CN107569665B - Shampoo for preventing and treating alopecia - Google Patents
Shampoo for preventing and treating alopecia Download PDFInfo
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Abstract
The invention relates to a shampoo for preventing and treating alopecia, which is characterized in that the shampoo is prepared from 40-80% of ginger oil extracted from ginger and 20-60% of rhizoma acori graminei volatile oil extracted from rhizoma acori graminei in percentage by weight, and the sum of the dosage of the ginger and the rhizoma acori graminei in one liter of shampoo is 200 g. The traditional Chinese medicine composition has the effects of relaxing capillary vessels, enhancing blood circulation, improving hair follicle nutrition, preventing and treating alopecia, stimulating new hair growth and strengthening hair roots.
Description
Technical Field
The invention relates to medical preparations, in particular to a pharmaceutical preparation containing undefined structures from plants, which is suitable for preventing and treating alopecia.
Technical Field
Alopecia, or baldness, is a skin disorder characterized by a reduction in hair. It has many kinds, such as congenital alopecia, alopecia areata and androgenetic alopecia, but its etiology is not completely clear. Generally, it is considered that there is a certain relationship with genetics, endocrine function, infection focus, autoimmune function, mental factors, and nutritional status. The disease seriously affects the beauty treatment and often brings much trouble and pain to patients. The course of disease is lingering and recurrent. However, no specific medicine for clinically preventing and treating the disease is available so far, and the modern medicine is unsatisfactory in curative effect and large in side effect for treating the disease. Therefore, the important significance of seeking a medicament with good curative effect and small side effect for preventing and treating alopecia is realized in the aspect of traditional Chinese medicine.
The patent application with the publication number of CN106539731A discloses a hair nourishing and hair care gel shampoo, which is prepared from the following raw materials in parts by weight: 30-40 parts of sericin powder, 14-18 parts of bletilla striata powder, 11-14 parts of myristic acid, 5-15 parts of glycerol, 1-5 parts of lanolin, 10-15 parts of stearic acid monoglyceride, 12-20 parts of polygonum multiflorum powder, 11-14 parts of folium artemisiae argyi, 5-10 parts of polyethylene glycol monostearate, 5-10 parts of tea polyphenol, 2-5 parts of rhizoma acori graminei, 5-15 parts of cajeput, 10-15 parts of ginger extract, 2-5 parts of foaming agent and 50-70 parts of water. The hair washing plaster has more flavors and is difficult to control quality.
Disclosure of Invention
The invention aims to solve the problem of providing the shampoo for preventing and treating the alopecia, which has less medicinal odor and obvious curative effect.
The technical scheme for solving the problems is as follows:
a shampoo for preventing and treating alopecia is characterized in that the shampoo is prepared from 40-80% of ginger oil extracted from ginger and 20-60% of rhizoma acori graminei volatile oil extracted from rhizoma acori graminei in percentage by weight, and the sum of the dosage of the ginger and the dosage of the rhizoma acori graminei in one liter of shampoo is 200 g.
The optimal scheme of the shampoo is that each liter of the shampoo is prepared from 160g of ginger oil extracted from ginger and 40g of rhizoma acori graminei volatile oil extracted from rhizoma acori graminei.
The shampoo is prepared by the following method:
(1) extracting volatile oil from rhizoma Zingiberis recens by steam distillation;
(2) extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
(3) mixing ginger oil and rhizoma Acori Graminei volatile oil, adding adjuvants, and making into shampoo by conventional method.
Compared with the prior art, the shampoo has the following advantages:
the shampoo provided by the invention is prepared from ginger and rhizoma acori graminei, has few medicinal ingredients, simple and special medicinal effects, remarkable curative effect and no side effect, and is beneficial to quality control.
To facilitate a better understanding of the present invention by the public, the following clinical and animal experiments further illustrate the beneficial effects of the present invention.
First, clinical observation
The source of the cases is: the 96 alopecia patients were all from outpatients and inpatients at the first subsidiary hospital of the Guangzhou university of traditional Chinese medicine. Age is not limited, and the trial is performed after the patient signs an informed consent.
Diagnostic criteria: all cases were diagnosed as alopecia according to the diagnostic criteria of "dermatology of traditional Chinese medicine".
