Traditional Chinese medicine composition with skin repairing effect and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition with a skin repairing effect, the traditional Chinese medicine composition is composed of effective components and medically acceptable auxiliary materials, and the effective components are prepared from the following raw material medicines in parts by weight: 10-35 parts of solanum lyratum, 45-75 parts of angelica dahurica, 20-60 parts of aloe, 10-30 parts of codonopsis pilosula, 10-30 parts of ligusticum wallichii and 10-30 parts of flowers. The traditional Chinese medicine composition disclosed by the invention has a synergistic effect, has the effects of relieving skin inflammation, remarkably increasing the water content of skin, delaying the loss of skin collagen, relieving wrinkles and improving the dry state of the skin, and has remarkable effects of preventing and treating water shortage and dryness of the skin and repairing damaged skin.

Description

Technical Field

[0001] The invention relates to the technical field of preparation methods of skin care products, and in particular to a pharmaceutical composition containing an undetermined structure from traditional Chinese medicine. The composition is suitable for skin repair and care. Background Art

[0002] Skin problems are a common problem for most people in daily life. Problem skin and skin damage caused by ultraviolet rays directly affect a person's appearance and psychological state, and have a negative impact on the patient's mental health and quality of life. Common skin problems include: allergic skin diseases, infectious skin diseases and a series of other problems, such as keratosis pilaris, folliculitis, dryness, oiliness, etc.

[0003] Skin diseases are recognized by the industry as common and frequently occurring diseases, with various types, long treatment periods, prolonged course of disease, easy chronicity, and difficulty in curing, which bring serious physical discomfort and psychological burden to patients. Therefore, early intervention and timely repair of skin problems can help reduce people's appearance anxiety and psychological pressure, and improve the national health level.

[0004] Although there are many kinds of products for the prevention and treatment of skin problems, they often have a single function, lack multiple functions, and have certain limitations. Exploring products with skin repair functions that meet the multi-dimensional needs of the public for healthy and natural skin and both internal and external care has always been the focus and trend in the field of natural skin care research.

[0005] Compared with chemical synthetic products, Chinese herbal medicine has more active ingredients and has much less side effects on the human body, so it is safer. The natural active ingredients contained in it are widely used in modern cosmetics and play various roles, such as whitening and removing spots, anti-aging and anti-wrinkle, moisturizing, anti-inflammatory, sun protection, anti-dandruff and anti-itching, etc. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition with skin repairing effect, which can repair the skin without chemical additives and reduces skin irritation, and a preparation method thereof.

[0007] To solve the above technical problems, the technical solution provided by the present invention is: a Chinese medicine composition with skin repairing effect, comprising white peony root, angelica dahurica, aloe, codonopsis pilosula, chuanxiong rhizome, and flowers, wherein the proportions of each component are 10-35 parts of white peony root, 45-75 parts of angelica dahurica, 20-60 parts of aloe vera, 10-30 parts of codonopsis pilosula, 10-30 parts of chuanxiong rhizome, and 0-30 parts of flowers.

[0008] Among them, preferably, the aloe vera and the flowers are fresh materials; the white safflower, the angelica dahurica, the codonopsis pilosula and the ligusticum chuanxiong are processed Chinese medicinal materials.

[0009] Preferably, the flowers include any one of roses, lavender and jasmine.

[0010] A method for preparing a traditional Chinese medicine composition having a skin repairing effect, comprising weighing raw materials of various weight ratios, crushing and mixing the raw materials, and extracting effective components from the raw materials to obtain an extract;

[0011] Weighing Radix Bletillae Sinensis, Radix Angelicae Dahuricae, Codonopsis Pilosulae, and Rhizoma Chuanxiong, crushing and mixing the raw materials by using a wall-breaking process, adding an equal amount of medical ethanol to perform alcohol immersion for 4 to 6 days, and then taking the filtrate;

[0012] Take fresh aloe vera, break the skin, add one times the amount of pure water to soak, crush and squeeze it using a wall-breaking process, and then soak it in an equal amount of medical ethanol for alcohol soaking for 1 day and then take the filtrate;

[0013] Take any one of rose, lavender and jasmine, add three times the amount of pure water, soak for two hours, crush and squeeze using a wall-breaking process, soak in an equal amount of medical ethanol for alcohol soaking for 1 day, and then take the filtrate.

[0014] Preferably, the extract is concentrated to obtain a concentrated thick paste, including concentrating the extract to a primary thick paste with a relative density of 1.0 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating it to a secondary thick paste with a relative density of 1.0 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a finished product.

[0015] Preferably, the Chinese medicine composition comprises a cream, a lotion, a spray or a gel.

[0016] The effects of each component in the prescription are as follows:

[0017] White peony: It has antibacterial and anti-inflammatory effects, and can remove edema. It can relieve skin itching, redness, inflammation, and swelling. At the same time, it is rich in arbutin, saponins and other substances that have anti-inflammatory and antioxidant effects, which can inhibit the formation of melanin, thereby playing a role in whitening and brightening the skin tone.

[0018] Angelica dahurica: It contains a variety of active ingredients, has anti-inflammatory, antibacterial and antioxidant effects, and can relieve skin inflammation, acne and other problems. In addition, the flavonoids and coumarin components in Angelica dahurica can reduce the damage of free radicals to the skin barrier, promote cell regeneration, help the skin restore its elasticity and radiance, and also promote blood circulation, improve dull skin tone, and help restore the health and radiance of the skin.

[0019] Aloe vera: It is rich in vitamins, amino acids and mucopolysaccharides. It has the effects of moisturizing, relieving inflammation and itching, anti-allergy, promoting wound healing, and inhibiting scar formation. It can be used to moisturize dry skin, moisturize and lock in moisture after bathing, and calm and repair skin after sun exposure. It can also inhibit the growth of microorganisms on the skin, and has the effects of whitening, moisturizing, and repairing damaged skin.

[0020] Codonopsis: The various nutrients contained in Codonopsis can nourish the skin and improve the skin's metabolism, thereby achieving the effect of even skin tone. At the same time, the saponins and polysaccharides therein can nourish the skin, enhance the skin's antioxidant capacity, and can inhibit the formation of melanin, thereby brightening the skin tone.

[0021] Chuanxiong: Chuanxiong has the effect of promoting blood circulation and removing blood stasis, which can improve blood circulation, increase blood oxygen supply to the skin, improve skin metabolism, and help improve dull skin. In addition, Chuanxiong also has certain anti-inflammatory and antioxidant effects, which can effectively relieve skin inflammation and allergies, and can enhance skin defense capabilities.

[0022] The advantages of the present invention compared with the prior art are:

[0023] 1. The Chinese medicine composition of the present invention is a pure natural plant formula, does not contain antibiotics or hormone substances, and is safe and has no burden on the human body and skin.

[0024] 2. It integrates traditional and modern Chinese medicine theories with human symptom characteristics, has scientific compatibility, comprehensive formulation, and advanced processing and preparation technology. The composition can also be prepared into creams, lotions, sprays or gels and other forms for easy use.

[0025] 3. The formula contains Chinese medicinal herbs such as Bletilla striata and Angelica dahurica which can quickly eliminate skin inflammation and improve the skin's ability to resist oxidative stress, as well as Rhizoma Chuanxiong and Codonopsis pilosula which have skin nourishing effects, and Aloe vera which has skin repairing effects and promotes skin healing. The medicinal effects of anti-inflammatory, moisturizing and repairing are combined to effectively improve the problem of damaged skin barrier. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a comparison chart of mouse skin experiments.

