CN111973607A - Compound external preparation for preventing and treating alopecia and promoting hair growth - Google Patents
Compound external preparation for preventing and treating alopecia and promoting hair growth Download PDFInfo
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- CN111973607A CN111973607A CN202010931490.2A CN202010931490A CN111973607A CN 111973607 A CN111973607 A CN 111973607A CN 202010931490 A CN202010931490 A CN 202010931490A CN 111973607 A CN111973607 A CN 111973607A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/14—Drugs for dermatological disorders for baldness or alopecia
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Abstract
The invention provides a compound external preparation for preventing and treating alopecia and promoting hair growth, which comprises the following specific components in part by weight: every 100ml of solvent contains 1-50g of metformin, 0.1-10mg of finasteride, 0.1-50g of minoxidil, 10.1-50mg of vitamin B and 60.1-50 mg of vitamin B; the solvent is water or ethanol. Compared with single minoxidil, metformin, vitamin B1+ B6 or two medicine combinations (finasteride oral administration + minoxidil external application, minoxidil + vitamin B1), the composition can activate hair follicle stem cells, and more hair follicle cells end the resting period and enter the growth period; the hair follicle can be regenerated in the growth period, the length is longer, and the hair papilla volume is larger; the medicines of the formula can achieve synergistic effect, and have remarkable effects in treating alopecia and promoting hair growth.
Description
Technical Field
The invention relates to the technical field of pilatory, in particular to a medicine for preventing and treating alopecia and promoting hair growth.
Background
The number of people with alopecia is extremely large and may not be considered a life-threatening disease. However, thinning of hair, baldness (hair loss) is an important factor affecting the appearance of people, and it has a great harm to one's self-esteem, mental health and overall quality of life. Therefore, it is very important to research the technology for treating alopecia and promoting hair growth.
Alopecia is mainly classified into alopecia areata, male pattern alopecia, female pattern alopecia, telogen alopecia, etc. Any link affecting the hair growth process can lead to hair loss. Such as bacterial viral infections, sex hormone disorders, vitamin and mineral deficiencies, etc., can lead to hair loss.
The hair growth mechanism is relatively clear at present. Firstly, hair follicle cells are transformed into hairs, and the hairs begin to grow, and the process lasts for 2-7 years; subsequently, the hair follicle enters a catagen phase, which is a transitional phase that lasts for 2-3 weeks, and the hair stops growing and is easily shed; the follicle then goes to telogen over a period of about 3 months, during which time the hair will naturally shed and the follicle is again ready to regenerate for the next cycle.
On average 85% -90% of the follicles in the healthy scalp are in anagen phase to ensure thick hair, but in the case of people with telogen effluvium, 30% or more of the follicles may be in telogen phase. A large number of hair follicles are put into dormancy and do not produce hairs, which is a direct cause of hair loss in many people. It has been found in mice that reduced autophagy delays the follicular cycle and affects hair growth. Huang et al found that a common metabolite, alpha-ketoglutarate (alpha-KG), stimulates autophagy and promotes hair growth. The investigators selected mice whose skin follicles began to enter the telogen phase, shaved their back hairs (after which their hairs did not regrow), and then applied α -KG once a day. As a result, autophagy of these follicles in the telogen phase was significantly enhanced, and the anagen phase was initiated 7 days after the stimulation with α -KG. This suggests that α -KG is indeed able to wake up hair follicles by activating autophagy. Recently, researchers applied metformin aqueous solution to the back of the mice, and after 18 days, the application began to be clearly distinguished from the control group. However, the combined use of the preparation and other medicaments is not reported, and a corresponding product is not available.
Currently, there are two main types of products on the market for preventing hair loss, one of which is minoxidil, which, since the 90 s of the 20 th century, is used in topical form at a concentration of 2% (no prescription) and at 3% and 5% (by prescription). Although studies have demonstrated that 5% minoxidil is more effective than 2% concentration minoxidil, minoxidil is less effective at promoting hair regrowth than 40%. Minoxidil is considered to be a topical gold standard that can be used to treat hair loss. The other is finasteride which is generally orally administered at a dose of 1 mg/day, has the effect of inhibiting alopecia of about 80 percent and the effect of increasing hair growth of about 65 percent, and has remarkable effect, but the therapeutic effect of the finasteride is still lower for hereditary seborrheic alopecia.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide the compound external preparation for preventing and treating alopecia and promoting hair growth, which has simple use and obvious effect, is obviously higher than the curative effect of a single existing product, is also better than the simple combined use effect of two products, and generates a synergistic effect between formulas.
