair loss.

[0009] The technical solutions of the present invention for solving the above problems are as follows:

[0010] A pharmaceutical composition for treating spleen and kidney deficiency-type hair loss, comprising an active ingredient and medically acceptable excipients, wherein the active ingredient is made from the following raw materials in the following weight percentages:

[0011] Rehmannia glutinosa 8-10%, Cuscuta chinensis 6-8%, Ligustrum lucidum 6-8%, Astragalus 16-20%, Lycium barbarum 8-10%, Viscum album 8-10%, stir-fried Atractylodes macrocephala 6-8%, Salvia miltiorrhiza 8-10%, Mulberry 8-10%, Angelica dahurica 5-7%, Pine needles 8-10%.

[0012] The pharmaceutical composition of the present invention, wherein the optimal ratio of the raw materials is:

[0013] Rehmannia glutinosa 9.0%, Cuscuta chinensis 7.2%, Ligustrum lucidum 7.2%, Astragalus 18.4%, Lycium barbarum 9.0%, Viscum album 9.0%, stir-fried Atractylodes macrocephala 7.2%, Salvia miltiorrhiza 9.0%, Mulberry 9.0%, Angelica dahurica 6.0%, Pine needles 9.0%.

[0014] The pharmaceutical composition of the present invention, wherein the active ingredient is prepared by the following method:

[0015] Take the other medicinal ingredients of the medicine except Salvia miltiorrhiza, add 12 times the amount of water according to the formula, decoct after 1 hour and 50 minutes, add Salvia miltiorrhiza and continue to decoct for 10 minutes, filter, add 10 times the amount of water to the residue and decoct for 2 hours, filter, combine the two decoctions, and concentrate under reduced pressure to a relative density of 1g / mL at 25°C to obtain the active ingredient.

[0016] The pharmaceutical composition of the present invention is a conventional mixture, granules, tablets or capsules.

[0017] Hair loss is a common dermatological condition, including seborrheic alopecia, alopecia areata, and alopecia universalis. Its main manifestations include increased hair loss, thinning hair, a receding hairline, and hair follicle atrophy. Traditional Chinese Medicine (TCM) believes that "hair is the residue of blood," and increased hair loss is associated with blood deficiency. Based on years of clinical experience, the inventors have further proposed that the root cause of hair loss lies in spleen and kidney deficiency: the spleen and stomach are the hubs for the ascending and descending of Qi. Spleen deficiency prevents the ascending of Qi and blood, preventing them from reaching the scalp, resulting in fine, sparse hair. The kidneys are responsible for storing essence, and since essence and blood share a common origin, kidney essence deficiency leads to a deficiency in the body's Yin and Blood, leading to malnutrition and atrophy of hair follicles. These patients should be diagnosed with spleen and kidney deficiency, and treatment should focus on strengthening the kidneys and spleen, nourishing blood, and promoting hair growth.

[0018] This prescription uses Astragalus and Lycium barbarum as the main herbs, strengthening the spleen and replenishing Qi, nourishing the kidney and replenishing essence, and replenishing Qi and generating blood. Rehmannia glutinosa and Ligustrum lucidum as the auxiliary herbs, nourishing the kidney and yin, tonifying the liver and kidney, and assisting the main herbs in replenishing blood and darkening hair. It also has a suitable cold and heat effect, replenishing blood without hindering the spleen. Cuscuta chinensis, Morus alba, stir-fried Atractylodes macrocephala, Salvia miltiorrhiza, mulberry, and pine needles as auxiliary herbs, which not only assist the main herbs in strengthening the spleen and eliminating dampness, nourishing the kidney and nourishing Yin, but also enable the auxiliary herbs to replenish without stagnation. Angelica dahurica acts as an auxiliary herb, guiding the medicinal power upward to the pores of the scalp. The entire prescription works together to strengthen the kidney and spleen, nourish blood and promote hair growth, and has a suitable cold and warm effect, with a tonifying and dispersing effect.

