CN114288309B

CN114288309B - A composition containing pulsatilla saponin B5 as effective component for promoting hair growth

Info

Publication number: CN114288309B
Application number: CN202210056919.7A
Authority: CN
Inventors: 郭秋岩; 王继刚
Original assignee: Institute of Materia Medica of CAMS
Current assignee: Guangxi Xinhai Pharmaceutical Technology Co Ltd
Priority date: 2022-01-18
Filing date: 2022-01-18
Publication date: 2022-11-01
Anticipated expiration: 2042-01-18
Also published as: CN114288309A

Abstract

The invention discloses a composition for promoting hair growth, which contains pulsatilla saponin B5 as an effective component. Experiments show that the pulsatilla saponin B5 can promote the hair growth of a mouse depilation region, improve the growth speed and increase the number of hair follicles, and has the advantages of no toxic or side effect, low cost and quick response. Therefore, the pulsatilla chinensis saponin B5 and preparation auxiliary materials can be used for preparing a composition or a medicament for promoting hair growth.

Description

A composition containing pulsatilla saponin B5 as effective component for promoting hair growth

Technical Field

The invention relates to the field of medicines, and in particular relates to a composition for promoting hair growth, which contains pulsatilla saponin B5 as an active ingredient.

Background

Alopecia is a common intractable disease characterized by hair loss, which can be caused by various factors, such as mental stress, dietary imbalance, infection, hormones, immunity, heredity, and the like. The current FDA approved drugs for promoting hair growth are minoxidil and finasteride. Although these drugs can promote hair growth to some extent, there are inevitable side effects. The long-term use of minoxidil can cause edema or arrhythmia, and after 6 months or 1 year, the efficacy is weakened; finasteride can lead to sexual dysfunction, depression or suicidal ideation, and even increase the probability of birth defects. In addition, the two drugs for promoting hair growth have poor efficacy and high price in treatment. Therefore, the development of a composition for promoting hair growth, which has no toxic or side effect, takes effect quickly and has low cost, is urgently needed.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides a composition for promoting hair growth, which comprises the pulsatilla saponin B5 as an effective component.

The invention discloses a composition for promoting hair growth, which contains pulsatilla chinensis saponin B5 as an effective component, and the composition comprises pulsatilla chinensis saponin B5 and preparation auxiliary materials.

Pulsatillae saponin B5 has molecular formula of C₅₉H₉₈O₂₆The molecular weight is 1223.41, and the structure is shown in formula (I):

further, the composition is any one of shampoo, hair conditioner, hair care essential oil, hair care essence, hair care spray, hair tonic, hair spray, hair lotion, hair mask, hair setting agent, mousse, hair treatment gel and hair dye.

The invention also provides a medicine for promoting hair growth, which contains the pulsatilla saponin B5 as an effective component, and a composition for promoting hair growth.

Further, the medicament is any one of emulsion, cream, pill, dripping pill, capsule, granule, powder, liniment, cataplasm, spray, oral liquid, decoction, injection, sustained release preparation or controlled release preparation.

Further, the effective concentration of the pulsatilla chinensis saponin B5 is 0.5-2 mg/mL.

The invention also provides application of the pulsatilla saponin B5 in preparing a composition for promoting hair growth; the composition is in any form selected from the group consisting of shampoo, hair conditioner, hair care essential oil, hair care essence, hair care spray, hair tonic, hair gel, hair lotion, hair mask, hair setting agent, mousse, hair treatment gel, and hair dye.

The invention also provides application of the pulsatilla saponin B5 in preparation of a medicine for promoting hair growth.

The invention also provides application of the pulsatilla saponin B5 as a unique active ingredient in preparation of the composition.

The invention also provides application of the pulsatilla saponin B5 as a unique active ingredient in preparation of the medicine.

In conclusion, compared with the prior art, the invention achieves the following technical effects:

1. aiming at the current clinical drug requirements which need to be solved urgently for promoting hair growth, the invention discovers a new application of pulsatilla chinensis saponin B5 in effectively promoting hair growth.

2. Compared with the existing western medicines, the pulsatilla chinensis saponin B5 has low price, reduces the treatment cost, relieves the economic burden of patients, and meets the current clinical requirements.

