CN115487245A

CN115487245A - Blood nourishing and hair growth promoting ointment and preparation method thereof

Info

Publication number: CN115487245A
Application number: CN202211298106.5A
Authority: CN
Inventors: 刘乾; 杨景锋; 程锴; 郭怡佳; 张潇; 程都
Original assignee: Shaanxi University of Chinese Medicine
Current assignee: Shaanxi University of Chinese Medicine
Priority date: 2022-10-21
Filing date: 2022-10-21
Publication date: 2022-12-20
Anticipated expiration: 2042-10-21
Also published as: CN115487245B

Abstract

The invention discloses a blood nourishing and hair growth promoting ointment which is prepared from the following raw materials in percentage by weight: 12.5 percent of radix rehmanniae recen, 6.25 percent of angelica, 4.17 percent of hemlock parsley, 6.25 percent of raw white peony root, 12.5 percent of mulberry, 6.25 percent of black sesame, 4.17 percent of donkey-hide gelatin, 12.5 percent of glossy privet fruit, 6.25 percent of eclipta, 12.5 percent of cacumen biotae, 6.25 percent of hawthorn, 4.16 percent of dried orange peel and 6.25 percent of medlar. The blood nourishing and hair growing cream can nourish blood sources, nourish yin and grow hair, is suitable for parturients in recovery period, patients with chronic diseases, sub-health people and the like in abnormal condition groups such as alopecia and the like caused by deficiency of qi and blood for a long time, and is particularly suitable for alopecia groups caused by menorrhagia and postpartum deficiency.

Description

Blood nourishing and hair growth promoting ointment and preparation method thereof

Technical Field

The invention belongs to the technical field of hair nourishing traditional Chinese medicine ointment, and particularly relates to a blood nourishing and hair growth promoting ointment and a preparation method thereof.

Background

Postpartum alopecia is a symptom which is easy to appear in puerperium of women, and is usually generated 2-7 months after the women are born, according to statistics, about 35-45% of women have alopecia with different degrees after childbirth, such as alopecia symptom is not obvious, can recover naturally without coordination, and if the alopecia symptom is obvious or accompanied by insomnia, mental fatigue, hypodynamia, less milk and other symptoms, the postpartum alopecia needs to be treated.

Disclosure of Invention

The technical problem to be solved by the invention is to overcome the defects of the prior art and provide a blood-nourishing and hair-growing cream and a preparation method thereof.

The technical scheme for solving the technical problems is as follows: a paste for nourishing blood and promoting hair growth is prepared from the following raw materials in percentage by weight: 12.5 percent of radix rehmanniae recen, 6.25 percent of angelica, 4.17 percent of hemlock parsley, 6.25 percent of raw white peony root, 12.5 percent of mulberry, 6.25 percent of black sesame, 4.17 percent of donkey-hide gelatin, 12.5 percent of glossy privet fruit, 6.25 percent of eclipta, 12.5 percent of cacumen biotae, 6.25 percent of hawthorn, 4.16 percent of dried orange peel and 6.25 percent of medlar.

The preparation method of the blood nourishing and hair growth promoting ointment comprises the following steps:

(1) Mixing radix rehmanniae, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, radix Paeoniae alba, mori fructus, semen Sesami Niger, colla Corii Asini, fructus Ligustri Lucidi, ecliptae herba, folium Platycladi, fructus crataegi, pericarpium Citri Tangerinae and fructus Lycii, decocting with water for three times, the first time for 2 hr, the second time for 1.5 hr, the third time for 1.5 hr, and the third time for 100-120 deg.C.

(2) Mixing decoctions decocted for three times in the step (1), filtering with a 100-mesh sieve, and concentrating the filtrate into a clear paste concentrated solution;

(3) And (3) pulverizing 100g of donkey-hide gelatin, sieving with a 100-mesh sieve, adding the clear paste obtained in the step (2), stirring until the clear paste is completely melted, adding 120-180 g of refined honey, stirring uniformly, decocting with slow fire, and continuously stirring to obtain the blood-nourishing and hair-growing paste.

