A syndrome-differentiated traditional Chinese medicine hair-growing ointment preparation

Abstract

The application discloses a traditional Chinese medicine hair blackening ointment preparation for syndrome differentiation and classification. The application provides a specific compounding scheme for three different syndromes of kidney deficiency type, blood heat type and liver stagnation type. The preparation takes prepared rehmannia root, madder, angelica, female privet fruit and cypress leaf as basic raw medicinal materials; on the basis, black sesame seed and medlar are added as the first auxiliary medicine for the kidney deficiency type, chrysanthemum and mulberry leaf are added as the second auxiliary medicine for the blood heat type, and bupleurum and bergamot are added as the third auxiliary medicine for the liver stagnation type. The application realizes the personalized and accurate treatment of the white hair disease by combining the syndrome differentiation and classification theory of traditional Chinese medicine, and improves the white hair problems of different constitutions through the personalized synergistic mechanism of kidney tonification and essence filling, blood nourishing and blood activating, blood cooling and hair blackening, and liver soothing and qi regulation. The white hair disease problems are solved from the internal conditioning, the medicinal materials and auxiliary medicines are all homologous varieties of medicine and food, are safe and non-toxic, are suitable for long-term use, and the preparation process is simple, and the effective rate is greatly improved compared with the general ointment.

Description

Technical Field

[0001] This invention relates to the field of hair darkening technology, specifically to a traditional Chinese medicine hair darkening ointment preparation based on syndrome differentiation. Background Technology

[0002] Gray hair refers to the partial or complete whitening of hair due to abnormal aging. It is a significant symptom affecting young and middle-aged people today, and it shows a clear trend of affecting younger people. Currently, the main methods for treating gray hair include external application and internal administration.

[0003] Topical treatments primarily involve hair dyes. Chemical hair dyes often contain ingredients like phenylenediamine, which, while providing good coloring, can easily cause contact dermatitis, and long-term use may damage hair follicles. Natural plant-based hair dyes, while gentler, suffer from poor color stability and require a long treatment time. Among oral treatments, chemical drugs such as hormones and nutrients may promote melanin production, but due to their broad involvement in regulating various life processes, they pose higher safety risks and have not yet become a routine treatment method.

[0004] Traditional Chinese medicine (TCM) and its compound formulas have a long history and wide application in treating gray hair. Among these, ointments are a significant dosage form for TCM hair-darkening due to their ease of absorption, pleasant taste, and suitability for long-term use. However, analysis of existing TCM hair-darkening ointments reveals that they are all generic formulas, failing to differentiate between TCM syndrome types or constitutions associated with gray hair. According to TCM theory, gray hair is related to various pathogenesis factors such as kidney deficiency, blood heat, and liver stagnation. The treatment principles for different syndrome types differ fundamentally: kidney deficiency requires tonifying the kidneys and replenishing essence, blood heat requires cooling the blood and clearing heat, and liver stagnation requires soothing the liver and regulating qi. Generic formulas cannot simultaneously address these diverse treatment needs, leading to poor results for some patients (especially those with liver stagnation or blood heat). This approach of treating multiple syndromes with one formula fails to reflect the core advantages of TCM's syndrome differentiation and treatment, and is ill-suited to meet the needs of personalized clinical treatment.

[0005] Therefore, how to provide a traditional Chinese medicine hair darkening ointment that can achieve personalized and precise treatment for different TCM syndromes of gray hair, so that patients with different syndromes such as kidney deficiency, blood heat, and liver stagnation can receive targeted treatment, is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine hair-darkening ointment preparation based on syndrome differentiation, thereby solving the technical problem that "existing general-purpose hair-darkening ointments are unable to meet the treatment needs of patients with different syndromes, resulting in poor efficacy for some syndromes".