[0027] Figure 2 It is a data graph of drug treatment at different concentrations. DETAILED DESCRIPTION

[0028] References to embodiments of the present invention will now be provided in detail, one or more examples of which are described below. Each example is provided as an explanation rather than a limitation of the present invention. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the present invention without departing from the scope or spirit of the present invention. For example, a feature illustrated or described as part of one embodiment may be used in another embodiment to produce a further embodiment.

[0029] Therefore, it is intended that the present invention covers such modifications and variations that fall within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are obvious from the following detailed description. Those of ordinary skill in the art will appreciate that this discussion is only a description of exemplary embodiments and is not intended to limit the broader aspects of the present invention.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0031] The terms "comprises", "includes" or any other variation thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element limited by the sentence "comprises a ..." does not exclude the presence of additional identical elements in the process, method, article or device that includes the element. In addition, the terms "first" and "second" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated.

[0032] Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of the invention, "plurality" means at least two, such as two, three, etc., unless otherwise clearly and specifically defined, and in the description of the present invention, "several" means at least one, such as one, two, etc., unless otherwise clearly and specifically defined.

[0033] Except as shown in the operating examples or otherwise indicated, all numbers used in the specification and claims to indicate the amount of ingredients, physicochemical properties, etc. are understood to be adjusted by the term "about" in all cases. For example, therefore, unless otherwise indicated, the numerical parameters listed in the above specification and the appended claims are approximate values, and those skilled in the art will be able to use the teachings disclosed herein to seek to obtain the desired properties and appropriately change these approximate values. The use of numerical ranges expressed as endpoints includes all numbers within the range and any range within the range, for example, 1 to 5 includes 1, 1.1, 1.3, 1.5, 2, 2.75, 3, 3.80, 4 and 5, etc.

[0034] As shown in combination, a traditional Chinese medicine composition with skin repairing effect includes white peony root, angelica dahurica, aloe, Codonopsis pilosula, Ligusticum chuanxiong, and flowers, wherein the ratio of each component is 10-30 parts of white peony root, 50-70 parts of angelica dahurica, 30-50 parts of aloe, 10-30 parts of Codonopsis pilosula, 10-30 parts of Ligusticum chuanxiong, and 10-30 parts of flowers.

[0035] In one embodiment

[0036] The proportions of each component are 15-35 parts of Bletilla striata, 55-75 parts of Angelica dahurica, 35-55 parts of Aloe vera, 15-35 parts of Codonopsis pilosula, 15-35 parts of Ligusticum chuanxiong and 15-35 parts of flowers.

[0037] In one embodiment

[0038] The proportions of each component are 10-35 parts of Bletilla striata, 50-75 parts of Angelica dahurica, 30-55 parts of Aloe vera, 10-35 parts of Codonopsis pilosula, 10-35 parts of Ligusticum chuanxiong and 10-35 parts of flowers.

[0039] More specifically

[0040] The ratio of each component is 20 parts of white peony root, 60 parts of angelica dahurica, 40 parts of aloe, 20 parts of codonopsis pilosula, 20 parts of ligusticum chuanxiong and 20 parts of flowers, and the flowers include any one of rose, lavender and jasmine, which can be selected according to needs to improve the smell of the composition.

[0041] Example 1 (emulsion)

[0042] A method for preparing a traditional Chinese medicine composition with skin repairing effect comprises weighing raw materials of various weight proportions, including 20 parts of white peony root, 60 parts of angelica dahurica, 40 parts of aloe vera, 20 parts of codonopsis pilosula, 20 parts of ligusticum chuanxiong and 20 parts of flowers, crushing and mixing the raw materials, adding pure water ten times of their weight to a vacuum homogenizing emulsifier for heating and extraction, the extraction time is 2 to 3 hours, and filtering the solution to obtain an extract.

[0043] The method also includes concentrating the extract to obtain a concentrated thick paste, including concentrating the extract to a primary thick paste with a relative density of 1.1 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating the primary thick paste to a secondary thick paste with a relative density of 1.1 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a finished product.

[0044] The Chinese medicine composition can be used as an ointment, a lotion, a spray or a gel through the extract or the secondary thick paste.

[0045] In one embodiment

[0046] Weigh 20 parts of Radix Sophorae Fructus, 60 parts of Radix Angelicae Dahuricae, 20 parts of Codonopsis Pilosulae, and 20 parts of Rhizoma Chuanxiong, crush and mix the raw materials by using a wall-breaking process, add an equal amount of medical ethanol after mixing, and immerse for 4 to 6 days, then take the filtrate;

[0047] Take 40 parts of fresh aloe vera, break the skin, add one times the amount of pure water to soak, crush and squeeze by wall breaking technology, soak in an equal amount of medical ethanol for alcohol soaking for 1 day, and then take the filtrate;

[0048] Take roses, add three times the amount of pure water, soak for two hours, crush and squeeze them using a wall-breaking process, soak them in an equal amount of medical ethanol for alcohol soaking for one day, and then take the filtrate; and prepare a skin care composition with rose fragrance.

[0049] In this step, you can also

[0050] Take lavender, add three times the amount of pure water, soak for two hours, crush and squeeze by using a wall-breaking process, soak in an equal amount of medical ethanol for alcohol soaking for one day, and then take the filtrate; and prepare a skin care composition with lavender fragrance.

[0051] or

[0052] Jasmine flowers are added with three times the amount of pure water and soaked for two hours, then crushed and squeezed by using a wall-breaking process, and then immersed in an equal amount of medical ethanol for alcohol soaking for one day, and then the filtrate is collected; a skin care combination with jasmine fragrance is prepared.

[0053] The extract is concentrated to obtain a concentrated thick paste, including concentrating the extract to a primary thick paste with a relative density of 1.1 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating it to a secondary thick paste with a relative density of 1.1 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a semi-finished product.

[0054] When using, weigh 1.0 g of the above thick paste or freeze-dried powder, add 20 ml of distilled water, and stir until it is completely dissolved to prepare a mixture of active ingredients;

[0055] Take 5 g of beeswax and 25 g of liquid paraffin, mix well, and heat to 80°C to prepare the oil phase;

[0056] Take 2g of polysorbate 80, 0.2g of sorbic acid and 20ml of distilled water, mix well, and heat to 80°C to prepare an aqueous phase;

[0057] The prepared water phase is added to the prepared oil phase during stirring, and after stirring to room temperature, the prepared active ingredient mixture is added, and then distilled water is added to 100 g, and the emulsion is obtained after stirring evenly.

[0058] Embodiment 2 (gel)

[0059] Weigh the raw materials in each weight ratio, 20 parts of white peony root, 60 parts of angelica dahurica, 40 parts of aloe, 20 parts of codonopsis pilosula, 20 parts of ligusticum chuanxiong, and 20 parts of flowers, crush and mix the raw materials, add pure water ten times its weight into a vacuum homogenizing emulsifier for heating and extraction, the extraction time is 2 to 3 hours, and filter the solution to obtain an extract.

[0060] The extract is concentrated to obtain a concentrated thick paste, which includes concentrating the extract to a primary thick paste with a relative density of 1.1 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating it to a secondary thick paste with a relative density of 1.1 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a semi-finished product. The composition prepared in this way has less irritation to the skin and a milder drug effect.

[0061] When using, weigh 1.0 g of the above thick paste or freeze-dried powder, add 20 ml of distilled water, stir until it is completely dissolved, and prepare a mixture of active ingredients; add 10 ml of distilled water, stir until it is completely dissolved, then add 0.5 g of swollen carbomer, 0.1 g of ethylparaben and 50 ml of distilled water, stirring continuously, and finally add distilled water to 100 g, stir well to obtain a gel.

