Anti-inflammatory and anti-oxidation traditional Chinese medicine composition and lipstick and application thereof

Abstract

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight through the following method: taking 15 parts of astragalus membranaceus, 6 parts of rhizoma anemarrhenae, 6 parts of cortex phellodendri, 4 parts of angelica sinensis, 3 parts of cinnamon, 5 parts of liquorice and 5 parts of ampelopsis grossedentata vines, adding water of which the weight is 10 times of the total weight of the raw material medicines, soaking for 0.5 hour, and performing reflux extraction twice for 1.5 hours each time; in the extraction process, Chinese angelica and cinnamon aromatic water which is equivalent to two times of the volume of the prescription is collected for later use; concentrating the water extract at 60-80 DEG C under reduced pressure, and drying to obtain a dry extract; preparing an inclusion compound from aromatic water by using beta-cyclodextrin, drying and crushing; and uniformly mixing the dry extract with the aromatic water beta-cyclodextrin inclusion compound. The invention further discloses a lipstick containing the composition and application of the lipstick.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition with anti-inflammatory and antioxidant properties, its lip balm, and its application. Background Technology

[0002] Cheilitis, a specific inflammatory disease occurring on the mucous membranes of the lips, is caused by a variety of factors, including ultraviolet radiation, cold, dryness, allergens, physical irritation, psychological stress, autoimmune disorders, and genetics. The skin of the lips, being one of the thinnest parts of the body and lacking the protection of sebaceous glands, is easily affected by these factors, leading to dryness, peeling, cracking, itching, pain, and even erosion and exudation. The inflammation is recurrent and difficult to cure completely. In Traditional Chinese Medicine (TCM), cheilitis falls under the category of "lip wind," caused by wind-dampness and heat accumulating in the lip skin. The prolonged course of the disease leads to blood deficiency and wind-dryness, resulting in malnourishment of the skin and changes such as dryness and peeling. Chronic cheilitis is localized, making external treatment the first choice. Currently, most lip balms on the market focus on moisturizing and coloring, with fewer functional ingredients (such as anti-inflammatory and antioxidant agents). Some cheilitis patients develop a dependence on steroid ointments, which can easily cause adverse reactions. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition with anti-inflammatory and antioxidant properties, as well as its lip balm and application.

[0004] The first aspect of this invention is to provide a traditional Chinese medicine composition with anti-inflammatory and antioxidant functions, which is prepared from the following raw materials in the following parts by weight by the following method: take 15 parts of Astragalus membranaceus, 6 parts of Anemarrhena asphodeloides, 6 parts of Phellodendron chinense, 4 parts of Angelica sinensis, 3 parts of Cinnamomum cassia, 5 parts of Glycyrrhiza uralensis, and 5 parts of Ampelopsis japonica, add 10 times the total weight of the raw materials in water, soak for 0.5 hours, and reflux extract twice, each time for 1.5 hours; during the extraction, collect the aromatic water of Angelica sinensis and Cinnamomum cassia equivalent to 2 times the volume of the prescription for later use; concentrate the aqueous extract under reduced pressure at 60~80℃ and dry to obtain a dry extract; take the aromatic water and prepare an inclusion complex with β-cyclodextrin, dry and pulverize; mix the dry extract and the aromatic water β-cyclodextrin inclusion complex.

[0005] In a preferred embodiment, the traditional Chinese medicine composition contains astragaloside A, anemarrhena saponin BII, mangiferin, berberine hydrochloride, berberine hydrochloride and dihydromyricetin.

[0006] In another preferred embodiment, the preparation method of the aromatic water β-cyclodextrin inclusion complex is as follows: take aromatic water, heat to 40~50℃, add β-cyclodextrin with a concentration of 20g / L for inclusion, keep warm and stir at 300~700 r / min for 30~40 min, after stirring, let it cool to room temperature, refrigerate at 4℃ for 24h, wait for the inclusion complex to precipitate, filter, wait for no water to flow out, wash with saturated β-cyclodextrin aqueous solution, wait for no water to flow out, collect the inclusion complex precipitate, dry, and grind into powder.

[0007] A second aspect of the present invention is to provide a lip balm with anti-inflammatory and antioxidant functions, the lip balm containing the above-mentioned traditional Chinese medicine composition.