3. The pulsatilla chinensis saponin B5 is used as an effective component of a composition or a medicament, and has good safety and no toxic or side effect.

4. The composition for promoting hair growth, which contains the pulsatilla saponin B5 as the active ingredient, can take effect after being continuously used for 2 weeks, and has the advantages of quick response and short treatment period.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a photograph of the skin of the hair-removed area of the back of each group of mice according to the present invention.

FIG. 2 shows HE staining results of skin at hair-removed areas of mice in each group according to the present invention.

FIG. 3 shows statistics of hair follicle counts in various groups of mice according to the present invention.

FIG. 4 is a hair growth rate score for each group of mice in accordance with the present invention.

FIG. 5 is a statistical result of the body weights of the mice in each group according to the embodiment of the present invention.

Detailed Description

In order to make those skilled in the art better understand the technical solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, shall fall within the scope of protection of the present invention.

Reagents, methods and apparatus used in the present invention are conventional in the art unless otherwise indicated.

Example 1

(1) Laboratory animal

Purchased from the national institute for food and drug testing, KM mice, males, 18-20g, spf grades, production license number: SCXK2017 (Jing) -0005. Feeding in animal center of Chinese medicine basic theory research institute of Chinese academy of traditional Chinese medicine in barrier environment with license number SYXK (Jing) 2021-0017.

(2) Experimental reagent

Depilatory agent: WEITING depilatory cream, manufactured by LIJIEZENG (France) Limited. Import cosmetic approval document No.: a cosmetic special letter J20130034; positive minoxidil liniment: shanxi Dong Ant Bio-pharmaceuticals, inc.

(3) Molding and administration method

The backs of the mice in the other groups were all depilated except for the normal control group.

Animal grouping: blank group, model group, matrix vaseline group, pulsatilla saponin B5-low dose group, pulsatilla saponin B5-medium dose group, pulsatilla saponin B5-high dose group, and positive drug minoxidil liniment, wherein each group contains 10 mice. Dissolving pulsatilla saponin B5 and minoxidil liniment of each group by using vaseline, administering matrix group vaseline to the vaseline group, wherein low, medium and high doses of pulsatilla saponin B5 are respectively 0.5, 1 and 2mg/mL, administering for 2 times every day, continuously administering for 2 weeks, taking materials, taking the mice of each group, removing the skin of a hair area, fixing, performing HE (high-intensity eosin) staining, and counting the number of hair follicles under a microscope.

(4) Observation index

(A) Back hair growth condition

The degree of skin growth in the hairless area on the back of each group of mice is compared by taking photographs to evaluate the speed of hair growth (the scoring standard is according to the reference document [ summer, dawn, summer star, he Weiping, zhu Yun, gingko hair growth mixture promotes the effect research of the hair growth of the mice, guangxi traditional Chinese medicine, 2013,36 (05): 69-72] is that hairless growth is-0 point, light hair grows to fill the hairless area-1 point, the length and density of new hair are about half of the hairless area-2 points, and the length and density of new hair are no different from the hairless area by-3 points);

(B) Number of hair follicles in skin

After the mice were sacrificed, the skin tissues on the back were fixed, and the number of hair follicles in the skin was counted by paraffin section HE staining to evaluate the efficacy of promoting hair growth.

After 2 weeks of continuous administration, skin pictures of the back depilated areas of each group of mice are taken, as can be seen from fig. 1, the hair growth of the model group is less, the dissolved matrix vaseline has no significant influence on the hair growth, the matrix has no hair growth promoting effect, and the low, medium and high doses of the pulsatilla saponin B5 and the positive minoxidil tincture can promote the hair growth of the back depilated areas of the mice to different degrees. The skin of each group of mice is taken, embedded and sliced, and then HE staining is carried out, the HE staining result is shown in figure 2, and the result shows that the number of hair follicles of the low, medium and high dose groups of the pulsatilla saponin B5 is obviously increased compared with that of the model group; counting the number of hair follicles in skin tissues of each group of mice according to the HE staining picture, and obtaining a result shown in figure 3, wherein compared with a blank group, the number of hair follicles in skin in a back hair removal area of the model group of mice is obviously reduced; the matrix vaseline has no obvious influence on the hair growth; the low, medium and high dose groups of the pulsatilla saponin B5 can obviously increase the number of hair follicles in the skin of the hair-removed area of the back of the mouse. The results of fig. 2 and 3 demonstrate that pasqueflower saponin B5 does have the effect of increasing the number of hair follicles. The hair growth rate scores of the mice in each group are shown in figure 4, and as can be seen from figure 4, the hair growth rate scores of the matrix vaseline group and the model group are not obviously different, which indicates that the dissolving matrix has no hair growth promoting effect; compared with the model group, the pulsatilla saponin B5 high-dose group significantly accelerated the hair growth rate of the hair removal area on the back of the mice. In addition, the results in fig. 5 show that the administration time of 2 weeks has no significant effect on the body weight of the mice, which indicates that the pulsatilla saponin B5 has no toxic or side effect on the mice.