[0019] The medication for treating spleen and kidney deficiency-related hair loss described in this invention is an optimized and streamlined version of existing medications for treating postpartum hair loss in women. Its improvements include: 1. In terms of medicinal properties, six herbs—Cyperus rotundus, Paeonia lactiflora, Curcuma zedoaria, Albizzia julibrissin bark, Taraxacum mongolicum, and Dictamnus radix—are omitted and replaced with Lycium barbarum (equivalent to replacing these six herbs with Lycium barbarum); 2. In terms of formula structure, Astragalus membranaceus is reused and combined with the added Lycium barbarum as the main ingredient. These improvements can produce the following beneficial effects: 1. Traditional Chinese Medicine believes that "the beauty of the kidney is in the hair" and "hair is the residue of blood." Abundant kidney essence and yin blood are prerequisites for good hair growth. Lycium barbarum, with its sweet taste and neutral nature, enters the kidney and liver meridians, tonifying the kidney and replenishing essence, as well as nourishing the liver and blood. Using it to replace the six herbs in the original formula that lack both blood-nourishing and kidney-tonifying properties better aligns with the core therapeutic approach. At the same time, although the original prescription contains Rehmannia glutinosa and Ligustrum lucidum fruit to nourish the kidney and yin, Rehmannia glutinosa is nourishing and Ligustrum lucidum fruit is cool, while Lycium barbarum fruit is neutral and not greasy, which can buffer the cold and greasy effects of other medicines, improve the spleen and stomach transportation and drug absorption, and is more in line with the treatment needs of "spleen deficiency"; second, Astragalus membranaceus and Lycium barbarum are used as the main medicines. Large doses of Astragalus membranaceus strengthen the acquired spleen to generate qi and blood, and Lycium barbarum nourishes the innate kidney to replenish the essence. The two are properly matched to form a strong synergistic effect of "strengthening the spleen to nourish the kidney, and nourishing the kidney to warm the spleen", highlighting the key points of the treatment method of "strengthening the spleen, replenishing qi and nourishing the kidney".

[0020] From the above analysis, it can be seen that the prescription of the present invention creatively introduces wolfberry, increases the dosage of astragalus, and removes the inappropriate six herbs, making the prescription structure more reasonable, more in line with the core treatment method of spleen and kidney deficiency type hair loss, and has significant clinical efficacy.

[0021] Animal experiments

[0022] 1. Drugs and reagents:

[0023] Patented prescription group: The medicine used in this group is the mixture of Example 1 below.

[0024] Control group: Take 20g of Astragalus, 15g of Atractylodes, 15g of Rehmannia, 15g of Salt Ligustrum lucidum fruit, 15g of Salt Cuscuta seed, 15g of Morus parasiticus, 15g of Salt Morus, 30g of Salvia miltiorrhiza, 10g of Red Peony Root, 15g of Vinegar-soaked Cyperus, 15g of Curcuma, 15g of Albizzia julibrissin bark, 15g of Taraxacum, 15g of Angelica dahurica, 15g of Dictamnus bark, and 15g of pine needles; add water and decoct three times, adding 8-12 times the amount of water each time. After boiling over high heat, simmer over low heat for 30-60 minutes. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a crude drug content of 4.371g / mL.

[0025] Positive drug group: Finasteride, purchased from Shanghai Yisheng Biotechnology Co., Ltd.

[0026] Modeling reagents: hydrocortisone, purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; testosterone, purchased from Shanghai Yisheng Biotechnology Co., Ltd.

[0027] Experimental animals: 40 Balb / c male mice, weighing 18-22 g, were purchased from Guangdong Medical Animal Experiment Center;

[0028] Experimental instruments: analytical balance (Guangzhou Xiangyi Mechanical and Electrical Equipment Co., Ltd.), low-temperature high-speed centrifuge (Germany Eppendorf).

[0029] 2 Experimental methods

[0030] 2.1 Method for establishing a mouse model of hair loss caused by spleen and kidney deficiency

[0031] Mice were gavaged with hydrocortisone (3.3 mg / kg) daily for 14 consecutive days. During the modeling period, the appearance indicators of the mice, such as coat condition, activity, spirit, food intake, body weight, stool characteristics, and weight changes, were observed; on the 15th day, the mice were shaved and the hair on the back was removed with a depilatory cream. Testosterone was applied to the back of the mice at a dose of 10 mg / kg for 21 days. The skin and hair growth of the depilated area of ​​each group of mice were observed every day, and the time when the skin color of the depilated area of ​​each mouse changed from pink to black and the time when hair began to grow were recorded. The model was considered successful when the back of the mouse was smooth and pink and the hair no longer grew.

[0032] 2.2 Animal grouping and drug administration

[0033] 40 mice were randomly divided into 5 groups (n=8):

[0034] Blank control group: gavage with normal saline;

[0035] Model group: modeling + oral administration of normal saline;

[0036] Positive drug group: modeling + oral administration of finasteride (0.5 mg / kg);

[0037] Control group: Modeling + oral administration of control decoction (clinically equivalent dose).