Further, the ratio of the amount of the Chinese medicinal materials in the clear paste concentrated solution to the water content in the step (2) is 1.25-1.28.

Further, the ratio of the amount of the medicinal materials of the blood-nourishing and hair-growing paste to the water content in the step (3) is not less than 1.32.

The blood nourishing and hair growing cream can nourish blood sources and yin and grow hair, is suitable for parturients in recovery period, patients with chronic diseases, sub-health people and other people with body quality deviation state such as alopecia caused by deficiency of qi and blood for a long time, and is particularly suitable for alopecia people with menorrhagia and postpartum deficiency.

Drawings

FIG. 1 shows the hair growth of the mice of each group in the animal experiment of the present invention.

FIG. 2 is a graph showing the hair growth scores of the groups of mice in the animal experiment

FIG. 3 is a cross-sectional view of the skin tissue of each group of mice in the animal experiment.

FIG. 4 is a longitudinal section of the skin tissue of each group of mice in the animal experiment.

FIG. 5 shows the measurement of the liver and kidney function of a mouse orally administered with the blood-nourishing and hair-growing ointment in an animal experiment.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

The blood nourishing and hair growth promoting cream is prepared from the following raw materials in parts by mass: 125g of radix rehmanniae recen, 62.5g of angelica sinensis, 41.7g of ligusticum wallichii, 62.5g of raw white peony root, 125g of mulberry, 62.5g of black sesame, 41.7g of donkey-hide gelatin, 125g of glossy privet fruit, 62.5g of herba ecliptae, 125g of cacumen biotae, 62.5g of hawthorn, 41.6g of dried orange peel and 62.5g of medlar.

(2) And (2) merging the decoction liquid decocted for three times in the step (1), filtering the decoction liquid by using a 100-mesh sieve, and concentrating the filtrate into clear paste concentrated solution, wherein the ratio of the amount of the traditional Chinese medicinal materials to the water content in the clear paste concentrated solution is 1.25-1.28.

(3) And (3) taking 100g of donkey-hide gelatin, pulverizing, sieving with a 100-mesh sieve, adding the clear paste obtained in the step (2), stirring until the clear paste is completely melted, adding 120-180 g of refined honey, stirring uniformly, decocting with slow fire, and continuously stirring to obtain the blood-nourishing and hair-growing paste, wherein the ratio of the medicinal material amount to the water content of the blood-nourishing and hair-growing paste is not less than 1.32.

1. Clinical experiments

In order to verify the treatment effect of the blood nourishing and hair growing cream formula, the inventor conducts a drug effect test on the cream formula prepared according to the proportion in 2021 month to 6 months, and the test conditions are as follows:

1.1, test drugs: the invention relates to a blood nourishing and hair growth promoting cream formula, wherein each bag contains 20g.

1.2, clinical data: the invention adopts the blood nourishing and hair growth cream formula to treat 30 postpartum alopecia, selects 60 postpartum alopecia patients who are treated by dermatology department at subsidiary hospitals of Shanxi Chinese medicine university from 1 month to 2021 month and 6 months, and divides the 60 patients into a treatment group and a control group by adopting a random digital table method, wherein each group comprises 30 postpartum alopecia patients. All patients are female and all the patients have alopecia symptoms in months after production.

The treatment group comprises 30 patients with the age of 23-35 years, the average age of 28.3 +/-2.8 years, the course of disease of 2-14 months and the average age of 3.7 +/-1.1 months; the age of the control group is 24-34 years, the average age is 27.7 +/-2.6 years, the course of disease is 3-15 months, and the average age is 3.9 +/-1.1. The general data comparison of two groups of patients has no statistical significance (P is more than 0.05) and is comparable.

1.3, diagnostic criteria: according to the guidance principle of clinical research of new Chinese medicine,

and (3) healing: the hair stops falling off, the alopecia grows out completely, the distribution density, the thickness and the color of the alopecia are the same as those of a hair-strengthening area, and the sebum secretion is recovered to be normal.