Inclusion criteria were: the diagnostic standard is met; age 30-45 years old; those who had to discontinue the medication associated with the improvement of the condition 2 weeks before the trial; there have been no other diseases associated with hair loss in the near future;
exclusion criteria: those that do not meet inclusion criteria; patients with over 10 years of disease and atrophy of hair follicles; those with severe systemic, chronic wasting disease;
the treatment method comprises the following steps: the treatment groups 1-3 were treated with shampoos as described in examples one, five and six, respectively, and the control group was prepared according to the method described in example 2 of patent application publication No. CN106539731A, and was administered externally 1 time a day, 5-10ml each time. 4 weeks is a course of treatment, and 3 courses of treatment are used.
The curative effect standard is as follows: according to the therapeutic effect standard for treating alopecia formulated in the clinical research guideline of new traditional Chinese medicine, the traditional Chinese medicine composition is effective: the hair stops falling off, and the new hair is regenerated by more than 30 percent and comprises vellus hairs and white hairs; and (4) invalidation: those with insufficient hair regrowth or continued hair loss.
The statistical method comprises the following steps: all data were statistically analyzed using SPSS 19.0 statistical software, and the counts were checked using the chi-square test and P <0.05 compared to the control.
The therapeutic effect results after treatment of each treatment group are shown in table 1.
TABLE 1 post-treatment efficacy of each treatment group
Note: p <0.05 compared to control.
The statistical results show that the treatment groups 1 and 2 have higher effective rate for preventing alopecia than the control group, and the difference has statistical significance (P is less than 0.05). However, treatment group 3 was not comparable to the control group. It is shown that the treatment groups 1 and 2 have better alopecia prevention effect than the shampoo paste prepared by the method disclosed in the patent application with the publication number of CN106539731A, and the treatment group 3 has equivalent curative effect to the shampoo paste prepared by the method disclosed in the patent application with the publication number of CN 106539731A.
Second, animal test
The tested drugs are:
model group: physiological saline.
Experimental group 1: a shampoo according to example one below.
Experimental group 2: the shampoo of example five below.
Experimental group 3: the shampoo of example six below.
Control group 1: ginger oil of example 1.
Control group 2: the grass-leaved sweetflag volatile oil of example 1.
Control group 3: prepared according to the method described in example 2 of the patent application with the publication number CN 106539731A.
Administration dose: the model group is given physiological saline, and the administration doses of the experimental group 1-3 and the control group 1-3 are 5g/kg and 2 times/day according to the raw material medicaments. The administration method is topical cleaning.
Experimental results on the Effect on the Hair growth cycle
1.1 Experimental animals: 42C 57BL6 mice, female, 8 weeks, 15-20 g, homologous, available from the institute of pharmaceutical technology, national academy of sciences. Mice with a pink skin and hair belonging to telogen were selected. The hair cycle of the C57BL6 mice is synchronous, and the phase change of the hair cycle can be judged according to the skin color, wherein the skin in the hair growth period is black, the skin in the hair retrogression period is gray, and the hair in the hair rest period is pink.
1.2 establishing a mouse alopecia model: mixing rosin and paraffin wax 1:1, heating to melt, uniformly coating the mixture on the back of a mouse, wherein the coating area is about 2cm multiplied by 3cm, cooling to solidify, and removing the back hair. The anagen phase of the hair was confirmed to be in the telogen phase.
1.3 animal groups: the next day of depilation, mice with smooth and undamaged depilation regions were selected and randomly divided into 7 groups of 6 animals per group.
1.4 administration: the topical skin is directly smeared with cotton swab for administration, and administered for 2 times every day at regular time, wherein the dose of each time is 5g/kg based on the raw materials, and the administration is continuously carried out for 20 days.
1.5 statistical treatment: all data were statistically analyzed using SPSS 19.0 statistical software, and the data were expressed as means. + -. standard deviation (x. + -.s).
1.6 observations record the results: observing the change of the skin and the hair color of the mice every day, and recording the time from the application of the medicine to the blackening of the skin color of the hair-removed area of the back of each animal; the control group recorded the time from day 1 after depilation to the beginning of skin darkening in the depilated area; the hair removal zone began to darken to full hair and photographs were taken periodically. The observation indexes are as follows: skin and hair color changes of mice; ② counting hair follicles, counting hair follicles of 3 high power fields (x 400) per case, taking the mean value and performing statistical treatment.