[0008] In a preferred embodiment, the lipstick is made from mixture A and mixture B, wherein mixture A contains the following components by weight percentage: 8% jojoba oil, 18% camellia oil, 15% hydrogenated polyisobutylene, 0.5% ethylhexylglycerin, and 13% an aqueous solution of the traditional Chinese medicine composition; and mixture B contains the following components by weight percentage: 1% squalane, 12% shea butter, 6% bis-diglyceride polyacryladiate-2, 10% beeswax, 8% carnauba wax, 5% candelilla wax, 1% synthetic wax, and 2.5% tocopheryl acetate.

[0009] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of anti-inflammatory and antioxidant products.

[0010] Details of various aspects of the invention will be described in detail in the following sections. The features, objects, and advantages of the invention will become more apparent from the following description and the claims. Attached Figure Description

[0011] Figure 1 Changes in inflammatory factor levels after administration of the traditional Chinese medicine composition of the present invention

[0012] Figure 2 Changes in NO levels after administration of the traditional Chinese medicine composition of the present invention Detailed Implementation

[0013] The present invention relates to a traditional Chinese medicine composition for anti-inflammatory and antioxidant effects on the skin, comprising Astragalus membranaceus, Anemarrhena asphodeloides, Phellodendron chinense, Angelica sinensis, Cinnamomum cassia, Glycyrrhiza uralensis, and Ampelopsis japonica. Astragalus membranaceus is the principal herb, exerting the effects of promoting body fluid production, nourishing blood, and relieving stagnation. Anemarrhena asphodeloides and Phellodendron chinense serve as assistant herbs, with Anemarrhena asphodeloides nourishing yin and clearing heat, and Phellodendron chinense clearing heat and drying dampness. Angelica sinensis, Cinnamomum cassia, Glycyrrhiza uralensis, and Ampelopsis japonica serve as adjuvant herbs, with Angelica sinensis tonifying blood and promoting blood circulation, Cinnamomum cassia warming yang and transforming qi, Ampelopsis japonica clearing heat and detoxifying, and Glycyrrhiza uralensis tonifying the spleen and replenishing qi, clearing heat and detoxifying, and harmonizing the effects of the other herbs. The entire formula has the effects of nourishing blood and promoting blood circulation, nourishing yin and drying dampness, and clearing heat and detoxifying.

[0014] This invention utilizes a specific combination of Astragalus membranaceus (principal ingredient) with Anemarrhena asphodeloides and Phellodendron chinense (assistant ingredients), and Angelica sinensis, Cinnamomum cassia, Glycyrrhiza uralensis, and Ampelopsis japonica (adjuvant ingredients) in a specific ratio. This combination not only inhibits key inflammatory factors (such as IL-6 and TNF-α) but also significantly enhances antioxidant capacity. Furthermore, the composition encapsulated with aromatic water by β-cyclodextrin exhibits even stronger anti-inflammatory effects. The composition prepared by this invention provides a novel drug combination scheme for the treatment of cheilitis.

[0015] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0016] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of this invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0017] The features mentioned above in this invention, or the features mentioned in the embodiments, can be combined arbitrarily. All features disclosed in this patent specification can be used in any compositional form, and each feature disclosed in the specification can be replaced by any alternative feature that provides the same, equivalent, or similar purpose. Therefore, unless otherwise specified, the disclosed features are merely general examples of equivalent or similar features.

[0018] Example 1: Preparation of Traditional Chinese Medicine Composition

[0019] Weigh out 30g, 12g, 12g, 8g, 6g, 10g, and 10g respectively of Astragalus membranaceus, Anemarrhena asphodeloides, Phellodendron chinense, Angelica sinensis, Cinnamomum cassia, Glycyrrhiza uralensis, and Ampelopsis japonica. Add water equal to 10 times the total weight of the raw materials, soak for 0.5 hours, and reflux extract twice, each time for 1.5 hours. During the extraction, collect the aromatic water of Angelica sinensis and Cinnamomum cassia equivalent to twice the prescribed volume for later use. Filter the decoction, combine the filtrates, concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, density 1.08, and spray dry at 150℃ to obtain the dry extract sample.

[0020] Preparation of β-cyclodextrin inclusion complex: Collect 180 mL of aromatic water, heat to 40 °C, add 3.6 g of β-cyclodextrin inclusion complex (concentration of 20 g / L), stir at 500 r / min for 30 min, after stirring, let it cool to room temperature, refrigerate at 4 °C for 24 h, wait for the inclusion complex to precipitate, filter, and after no water flows out, wash with saturated β-cyclodextrin aqueous solution, after no water flows out, collect the inclusion complex precipitate, dry, grind into powder, and obtain white powdery inclusion complex.