[0007] To achieve the above objectives, the present invention is implemented using the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine hair darkening ointment preparation based on syndrome differentiation, characterized in that it includes basic raw materials and excipients, wherein the basic raw materials contain the following components in parts by weight: 1-6 parts of Rehmannia glutinosa, 1-5 parts of Rubia cordifolia, 1-3 parts of Angelica sinensis, 1-4 parts of Ligustrum lucidum, and 1-3 parts of Platycladus orientalis. The adjuvant drugs include: a first adjuvant drug for kidney deficiency type, a second adjuvant drug for blood heat type, and a third adjuvant drug for liver stagnation type.

[0008] The first adjuvant contains the following components in parts by weight: 1-2 parts black sesame seeds and 0.5-1.5 parts wolfberries.

[0009] The second adjuvant contains the following components in parts by weight: 0.5 to 2 parts of chrysanthemum and 0.5 to 1 part of mulberry leaf.

[0010] The third adjuvant contains the following components in parts by weight: 1-3 parts Bupleurum and 1-2 parts Citrus medica.

[0011] Secondly, the present invention provides a method for preparing a traditional Chinese medicine hair-darkening ointment based on syndrome differentiation, comprising the following steps: (1) According to the prescription based on syndrome differentiation, put the weighed raw materials into the decoction pot and add water to soak them; (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, add water after the decoction is finished, boil again and keep it simmering for 1 hour, combine the decoctions, remove the foam, and obtain the hair darkening cream preparation.

[0012] Specifically, in step (1), the amount of water added to the decoction pot is more than 10 cm above the surface of the herbs.

[0013] Specifically, the soaking time in step (1) is 10 to 14 hours.

[0014] Specifically, the decocting process described in step (2) is repeated 2 to 3 times.

[0015] Compared with the prior art, the beneficial effects achieved by the present invention are: (1) This invention designs exclusive formulations for common clinical types of gray hair such as kidney deficiency, blood heat, and liver stagnation. By adjusting the proportion of core ingredients in the basic formula or adding medicinal and edible auxiliary ingredients, it can match the core pathogenesis of different syndromes. Clinical experiments show that the effective rate of the hair darkening ointment of this invention for each syndrome type of gray hair is over 83%, of which the effective rate for kidney deficiency and blood heat types is over 90%, which is higher than that of the general basic formula. This fully reflects the core advantages of TCM syndrome differentiation and treatment and achieves precise treatment of gray hair.

[0016] (2) The present invention confirms by in vitro tyrosinase activation rate determination that the extracts of each embodiment have a good activation effect on the enzyme, with an activation rate of over 920%, indicating that the formula of the present invention can effectively promote melanin production and verify its hair darkening mechanism at the molecular level; among them, the kidney deficiency type has the highest activation rate, which is consistent with the clinical efficacy trend, reflecting the intrinsic relationship between the core treatment of tonifying the kidney and replenishing essence and the activity of key enzymes in melanin synthesis.

[0017] (3) The medicinal materials and excipients used in this invention are all Chinese medicines that are both food and medicine or can be used in health food. They have no obvious toxic side effects and avoid the safety risks of chemical drugs. The ointment dosage form has a good taste and is easy to absorb, making it suitable for long-term use by teenagers and young adults. The preparation process adopts the traditional ointment-making method, which is simple to operate and does not require special equipment. It is suitable for large-scale production, and the raw materials are readily available and the cost is controllable. Attached Figure Description

[0018] Figure 1 Photos of the hair of volunteers with different syndrome types before and after taking the hair darkening cream. Detailed Implementation

[0019] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0020] Based on the traditional Chinese medicine theory that hair is an extension of blood and the health of the kidneys is reflected in the hair, this invention believes that the occurrence of gray hair is closely related to kidney essence deficiency, internal disturbance of blood heat, and stagnation of liver qi. Accordingly, this invention uses Rehmannia glutinosa, Rubia cordifolia, Angelica sinensis, Ligustrum lucidum, and Platycladus orientalis leaves as the base formula, and adds medicinal and food-derived auxiliary medicines according to the characteristics of different syndrome types to achieve precise treatment based on syndrome differentiation.