[0062] In one embodiment

[0063] Weigh 20 parts of Radix Sophorae Fructus, 60 parts of Radix Angelicae Dahuricae, 20 parts of Codonopsis Pilosulae, and 20 parts of Rhizoma Chuanxiong, crush and mix the raw materials by using a wall-breaking process, add an equal amount of medical ethanol after mixing, and immerse for 4 days before taking the filtrate;

[0064] Take 40 parts of fresh aloe vera, break the skin, add one times the amount of pure water to soak, crush and squeeze by wall breaking technology, soak in an equal amount of medical ethanol for alcohol soaking for 1 day, and then take the filtrate;

[0065] Take roses, add three times the amount of pure water, soak for two hours, crush and squeeze them using a wall-breaking process, soak them in an equal amount of medical ethanol for alcohol soaking for one day, and then take the filtrate; and prepare a skin care composition with rose fragrance.

[0066] In this step, you can also

[0067] Take lavender, add three times the amount of pure water, soak for two hours, crush and squeeze by using a wall-breaking process, soak in an equal amount of medical ethanol for alcohol soaking for one day, and then take the filtrate; and prepare a skin care composition with lavender fragrance.

[0068] or

[0069] Jasmine flowers are added with three times the amount of pure water and soaked for two hours, then crushed and squeezed by using a wall-breaking process, and then immersed in an equal amount of medical ethanol for alcohol soaking for one day, and then the filtrate is collected; a skin care combination with jasmine fragrance is prepared.

[0070] The extract is concentrated to obtain a concentrated thick paste, which includes concentrating the extract to a primary thick paste with a relative density of 1.1 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating it to a secondary thick paste with a relative density of 1.1 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a finished product.

[0071] The Chinese medicine composition when used includes cream, lotion, spray or gel.

[0072] Example 3 (ointment)

[0073] Weigh the raw materials of various weight ratios, including 20 parts of white peony root, 60 parts of angelica root, 40 parts of aloe, 20 parts of codonopsis pilosula, 20 parts of ligusticum chuanxiong, and 20 parts of flowers, crush and mix the raw materials, add pure water ten times of its weight to a vacuum homogenizing emulsifier for heating and extraction, and the extraction time is 2 to 3 hours, and filter the solution to obtain an extract. The composition prepared in this way has less irritation to the skin and a more moderate medicinal effect.

[0074] The extract is concentrated to obtain a concentrated thick paste, which includes concentrating the extract to a primary thick paste with a relative density of 1.1 to 1.25, subjecting the primary thick paste to ethanol precipitation to obtain a filtrate, and then concentrating it to a secondary thick paste with a relative density of 1.1 to 1.25, and filling the obtained secondary thick paste into a PET bottle protected from ultraviolet light as a finished product.

[0075] When using, weigh 1.0 g of the above thick paste or freeze-dried powder, add 20 g of glycerin to grind and dissolve it, add 79 g of vaseline in portions, and continue grinding to obtain an ointment.

[0076] The beneficial effects of the Chinese medicine composition of the present invention will be further confirmed by the following studies.

[0077] Example 4 (Animal efficacy experiment 1)

[0078] 1. Experimental Materials

[0079] (1) Experimental animals: SPF female Kunming mice, weighing 18-21 g. The experimental animals were provided by Beijing Fuhuakang Biotechnology Co., Ltd., license number: SYXK(Gan)2020-0001.

[0080] (2) Test drug

[0081] Control group 1: Take 2g of vitamin E, grind it, add 100ml of glycerol to dissolve it, shake well before use to prepare vitamin E solution;

[0082] Control group 2: The mixture was prepared according to the ratio of Example 1 except for the Angelica dahurica extract, and then the gel was prepared according to the method of Example 2.

[0083] Control group 3: The gel was prepared according to the ratio of Example 1 except for the extract of Solanum lyratum.

[0084] Experimental group 1: the emulsion prepared in Example 1 above was taken.

[0085] Experimental group 2: The gel prepared in Example 1 above was taken.

[0086] Experimental group 3: the ointment prepared in Example 1 above was taken.

[0087] Glutathione peroxidase (GSH-Px) kit, superoxide dismutase (SOD) kit, interleukin 1β (IL-1β) kit, interleukin 6 (IL-6) kit, matrix metalloproteinase 1 (MMP-1) kit, etc. were purchased from Hangzhou Noyang Biotechnology Co., Ltd.

[0088] (II) Experimental methods

[0089] 70 SPF female Kunming mice (18-21 g) were selected and fed adaptively for 3 days. The hair on the back of the mice was removed using a shaver and depilatory cream. The depilatory area was about 2×3 cm. 2 ; Then the mice were randomly divided into 7 groups: blank group, control group (1, 2, 3) and experimental group (1, 2, 3), 10 mice in each group. The mice were medicated once a day for 8 consecutive weeks; the dosage of each dose was based on the weight of the mice, blank group: 20mg / 20g distilled water, control group 1: 20mg / 20g vitamin E, control group 2: 10mg / 20g lacking angelica extract, control group 3: 10mg / 20g lacking smilax china extract, experimental groups 1-3: 10mg / 20g active ingredient (extract). Each group of mice was exposed to 100mJ / cm 2 The irradiation dose was 5 times a week, and the irradiation dose increased by 100mJ / cm each week thereafter. 2 , until the 5th week 500mJ / cm 2 Then maintain 500mJ / cm 2 The experiment ended at the 8th week.

[0090] (1) Index evaluation

[0091] ① Macroscopic evaluation of skin

[0092] During the experiment, the macroscopic features of the mouse back skin related to photoaging (deep and coarse wrinkles, loose skin, thickening, erythema, etc.) were observed and evaluated. The mice were anesthetized with ether, and the skin in the middle of their backs was photographed. The skin was macroscopically scored according to the skin photoaging scoring criteria in Table 1 (0-normal skin, 8-severely damaged skin), and the examination was performed once a week for a total of 8 weeks.

[0093] Table 1 Scoring criteria for skin barrier damage

[0094]

[0095] ②Skin moisture measurement

[0096] At the end of the 8th week, the back hair removal area of ​​each group of mice was approximately 2 × 3 cm 2 After the mice were killed by cervical dislocation, the full-thickness skin (excluding subcutaneous fat) of the depilated back was immediately removed, and about 0.2 g of skin was quickly cut and accurately weighed for wet weight. Then it was placed in an oven and dried at 105°C for 4 hours, and its dry weight was weighed. The skin water content of each group of animals was calculated according to the following formula: Skin water content percentage = (M (湿重-干重 ) / M 湿重 )×100%.

[0097] ③ Determination of antioxidant indexes in skin tissue

[0098] The mice in each group were killed by cervical dislocation 2 hours after the last administration. 0.3 g of the mouse back skin (with subcutaneous fat removed) was weighed and rinsed twice in ice-cold saline. After being dried with filter paper, the tissue was accurately weighed. The tissue was cut into pieces and packaged on an ice box. The contents of SOD and GSH-Px were determined according to the procedures of the kit.

[0099] ④ Determination of inflammatory factor content in skin tissue

[0100] Mice in each group were killed by cervical dislocation 2 hours after the last administration. 0.3 g of mouse back skin (with subcutaneous fat removed) was weighed and rinsed twice in ice-cold saline. After being dried with filter paper, the tissue was precisely weighed. The tissue was cut into pieces and packaged on an ice box. The contents of IL-1β and IL-6 were determined according to the ELISA kit.

[0101] ⑤ Determination of the content of matrix metalloproteinases in skin tissue

[0102] Mice in each group were killed by cervical dislocation 2 hours after the last administration. 0.2 g of mouse back skin (with subcutaneous fat removed) was weighed and rinsed twice in ice-cold saline. After being dried with filter paper, the tissue was accurately weighed. The tissue was cut into pieces and packaged on an ice box. The MMP-1 content was determined according to the ELISA kit.