In summary, it can be determined that the following technical effects can be achieved by using the pulsatilla saponin B5:

(1) Promoting the hair growth of the mouse depilation area.

(2) The hair growth speed is improved.

(3) Increasing the number of hair follicles.

(4) Has no toxic and side effects.

(5) Can take effect after being continuously administrated for 2 weeks, and has quick response and short treatment period.

The present invention can be produced in various embodiments depending on the kind of components, content of components, dosage form, and the like. For example:

embodiment 1: a washing and protecting product taking the pulsatilla saponin B5 as an effective component;

can be prepared into any form selected from the group consisting of hair essence, hair conditioner, hair care essential oil, hair care essence, hair care spray, hair tonic, hair gel, hair lotion, hair mask, hair setting agent, mousse, hair treatment gel, and hair dye.

Embodiment 2: an emulsion or cream containing Pulsatillae saponin B5 as effective component;

generally, a semisolid at normal temperature is called a cream, a fluid state is called a milk or an emulsion, and the emulsion is two liquids which are not mutually soluble, wherein one phase is dispersed in the other phase as tiny droplets to form a system, and one phase existing in the form of liquid beads is generally matched as a dispersed phase or an internal phase and the other phase is matched as a dispersed medium or an external phase.

Common auxiliary materials for the lotion or cream are: emulsifier, antioxidant, tackifier, pH regulator and oily material.

Emulsifier: the addition of an emulsifier is necessary to form a stable emulsion.

pH regulator: to avoid excessive irritation and to improve stability, buffer solutions are commonly used to stabilize the pH of the solution. Commonly used buffer solutions include boric acid buffer, phosphate buffer, and the like.

Tackifier: methylcellulose (MC), polyvinyl alcohol (PVA), carbomer, povidone (PVP) and the like are commonly used, and CMC-Na is not commonly used because of incompatibility with alkaloid salt and chlorhexidine.

Oily raw materials: emulsions or creams often incorporate various oily materials which contribute to their shaping, stabilizing or imparting color, fragrance and other characteristics, and these materials are formulated in relatively small but extremely important amounts. Mainly comprises grease, such as wax, hydrocarbon and synthetic grease.

Embodiment 3: an oral liquid containing Pulsatillae saponin B5 as effective component;

taking oral liquid as an example, the oral liquid is a new formulation developed on the basis of decoction and injection, has the advantages of small dosage, quick absorption, stable quality, convenient carrying and taking and easy storage, contains various effective components, and has great influence on quality and taste. On the premise of not changing the structure and the function of the main active ingredients, how to retain the active ingredients to the maximum extent and improve the taste is a difficulty of selecting auxiliary materials. The oral liquid can be added with auxiliary materials to improve the taste, the clarity, the stability and the product quality.

The common auxiliary materials of the oral liquid comprise: solvent, aromatic, correctant, clarifier, antiseptic, etc., and these adjuvants can be added simultaneously or optionally, wherein the solvent is essential and water can be used. The different adjuvants are combined with sweetener, aromatic, clarifying agent or antiseptic, or the combination of sweetener and antiseptic, preferably the combination of sweetener and antiseptic. Part of the auxiliary materials have the functions of sweetening and enhancing the fragrance, and only one auxiliary material needs to be added at the moment.

For oral liquids, preferably, the sweetener is selected from one or more of aspartame, xylitol, aspartame and sucralose.

For the oral liquid, preferably, the preservative is selected from one or more of paraben, butyl hydroxyanisole, butyl hydroxytoluene and sorbic acid.