[0021] The inclusion complex and the dry extract are mixed evenly to obtain the composition.

[0022] Example 2: Quantitative analysis of traditional Chinese medicine composition using high performance liquid chromatography.

[0023] (1) Content determination method 1

[0024] The contents of mangiferin, berberine hydrochloride, berberine hydrochloride, and dihydromyricetin in the traditional Chinese medicine composition of Example 1 were determined by high performance liquid chromatography.

[0025] 1) Chromatographic conditions

[0026] The chromatographic column was an Agilent Eclipse XDB-C18 (250 × 4.6 mm, 5 μm), with acetonitrile (A) and 0.15% phosphoric acid solution (B) used for gradient elution (0–12 min, 8%–10% A; 12–13 min, 10%–13% A; 13–17 min, 13%–14% A; 17–27 min, 14%–15% A; 27–29 min, 15%–20% A; 29–40 min, 20% A; 40–41 min, 20–21% A; 41–55 min, 21% A; 55–56 min, 21–24% A; 56–66 min, 24% A; 66–67 min, 24%–40% A); the detection wavelength was 240 nm; and the flow rate was 1 mL / min. The column speed was 30 mL / min, the column temperature was 30℃, and the injection volume was 10 μL.

[0027] 2) Preparation of reference solution

[0028] Accurately weigh appropriate amounts of mangiferin, berberine hydrochloride, berberine hydrochloride, and dihydromyricetin reference standards, place them in appropriate volumetric flasks, and add methanol to prepare reference solutions with mass concentrations of 0.708, 0.489, 0.398, and 0.421 mg / mL, respectively. Mix the reference solutions for later use.

[0029] 3) Preparation of the test solution

[0030] Accurately weigh 1 g of the composition and place it in a stoppered conical flask. Accurately transfer 10 mL of 50% methanol into each flask, sonicate (300 W power, 25 kHz frequency) for 30 minutes, and filter through a 0.45 μm organic filter membrane to obtain the final product. The content results are shown in Table 1.

[0031] (2) Content determination method 2

[0032] The contents of astragaloside A and anemarrhena saponin BII in the composition were determined by high performance liquid chromatography.

[0033] 1) Chromatographic conditions

[0034] The chromatographic column was an Agilent Eclipse XDB-C18 (250 × 4.6 mm, 5 μm), acetonitrile (A)-water (B), gradient elution (0 ~ 12 min, 25% A; 12 ~ 13 min, 25% ~ 32% A; 13 ~ 30 min, 32% A); flow rate 1 mL / min, column temperature 30 ℃, injection volume 20 μL.

[0035] 2) Preparation of reference solution

[0036] Take appropriate amounts of astragaloside A and anemarrhena saponin BII reference standards, accurately weigh them, place them in appropriate volumetric flasks, add 80% methanol to prepare mass concentrations of 0.535 and 0.524 mg / mL respectively, and mix the reference standard solutions for later use.

[0037] 3) Preparation of the test solution

[0038] Weigh 1 g of the composition accurately, transfer 20 mL of water accurately, add the mixture and disperse it by sonication. Extract the mixture three times with 90 mL of water-saturated n-butanol solution, combine the n-butanol layers, and then extract it twice with 45 mL of ammonia solution. Discard the ammonia layer, evaporate the n-butanol layer to dryness, and dilute to a volumetric flask with methanol in 5 mL.

[0039] Table 1. Results of determination of the content of each active ingredient in the composition (mg / g, n=3)

[0040]

[0041] The results showed that the contents of astragaloside A, anemarrhena saponin BII, mangiferin, berberine hydrochloride, berberine hydrochloride, and dihydromyricetin in the composition were 0.627, 6.168, 1.746, 8.313, 1.422, and 30.04 mg / g, respectively.