[0103] (2) Statistical examination

[0104] All data were analyzed using SPSS 21.0 statistical software and presented as “mean ± standard deviation”. ". One-way analysis of variance was used to compare the differences among the groups, and the LSD method (when the variances were equal) or Dunnett's method (when the variances were unequal) was used for multiple comparisons within the groups. P < 0.05 indicated a significant difference, and P < 0.01 indicated an extremely significant difference.

[0105] Example 5 (Study on the principles of formulation)

[0106] 1. Experimental Materials

[0107] 1.1 Main reagents: medical ethanol (Chengdu Kelong Chemical Co., Ltd.), medical vaseline, beeswax, polysorbate 80 (Shanghai Aladdin Biochemical Technology Co., Ltd.), liquid paraffin, sorbic acid, carbomer, ethylparaben, glycerin (Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.).

[0108] 1.2 Main instruments: BT25S 1 / 100000 electronic balance (Sartorius, Germany); drying oven (Shaoxing Bowei Instrument Equipment Co., Ltd.), vacuum homogenizing emulsifying pot (Yangzhou United Chemical Machinery Co., Ltd.).

[0109] (II) Preparation of different test samples:

[0110] (1) Sample 1: According to the prescription of Example 1, the Chinese medicine composition of the present invention was prepared: 120 g of Sophora flavescens, 360 g of Angelica dahurica, 120 g of Codonopsis pilosula, and 120 g of Ligusticum chuanxiong were washed and set aside, and the raw materials were crushed and mixed by a wall-breaking process. After mixing, an equal amount of medical ethanol was added for soaking for 4 to 6 days, and the filtrate was obtained; 240 g of fresh aloe vera was peeled, and an equal amount of purified water was added for soaking, and then the crushed and squeezed by a wall-breaking process, and then the filtrate was soaked in an equal amount of medical ethanol for 1 day, and the filtrate was obtained; 120 g of lavender was added to three times the amount of purified water, and then soaked for two hours, and then the crushed and squeezed by a wall-breaking process, and then the filtrate was soaked in an equal amount of medical ethanol for 1 day, and the filtrate was obtained; the above filtrates were combined to obtain the effective ingredient.

[0111] (2) Sample 2: According to the prescription of Example 1, a Chinese medicine composition lacking Bletilla striata and Angelica dahurica was prepared. 120 g of Codonopsis pilosula and 120 g of Ligusticum chuanxiong were washed and set aside, 240 g of fresh aloe vera and 120 g of lavender were taken, and the preparation method of the active ingredient was the same as that of Sample 1.

[0112] (3) Sample 3: According to the prescription of Example 1, a Chinese medicine composition lacking the adjuvant drugs Codonopsis pilosula and Chuanxiong was prepared. 120 g of Sophora flavescens and 360 g of Angelica dahurica were washed and set aside, 240 g of fresh aloe vera was peeled, and 120 g of lavender was prepared. The preparation method of the active ingredient was the same as that of Sample 1.

[0113] (4) Sample 4: According to the prescription of Example 1, a Chinese medicine composition lacking adjuvant aloe vera was prepared. 120 g of Sophora flavescens, 360 g of Angelica dahurica, 120 g of Codonopsis pilosula, 120 g of Ligusticum chuanxiong were washed and set aside, and 120 g of Lavender was used. The preparation method of the active ingredient was the same as that of Sample 1.

[0114] (5) Sample 5: According to the prescription of Example 1, a Chinese medicine composition lacking flower extract was prepared. 120 g of Sophora flavescens, 360 g of Angelica dahurica, 120 g of Codonopsis pilosula, and 120 g of Ligusticum chuanxiong were washed and set aside, and 240 g of fresh aloe vera was taken. The preparation method of the active ingredient was the same as that of Sample 1.

[0115] (6) Sample 6: According to the prescription of Example 1, the dosage of the auxiliary drug Codonopsis pilosula, the auxiliary drug Chuanxiong, the adjuvant drug Lu and the adjuvant drug flower was fixed, and a Chinese medicine composition with a proportion lower than that of the main drug Bletilla striata (8%) and the main drug Angelica dahurica (30%) was prepared. 86g of Bletilla striata, 324g of Angelica dahurica, 134g of Codonopsis pilosula, 134g of Chuanxiong, 268g of Aloe vera and 134g of Lavandula officinalis were washed and set aside. The preparation method of the effective ingredients was the same as that of Sample 1.

[0116] (7) Sample 7: According to the prescription of Example 1, the dosage of the auxiliary drug Codonopsis pilosula, the auxiliary drug Chuanxiong, the adjuvant drug Aloe vera and the flower was fixed, and the Chinese medicine composition with the endpoint values ​​of the proportion range of the main drug Bletilla striata (9%) and the main drug Angelica dahurica (31%) was prepared. Take 97g of Bletilla striata, 335g of Angelica dahurica, 130g of Codonopsis pilosula, 130g of Chuanxiong, 258g of Aloe vera, and 130g of Lavender, wash and set aside, and the preparation method of the effective ingredient is the same as that of Sample 1.

[0117] (8) Sample 8: According to the prescription of Example 1, the dosage of the auxiliary drug Codonopsis pilosula, the auxiliary drug Chuanxiong, the adjuvant drug Aloe vera and the flower extract was fixed, and a Chinese medicine composition with the main drug Bletilla striata (11%) and the main drug Angelica dahurica (33%) in the middle of the proportion range was prepared. Take Bletilla striata 119g, Angelica dahurica 356g, Codonopsis pilosula 121g, Chuanxiong 121g, Aloe vera 242g, and Lavender 121g, wash and set aside, and the preparation method of the active ingredient is the same as that of Sample 1.

[0118] (9) Sample 9: According to the prescription of Example 1, the dosage of the auxiliary drug Codonopsis pilosula, the auxiliary drug Chuanxiong, the adjuvant drug Aloe vera and the adjuvant drug flower was fixed, and a Chinese medicine composition with the endpoint values ​​of the proportion of the main drug Bletilla striata (13%) and the main drug Angelica dahurica (35%) was prepared. Take 141g of Bletilla striata, 378g of Angelica dahurica, 112g of Codonopsis pilosula, 112g of Chuanxiong, 225g of Aloe vera and 120g of Lavender, wash and set aside, and the preparation method of the effective ingredient is the same as that of Sample 1.

[0119] (10) Sample 10: According to the prescription of Example 1, the dosage of the auxiliary drug Codonopsis pilosula, the auxiliary drug Chuanxiong, the adjuvant drug Aloe vera and the envoy drug flower extract was fixed, and a Chinese medicine composition with a higher proportion of the main drug Bletilla striata (14%) and the main drug Angelica dahurica (36%) was prepared. Take 151g of Bletilla striata, 389g of Angelica dahurica, 108g of Codonopsis pilosula, 108g of Chuanxiong, 216g of Aloe vera and 108g of Lavender, wash and set aside, and the preparation method of the effective ingredient is the same as that of Sample 1.

[0120] (III) Experimental methods

[0121] 3.1 Investigation of the optimal action time and concentration of the Chinese medicine composition of the present invention on HaCaT cell damage and repair

[0122] Take a HaCat cell suspension with good growth status and adjust the number of cells in the suspension to 2×10 5 / mL, inoculated in 96-well plates, 100μL per well, 6 parallel wells per group, cultured for 24h, given Chinese medicine composition for intervention, the concentration gradient is 5% (v / v), 1% (v / v), 0.2% (v / v), 0.05% (v / v), 0.01% (v / v), the control group added DMEM complete medium, the blank group did not contain cells, only DMEM complete medium. After incubation for a certain period of time, placed in a microplate reader, and the OD450 value was measured.