[0021] Basic active pharmaceutical ingredients Rehmannia glutinosa (principal herb): It is sweet, warm and moist in nature, enters the liver and kidney meridians, and is specifically used to tonify the kidneys and replenish essence, nourish yin and blood, and can treat deficiency of essence and blood.

[0022] Madder root (assistant medicine): It cools the blood and stops bleeding, promotes blood circulation and removes blood stasis. It can clear heat and prevent the greasy and cloying nature of Rehmannia glutinosa from hindering the stomach. It can also clear the blood vessels in the scalp so that the nourishment is not stagnant.

[0023] Angelica sinensis (assistant herb): It is pungent, sweet, warm and moistening. It nourishes blood, invigorates blood circulation, regulates menstruation and moistens dryness. It works synergistically with Rehmannia glutinosa to enhance blood nourishment and also assists Rubia cordifolia in invigorating blood circulation and removing stagnation.

[0024] Ligustrum lucidum (adjuvant): Nourishes the liver and kidneys, darkens hair and improves eyesight, gently tonifies the liver and kidneys, and clears deficiency heat. It is an adjuvant to Rehmannia glutinosa.

[0025] Platycladus orientalis leaves (guide herb): bitter and slightly cold, cools the blood and stops bleeding, promotes hair growth and darkens hair, directly reaches the hair follicles, and can guide the above components to the head.

[0026] Significance of Syndrome Differentiation and Adjuvant Drug Compatibility Kidney deficiency type: The pathogenesis is deficiency of kidney essence and insufficiency of marrow. The treatment should focus on tonifying the kidney and replenishing essence. The proportion of prepared rehmannia root should be increased in the basic formula, and black sesame and wolfberry should be added. Black sesame is sweet and neutral, and it can tonify the liver and kidney and benefit essence and blood. Wolfberry is sweet and neutral, and it can nourish the liver and kidney and benefit essence and improve eyesight. Both of them are food and medicine, which can enhance the tonification of the kidney and replenishment of essence, so that the essence and blood are abundant and nourish the hair.

[0027] Blood-heat type: The pathogenesis is excessive heat in the blood, which scorches the pores. The treatment should be to cool the blood and clear heat. The proportion of madder root should be increased in the basic formula, and chrysanthemum and mulberry leaf should be added. Chrysanthemum is pungent, sweet, bitter and slightly cold, which can dispel wind-heat, calm the liver and improve eyesight; mulberry leaf is bitter, sweet and cold, which can dispel wind-heat, clear the lungs and moisten dryness. The two are mild and dispersing, and together with madder root and arborvitae leaf, they can clear the floating heat in the blood and improve the dry and hot environment of the scalp.

[0028] Liver Qi Stagnation Type: The pathogenesis is liver qi stagnation and poor blood circulation. The treatment should focus on soothing the liver and regulating qi. The basic formula is a balanced tonifying and purging formula, combined with Bupleurum and Buddha's Hand. Bupleurum is bitter, pungent and slightly cold, soothing the liver, relieving stagnation and raising yang qi; Buddha's Hand is bitter, pungent, sour and warm, soothing the liver, regulating qi, harmonizing the middle and resolving phlegm. The two are pungent and dispersing, promoting qi circulation and smoothing the flow of qi, so that essence and blood can reach the hair roots smoothly, making up for the insufficient liver-soothing power of the basic formula.

[0029] A traditional Chinese medicine hair-darkening ointment preparation based on syndrome differentiation, comprising the following raw materials in parts by weight: This invention provides a traditional Chinese medicine hair-darkening ointment preparation based on syndrome differentiation, characterized in that it comprises basic raw materials and excipients, wherein the basic raw materials comprise the following components in parts by weight: 1-6 parts of Rehmannia glutinosa, 1-5 parts of Rubia cordifolia, 1-3 parts of Angelica sinensis, 1-4 parts of Ligustrum lucidum, and 1-3 parts of Platycladus orientalis. The adjuvant drugs include: a first adjuvant drug for kidney deficiency type, a second adjuvant drug for blood heat type, and a third adjuvant drug for liver stagnation type.