[0038] Patented formula group: modeling + oral gavage of patented formula decoction (clinically equivalent dose).

[0039] The drug was administered on the day of modeling and continued for 35 days, and samples were collected on the 36th day.

[0040] 2.3 Evaluation of spleen and kidney deficiency syndrome in mice

[0041] Diagnostic criteria for spleen and kidney deficiency in mice: Reference was made to the organ location syndrome criteria and deficiency criteria for mice reported in the literature: (1) Spleen: decreased appetite, abdominal distension, emaciation, diarrhea, anal prolapse, unstable gait, decreased activity, sluggish movement, shortened distance traveled by the head and back; anal prolapse; loose or wet stools, wet and rotten stools, mucous stools, foul diarrhea; abdominal masses or spleen lesions. (2) Kidney: old age, weakness, emaciation, dysplasia, reproductive and genital abnormalities, abnormal urine, drooping tail, or kidney lesions. Each item meeting the relevant criteria was scored as 1 point, and the total score for the spleen and kidneys was calculated.

[0042] 2.4 Mouse hair growth scoring

[0043] The skin and hair growth of the depilated areas of each group of mice were observed daily. The time it took for the skin color of the depilated area to change from pink to black and the time it began to grow hair were recorded. On the 36th day of the experiment, each group was photographed and recorded. A microscopic imaging system was used to perform macroscopic examinations, comparing hair growth across the 36-day period and scoring the following: no growth, flesh-colored skin in the depilated area, scored 0; gray skin in the depilated area, scored 1; black skin in the depilated area, scored 2; and black skin in the depilated area with some hair growth, scored 3.

[0044] 2.5 HE staining and histopathological examination of mouse back skin

[0045] On day 36 of the experiment, 1 cm x 1 cm lesions were harvested from the back for skin histology assessment. Animal skin tissue was stored in 10% buffered formalin at room temperature. The formalin-buffered skin tissue was dehydrated, embedded in paraffin, and cut into 4 μm sections using a microtome. The sections were hydrated, stained with hematoxylin and eosin (HE), and histologically observed under a microscope. Histological images of mice from different groups were compared to observe histopathological changes, namely, hair follicles, hair roots, dermal edema, and skin morphology.

[0046] 2.6 Statistical methods

[0047] The results were expressed as mean ± standard deviation (Mean ± SD). The data were compared with one-way ANOVA test to compare the significant differences among the groups, with P < 0.05 as the standard for statistically significant differences.

[0048] 3 Results

[0049] 3.1 Body weight changes of mice in each group

[0050] Compared with the control group, the mice in the model group showed reduced activity and a significant decrease in weight, which is consistent with the characteristics of mice with spleen and kidney deficiency syndrome. As the modeling time of spleen and kidney deficiency syndrome increases, the mice's fur becomes coarse, messy, and dull, their activity decreases, their spirits become listless, they become lazy, their food intake decreases, their appearance becomes noticeably thinner, their lips and nose become pale and dull, and their stools become dry and loose. After treatment with the patented prescription group, their weight has significantly decreased (Table 1), their mental state has significantly improved, and their stools have gradually formed, indicating that the patented prescription group can effectively improve the symptoms of weight loss in mice with spleen and kidney deficiency syndrome, and shows better efficacy than mice in the control prescription group (Table 2). Compared with the model group, the weight and symptom scores of mice in the control prescription group did not significantly improve, indicating that the control prescription group cannot effectively improve the symptoms of spleen and kidney deficiency syndrome.

[0051] Table 1 Comparison of body weight of mice in each group (g)

[0052]

[0053]

[0054] Note: #### Compared with the blank group, P<0.001; ns compared with the model group, P>0.05; *** compared with the model group, P<0.001; $$ compared with the control, P<0.01.

[0055] Table 2 Comparison of spleen and kidney deficiency syndrome scores in each group of mice

[0056]

[0057] Note: #### Compared with the blank group, P<0.001; ns compared with the model group, P>0.05; *** compared with the model group, P<0.001; $$$ compared with the control, P<0.001.