[0123]

[0124] 3.2 Effect of the Chinese medicine composition of the present invention on HaCaT cell damage caused by UVB

[0125] HaCaT cells were inoculated in 96-well plates and cultured to a density of about 80% for UVB radiation treatment. Before treating HaCaT cells, the old culture medium in the well plate was aspirated and discarded, and new culture medium was added after washing with PBS. After the cells were treated in groups according to different drug concentrations and radiation times, the 96-well plate in which the cells were cultured was placed under a UVB phototherapy device for parallel irradiation and measured with an ultraviolet meter to make the ultraviolet irradiation intensity reach 1mW / cm2. The UVB irradiator and the well plate were wrapped with tin foil, and the blank group was covered with tin foil to avoid ultraviolet radiation. The irradiation time was 4min, and the radiation dose was 2.4J / cm2 (calculation formula: radiation dose (mJ / cm2) = radiation power (mW / cm2) × radiation time (s); radiation intensity was 10mW / cm2). After continuing to incubate in the incubator for 24h, the CCK-8 method was used for detection, and A450 was measured on an enzyme marker to calculate the proliferation rate of HaCaT cells.

[0126] 3.3 Study on the formulation principles of the Chinese medicine composition of the present invention

[0127] ① In vitro efficacy study of the Chinese medicine composition of the present invention and each separated prescription group: The optimal effective concentration and action time of the test sample 1 on HaCaT cells can be known from the experimental results of 3.1-3.2. This concentration and time were fixed, and the efficacy of the whole prescription group and each separated prescription group on the UVB radiation-induced cell damage model was studied respectively. The specific operation steps refer to 3.2.

[0128] ② Investigation on the proportion of monarch medicine:

[0129] The monarch drug is the core of the comprehensive effect of all drugs in the prescription. The change of the proportion of the monarch drug in the whole prescription will affect the efficacy and performance of the whole prescription. Therefore, this study adopted a two-factor three-level factorial design, with the change of the ratio of Bletilla striata and Angelica dahurica as the investigation factor, each factor took 3 levels, and the HaCaT cell survival rate was used as the investigation index for the prescription design, and the optimal ratio of Bletilla striata and Angelica dahurica in the double monarch drug was obtained. The factor level design is shown in Table 7.

[0130] According to the optimal ratio of the two medicines Bletilla striata and Angelica dahurica, the weight percentage of one of the medicines in the whole prescription was fixed, and the protective effect of the changes in the weight percentages of Bletilla striata and Angelica dahurica on HaCaT cells was investigated respectively, and the effective proportion range of Bletilla striata and Angelica dahurica was obtained. Finally, the two end values, the middle value, and the values ​​above and below the proportion range of the two were taken for experimental verification, so as to determine the effective range of Bletilla striata and Angelica dahurica.

[0131] 3.4 Statistical methods

[0132] SPSS26.0 was used for statistical analysis, p<0.05 indicated significant differences, p<0.01 indicated extremely significant differences; and graphs were drawn. The experimental results were expressed as mean±SD and analyzed using GraphPad Prism 8.0.2 statistical software. One-way ANOVA was used to compare differences among the groups.

[0133] (IV) Experimental results and discussion

[0134] 4.1 Animal experiments

[0135] 4.1.1 Macroscopic improvement of the skin of photoaged mice by the Chinese medicine composition of the present invention

[0136] Representative photos of the macroscopic appearance of the back skin of mice in each group at the end of the 8th week, such as Figure 1 As shown. Four weeks after UV radiation modeling, mice in the blank group began to show typical macroscopic skin damage such as wrinkles, erythema, peeling, and irregular thickening. At the end of the 8th week, the back skin of mice in experimental groups 1, 2, and 3 was healthy and smooth, with a few fine wrinkles; in control group 1, slight erythema lesions were occasionally seen, and a few shallow wrinkles appeared; in control groups 2 and 3, a few deep wrinkles and slight erythema and other skin damage phenomena appeared.

[0137] The macroscopic scores of mice in each group were recorded weekly, and the results are shown in Table 2. At the end of the 8th week of the experiment, the macroscopic scores are shown in Table 2. The macroscopic scores of the skin of mice in each group were significantly reduced compared with the blank group (P < 0.01), while the macroscopic scores of the control group 1, experimental group 2, and experimental group 3 were not statistically significant compared with the experimental group 1 (P > 0.05), and the macroscopic scores of the skin of mice in the control group 2 and control group 3 were significantly increased compared with the experimental group 1 (P < 0.01); the above experimental results indicate that the Chinese medicine composition has a certain repair effect on the macroscopic damage of the skin induced by ultraviolet radiation, and the combined use of the double-king medicines, white peony root and white angelica root, makes the protective effect better.

[0138] Table 2 Results of macroscopic scoring of mouse skin in the eighth week

[0139]

[0140] (Note: Compared with the blank group, * P<0.01; compared with experimental group 1, # P<0.01, ★ P>0.05)

[0141] 4.1.2 Effect of the Chinese medicine composition of the present invention on the water content of mouse skin

[0142] When the skin is exposed to ultraviolet radiation for a long time, the loss of moisture and collagen in the skin will be accelerated, causing dry and dull skin, and accelerating skin aging and wrinkling. The test results of mouse skin moisture content in this experiment are shown in Table 3. The skin moisture content of mice in each group was significantly higher than that of the blank group (P < 0.01), while the skin moisture content of mice in the control group 1, experimental group 2, and experimental group 3 was not statistically significant compared with that in the experimental group 1 (P > 0.05); the skin moisture content of mice in the control group 2 and control group 3 was significantly lower than that in the experimental group 1 (P < 0.01); the above experimental results indicate that the Chinese medicine composition can prevent the loss of skin moisture caused by ultraviolet radiation to a certain extent, improve the hydration capacity of the skin, and the combined use of the double-king medicines, white peony root and white angelica root, makes it more effective in maintaining the moisture content of the skin.

[0143] Table 3 Results of mouse skin moisture content

[0144]

[0145]

[0146] (Note: Compared with the blank group, * P<0.01; compared with experimental group 1, # P<0.01, ★ P>0.05)

[0147] 4.1.3 Effect of the Chinese medicine composition of the present invention on the collagen content of mouse skin tissue

[0148] The results of collagen content determination are shown in Table 4. The collagen content of mouse skin in each group was significantly higher than that in the blank group (P < 0.01), while there was no statistically significant difference in the collagen content of mouse skin between the control group 1, experimental group 2, and experimental group 3 compared with experimental group 1 (P > 0.05); the collagen content of mouse skin between the control group 2 and control group 3 was significantly lower than that of experimental group 1 (P < 0.01). The above experimental results indicate that the Chinese medicine composition can promote the synthesis of collagen or inhibit the degradation of collagen, and the combined use of the two medicines, Radix Angelicae Dahuricae and Radix Angelicae Dahuricae, is helpful to promote the level of collagen in the skin.

[0149] Table 4 Results of skin collagen content

[0150]

[0151] (Note: Compared with the blank group, * P<0.01, compared with experimental group 1, # P<0.01, ★ P>0.05)

[0152] 4.1.4 Effect of the Chinese medicine composition of the present invention on the antioxidant capacity of mouse skin tissue

[0153] The activity of antioxidant enzymes (such as superoxide dismutase SOD, glutathione peroxidase GSH-Px) is an important indicator for evaluating the body's antioxidant capacity. As shown in Table 6, the SOD content of the mouse skin in each group was significantly higher than that in the blank group (P < 0.01), while there was no statistically significant difference in the SOD content of the mouse skin between the control group 1, the experimental group 2, and the experimental group 3 compared with the experimental group 1 (P > 0.05); the SOD content of the mouse skin in the control group 2 and the control group 3 was significantly lower than that in the experimental group 1 (P < 0.01).