[0030] The first adjuvant contains the following components in parts by weight: 1-2 parts black sesame seeds and 0.5-1.5 parts wolfberries.

[0031] The second adjuvant contains the following components in parts by weight: 0.5 to 2 parts of chrysanthemum and 0.5 to 1 part of mulberry leaf.

[0032] The third adjuvant contains the following components in parts by weight: 1-3 parts Bupleurum and 1-2 parts Citrus medica.

[0033] In this invention, Rehmannia glutinosa, Rubia cordifolia, Angelica sinensis, Ligustrum lucidum, and Platycladus orientalis leaves are used as the base formula. Customized formulations are designed for different types of gray hair, such as kidney deficiency, blood heat, and liver stagnation. The formula is made by adjusting the proportions of the base formula or adding medicinal and edible auxiliary materials. For the kidney deficiency type, the formula focuses on tonifying the kidney and adds black sesame and wolfberry. For the blood heat type, the formula focuses on cooling the blood and adds chrysanthemum and mulberry leaves. For the liver stagnation type, the formula is balanced and adds Bupleurum chinense and Citrus medica.

[0034] A method for preparing a traditional Chinese medicine hair-darkening ointment based on syndrome differentiation, comprising the following steps: (1) According to the compatibility, put the weighed raw materials into the decoction pot, add water and soak for 10-14 hours, the amount of water should be 10cm above the surface of the medicine; (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction. After one decoction is completed, add water to cover the surface of the medicine by 10 cm, boil again and keep it simmering for 1 hour. Repeat the same steps 2 to 3 times, combine the filtrates and concentrate them to remove the foam and obtain hair darkening ointment.

[0035] Raw material sourcing and quality control All medicinal materials used in this invention are prepared Chinese medicinal herbs that conform to the standards of the 2020 edition of the Pharmacopoeia of the People's Republic of China, specifically sourced as follows: Rehmannia glutinosa (purchased from Chongqing Kangdi Pharmaceutical Co., Ltd.), Rubia cordifolia (purchased from Hebei Qixin Chinese Medicine Granules and Slices Co., Ltd.), Angelica sinensis (purchased from Chongqing Kangdi Pharmaceutical Co., Ltd.), Ligustrum lucidum (purchased from Sichuan Wangsheng Pharmaceutical Group Co., Ltd.), and Platycladus orientalis leaves (purchased from Chongqing Kangdi Pharmaceutical Co., Ltd.). The auxiliary herbs for each syndrome type, including black sesame, wolfberry, chrysanthemum, mulberry leaf, Bupleurum chinense, and Citrus medica, are all medicinal and edible varieties, conforming to the 2020 edition of the Chinese Pharmacopoeia and relevant national food safety standards, ensuring the safety and quality controllability of the preparation.

[0036] Example 1: Hair Darkening Cream for Kidney Deficiency Formula: 6 parts Rehmannia glutinosa, 1 part Rubia cordifolia, 1 part Angelica sinensis, 1 part Ligustrum lucidum, 1 part Platycladus orientalis, 1 part black sesame, 0.5 parts Lycium barbarum.

[0037] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 10 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, then filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the kidney deficiency type hair darkening ointment.

[0038] Example 2; Hair Darkening Cream for Kidney Deficiency Formula: 4 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 2 parts Ligustrum lucidum, 2 parts Platycladus orientalis, 1.5 parts black sesame, and 1 part Lycium barbarum.

[0039] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, then filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the kidney deficiency type hair darkening ointment.

[0040] Example 3; Hair Darkening Cream for Kidney Deficiency Formula: 3 parts Rehmannia glutinosa, 5 parts Rubia cordifolia, 3 parts Angelica sinensis, 4 parts Ligustrum lucidum, 3 parts Platycladus orientalis, 2 parts black sesame, and 1.5 parts Lycium barbarum.

[0041] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 14 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, then filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the kidney deficiency type hair darkening ointment.