The effect is shown: the hair stops falling off, the hair loss is regenerated to more than 70 percent, the density, the thickness and the color of the hair are all close to those of a hair-care area, and the sebum secretion is obviously reduced.

The method has the following advantages: hair stops shedding, hair loss is regenerated by more than 30%, and vellus hairs and white hairs grow out.

And (4) invalidation: the alopecia regeneration is less than 30% or the alopecia is still continued.

1.4, treatment method: the two groups of patients are generally treated, and the treatment period comprises that spicy and greasy food is forbidden to be eaten during the treatment period, the patients pay attention to rest, the patients are prevented from being scalded by hot water, the patients are not suitable to be washed on duty, the healthy and stable mood is kept, and the mental stress and excitement are avoided.

The control group orally administered oryzanol tablets each time by lOmg, 3 times per day, and vitamin B1 tablets each time by lOmg, 3 times per day.

The treatment group adopts blood nourishing and hair growth promoting ointment for treatment, 20g is taken once, the treatment group is taken after breakfast and supper, 1 month is 1 treatment course, and the treatment effect is observed after 1 treatment course.

1.5, treatment results and analysis: as shown in Table 1

TABLE 1 Experimental results of the present invention

Group of	Number of examples	Recovery method	Show effect	Is effective	Invalidation	Total effective rate
							Treatment group	30	8	16	4	2	80％
Control group	30	5	15	6	4	66.7％

As can be seen from the table 1, in the treatment process, the total effective rate of the treatment group is 80%, the total effective rate of the control group is 66.7%, and the treatment effect of the treatment group is remarkable.

1.6, the usage and dosage of the invention: the medicine is taken three times after meals every day, and one bag is taken orally every time, and each bag is 20g.

1.7, storage of the invention: sealing, cooling, drying and storing.

1.8, the effective period of the invention: for 2 years.

2. Animal experiments

In order to carry out standardized evaluation on the clinical efficacy and safety of the blood-nourishing and hair-growing ointment for treating the AGA, a Dihydrotestosterone (DHT) -induced C57BL/6 mouse AGA model is established through animal experimental study, and 48 male C57BL/6 mice with the age of 10 weeks are randomly divided into 4 groups of 12 mice. The group is blank control group, model group, positive group, and normal dosage group of blood nourishing and hair growth promoting paste. The hair growth condition of the mice is evaluated through the skin color change, the dermis thickness, the hair follicle form, the number and the like of the mice, the influence of the blood-nourishing hair-growing cream on the hair growth of a DHT-induced C57BL/6 mouse androgenetic alopecia model and the change of the liver and kidney functions of the hair-growing cream are observed, and the experimental process and the result are as follows:

2.1 Experimental animals and groups

48 male C57BL/6 mice, SPF grade, 10 weeks old, body mass 20-25 g, experimental animal and animal feed padding are purchased from Sounda major laboratory animals Co., ltd, animal license number: SCXK 2020-030. The animal feed is bred in the center barrier environment (approval number: SYXK (Shaan) 2017-004) of SPF-level experimental animals in Shaanxi Chinese medicine resource industrialized province co-construction collaborative innovation center, 12h light and shade alternation is kept indoors, the temperature is 24 +/-0.5 ℃, the humidity is 53 +/-1%, the animal experiment conforms to the regulation of the university of the Shaanxi Chinese medicine experimental animals in management and use, and the principle of 3R is met. After being adaptively fed with common feed for 1 week, the feed is numbered according to body mass and randomly divided into 4 groups, 12/group and 4/cage (IVC cage) according to body mass, and the specific groups are as follows: a: blank control group; b: a model group; c: a positive group; d: the normal dosage group of the blood nourishing and hair growth promoting ointment.

2.2 Experimental drugs

Blood-nourishing and hair-growing ointment 0.47 g/mL ^-1 A liquid.