[0154] As shown in Table 5, the GSH-Px content of the mouse skin in each group was significantly higher than that in the blank group (P < 0.01), while there was no statistically significant difference in the antioxidant enzyme content of the mouse skin between the control group 1, the experimental group 2, and the experimental group 3 compared with the experimental group 1 (P > 0.05); the GSH-Px content of the mouse skin between the control group 2 and the control group 3 was significantly lower than that of the experimental group 1 (P < 0.01). The above experimental results indicate that the Chinese medicine composition can significantly enhance the antioxidant capacity of the skin tissue, thereby counteracting the significant increase in the oxidative stress pressure in the body induced by ultraviolet radiation.

[0155] Table 5 Skin antioxidant enzyme results

[0156]

[0157] (Note: Compared with the blank group, * P<0.01, compared with experimental group 1, # P<0.01, ★ P>0.05)

[0158] 4.1.5 Intervention of the Chinese medicine composition of the present invention on the overexpression of inflammatory factors in mouse skin tissue

[0159] Most skin problems (such as acne, eczema, etc.) involve skin inflammation, and the level of inflammatory factors is an important indicator of the progression of inflammation. As shown in Table 6, the content of IL-1β in the skin of mice in each group was significantly lower than that in the blank group (P < 0.01), and there was no statistically significant difference in the content of IL-1β in the skin of mice in the control group 1, experimental group 2, and experimental group 3 compared with experimental group 1 (P > 0.05); the content of IL-1β in the skin of mice in the control group 2 and control group 3 was significantly higher than that in the experimental group 1 (P < 0.01).

[0160] As shown in Table 6, the content of IL-6, an inflammatory factor in the skin of mice in each group, was significantly lower than that in the blank group (P < 0.01). There was no statistically significant difference in the content of IL-6 in the skin of mice between the control group 1, experimental group 2, and experimental group 3 and experimental group 1 (P > 0.05). The content of inflammatory factor in the skin of mice between the control group 2 and control group 3 was significantly increased compared with that of the experimental group 1 (P < 0.01).

[0161] Table 6 Results of skin inflammatory factors

[0162]

[0163] (Note: Compared with the blank group, * P<0.01, compared with experimental group 1, # P<0.01, ★ P>0.05)

[0164] The above experimental results suggest that the Chinese medicine composition can inhibit the overexpression of inflammatory factors associated with skin damage.

[0165] 4.1.6 Intervention of the Chinese medicine composition of the present invention on the abnormal secretion of MMP-1 in mouse skin tissue

[0166] Matrix metalloproteinase 1 (MMP-1) is the main enzyme that causes aging symptoms such as wrinkles and decreased elasticity of the skin, and is closely related to the synthesis and secretion of other metalloproteinases. As shown in Table 7, the content of MMP-1 in the skin of mice in each group was significantly lower than that in the normal group (P < 0.01), and there was no statistically significant difference in the content of MMP-1 in the skin of mice in the control group 1, experimental group 2, and experimental group 3 compared with experimental group 1 (P > 0.05); the content of MMP-1 in the skin of mice in the control group 2 and control group 3 was significantly increased compared with experimental group 1 (P < 0.01); the above experimental results indicate that the Chinese medicine composition can significantly reduce the abnormal secretion of MMP-1 induced by ultraviolet radiation, thereby inhibiting the excessive degradation of collagen in the skin of mice.

[0167] Table 7 Skin MMP-1 results

[0168]

[0169] (Note: Compared with the blank group, * P<0.01, compared with experimental group 1, # P<0.01, ★ P>0.05)

[0170] 4.2 Results of research on formulation principles

[0171] 4.2.1 Effect of the Chinese medicine combination and its separate prescriptions on UVB-induced HaCaT cell damage

[0172] Skin, as the largest organ on the human body surface, has the function of protecting the human body from external damage. Ultraviolet radiation is the main source of damage to the human epidermis, among which UVB can directly damage the keratinocytes on the surface of the skin, causing skin redness, swelling, burns and desquamation. As the main cause of skin light damage, UVB mainly affects cell morphology and changes cell function, causing cell damage. Human immortal keratinocyte line (HaCaT) is located in the epidermis, has similar differentiation characteristics to keratinocytes, stable genetic properties, etc., and is often used as a model cell for studying various types of skin damage repair. Based on the susceptibility of HaCaT to UVB, the efficacy of the Chinese medicine composition described in the test sample 1 was investigated in order to determine the optimal protection concentration and intervention time, and the split prescription study was carried out by fixing the optimal protection concentration and intervention time, that is, the efficacy of the test samples 2-5 after removing the monarch drug, minister drug, adjuvant drug, and adjuvant drug was investigated to compare the difference between the split prescription group and the whole prescription group.

[0173] The results of the investigation on the optimal concentration and intervention time are as follows Figure 2 As shown. After measuring the OD450 values ​​of cells in each group after different concentrations of drugs were treated for different time periods, it was found that the cell viability of the 4-hour incubation was significantly higher than that of the other treatment groups, and in the 4-hour treatment group, the cell proliferation rate of the 0.2% v / v, 0.05% v / v, and 0.01% v / v drug treatment groups was much higher than 1% v / v. When the drug concentration was greater than 1% v / v, the proliferation ability of HaCat cells showed an inhibitory trend. When the concentration was less than 0.2% (v / v), the cell proliferation ability gradually increased; when the drug concentration was constant, with the increase of intervention time, the cell proliferation ability showed a trend of first increasing and then decreasing. Therefore, 0.05% was selected as the experimental concentration in the subsequent efficacy experiment, and the drug intervention time was 4h.

[0174] UVB will cause endogenous apoptosis of cells to a certain extent, thereby affecting the normal proliferation of cells. The cell survival rate can indicate the cell state to a certain extent, and the higher the survival rate, the better the cell state. After the Chinese medicine composition of the present invention is dissolved in the culture medium, the cells affected by UVB are repaired, and the cell proliferation ability is improved to a certain extent after incubation for 24 hours. Referring to Table 8, the cell survival rate of the model group is 65.31%, which is significantly lower than that of the normal group (P < 0.01), and the cell survival rate of the Chinese medicine composition with different concentrations is increased to varying degrees compared with the model group, and the results are extremely significantly different (P < 0.01). The above experimental results indicate that the Chinese medicine composition has the ability to promote cell survival.

[0175] Table 8 Effect of the Chinese medicine composition of the present invention on the survival rate of HaCaT cells induced by UVB

[0176]

[0177]

[0178] (Note: Compared with the normal group, * P<0.01; compared with the model group, # P<0.01)

[0179] 4.2.2 Intervention of the Antioxidant Ability of the Chinese Medicine Composition of the Present Invention on UVB-Induced Cell Damage

[0180] SOD can remove free radicals in the body, improve skin condition, reduce skin problems such as wrinkles and spots, make the skin smoother and more elastic, and avoid excessive accumulation of free radicals, which may cause cell membrane lipid oxidation and rupture, leading to cell damage or death. As shown in Table 9, after UVB intervention, the SOD activity of the model group decreased from 28.43U / mgprot to 13.34U / mgprot, which was significantly different from the normal group (P<0.01); in the intervention groups of each concentration of the Chinese medicine composition, the SOD content was significantly different from that of the model group (P<0.01). The above experimental results suggest that the Chinese medicine composition can significantly enhance the antioxidant capacity of cells, thereby counteracting the significant increase in oxidative stress in the body induced by ultraviolet radiation.