[0042] Example 4; Blood-Heat Type Hair Darkening Ointment Formula: 1 part Rehmannia glutinosa, 4 parts Rubia cordifolia, 2 parts Angelica sinensis, 3 parts Ligustrum lucidum, 2 parts Platycladus orientalis leaves, 2 parts Chrysanthemum morifolium, 0.5 parts Morus alba leaves.

[0043] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the blood heat type hair darkening ointment.

[0044] Example 5; Blood-Heat Type Hair Darkening Ointment Formula: 3 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 2 parts Ligustrum lucidum, 2 parts Platycladus orientalis leaves, 1 part Chrysanthemum morifolium, 1 part Morus alba leaves.

[0045] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the blood heat type hair darkening ointment.

[0046] Example 6; Blood-Heat Type Hair Darkening Ointment Formula: 2 parts Rehmannia glutinosa, 5 parts Rubia cordifolia, 1 part Angelica sinensis, 1 part Ligustrum lucidum, 2 parts Platycladus orientalis leaves, 0.5 parts Chrysanthemum morifolium, and 1 part Morus alba leaves.

[0047] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates and concentrate them to remove the foam, and obtain the blood heat type hair darkening ointment.

[0048] Example 7; Hair Darkening Cream for Liver Stagnation Formula: 3 parts Rehmannia glutinosa, 2 parts Rubia cordifolia, 1 part Angelica sinensis, 4 parts Ligustrum lucidum, 3 parts Platycladus orientalis, 3 parts Bupleurum chinense, and 1 part Citrus medica.

[0049] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates for concentration, remove the foam, and obtain the liver stagnation type hair darkening ointment.

[0050] Example 8; Hair Darkening Cream for Liver Stagnation Formula: 4 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 2 parts Ligustrum lucidum, 2 parts Platycladus orientalis, 1.5 parts Bupleurum chinense, 1.5 parts Citrus medica.

[0051] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates for concentration, remove the foam, and obtain the liver stagnation type hair darkening ointment.

[0052] Example 9; Hair Darkening Cream for Liver Stagnation Formula: 3 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 1 part Ligustrum lucidum, 3 parts Platycladus orientalis, 1 part Bupleurum chinense, 2 parts Citrus medica.

[0053] Preparation: (1) According to the formula, put the weighed raw materials into the decoction pot, add water and soak for 12 hours. The amount of water added is 10cm above the surface of the medicine. (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, and the first decoction is completed. Add water to cover the surface of the medicine by 10 cm, boil, and keep it simmering for 1 hour, filter out the decoction, and the second decoction is completed. Repeat the same steps to complete the third decoction. Combine the three filtrates for concentration, remove the foam, and obtain the liver stagnation type hair darkening ointment.

[0054] Comparative Example 1; General-purpose basic method Formula: 4 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 2 parts Ligustrum lucidum, 2 parts Platycladus orientalis leaves, prepared in the same way as in Example 2.

[0055] Comparative Example 2: Kidney deficiency type patients took the blood-heat type hair-darkening ointment of Example 6. Formula: 2 parts Rehmannia glutinosa, 5 parts Rubia cordifolia, 1 part Angelica sinensis, 1 part Ligustrum lucidum, 2 parts Platycladus orientalis leaves, 0.5 parts Chrysanthemum morifolium, and 1 part Morus alba leaves.

[0056] Preparation: Weigh the basic raw materials and excipients according to the above proportions, and decoct and concentrate them according to the preparation method described in Example 6 to obtain the blood-heat type hair-darkening ointment.

[0057] Comparative Example 3: Patients with blood-heat type took the liver-stagnation type hair-darkening ointment of Example 8. Formula: 3 parts Rehmannia glutinosa, 3 parts Rubia cordifolia, 2 parts Angelica sinensis, 2 parts Ligustrum lucidum, 2 parts Platycladus orientalis, 1.5 parts Bupleurum chinense, 1.5 parts Citrus medica.

[0058] Preparation: Weigh the basic raw materials and excipients according to the above proportions, and decoct and concentrate them according to the preparation method described in Example 8 to obtain the liver stagnation type hair darkening ointment.