The antiseptic can be selected from p-hydroxybenzoate, butylhydroxytoluene or sorbic acid, preferably butylhydroxytoluene. Combinations may also be used, for example, of hydroxybenzoate esters with butylhydroxytoluene, or butylhydroxytoluene with sorbic acid, or parabens, butylhydroxytoluene and sorbic acid.

For oral liquid, preferably, the aromatic is fruit essence.

For oral liquid, preferably, the clarifying agent is one or a mixture of chitosan and gelatin.

Embodiment 4: a tablet with pulsatilla chinensis saponin B5 as an active ingredient;

the tablet has the advantages of accurate dosage, stable quality, convenient administration, carrying and transportation, etc.

For tablets, the formulation auxiliary materials comprise one or more of diluent, binder, lubricant and disintegrant, and the combination of diluent, binder, lubricant and disintegrant is preferred.

For tablets, preferably, the diluent is one or more of cellulose and inorganic salts. Such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw material and assist the shaping.

For tablets, preferably, the binder is one or more of water, ethanol, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin, polyvinylpyrrolidone, and the like.

For tablets, preferably, the lubricant is one or more of magnesium stearate, aerosil, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.

For the tablet, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, crospovidone, croscarmellose sodium and the like.

Embodiment 5: a capsule taking the pulsatilla saponin B5 as an effective component;

in the present invention, the capsule mainly improves stability and bioavailability. The preparation auxiliary material is a capsule shell, and the capsule shell is a hard capsule shell or a soft capsule shell.

Embodiment 6: granule containing Pulsatillae saponin B5 as effective component;

the granule can be directly swallowed or drunk by infusing with warm water, and has convenient application and carrying, and rapid dissolution and absorption. The formulation adjuvants used in the granule are similar to those used in tablet, and include one or more of filler, binder, wetting agent, disintegrant, lubricant and film coating material.

For granules, preferably, the filler is one or more of cellulose and inorganic salts. Such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw material and assist the shaping.

For the granules, preferably, the binder is one or more of water, ethanol, sodium carboxymethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, gelatin, polyvinylpyrrolidone, and the like.

For granules, preferably, the wetting agent is water or ethanol or a mixture of both. Such as one or more of magnesium stearate, aerosil, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.

For granules, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, crospovidone, croscarmellose sodium, and the like.

For granules, preferably, the film coating material is one or more of hydroxypropyl methylcellulose, polyethylene glycol, cellulose acetate phthalate and polyvinyl acetal diethylamine acetate.

Embodiment 7: a powder containing Pulsatillae saponin B5 as effective component.

The invention can also be prepared into powder, and the powder is convenient to be divided into dose and taken.

Taking beverage as an example, the composition of the invention can be prepared into beverages with different flavors, and is popular as daily beverage.

The preparation adjuvant used for beverage is at least one of clarifier, antiseptic and flavoring agent.

The composition of the invention can also be prepared into other powders, such as functional milk powder, and the added auxiliary materials are mainly milk powder, such as skimmed milk powder and skimmed sugar-free milk powder.

The above embodiments can adjust the dosage of the unit product to suit different applications, such as medicines, health products, foods, etc.

In view of the above embodiments, the present invention discloses a composition for promoting hair growth, comprising pasqueflower saponin B5 as an active ingredient. The composition comprises pulsatilla chinensis saponin B5 and preparation auxiliary materials. Experiments show that the pulsatilla saponin B5 can promote the hair growth of a mouse depilation region, improve the growth speed and increase the number of hair follicles, and has the advantages of no toxic or side effect, low cost and quick response. Therefore, the pulsatilla saponin B5 and preparation auxiliary materials can be used for preparing a composition or a medicament for promoting hair growth.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The application of the pulsatilla chinensis saponin B5 as the only active ingredient in preparing the composition for promoting hair growth; the composition is in any form selected from the group consisting of shampoo, hair conditioner, hair care essential oil, hair care essence, hair care spray, hair tonic, hair gel, hair lotion, hair mask, hair setting agent, mousse, hair treatment gel, and hair dye.

2. The application of the pulsatilla saponin B5 as a unique active ingredient in preparing a medicament for promoting hair growth; the medicine is any one of lotion, cream, powder, liniment, cataplasma and spray.