1.7 results of the experiment
1.7.1 mouse skin and hair changes: the model group of mice had a change from pink to black in the local skin 10 days after epilation, new hairs grew 16 days later, a change from grey to pink in the skin 18 days, and a total of 8 days for the skin black and grey. Secondly, the local skin of the mice in the experimental groups 1 and 2 gradually becomes black after the hair is plucked in 5 th to 6 th days, the hair enters the growth period, new hair grows out after 10 days, the skin color is changed into pink (rest period) through gray (catagen) in 20 days, and the skin black and gray are continuously kept for about 15 days; ③ the experiment group 3 mice gradually appeared black on local skin 6 days after epilation, the hair enters the growth phase, new hair grows out after 9 days, the skin color changes to pink (rest phase) through gray (catagen) at 20 days, and the skin black and gray lasts for 15 days; fourth, the local skin of the mice in the control group 2 changed from pink to black on the 8 th day after epilation, new hairs grew out after 10 days, the skin changed from grey to pink again on the 19 th day, and the skin black and grey continued for 12 days. Fifthly, the local skin of the mice in the control groups 1 and 4 turns from pink to black on the 7 th day after epilation, new hair grows out after 10 days, the skin turns to pink again through gray on the 19 th day, and the skin black and gray last for 13 days.
1.7.2 changes in Hair follicle Density
Table 2 experimental effect of groups on hair follicle density in mice
| Group of | Number of samples (n) | Dosage (g/kg) | Number of hair follicles (single/high power field) |
| Model set | 8 | 5 | 11.37±1.62@ |
| Experimental group 1 | 8 | 5 | 25.35±1.67*@$# |
| Experimental group 2 | 8 | 5 | 23.92±1.24*@$# |
| Experimental group 3 | 8 | 5 | 22.26±1.49*@$ |
| Control group 1 | 8 | 5 | 17.83±1.54* |
| Control group 2 | 8 | 5 | 14.98±1.39# |
| Control group 3 | 8 | 5 | 20.38±1.71*@$ |
Note: p <0.05 compared to model group; @ P <0.05 compared to control 1; p is less than 0.05 compared with the control group 2; compared to control 3, # P < 0.05.
Statistical results show that the number of hair follicles in the control group 1 is increased and P is less than 0.05 compared with the model group, while the ratio of P in the control group 2 to the model group is more than 0.05, which indicates that the hair follicle growth can be promoted in the control group 1 but the effect of the control group 2 is not obvious. However, the numbers of hair follicles of the experimental groups 1, 2 and 3 using the two volatile oils are obviously increased compared with those of the control groups 1 and 2, which shows that the effect of the two volatile oils is obviously enhanced, but compared with the control group 3, the numbers of the hair follicles of the experimental groups 1 and 2 are obviously increased, and the experimental group 3 has no obvious statistical difference, which shows that compared with the patent application example 2 with the publication number of CN106539731A, the effects of the experimental groups 1 and 2 on promoting the growth of the hair follicles are obviously better, and the effect of the experimental group 3 is equivalent to the curative effect.
(II) results of experiments on sebum metabolism
1.1 Experimental animals: SPF-grade KM mice with half male and female bodies and weight of 18-22g
1.2 establishing a mouse alopecia model: the injection is made by injecting 0.01mg/10 g.d dose of testosterone propionate subcutaneously at the back of the neck, 1 time per day, and continuously injecting for 30 d.
1.3 animal groups: the test results were randomly divided into 7 groups of 10 individuals, each group consisting of model group, experimental group 1-3, and control group 1-3.
1.4 administration: the mice had their backs depilated (about 3.0 cm. times.3.0 cm), and the drugs were applied to the backs at 5g/kg (2 times/day (about 2.5 cm. times.2.5 cm)) for 7 days.
1.5 statistical treatment: all data were statistically analyzed using SPSS 19.0 statistical software, and the data were expressed as means. + -. standard deviation (x. + -.s).
1.6 observations record the results: the mice were sacrificed by decapitation 30min after the last administration, and skin tissue blocks of approximately 1.0X1.0cm of the depilated area were cut out and fixed with 10% formalin. Sections were routinely paraffin-embedded, stained with hematoxylin-eosin, 2 serial sections per case, and observed under light. Sebum secretion rate: the test glass dish was degreased, dried with alcohol and weighed (W1), the skin of the mouse abdominal observation area was disinfected with alcohol and the administration was stopped, the mouse was sacrificed after fixing on a wooden board for 2h, the oil in the skin of the mouse abdominal observation area was sufficiently eluted with petroleum ether, the washing solution was collected in the glass dish and weighed again after being volatilized again (W2). And calculates the value. Sebum secretion rate (W2-W1)/area/time.