[0059] Test Results Test Example 1: Pharmacological Test of Hair Darkening Ointment Test method: Adolescent volunteers aged 14-35 years, regardless of gender, diagnosed by traditional Chinese medicine with gray hair of blood-heat type, kidney deficiency type, or liver stagnation type were selected. They were randomly divided into three groups according to their syndrome type, with no less than 12 cases in each group. Volunteers in each group were randomly given the hair-darkening ointment preparations of Examples 2, 5, 8 and Comparative Examples 1-3 of this invention. The method of administration was once a day, 1-2 mL orally each time (swallowed directly or taken with warm water) for 60 consecutive days.

[0060] Figure 1 Photos of the hair of volunteers with different disease types before and after taking the hair-darkening cream. Figure 1 (a) Photos of volunteers with kidney deficiency and liver stagnation before taking the medication, respectively. Figure 1 (b) Photos of volunteers with kidney deficiency and liver stagnation after 60 days of treatment, respectively. Figure 1 It can be seen that after taking the medication for 60 days, the volunteers' gray hair decreased and their hair color turned black.

[0061] Table 1

[0062] As shown in Table 1, the efficacy rates of the various types of hair darkening ointments of the present invention (Examples 2, 5, and 8) after 60 days of use ranged from 83% to 92%. Among them, the efficacy rate of Example 2 (Kidney Deficiency Type) was the highest, reaching 91.67%, while the efficacy rates of Example 5 (Blood Heat Type) and Example 8 (Liver Stagnation Type) were both 83.33%.

[0063] The efficacy rate of Comparative Example 1 (general basic formula) was 58.33%, which was lower than that of each dialectical example.

[0064] The efficacy rates of Comparative Example 2 (patients with kidney deficiency taking the blood-heat type formula) and Comparative Example 3 (patients with blood-heat type taking the liver-stagnation type formula) were 41.67% and 33.33%, respectively, which were far lower than those of the corresponding example groups.

[0065] The results showed that the syndrome differentiation and combination of the present invention can improve the clinical efficacy. Mismatch of syndrome differentiation or failure to differentiate syndromes will lead to a significant decrease in the effective rate. The effect of hair darkening cream is relatively limited when the number of gray hairs is more than 50% or the gray hair is related to genetic factors. In addition, some volunteers did not show obvious changes in gray hair during the cycle, which is related to individual absorption differences. It is necessary to extend the duration of use to further improve the effect.

[0066] Tyrosinase activation rate test: The activation effect of each embodiment and comparative example on tyrosinase, a key enzyme in melanin production, was evaluated by in vitro tyrosinase activity assay, and its hair darkening potential was verified at the molecular level.

[0067] Take the Chinese herbal medicine slices from Examples 1-9 and Comparative Example 1 respectively, mix them according to the corresponding compatibility ratio, pulverize them, pass them through a 40-mesh sieve, accurately weigh 10g of each sample powder, put them into a Chinese herbal medicine bag, place them in a decoction container, add 10 times the amount of water and soak for 30 minutes, decoct three times (keeping a gentle boil for 1 hour after each boiling), combine the filtrates, concentrate and make up to 100mL, to prepare a decoction with a mass concentration of 100g·L⁻¹. - The herbal extract ¹ is refrigerated at 4°C for later use.

[0068] Preparation of Phosphate Buffered Sodium (PBS): Prepare a PBS solution with pH 6.8 by disodium hydrogen phosphate and sodium dihydrogen phosphate.

[0069] L-Tyrosine Solution: Accurately weigh L-tyrosine and prepare a 1 mg / mL solution with PBS. - ¹ of the solution.

[0070] Tyrosinase solution: Dilute with PBS to 200 U / mL immediately before use. - ¹.