[0042] Example 3 Evaluation of the anti-inflammatory effect of the traditional Chinese medicine composition

[0043] (1) Expression of inflammatory factors after drug administration in cell model

[0044] RAW264.7 cells in logarithmic growth phase were seeded into 6-well plates according to the above procedure and divided into a blank group, an LPS model group (1 μg / mL), and a traditional Chinese medicine combination treatment group (25, 50, and 100 μg / mL). Each group was repeated three times. After cell culture and adhesion, the old culture medium was discarded, and each treatment group was pretreated with LPS-containing medium and cultured for 24 h. The cell culture supernatant was transferred to a 4 mL centrifuge tube and centrifuged at 1000×g at 4 ℃ for 20 min. The supernatant was stored at -20 ℃, and the expression of inflammatory factors TNF-α, IL-6, and IL-1β in the cell supernatant was detected using an ELISA kit. The specific operation steps were performed according to the kit instructions.

[0045] The results show that, as shown in Table 2 and Figure 1 As shown, treatment with LPS (1 μg / mL) significantly increased the levels of IL-6, IL-1β, and TNF-α compared to the blank control group. Compared to the LPS model group, the combination treatment group inhibited the expression of inflammatory factors in the supernatant at concentrations of 25, 50, and 100 μg / mL in a dose-dependent manner. The combination (25 μg / mL) significantly reduced IL-6 and TNF-α levels, but relatively reduced IL-1β, with no significant difference compared to the model group. The combination (50 μg / mL and 100 μg / mL) significantly reduced the levels of IL-6, IL-1β, and TNF-α. Therefore, the inhibitory effect of this combination on inflammatory factors is dose-dependent. Meanwhile, the project team further observed the effects of the aqueous extract (50 μg / mL) and the aromatic aqueous β-cyclodextrin inclusion complex (50 μg / mL). The results showed that the aromatic aqueous β-cyclodextrin inclusion complex had a stronger inhibitory effect on IL-6, IL-1β and TNF-α than the aqueous extract. Therefore, the combination of aromatic aqueous β-cyclodextrin inclusion complex and aqueous extract can obtain the composition with the best anti-inflammatory effect.

[0046] Table 2. Effects of different drug concentrations on the expression of cellular inflammatory factors.

[0047]

[0048] Note: ** Compared with the LPS group, P < 0.01 (mean ± SD, n=3).

[0049] (2) Expression of NO in cell supernatant

[0050] Following the steps above, plate 6-well plates, add 2 mL of culture medium to each well, and adjust the cell density to 5 × 10⁶ cells / well. 5Cells / well. Cell grouping and drug concentration are the same as above. After culturing for 24 h, aspirate the supernatant and centrifuge at 1000 rpm for 3 min. Add the centrifuged supernatant to a new centrifuge tube. Prepare a new 96-well plate, aspirate 50 μL from each group into the 96-well plate, and set up 6 replicates per group. Then, add 50 μL of Griess Reagent I solution and 50 μL of Griess Reagent II solution to the 96-well plate sequentially, and measure and record the OD value of each well at 540 nm using a microplate reader.

[0051] As shown in Table 3 and Figure 2 As shown, treatment with LPS (1 μg / mL) significantly increased nitric oxide levels compared to the blank control group. Compared to the LPS model group, the combination treatment group inhibited NO levels in the cell supernatant at concentrations of 25, 50, and 100 μg / mL in a dose-dependent manner, with a significantly lower NO content at 100 μg / mL compared to LPS. The aqueous extract (50 μg / mL) and the aromatic water-β-cyclodextrin inclusion complex (50 μg / mL) showed some inhibitory effect on NO release from cells, but no significant difference was observed compared to the model group, indicating that the inhibitory effect of this combination on cellular NO levels is dose-dependent.

[0052] Table 3. Effects of different drug concentrations on cellular NO release.

[0053]

[0054] Note: * Compared with the LPS group, P < 0.05. ** Compared with the LPS group, P < 0.01 (mean ± SD, n=3).

[0055] Example 4 Evaluation of the antioxidant effect of traditional Chinese medicine composition

[0056] This invention selects the DPPH method as the evaluation method for the antioxidant activity of this composition, and the results are expressed using IC50. 50 The results indicate that the positive drugs for component activity evaluation were ascorbic acid VC and vitamin E analog Trolox, while the positive drugs for extract activity evaluation were ascorbic acid VC and 2,6-di-tert-butyl-p-cresol (BHT).

[0057] (1) Preparation of the test solution of the composition

[0058] Accurately weigh 1 g of the composition, add 25 mL of water and sonicate for 30 min. After cooling to room temperature, centrifuge and take the supernatant. Dilute with water stepwise to obtain a series of sample solutions of different concentrations.