[0181] Table 9 Effect of the Chinese medicine composition of the present invention on the activity of SOD in HaCaT cells induced by UVB

[0182]

[0183] (Note: Compared with the normal group, * P<0.01; compared with the model group, # P<0.01)

[0184] Lipid peroxidation refers to a typical free radical chain reaction involving active oxygen, and the final product is a reactive aldehyde, such as malondialdehyde (MDA). MDA will hinder the normal growth of cells, destroy their tissue structure, and cause protein denaturation. MDA is an important product of lipid peroxidation, so the degree of lipid peroxidation in the body can be reflected by measuring the MDA content. As shown in Table 10, after UVB intervention, the MDA content contained in each group of cells showed an upward trend, and the MDA content in the model group cells increased to 43.38nmol / mgprot, and the difference was extremely significant compared with the normal; the MDA content of each concentration group of the Chinese medicine composition decreased compared with the model group, and the difference was extremely significant. According to the change in MDA content, it can be seen that the Chinese medicine composition can inhibit lipid peroxidation to a certain extent, improve protein denaturation and other conditions occurring inside cells, and the optimal concentration of this composition is 0.05% v / v.

[0185] Table 10 Effect of the Chinese medicine composition of the present invention on MDA of HaCaT cells induced by UVB

[0186]

[0187] (Note: Compared with the normal group, * P<0.01; compared with the model group, # P<0.01)

[0188] 4.3 Effects of the Chinese medicine combination on UVB-induced HaCaT cell damage and activity

[0189] Based on the experimental results of 4.2.1 and 4.2.2, it can be known that the optimal effective concentration of test sample 1 in the HaCaT cell model. The optimal effective concentration was fixed, and the effects of the monarch, minister, assistant and envoy in the Chinese medicine composition of the present invention were further investigated by splitting the prescription. The results of the effects of the composition of the present invention and each split prescription group on the survival rate of HaCaT cells caused by UVB are shown in Table 11. In the HaCaT cell damage model caused by UVB, the cell survival rate of the model group was much lower than that of the normal group (P < 0.01). The whole prescription group (test sample 1), the adjuvant-free group (test sample 4), and the envoy-free group (test sample 5) can significantly improve the survival rate of HaCaT cells caused by UVB. The difference in the average survival rate of HaCaT cells compared with the model group was statistically significant (P < 0.01), and the monarch-free group (test sample 2) and the minister-free group (test sample 3) were compared with the model group. There was no statistically significant difference in the average cell survival rate (P > 0.05). In addition, the protective effect of the whole prescription group on HaCaT cells was higher than that of each separated prescription group (test samples 2-5), and the average cell survival rate was the highest (P>0.05), but the difference between the average cell survival rate of the group lacking the assistant drug and the average cell survival rate of the whole prescription group was not statistically significant (P>0.05), and the survival rate of the group lacking the monarch drug (test sample 2) was the lowest, indicating that the absence of any of the monarch, minister, assistant and assistant in the prescription will reduce the effect of the composition of the present invention. The results in Table 11 also show the protective effect: the group lacking the assistant drug> the group lacking the assistant drug> the group lacking the assistant drug> the group lacking the monarch drug; that is, the size of the drug power: monarch drug>minister drug>adjuvant drug>assistant drug.

[0190] Table 11 Effects of the composition of the present invention and its components on the survival rate of HaCaT cells induced by UVB (n=6)

[0191]

[0192]

[0193] (Note: Compared with the normal group, * P<0.01; compared with the model group, # P<0.01; compared with the model group, ▲ P>0.05)

[0194] The results of the HaCaT cell SOD activity test on the cells in the UVB damage model are shown in Table 12. Except for the group lacking the monarch drug (test product 2), the other groups (test products 1, 3, 4, 5) can significantly reduce the damage of HaCaT cells by UVB, and the SOD values ​​of HaCaT cells are significantly different from those of the model group (P < 0.01). The SOD activity of the group lacking the monarch drug (test product 2) and the group lacking the minister drug (test product 3) is much lower than that of the whole prescription group, and there is a significant difference (P < 0.01). The SOD activity of the other split prescription groups (test product 4, test product 5) is significantly different from that of the whole prescription group (P < 0.05). Judging from the experimental results, the full prescription group has the best protection effect, which means that the absence of any one of the monarch, minister, adjuvant and guiding drug in the prescription will reduce the effect of the composition of the present invention. The protection effect can also be seen from the results in Table 12: the guiding drug missing group > the adjuvant drug missing group > the minister drug missing group > the monarch drug missing group; that is, the order of drug potency is: monarch drug > minister drug > adjuvant drug > guiding drug.

[0195] Table 12 Effects of the Chinese medicine composition of the present invention and its separate prescription groups on the activity of SOD in HaCaT cells induced by UVB (n=6)

[0196]

[0197] (Note: Compared with the normal group, * P<0.01; compared with the model group, # P<0.01. )

[0198] Tables 11-12 above show that the prescription structure (monarch, minister, assistant and envoy) of this prescription is reasonably designed and conforms to the principles of prescription composition. (Edited by Li Ji and Lian Jianwei, "Prescription", China Traditional Chinese Medicine Press, 4th edition, August 2016, page 16; Jiang Yansheng. On the principles of prescription composition of TCM internal treatment for skin diseases [J]. Chinese Journal of Traditional Chinese Medicine Information, 2012, 19(08): 95-96.)

[0199] 4.4 Investigation of the proportion of the main drug in the traditional Chinese medicine composition of the present invention

[0200] The results of the formula splitting experiment in 4.3 show that the single absence of the monarch, minister, assistant and messenger in the formula will lead to a significant reduction in drug efficacy. Therefore, this section further investigates the proportion range of the monarch drug in order to determine the optimal ratio of the Chinese medicine composition of the present invention. The experimental design was carried out according to the factorial design table with two factors and three levels. The proportions of the ministerial drugs Codonopsis pilosula and Chuanxiong, the assistant drug Aloe vera, and the messenger drug flower extract were fixed, and the proportion of the monarch drug in the whole formula was changed by changing the ratio of the monarch drug. See Table 13 and Table 14 for the specific experimental scheme.

[0201] Table 13 Factor level table

[0202]

[0203] Table 14 Factorial design experimental plan

[0204]

[0205]

[0206] ① Protective effect on UVB-induced HaCaT cell damage

[0207] The effects of different factorial design groups on the survival rate of HaCaT cells in the UVB damage model are shown in Table 15 below.

[0208] Table 15 Effect of different factorial design groups on the survival rate of HaCaT induced by UVB (n=6)

[0209]

[0210] (Note: ##Compared with experimental group 5, P < 0.001; #Compared with experimental group 5, P < 0.01; ***Compared with model group, P < 0.001; **Compared with model group, P < 0.01; *Compared with model group, P < 0.05; ▲ Compared with the model group, P>0.05.)

[0211] The data in Table 15 were statistically analyzed for the main effects and interaction effects of each factor. The results showed that the P values ​​of the two main effects were <0.001, and the P value of the interaction effect was <0.01, and the differences were statistically significant, indicating that there was an interaction between Radix Angelicae Dahuricae and Radix Angelicae Dahuricae, and that they had a certain protective effect on HaCaT cell damage caused by UVB. Table 13 shows that the average cell survival value was the highest when factor A was at level 2 and factor B was at level 2, indicating that experimental group 5 was the optimal combination, that is, the composition of the present invention had the best protective effect on HaCaT cell damage caused by UVB.