1.7 results of the experiment
Table 3 experimental influence of groups on sebum secretion rate of mice
Note: p <0.05 compared to model group; @ P <0.05 compared to control 1; p <0.05 compared to control 2; compared to control 3, # P < 0.05.
The statistical result shows that the sebum secretion rate of the control group 1 is lower and P is less than 0.05 compared with the model group, and the comparison between the control group 2 and the model group is more than 0.05, which indicates that the control group 1 has better effect of inhibiting the sebum secretion rate. However, the sebum secretion rates of the experimental groups 1, 2 and 3 using the two volatile oils are obviously increased compared with the control groups 1 and 2, but no obvious statistical difference exists compared with the control group 3, which shows that the curative effect of the two volatile oils can be obviously enhanced when the two volatile oils are used together, and the curative effect of the two volatile oils is equivalent to that of the experimental group 2 disclosed in the patent application with the publication number of CN106539731A in the aspect of inhibiting the sebum secretion rate.
(III) Effect on androgen rat dehairing model
1.1 Experimental animals: SPF-level Wistar rat with half male and female body weight of 200-
1.2 establishing an alopecia model: the depilated area was determined by selecting a 9cm by 7cm area of fur on the back of each rat and staining the fur yellow with 3% picric acid solution. Except for the normal control group, animals in other groups injected with 5mg/kg d dose of testosterone propionate subcutaneously at the back of the neck, 1 time a day for 30 days continuously, to cause a fat loss model.
1.3 animal groups: the test samples were randomly divided into 8 groups of 10 samples each, including model group, experimental group 1-3, and control group 1-3.
1.4 administration: the medicine is applied to the depilatory area on the back of the mouse at the dose of 5g/kg for 1 time per day and is administered for 15 days according to the raw material medicine.
1.5 statistical treatment: all data were statistically analyzed using SPSS 19.0 statistical software, and the data were expressed as means. + -. standard deviation (x. + -.s).
1.6 observations record the results: after 3 weeks of continuous subcutaneous injection of testosterone propionate, the rat back hair color is dark and loses luster, hair shedding gradually occurs after 4 weeks, and residual hair becomes fine and brittle, which proves that the male hormonal alopecia model is successfully established.
1.7 results of the experiment
Table 8 experimental effect of groups on androgen rat hair loss model
Note: p <0.05 compared to model group; @ P <0.05 compared to control 1; p <0.05 compared to control 2; compared to control 3, # P < 0.05.
The statistical results show that compared with the model group, the control group 1 has lower depilation quantity per unit area and has statistical significance, while the control group 2 has no statistical significance compared with the model group, which indicates that the control group 1 has obvious effect of inhibiting alopecia but the control group 2 has no obvious effect. However, the numbers of hair removed per unit area of the experimental groups 1, 2 and 3 in which the two volatile oils are used are obviously reduced compared with those of the control groups 1 and 2, which shows that the two volatile oils are used together to obviously enhance the curative effect, but compared with the control group 3, the numbers of hair removed per unit area of the experimental groups 1 and 2 are obviously reduced, and the experimental group 3 has no obvious statistical difference, which shows that compared with the patent application example 2 with the publication number of CN106539731A, the experimental groups 1 and 2 have obviously better curative effect, and the experimental group 3 has equivalent curative effect.
Summary of the invention
The experiments show that the Chinese medicinal composition can enable hairs to enter a growth phase in advance, prolong the time of the growth phase, shorten a resting phase, enlarge hair follicles, promote the growth of the hair follicles and reduce the sebum secretion rate of mice. The Chinese medicinal composition has the effects of improving the growth of the penetrated hair and inhibiting the sebum secretion.
The experimental data also show that the sophora flavescens water extract and the acorus gramineus volatile oil in the traditional Chinese medicine shampoo have a synergistic effect.
Detailed Description
The total amount of the Chinese medicinal composition prepared in the following six examples is 200 g.
Example one
1. Prescription: 160g of ginger and 40g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps:
cleaning rhizoma Zingiberis recens, mashing, extracting with steam distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance to obtain rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding stearic acid 60g, triethanolamine 7.5ml, glyceryl monostearate 20g, glycerol 50g, oleum ricini 110g, AESA 8g, LSA 6g, ethyl p-hydroxybenzoate 0.5g, amino acid foaming agent 50g and distilled water, stirring, and mixing to obtain shampoo.