The technical scheme of the invention is as follows:
a compound external preparation for preventing and treating alopecia and promoting hair growth comprises the following specific components in parts by weight: every 100ml of solvent contains 1-50g of metformin, 0.1-10mg of finasteride, 0.1-50g of minoxidil, 10.1-50mg of vitamin B and 60.1-50 mg of vitamin B; the solvent is water or ethanol.
Preferably, each 100ml of solvent contains 10-40g of metformin, 1-7mg of finasteride, 4-40g of minoxidil, 78-20 mg of vitamin B11 and 20-20 mg of vitamin B62.
In a further preferred scheme, each 100ml of solvent contains 10-20g of metformin, 1-5mg of finasteride, 4-20g of minoxidil, 78-10 mg of vitamin B11 and 62-10 mg of vitamin B.
In a further preferred scheme, each 100ml of the solvent contains 16.5g of metformin, 1mg of finasteride, 5g of minoxidil, vitamin B12 mg and vitamin B62 mg.
In a further preferable scheme, 5-20g of skin penetrating agent is also contained in each 100ml of solvent, and the skin penetrating agent is selected from one or more of laurocapram, methyl laurate and borneol.
In a further preferable scheme, the solvent is ethanol with the mass concentration of 50-75%.
Preferably, the dosage form of the compound external preparation comprises aqua, ointment, gel, emulsion, liniment, paste, powder, spray and dressing containing the external preparation.
The invention also provides application of the compound external preparation in preparing a preparation for preventing and treating alopecia and promoting hair growth.
Compared with the prior art, the invention has the advantages that:
compared with single minoxidil, metformin, vitamin B1+ B6 or simple combined use of two medicines (finasteride oral administration + minoxidil external use, minoxidil + vitamin B1), the compound external preparation for preventing and treating alopecia and promoting hair growth can activate hair follicle stem cells, and more hair follicle cells end the resting period and enter the growth period; the hair follicle can be regenerated in the growth period, the length is longer, and the hair papilla volume is larger; the medicines of the formula can achieve synergistic effect, and have remarkable effects in treating alopecia and promoting hair growth.
Drawings
FIG. 1 is the number of skin follicles in the back of mice on day 30 (HE staining, 400 ×);
FIG. 2 is the effect of drug on mouse hair growth morphology (30d, HE staining, 400 ×).
Detailed Description
The detailed structure of the present invention will be further described with reference to the accompanying drawings and the detailed description.
Example 1:
a compound external preparation for preventing and treating alopecia and promoting hair growth comprises the following components: metformin 16.5g sample, finasteride 1mg sample, minoxidil 5mg sample, vitamin B12 mg, vitamin B62 mg, dissolved in 100ml of 50% alcoholic solution (50ml of absolute alcohol +50ml of distilled water).
The using method comprises the following steps: applied to scalp 2 times a day.
Example 2
A compound external preparation for preventing and treating alopecia and promoting hair growth comprises the following components: metformin 16.5g sample, finasteride 1mg sample, minoxidil 5mg sample, vitamin B12 mg, vitamin B62 mg, methyl laurate 8g dissolved in 50% alcohol solution 100ml (50ml absolute alcohol +50ml distilled water).
The using method comprises the following steps: applied to scalp 2 times a day.
Example 3
A compound external preparation for preventing and treating alopecia and promoting hair growth comprises the following components: metformin 16.5g was dissolved in 100ml of 50% alcohol solution (50ml of absolute alcohol +50ml of distilled water).
Example 4 effect comparison experiment (selecting part of experimental data to compare effects):
1 materials and methods
1.1 preparation of external use medicine
See examples 1-3.
1.2 animal modeling and drug intervention
1.2.1 mouse alopecia model establishment:
male C57BL/6J mice (SPF grade, 6 weeks old) were 5, purchased from the department of animal experimentation, Hunan Yay medical college, school of medicine, Zhongnan university. After the mice are raised in cages for 1 week, rosin and paraffin are heated, mixed and melted according to the proportion of 1:1, then the mixture is evenly smeared on the backs of the mice with the area of 2cm multiplied by 2cm, and the backs are removed after cooling and solidification so as to remove the back hair. The skin of the mice appeared black in the hair growth phase, gray in the catagen phase and pink in the telogen phase. After hair removal, the hair was confirmed to be in a resting stage in the growth cycle, and the skin was pink in color.
1.2.2 animal grouping and intervention:
after depilation, mice with smooth and non-damaged skin in the depilation region were selected and randomly divided into 5 groups of 3 mice each. The drug was applied to the back of the mice on the skin area of the model 2 times a day at 9 am and 6 pm, respectively. The grouping is as follows:
blank group: negative control;
experiment group a: 2% minoxidil;
experiment group B: : 16.5g/100ml metformin (example 3);
experiment group C: example 1;
experiment group D: vitamin B1+ vitamin B6 water solution, vitamin B12 mg, vitamin B62 mg and water 100 ml.