[0212] Table 16 Variance analysis of average survival rate of HaCaT cells on UVB model

[0213]

[0214]

[0215] In summary, Bletilla striata and Angelica dahurica have a synergistic effect on the UVB-induced HaCaT cell damage model, and Bletilla striata has the best protective effect at 11.1% and Angelica dahurica at 33.3%. Therefore, by fixing the proportion of Angelica dahurica, the protective effect of Bletilla striata at 8%, 9%, 10%, 11%, 12%, 13%, and 14% was investigated to determine the effective proportion range of the monarch drug Bletilla striata. See Table 17 for the specific experimental plan.

[0216] Table 17 Experimental plan for the effective proportion range of the main drug Sophora flavescens

[0217]

[0218] The protective effects of different proportions of Sophora flavescens on HaCaT cells in the UVB model are shown in Table 18. Experimental groups 3, 4, 5, and 6 all have protective effects on the UVB model, and the difference in HaCaT cell survival rate compared with the model group is statistically significant (P < 0.05, P < 0.01, P < 0.001). In addition, the protective effect of experimental group 4 is the best. In summary, the effective range of Sophora flavescens in the UVB model is 9% to 13%.

[0219] Table 18 Single factor investigation on the proportion of Sophora flavescens in the UVB-induced HaCaT cell injury model (n=6)

[0220]

[0221]

[0222] (Note: ***Compared with the model group, P < 0.001; **Compared with the model group, P < 0.01; *Compared with the model group, P < 0.05; ▲ Compared with the model group, P>0.05.)

[0223] By fixing the proportion of Bletilla striata, the protective effect of Angelica dahurica at 30%, 31%, 32%, 33%, 34%, 35% and 36% was investigated to determine the effective proportion range of the main drug Angelica dahurica. See Table 19 for the specific experimental plan.

[0224] Table 19 Experimental plan for the effective proportion range of the main drug Angelica dahurica

[0225]

[0226] The average cell survival rate of HaCaT cells in different Angelica dahurica proportion groups on the UVB model is shown in Table 20. Table 20 shows that experimental groups 3, 4, 5, and 6 all showed a certain protective effect on the UVB model. The difference in the average survival rate of HaCaT cells compared with the model group was statistically significant (P < 0.01, P < 0.001). In addition, experimental group 4 had the best protective effect. In summary, the main drug Angelica dahurica has an effective range of 31% to 35% on the UVB model.

[0227] Table 20 Single factor investigation on the proportion of Angelica dahurica in the UVB-induced HaCaT cell injury model (n=6)

[0228]

[0229]

[0230] (Note: ***Compared with the model group, P < 0.001; **Compared with the model group, P < 0.01.)

[0231] According to the above results, the two end values ​​(9%, 13%), the middle value (11%), the range values ​​above (14%) and below (8%) of the proportion of Bletilla striata and the two end values ​​(31%, 35%), the middle value (33%), the range values ​​above (36%) and below (30%) of the proportion of Angelica dahurica were taken for experimental verification. Corresponding to test samples 6-10, the total HaCaT cell protection rate of each group was calculated by the following formula, thereby verifying the effective range of Bletilla striata and Angelica dahurica.

[0232] HaCaT cell protection rate (%) = [(average survival rate of HaCaT cells in the experimental group) / (average survival rate of HaCaT cells in the control group)] × 100%

[0233] The validation of the effective proportion range of Shuangjun medicine was carried out in different experimental groups on the HaCaT cell model under UVB radiation. The results are shown in Table 21. Test samples 7, 8, and 9 all have protective effects. Compared with the model group, the difference in the protection rate of HaCaT cells is statistically significant (P < 0.05, P < 0.01, P < 0.001). In addition, test sample 8 has the best protection effect. In summary, the protection effect of 9-13% of Bletilla striata and 31-35% of Angelica dahurica is significantly better than that outside the above range.

[0234] Table 21 HaCaT cell protection rate verified by the range of Shuangjun drug efficacy (n=6)

[0235] Group Protection rate (%) Blank control group <![CDATA[100.00±0.00 *** ]]> Model Group 54.93±9.22 Test sample 6 <![CDATA[60.92±7.43 * ]]> Test sample 7 <![CDATA[72.28±8.31 * ]]> Test sample 8 <![CDATA[88.78±6.07 *** ]]> Test sample 9 <![CDATA[77.88±8.89 *** ]]> Test sample 10 <![CDATA[62.41±6.24 * ]]>

[0236] (Note: ***Compared with the model group, P < 0.001; **Compared with the model group, P < 0.01; *Compared with the model group, P < 0.05.)

[0237] The contents not described in detail in this specification belong to the prior art known to professional and technical personnel in this field.

[0238] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0239] The present invention and its implementation methods are described above, and such description is not restrictive. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design structures and embodiments similar to the technical solution without creativity, which should all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition with skin repairing effect, which is composed of effective ingredients and medically acceptable excipients, wherein the effective ingredients are made of the following raw materials: 10-35 parts of white peony root, 45-75 parts of angelica dahurica, 20-60 parts of aloe, 10-30 parts of codonopsis pilosula, 10-30 parts of chuanxiong, and 0-30 parts of flower.

2. A Chinese medicine composition with skin repairing effect according to claim 1, characterized in that The active ingredient is made of the following raw materials in percentage by weight: Sophora flavescens 11.11%, Angelica dahurica 33.33%, Aloe vera 22.22%, Codonopsis pilosula 11.11%, Ligusticum chuanxiong 11.11%, and flowers 11.12%.

3. A Chinese medicinal composition with skin repairing effect according to any one of claims 1 to 2, characterized in that: The flower is any one of rose, lavender and jasmine.

4. A method for preparing a Chinese medicine composition having skin repairing effect, characterized in that: The method comprises weighing raw materials of various weight ratios, crushing and mixing the raw materials, and extracting effective components from the raw materials to obtain extracts; (1) Weighing Radix Bletillae Sinensis, Radix Angelicae Dahuricae, Radix Codonopsis Pilosulae, and Rhizoma Chuanxiong, crushing and mixing the raw materials by using a wall-breaking process, adding an equal amount of medical ethanol to the mixture for alcohol immersion for 4 to 6 days, and then collecting the filtrate; (2) taking fresh aloe vera, breaking the skin, adding one times the amount of pure water to soak, crushing and squeezing by a wall-breaking process, and then soaking in an equal amount of medical ethanol for alcohol soaking for 1 day, and then taking the filtrate; (3) Take any one of rose, lavender and jasmine flowers, add three times the amount of pure water and soak for two hours, then crush and squeeze using a wall-breaking process, and then soak in an equal amount of medical ethanol for alcohol soaking for one day and then take the filtrate.

5. The method for preparing a traditional Chinese medicine composition having skin repairing effect according to claim 4, characterized in that: The extract is concentrated and dried to obtain the Chinese medicine composition extract.

6. The method for preparing a traditional Chinese medicine composition having skin repairing effect according to claim 4, characterized in that: The preparation of the extract also includes adding pure water ten times the weight of the raw material crushed material into a vacuum homogenizing emulsifier for heating and extraction. The extraction time is 2 to 3 hours, filtering the solution, dehydrating and drying it to obtain the extract.

7. The method for preparing a traditional Chinese medicine composition having skin repairing effect according to claim 1, characterized in that: The skin care composition of the present invention can be a common emulsion, gel, ointment or lotion; The skin care composition may also be a skin care lotion, a skin care gel, a cleansing milk, a facial mask or a skin care cream; The skin care composition is prepared by adding the active ingredients to the auxiliary materials required for various dosage forms according to a conventional method, wherein the weight percentage content of the active ingredients is 0.8% to 1.2%.

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