[0071] Determination Procedure: Take 4 test tubes and label them C1, C2, T1, and T2 respectively. Add 0.5 mL of deionized water and 2 mL of PBS to C1; add 1 mL of L-tyrosine solution, 0.5 mL of deionized water, and 1.0 mL of PBS to C2; add 0.5 mL of traditional Chinese medicine extract and 2 mL of PBS to T1; add 1 mL of L-tyrosine solution, 0.5 mL of traditional Chinese medicine extract, and 1.0 mL of PBS to T2. Incubate the four mixtures (C1, C2, T1, and T2) in a constant temperature incubator at 37℃ for 30 min, then add 0.5 mL of tyrosinase solution to each mixture, shake well, and react for 5 min. Immediately afterward, measure the absorbance (A) at 475 nm.

[0072] Calculate the tyrosinase activation rate I using the following formula.

[0073] I=[(A T2 -A T1 )-(A C2 -A C1 )] / (A C2 -A C1 )×100%, Among them: A T1 A T2 A C1 A C2 The absorbance of the corresponding mixtures after enzyme reaction was measured at 475 nm, and the specific results are shown in Table 2.

[0074] Table 2

[0075] As shown in Table 2, the tyrosinase activation rates of the syndrome differentiation groups (Examples 1-9) were generally high, all above 920%. Among them, the activation rate of Example 2 (Kidney Deficiency Type) was the highest, reaching 1285.3%, followed by Example 5 (Blood Heat Type) at 1103.8%, and Example 8 (Liver Stagnation Type) at 992.6%. The results indicate that the hair-darkening ointment of the present invention has a positive activating effect on tyrosinase in all syndrome differentiation groups, and can effectively promote melanin production, thus verifying its hair-darkening potential at the molecular level.

[0076] The activation rate of Comparative Example 1 was 850.2%, which showed some activation effect, but was lower than that of each syndrome differentiation group, indicating that adding adjuvant drugs and adjusting the ratio can enhance the activation effect of tyrosinase.

[0077] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No markings in the claims should be construed as limiting the scope of the claims.

Claims

1. A traditional Chinese medicine hair-darkening ointment preparation based on syndrome differentiation, characterized in that, It includes basic active pharmaceutical ingredients and excipients. The basic active pharmaceutical ingredients contain the following components in parts by weight: 1-6 parts Rehmannia glutinosa, 1-5 parts Rubia cordifolia, 1-3 parts Angelica sinensis, 1-4 parts Ligustrum lucidum, and 1-3 parts Platycladus orientalis. The adjuvant drugs include: a first adjuvant drug for kidney deficiency type, a second adjuvant drug for blood heat type, and a third adjuvant drug for liver stagnation type.

2. The hair-darkening cream preparation according to claim 1, characterized in that, The first excipient contains the following components in parts by weight: 1-2 parts black sesame seeds and 0.5-1.5 parts wolfberries.

3. The hair-darkening cream preparation according to claim 1, characterized in that, The second adjuvant contains the following components in parts by weight: 0.5 to 2 parts of chrysanthemum and 0.5 to 1 part of mulberry leaf.

4. The hair-darkening cream preparation according to claim 1, characterized in that, The third adjuvant contains the following components in parts by weight: 1-3 parts Bupleurum and 1-2 parts Citrus medica.

5. A method for preparing the hair-darkening cream formulation according to any one of claims 1-4, characterized in that, Includes the following steps: (1) According to the prescription based on syndrome differentiation, put the weighed raw materials into the decoction pot and add water to soak them; (2) First heat to a boil, then keep it simmering for 1 hour, filter out the decoction, add water after the decoction is finished, boil again and keep it simmering for 1 hour, combine the decoctions, remove the foam, and obtain the hair darkening cream preparation.

6. The method according to claim 5, characterized in that, The amount of water added to the decoction pot in step (1) is 10 cm above the surface of the herbs.

7. The method according to claim 5, characterized in that, The soaking time in step (1) is 10 to 14 hours.

8. The method according to claim 5, characterized in that, The decocting process described in step (2) is repeated 2 to 3 times.

9. The use of the hair-darkening ointment preparation according to any one of claims 1-4 in the preparation of a medicine for treating gray hair of the kidney deficiency type, blood heat type, or liver stagnation type.

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