Example two
1. Prescription: 150g of ginger and 50g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps:
cleaning rhizoma Zingiberis recens, mashing, extracting with steam distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance to obtain rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding AESA 8g, LSA 6g, stearic acid 60g, triethanolamine 7.5ml, glyceryl monostearate 20g, glycerol 50g, oleum ricini 11g, CAB-356.5 g and distilled water to constant volume of 1000ml, stirring, and mixing to obtain shampoo.
EXAMPLE III
1. Prescription: 140g of ginger and 60g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps:
cleaning rhizoma Zingiberis recens, mashing, extracting with steam distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance to obtain rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding stearic acid 60g, triethanolamine 7.5ml, glyceryl monostearate 20g, LSA 60g, CAB-3565 g, 650135 g, glycerol 50g, castor oil 110g, ethyl p-hydroxybenzoate 0.1g and distilled water to volume of 1000ml, stirring, and mixing to obtain shampoo.
Example four
1. Prescription: 120g of ginger and 80g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps: cleaning rhizoma Zingiberis recens, mashing, extracting with steam distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance to obtain rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding boric acid 10g and vitamin B15 pieces, AESA 80g, LSA 60g, CAB-3565 g, 650135 g, lauric acid sodium glutamate 30g, EDTA-2NA 1g, amino acid foaming agent 50g, glycerol 30g, propylene glycol 10g, sodium citrate 6g, sodium benzoate 2g, hexyl paraben 1.2g and distilled water to reach the constant volume of 1000ml, and stirring uniformly to obtain the shampoo.
EXAMPLE five
1. Prescription: 100g of ginger and 100g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps:
cleaning rhizoma Zingiberis recens, mashing, extracting with water vapor distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance as rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding boric acid 10g and vitamin B15 tablets, AESA 80g, LSA 60g, CAB-3565 g, 650135 g, lauric acid sodium glutamate 30g, EDTA-2NA 1g, amino acid foaming agent 50g, glycerin 30g, propylene glycol 10g, sodium citrate 6g, sodium benzoate 2g, hexyl paraben 1.2g and distilled water to reach the constant volume of 1000ml, stirring evenly,making into shampoo.
EXAMPLE six
1. Prescription: 80g of ginger and 120g of grassleaf sweelflag rhizome.
2. The preparation method comprises the following steps:
cleaning rhizoma Zingiberis recens, mashing, extracting with steam distillation for 2-3 times (6 times of water for the first time, 5 times of water for the second time, and 4 times of water for the third time for 1-3 hr each time), mixing the three extractive solutions, standing overnight, and collecting upper layer oily substance to obtain rhizoma Zingiberis recens oil;
extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
mixing ginger oil and rhizoma Acori Graminei volatile oil, adding boric acid 10g and vitamin B15 tablets, AESA170g, K1215 g, carbomer 20203 g, CMEA 15g, EDTA-2NA 1g, cocoyl diethanolamide 23g, small-particle-size emulsified silicone oil 18g, glycerol 30g, propylene glycol 10g, sodium citrate 6g, sodium benzoate 2g, methyl ester 20g and distilled water to reach the constant volume of 1000ml, and the shampoo is prepared by uniformly stirring.
Claims (3)
1. A shampoo for preventing and treating alopecia is characterized in that the shampoo is prepared from 40-80% of ginger oil extracted from ginger and 20-60% of rhizoma acori graminei volatile oil extracted from rhizoma acori graminei in percentage by weight, and the sum of the dosage of the ginger and the dosage of the rhizoma acori graminei in one liter of shampoo is 200 g.
2. The shampoo for preventing and treating alopecia according to claim 1, wherein each liter of the shampoo is prepared from 160g of ginger oil extracted from ginger and 40g of rhizoma acori graminei volatile oil extracted from rhizoma acori graminei.
3. The shampoo for preventing and treating alopecia according to claim 2, wherein the shampoo is prepared by the following method:
(1) extracting volatile oil from rhizoma Zingiberis recens by steam distillation;
(2) extracting volatile oil of rhizoma Acori Graminei from rhizoma Acori Graminei by steam distillation or supercritical carbon dioxide extraction;
(3) mixing ginger oil and rhizoma Acori Graminei volatile oil, adding adjuvants required by various dosage forms, and making into shampoo by conventional method.
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