DHT (purity is more than or equal to 98 percent, batch number is S80035DD 3) purchased from Shanghai Ji to Biochemical technology Limited; reagent grade corn oil was purchased from Shanghai Michelin Biochemical Co., ltd. (batch No: C13766577); dissolving 100mg DHT powder in corn oil to 60mL to obtain 1.7 mg/mL ^-1 And (6) suspension.

Finasteride tablets: hangzhou Memo Shadong pharmaceutical Co Ltd (batch No.: J01324A), prepared with purified water to 0.075 mg/mL ^-1 A liquid.

Vetting depilatory cream (Veet, france).

2.3. Main instrument

AU2700 model full-automatic biochemical analyzer (Beckman Corp., USA);

high speed cryogenic centrifuge Sigma 3K30 (Sigma);

SZ-93 model automatic double pure water distiller (Shanghai Yanglong Biochemical instruments factory);

a high temperature sterilizer (SANYO Co.);

model R136 paraffin slicer (Leica, germany);

TC-120S type biological tissue automatic dehydrator;

TB-718EL type freezer, embedding machine (Hubei Tai Wei science and technology industries, ltd.).

2.4 Experimental methods

2.4.1 establishment of AGA mouse model

In 3 groups of mice except the blank group, 7.5 mg/(kg. D) dihydrotestosterone suspension was injected into the skin of the mice in parallel to the back of the spinal column at multiple points by a 4mm cosmetic injection needle, and the blank group was injected with the same amount of corn oil for injection continuously for 8 days, and the mice were found to have different degrees of hair loss and the skin of the hair loss part was pale pink. On day 9, the injection was stopped, and after anesthesia with 4% chloral hydrate was successful, the back hair of the mice was shaved with a razor in an area of about 2cm × 2cm, and then a depilatory cream was applied according to the instructions to remove the remaining hair, confirming that the mouse hair was in a resting period (skin was pink).

2.4.2 grouped gavage of experimental animals

Dosing was started on day 2 after depilation. According to the results of the preliminary experiments, four groups of mice were subjected to intragastric gavage with different drugs as follows:

the positive control group is given with 0.65 mg/(kg d) of finasteride suspension, the blood-nourishing hair-growing ointment group is given with 4.11 g/(kg d), the blank control group and the model group are given with the same amount of physiological saline, the administration volume of each group is 0.2mL, 1 time per day, and 17d continuously.

2.4.3 Observation index and measurement

(1) Gross photographs were taken of mice under the same light source with A4 paper as background color after anesthesia with 4% chloral hydrate before (d 0) and 7, 17 days after dosing (d 7, d 17), respectively, and hair growth was recorded and scored: 0 minute: the skin in the depilation region is pink when the hair is not grown; 1 minute: the skin in the depilatory area was gray (less than 20% increase); and 2, dividing: the depilated area has black skin (more than 20% and less than 40%); and 3, dividing: the depilated area skin was black and had some hair growth (greater than 40%, less than 60% growth): and 4, dividing: the skin in the depilated area is black and has partial hair growth (60 to 80 percent of the hair growth); and 5, dividing: the hair growth in the epilation zone is substantially complete (80% to 100% growth).

(2) And (3) histological observation: after the administration of the drug for 17 days, 4% chloral hydrate is injected into the abdominal cavity of each group of mice for anesthesia, after the completion of photographing, the back hairs at the same positions of the original unhairing areas are shaved off, and the back hairs are completely scraped by a skin preparation knife, so that the skin on the back of the mice is fully exposed. Taking skin tissues with the size of about 2x2cm, trimming the skin into long strips with the width of 1cm, soaking the long strips in 4% paraformaldehyde, fixing the long strips for 24-36 h, taking out the long strips, performing gradient alcohol dehydration, paraffin embedding, trimming blocks and slicing, performing hematoxylin-eosin (HE) staining, observing the thickness of dermis and the thickness of fat layers of the skin tissues under an optical microscope, measuring the thickness of the dermis and the length of hair follicles of each group by using software in a combined manner, counting the total number of the hair follicles and the number of the hair follicles in different periods, and calculating the ratio of final hair to hair follicle.