[0058] 3.2 Hair growth of mice in each group

[0059] The hair growth on the back of each group of mice on the 36th day was as follows Figure 1 As shown in the table, phenotypic data show that hair growth on the backs of mice in the model group was suppressed compared to the normal control group throughout the experimental period, demonstrating that the animal model of androgenic alopecia was successfully established and stable. After treatment with finasteride and the patented formula, mice showed significant hair growth on their backs, and the hair growth trend remained significant, indicating that finasteride and the patented formula significantly improved the symptoms of hair loss in mice (Table 3). Compared with the model group, there was no significant improvement in hair growth on the backs of mice in the control formula group, indicating that the control formula was ineffective in improving the symptoms of hair loss in mice.

[0060] Table 3 Hair growth scores of mice in each group

[0061]

[0062] Note: #### Compared with the blank group, P<0.001; ns, compared with the model group, P>0.05; *, compared with the model group, P<0.05; ***, compared with the model group, P<0.001; $$, compared with the control, P<0.01.

[0063] 3.3 HE staining of skin tissue morphology of mice in each group

[0064] HE staining of the skin tissue of the hair loss model mice showed that ( Figure 2 ): The skin structure of the blank control group was intact, the hair follicles were evenly distributed, and the epidermal thickness was normal; the model group showed typical pathological changes of hair loss, manifested as a significant decrease in the number of hair follicles, a decrease in the proportion of the growth phase, epidermal thickening, and inflammatory infiltration in the dermis; both the positive drug group and the patented formula group were able to effectively improve the above pathological changes, among which the drug-treated group had the most significant effect, which could significantly restore the number of hair follicles, the epidermal thickness was close to the normal level, and the inflammatory infiltration was significantly reduced.

[0065] 4 Conclusion

[0066] This study successfully established a composite animal model of spleen and kidney deficiency-type hair loss by continuous oral administration of hydrocortisone (3.3 mg / kg) for 14 days combined with testosterone application on the back skin. This model can simulate the pathological characteristics of clinical spleen and kidney deficiency combined with hair loss. The mice in the model group showed typical symptoms of spleen and kidney deficiency (significant weight loss, mental depression, etc.) and severe back hair loss. The experimental results showed that the patented prescription treatment group can significantly improve the symptoms of spleen and kidney deficiency (weight recovery, improved mental state, increased coat gloss and improved stool characteristics), while significantly reducing the degree of hair loss and reducing epidermal thickness. Its overall therapeutic effect is comparable to that of the positive control drug finasteride group, and the score is significantly better than that of the control group; although the control group showed some changes after treatment, there was no statistical difference. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Figure 1 Photos of skin lesions on the backs of mice in each group;

[0068] Figure 2 HE staining of skin tissue. DETAILED DESCRIPTION

[0069] Example 1 (composition)

[0070] 1. Prescription:

[0071] 150g of Rehmannia glutinosa, 120g of Cuscuta seed, 120g of Ligustrum lucidum fruit, 300g of Astragalus membranaceus, 150g of Lycium barbarum, 150g of Viscum album, 120g of stir-fried Atractylodes macrocephala, 150g of Salvia miltiorrhiza, 150g of mulberry, 100g of Angelica dahurica, and 150g of pine needles.

[0072] 2. Preparation method:

[0073] (1) Take the other medicinal ingredients of the above-mentioned medicine except Danshen, add 12 times the amount of water according to the formula, decoct for 1 hour and 50 minutes, add Danshen and continue to decoct for 10 minutes, filter, add 10 times the amount of water to the residue and decoct for 2 hours, filter, combine the two decoctions, and concentrate under reduced pressure to a relative density of 1 g / mL at 25°C to obtain the above-mentioned active ingredient;

[0074] (2) Add flavoring agents to the active ingredient obtained in step (1), sterilize, and package into 100 mL / bottle to obtain a mixture.

[0075] Example 2 (granules)

[0076] 1. Prescription:

[0077] 160g of Rehmannia glutinosa, 130g of Cuscuta seed, 130g of Ligustrum lucidum fruit, 320g of Astragalus membranaceus, 150g of Lycium barbarum, 140g of Viscum album, 110g of stir-fried Atractylodes macrocephala, 140g of Salvia miltiorrhiza, 140g of Mulberry fruit, 100g of Angelica dahurica, and 140g of pine needles.

[0078] 2. Preparation method:

[0079] (1) Take the other medicinal ingredients of the above-mentioned medicine except Danshen, add 12 times the amount of water according to the formula, decoct for 1 hour and 50 minutes, add Danshen and continue to decoct for 10 minutes, filter, add 10 times the amount of water to the residue and decoct for 2 hours, filter, combine the two decoctions, and concentrate under reduced pressure to a thick paste (active ingredient) with a relative density of 1.30 at 25°C;

[0080] (2) The thick paste obtained in step (1) is vacuum dried, and then the auxiliary materials required for granules are added and crushed, granulated, dried, granulated, and packaged into granules of 10g / bag.