[0059] (2) Preparation of the test solution for the indicator components

[0060] Accurately weigh appropriate amounts of each reference standard, add appropriate amount of DMSO to prepare a 20 mM stock solution, and dilute stepwise with 50% methanol to obtain a series of sample solutions of different concentrations.

[0061] (3) Determination of the antioxidant activity of the composition

[0062] Take 100 μL of DPPH solution (0.65 mmol / L), add 10 μL of each sample solution, then add 140 μL of 50% methanol to dilute, mix well, and react at room temperature in the dark for 1 h. Measure the absorbance A at 517 nm, with 50% methanol as the blank solution.

[0063] Calculate the inhibition rate using the following formula:

[0064] Inhibition rate (%) = 100 * (A) 空白 -A 样品 ) / A 空白 (1)

[0065] Where A 空白 A represents the absorbance of the blank solution. 样品 IC represents the absorbance of the sample solution. 50 The calculation requires combining sample concentration and sample clearance rate, and using SPSS statistical analysis software.

[0066] (4) Results of antioxidant activity assay of the composition

[0067] The inhibition rate and IC were calculated according to formula (1) based on the test results. 50 The values ​​are expressed as mean ± standard deviation (Table 4).

[0068] The results showed that, in this composition, dihydromyricetin had the strongest antioxidant capacity, approaching that of the positive control drug L-ascorbic acid, followed by the aromatic aqueous β-cyclodextrin inclusion complex, whose antioxidant capacity IC50 was [missing value]. 50 The antioxidant capacity of the composition was 40.2 ± 8.8 μg / mL, and the IC50 value was [missing value]. 50 The concentration was 52.1 ± 1.9 μg / mL, which is stronger than the composition without the aromatic water β-cyclodextrin inclusion complex, further verifying the advantage of the present invention in simultaneously extracting water extract and aromatic water.

[0069] Table 4. Results of antioxidant activity determination of the composition and its active ingredients

[0070]

[0071] Example 5: Comparative Study of the Traditional Chinese Medicine Composition of the Present Invention with Literature Formulas

[0072] Experimental drugs: The traditional Chinese medicine composition was prepared according to Example 1. Preparation of drugs according to the literature formula: Coptis chinensis 16 parts, Phellodendron chinense 14 parts, Sophora flavescens 17 parts, Sanguisorba officinalis 14 parts, Punica granatum peel 13 parts, Kochia scoparia 14 parts, Astragalus membranaceus 16 parts, Atractylodes macrocephala 14 parts, Angelica sinensis 15 parts, Polygonum multiflorum 15 parts, Paeonia lactiflora 14 parts, Ligusticum chuanxiong 16 parts, Schizonepeta tenuifolia 16 parts, Saposhnikovia divaricata 16 parts, Uncaria rhynchophylla 14 parts, Glycyrrhiza uralensis 16 parts, Adenophora stricta 17 parts, Coix lacryma-jobi 16 parts, Poria cocos 18 parts, Rehmannia glutinosa 17 parts, Paeonia lactiflora 15 parts, Lycium chinense root bark 15 parts, Artemisia argyi 15 parts, Trichosanthes kirilowii 19 parts, Scutellaria baicalensis 16 parts, Anemarrhena asphodeloides 17 parts, Ophiopogon japonicus 19 parts. The raw medicinal materials (17 parts of celery, 16 parts of papaya, 15 parts of salvia miltiorrhiza, 15 parts of chicken blood vine, 15 parts of tribulus terrestris, 16 parts of magnolia officinalis, 16 parts of trumpet creeper, and 15 parts of sesame) were weighed and extracted twice by heating and reflux in ethanol. The raw medicinal materials extracted by ethanol were then extracted once by heating and reflux in water. The two extracts were combined and concentrated to obtain a medicinal extract. The extract was heated, concentrated, and prepared according to the method disclosed in the literature (Zhou Bopeng. A traditional Chinese medicine composition for treating atopic dermatitis and its preparation method. China, CN 103520572 B, 2015.12.23.).