(3) And (3) measuring the functions of the serum liver and the kidney: the mice are fasted overnight, blood is taken from eyeballs, the mice are stood and centrifuged (4 ℃,3000r/min,10 min), the upper serum is collected, and ALT, AST, urea and Crea are determined by the department of laboratory of subsidiary hospitals of Shanxi Chinese medicine university.

2.4.4, statistical methods: excel input data are analyzed by SPSS26.0 statistical software, single-factor variance analysis is used for comparison among groups, LSD (least squares) is used for comparison among groups when the variances are uniform, and P <0.05 shows that the differences have statistical significance. The graph was plotted using GraphPad Prism software.

2.5, results of the experiment

2.5.1, hair growth of mice in each group as shown in FIG. 1 and FIG. 2: in addition to the model groups, the hair growth scores of the groups gradually increased with the increase in the medication time. The blank group reached 2 points at d7 and 4 points at d17, and the positive control group and the blood-nourishing and hair-growth paste group both reached more than 5 points at d 17.

2.5.2, histological observation:

as shown in FIG. 3, the skin cross section was used to determine the number of follicles, and the number of follicles in 6 different areas was observed under a 40-fold optical microscope, and the average number of follicles in the blank group of mice in the selected area was 188. + -.5, and that in the model group was 70. + -.9. Compared with a blank group, the number of the hair follicles in the model group is obviously reduced (P < 0.05), the number of the hair follicles in the minoxidil group and the ligustrum lucidum alcohol extract group is respectively 165 +/-23, 116 +/-15, 157 +/-27 and 146 +/-23, and the hair follicles in the minoxidil group and the ligustrum lucidum alcohol extract group are obviously increased (P < 0.05) compared with the model group.

As shown in FIG. 4, the hair follicle morphology obtained from the longitudinal section of the skin was large in the number of the hair follicles and intact in the mice in the blank group, and at this time, the hair follicles had entered the resting stage and melanin formation was stopped (FIG. 4A); the hair follicle of the model group has short and sparse shape, the lower end of the hair follicle is degenerated, the hair papilla is thinned, the inner root sheath part disappears, and the hair is in a rod-shaped tail end (figure 4B); the positive control group (fig. 4C) and the blood-nourishing hair-growing cream group (fig. 4D) each had a large number of hair follicles, and the hair follicles were growing and large, and melanin formation was significant, so it was found that both the positive drug (finasteride) and the blood-nourishing hair-growing cream could improve the miniaturization of hair follicles caused by dihydrotestosterone, and maintain the normal morphology of hair follicles.

2.5.3, serum liver and kidney function determination: as shown in figure 5, the significance of ALT, AST, urea and Crea among the groups is more than 0.05, which indicates that the difference has no statistical significance, namely the oral blood-nourishing and hair-growing ointment has no damage to the liver and kidney functions of the mice.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.

Claims

1. The blood nourishing and hair growth promoting ointment is characterized by being prepared from the following raw materials in percentage by weight: 12.5 percent of radix rehmanniae recen, 6.25 percent of angelica, 4.17 percent of rhizoma ligustici wallichii, 6.25 percent of raw white peony root, 12.5 percent of mulberry, 6.25 percent of black sesame seed, 4.17 percent of donkey-hide gelatin, 12.5 percent of glossy privet fruit, 6.25 percent of herba ecliptae, 12.5 percent of cacumen biotae, 6.25 percent of hawthorn, 4.16 percent of dried orange peel and 6.25 percent of medlar.

2. A method for preparing the blood-nourishing and hair-growing paste according to claim 1, which comprises the following steps:

3. The preparation method of the blood nourishing and hair growth promoting paste according to claim 2, characterized in that: the ratio of the amount of the traditional Chinese medicines in the clear paste concentrated solution in the step (2) to the water content is 1.25-1.28.

4. The preparation method of the blood nourishing and hair growth promoting paste according to claim 2, characterized in that: the ratio of the amount of the medicinal materials of the blood-nourishing and hair-growing ointment to the water content in the step (3) is not less than 1.32.