[0081] Example 3 (composition)

[0082] 1. Prescription:

[0083] 150g of Rehmannia glutinosa, 130g of Cuscuta seed, 120g of Ligustrum lucidum fruit, 280g of Astragalus membranaceus, 150g of Lycium barbarum fruit, 160g of Viscum album, 130g of stir-fried Atractylodes macrocephala, 150g of Salvia miltiorrhiza, 150g of Mulberry fruit, 90g of Angelica dahurica, and 150g of pine needles.

[0084] 2. Preparation method:

[0085] Same as Example 1.

[0086] Example 4 (granules)

[0087] 1. Prescription:

[0088] 150g of Rehmannia glutinosa, 120g of Cuscuta seed, 130g of Ligustrum lucidum fruit, 310g of Astragalus membranaceus, 150g of Lycium barbarum fruit, 150g of Viscum album, 120g of stir-fried Atractylodes macrocephala, 140g of Salvia miltiorrhiza, 150g of Mulberry fruit, 100g of Angelica dahurica, and 140g of pine needles.

[0089] 2. Preparation method:

[0090] Same as Example 2.

[0091] Example 5 (composition)

[0092] 1. Prescription:

[0093] 150g of Rehmannia glutinosa, 130g of Cuscuta seed, 130g of Ligustrum lucidum fruit, 290g of Astragalus membranaceus, 150g of Lycium barbarum fruit, 140g of Viscum album, 130g of stir-fried Atractylodes macrocephala, 150g of Salvia miltiorrhiza, 150g of Mulberry fruit, 90g of Angelica dahurica, and 150g of pine needles.

[0094] 2. Preparation method:

[0095] Same as Example 1.

[0096] Example 6 (capsules)

[0097] The drug granules prepared according to the method of Example 1 were filled into gelatin capsules to prepare capsules.

[0098] Example 7 (tablet)

[0099] The drug granules prepared according to the method of Example 1 were added with powdered sugar, and 95% ethanol was used as a wetting agent to prepare a soft material. The granules were sieved through a 16-mesh sieve, dried, and compressed into tablets using a conventional method.

Claims

1. A pharmaceutical composition for treating alopecia due to spleen and kidney deficiency, the pharmaceutical composition comprising an active ingredient and medically acceptable excipients, wherein the active ingredient is prepared from the following raw materials in the following weight percentages: Rehmannia glutinosa 8-10%, Cuscuta chinensis 6-8%, Ligustrum lucidum 6-8%, Astragalus 16-20%, Lycium barbarum 8-10%, Viscum album 8-10%, stir-fried Atractylodes macrocephala 6-8%, Salvia miltiorrhiza 8-10%, Mulberry 8-10%, Angelica dahurica 5-7%, Pine needles 8-10%.

2. A pharmaceutical composition for treating spleen and kidney deficiency type hair loss according to claim 1, characterized in that, The active ingredient is made from the following raw materials in percentage by weight: Rehmannia glutinosa 9.0%, Cuscuta chinensis 7.2%, Ligustrum lucidum 7.2%, Astragalus 18.4%, Lycium barbarum 9.0%, Viscum album 9.0%, stir-fried Atractylodes macrocephala 7.2%, Salvia miltiorrhiza 9.0%, Mulberry 9.0%, Angelica dahurica 6.0%, Pine needles 9.0%.

3. A pharmaceutical composition for treating spleen and kidney deficiency type hair loss according to claim 1 or 2, characterized in that, The active ingredient is prepared by the following method: Take the other medicinal ingredients of the medicine except Salvia miltiorrhiza, add 12 times the amount of water according to the formula, decoct after 1 hour and 50 minutes, add Salvia miltiorrhiza and continue to decoct for 10 minutes, filter, add 10 times the amount of water to the residue and decoct for 2 hours, filter, combine the two decoctions, and concentrate under reduced pressure to a relative density of 1g / mL at 25°C to obtain the active ingredient.

4. A pharmaceutical composition for treating spleen and kidney deficiency type hair loss according to claim 3, characterized in that: The Chinese medicine composition is in the form of mixture, granules, tablets or capsules.

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