Experiment E group: finasteride 0.8mg orally and minoxidil 2% externally;
experiment F group 2% minoxidil + oral vitamin B12 mg.
1.3 statistical analysis
1.3.1 Observation and recording of results
The skin color and hair growth condition of the hairless area of the mouse are observed every day and are photographed regularly. And on the 19 th day, taking skin tissue blocks of hair removal areas on the backs of the mice of each group, fixing the skin tissue blocks by using 4% paraformaldehyde, embedding the skin tissue blocks into paraffin, carrying out HE staining, observing the skin tissue blocks under a light microscope, selecting 3 visual fields for counting hair follicles from each piece under a high power microscope, and enabling the visual fields not to be overlapped as much as possible.
1.3.2 statistical analysis
The variance analysis is carried out by adopting SPSS13.0 statistical software, mean plus or minus standard deviation
Representing the measurement data, comparison between two groups using independent samples t test, P<0.05 has statistical significance.
2 results
2.1 Observation of Back Hair growth in groups of mice
After 5 days, no obvious pink color is seen on the back skin of each group, the resting period is ended, and the growth period is started. On day 10, each group appeared blue with hair follicle formation, the deepest in group A, and the next in group C. Group C appeared a dense, uniform, dark blue color, darker than the blue color at day 15 of group a, and more uniformly distributed. On day 30, the blank group was not much different from group D, and A, B, C, E, F groups had more hair follicles than the blank group and group D, and the hairs were black and thicker than those of the two groups. In group C, example 1, the full element complex group, had more follicles than the other groups, and the hairs were darker and thicker.
2.2 morphological observation of growth of Hair on the Back of mice
2.2.1 number of hair follicles in mouse Back
On day 30 of the experiment, mice were sacrificed, and the skin on the back of the experimental area was taken, prepared for routine pathology, HE stained, and the hair follicle growth was observed with a light microscope and counted (table 1). The results are shown in FIG. 1 and Table 1. The statistical t-test results show: blank vs A, B, C, E, F, both had significant differences (P < 0.05); group D vs A, B, C, E, F, all with significant differences (P < 0.05); group C vs a, B, D, E, F and blank, all with significant differences (P < 0.05); blank vs D group, A vs B group, no difference (P >0.05), A vs F group, no difference (P > 0.05).
TABLE 1 groups of mice Back Hair follicles
From fig. 1, statistical t-test: blank vs A, B, C, E, F, both had significant differences (P < 0.05);
group D vs A, B, C, E, F, all with significant differences (P < 0.05); group C vs A, B, D, E, F group
And blank, both significantly different (P < 0.05); blank vs D group, A vs B group, no difference (P > 0.05). 2.2.2 Observation of growth of Hair tissue on the Back of mice
Morphologically (fig. 2, partial graph), the neogenetic hair follicles of experiment group C were in anagen phase, showing longer hair follicle length, larger hair papilla volume, lower end deep below the adipose layer and near the superficial surface of the muscle deep fascia layer; the volume of the hair papilla in the group B is smaller, and the lower end of the hair papilla is mostly only positioned at the middle-lower part of the dermis and the superficial fat layer; whereas the experimental group a was even smaller than the group a hair papillae, the lower end of which was located only in the middle-upper part of the dermis.
3 conclusion
Conclusion 1
The experiment shows that the full-element compound preparation (2mg minoxidil +16.5mg metformin, 2mg vitamin B1+2mg vitamin B6+1mg finasteride +50ml absolute alcohol +50ml distilled water) has stronger promotion effect on hair growth, and compared with single minoxidil, metformin, vitamin B1+ B6 medicaments, and compared with an experiment group E: finasteride 0.5mg orally and minoxidil 2% externally; in the experiment F group, compared with 2 percent minoxidil and oral vitamin B12 mg, more hair follicle stem cells can be activated, and more hair follicle cells end the resting period and enter the growing period; the new hair follicle is longer in the growth period, the hair papilla is larger in volume, and the lower end of the hair follicle reaches the lower part of the fat layer and is close to the shallow surface of the muscle deep fascia layer.
Conclusion 2
The full-element compound preparation disclosed by the invention is a novel compound preparation formed by aiming at each link of hair growth according to the physiological characteristics of the hair growth, and the formula of the embodiment 1 has obvious effects on treating alopecia and promoting the hair growth. We also made another formulation of example 2, which added penetrant and had slightly better treatment effect than example 1, but the treatment period was significantly shortened, and the number of hair follicles reached about 20, which was shortened by 5-6 days compared to example 1.
The above description is for the purpose of illustrating the present invention and is not intended to limit the scope of the present invention, and any person skilled in the art can substitute or change the technical solution of the present invention and its conception within the technical scope of the present invention, and the technical solution and the concept of the present invention are also intended to be covered by the scope of the claims of the present invention.
Claims (8)
1. A compound external preparation for preventing and treating alopecia and promoting hair growth comprises finasteride and minoxidil, and is characterized in that the specific components and the formula weight ratio are as follows: every 100ml of solvent contains 1-50g of metformin, 0.1-10mg of finasteride, 0.1-50g of minoxidil, 10.1-50mg of vitamin B and 60.1-50 mg of vitamin B; the solvent is water or ethanol.
2. The compound external preparation for preventing and treating alopecia and promoting hair growth according to claim 1, wherein each 100ml of the solvent contains 10-40g of metformin, 1-7mg of finasteride, 4-40g of minoxidil, 11-20 mg of vitamin B, and 62-20 mg of vitamin B.
3. The compound external preparation for preventing and treating alopecia and promoting hair growth according to claim 2, wherein each 100ml of the solvent contains 10-20g of metformin, 1-5mg of finasteride, 4-20g of minoxidil, 11-10 mg of vitamin B, and 62-10 mg of vitamin B.
4. The compound external preparation for preventing and treating alopecia and promoting hair growth according to claim 3, wherein the solvent contains metformin 16.5g, finasteride 1mg, minoxidil 5g, vitamin B12 mg, and vitamin B62 mg per 100 ml.
5. The compound external preparation for preventing and treating alopecia and promoting hair growth according to any one of claims 1 to 4, wherein each 100ml of the solvent further contains 5 to 20g of a skin penetrating agent, and the skin penetrating agent is selected from one or more of laurocapram, methyl laurate and borneol.
6. The compound external preparation for preventing and treating alopecia and promoting hair growth according to one of claims 1 to 4 or 5, wherein the solvent is ethanol with a mass concentration of 50% to 75%.
7. The compound external preparation for preventing and treating alopecia and promoting hair growth according to any one of claims 1 to 4, wherein the compound external preparation is in the form of a liquid, a paste, a gel, an emulsion, a liniment, a paste, a powder, a spray, or a dressing containing the external preparation.
8. Use of the compound external preparation according to any one of claims 1 to 6 for preparing a preparation for preventing and treating alopecia and promoting hair growth.
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| CN202010577437 | 2020-06-23 | ||
| CN2020105774377 | 2020-06-23 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112451525A (en) * | 2020-12-28 | 2021-03-09 | 苏州青雅启瑞生物科技有限公司 | Application of naftopidil and pharmaceutical composition thereof in preparation of drugs for treating alopecia |
| CN113413405A (en) * | 2021-07-07 | 2021-09-21 | 牛力 | Formula for treating androgenetic alopecia |
| CN114949055A (en) * | 2022-02-10 | 2022-08-30 | 上海希尔维生物科技有限公司 | Gardenia extract and oxoglutaric acid composition and application thereof in hair loss prevention and hair growth promotion field |
| CN115844984A (en) * | 2022-11-10 | 2023-03-28 | 药大制药有限公司 | Minoxidil external composition |
-
2020
- 2020-09-08 CN CN202010931490.2A patent/CN111973607A/en not_active Withdrawn
Non-Patent Citations (1)
| Title |
|---|
| 钟淑贤等: "龟板有效成分对小鼠毛囊生长和毛发生长周期的影响", 《中国美容医学》 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112451525A (en) * | 2020-12-28 | 2021-03-09 | 苏州青雅启瑞生物科技有限公司 | Application of naftopidil and pharmaceutical composition thereof in preparation of drugs for treating alopecia |
| CN113413405A (en) * | 2021-07-07 | 2021-09-21 | 牛力 | Formula for treating androgenetic alopecia |
| CN114949055A (en) * | 2022-02-10 | 2022-08-30 | 上海希尔维生物科技有限公司 | Gardenia extract and oxoglutaric acid composition and application thereof in hair loss prevention and hair growth promotion field |
| CN115844984A (en) * | 2022-11-10 | 2023-03-28 | 药大制药有限公司 | Minoxidil external composition |
| CN115844984B (en) * | 2022-11-10 | 2023-11-03 | 药大制药有限公司 | Minoxidil external composition |
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Application publication date: 20201124 |