[0073] Experimental methods: (1) Expression of inflammatory factors after cell modeling and drug administration. RAW264.7 cells in logarithmic growth phase were seeded in 6-well plates according to the above operation and divided into blank group, LPS model group (1 μg / mL), literature formula group and traditional Chinese medicine composition drug administration group. Each group was repeated three times. After the cells adhered to the plate, the inflammatory factors were detected according to the method in Example 3. The results are shown in Table 5. After the cells were treated with LPS (1 μg / mL), the contents of IL-6, IL-1β and TNF-α were significantly increased compared with the blank control group. Compared with the LPS model group, both literature formula group and traditional Chinese medicine composition drug administration group could inhibit the expression of inflammatory factors in the supernatant. The traditional Chinese medicine composition group had a stronger inhibitory effect on IL-6, IL-1β and TNF-α than literature formula group. Therefore, it is shown that the traditional Chinese medicine composition group of the present invention has a better anti-inflammatory effect.

[0074] Table 5. Effects of traditional Chinese medicine compositions and literature prescriptions on the expression of cellular inflammatory factors.

[0075]

[0076] Note: * Compared with the LPS group, P < 0.05. ** Compared with the LPS group, P < 0.01; # Compared with the literature group, P < 0.05. ## Compared with the literature group, P < 0.01 (mean ± SD, n=3).

[0077] (2) NO expression in cell supernatant. RAW264.7 cells were seeded in 6-well plates with 2 mL of culture medium per well, and the cell density was adjusted to 5 × 10⁻⁶ cells / well. 5 Cells / well. Cell grouping and drug concentration were the same as above. NO expression levels in cells were detected according to the method described in Example 3. As shown in Table 6, after treatment with LPS (1 μg / mL), the nitric oxide content significantly increased compared to the blank control group. Compared to the LPS model group, both the literature-prescribed group and the traditional Chinese medicine composition group inhibited NO content in the cell supernatant, and the inhibitory effect of the traditional Chinese medicine composition group on cellular NO release was significantly different from that of the literature-prescribed group.

[0078] Table 6. Effects of Traditional Chinese Medicine Compositions and Literature Formulas on Cellular NO Release Content

[0079]

[0080] Note: * Compared with the LPS group, P < 0.05. ** Compared with the LPS group, P < 0.01; # Compared with the literature group, P < 0.05 (mean ± SD, n=3).

[0081] (3) Evaluation of antioxidant activity. Preparation of the test solution of the composition: Accurately weigh 1 g of the composition or the composition in the literature, add 25 mL of water and extract by ultrasonication for 30 min, cool to room temperature and centrifuge, take the supernatant, and dilute with water stepwise to obtain a series of sample solutions of different concentrations. Preparation of the test solution of the index components: Accurately weigh an appropriate amount of each reference standard, add an appropriate amount of DMSO to prepare a 20 mM stock solution, and dilute with 50% methanol stepwise to obtain a series of sample solutions of different concentrations. The determination of the antioxidant activity of the composition was carried out according to the method in Example 4. The results showed that the traditional Chinese medicine composition had stronger antioxidant capacity, and its antioxidant capacity IC50 was higher than that of the traditional Chinese medicine composition. 50 The value was 46.3 ± 3.7 μg / mL, indicating that the antioxidant capacity of the traditional Chinese medicine composition of the present invention is superior to that of the literature composition.

[0082] Table 7 Results of antioxidant activity determination of traditional Chinese medicine compositions and literature prescriptions

[0083]

[0084] Example 6: Comparative Study of the Traditional Chinese Medicine Composition and Individual Formulas of the Present Invention

[0085] The herbal composition of Example 1 was prepared as follows: According to the prescribed dosage, 30g, 12g, 12g, 8g, 6g, 10g, and 10g of each of Astragalus membranaceus, Anemarrhena asphodeloides, Phellodendron chinense, Angelica sinensis, Cinnamomum cassia, Glycyrrhiza uralensis, and Grapevine were weighed. The herbs were soaked in 10 times their volume of water for 0.5 hours, and then refluxed twice, each time for 1.5 hours. During extraction, twice the volume of aromatic water was collected. The decoction was filtered, and the filtrates were combined and concentrated under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. After spray drying at 150℃, a dry extract sample was obtained. Preparation of β-cyclodextrin inclusion complex: Collect 180 mL of aromatic water, heat to 40-50℃, add 3.6 g of β-cyclodextrin (concentration 20 g / L), stir at 500 r / min for 30 min, after stirring, let stand at room temperature, refrigerate at 4℃ for 24 h, and wait for the inclusion complex to precipitate. Filter, and after no water flows out, rinse with saturated β-cyclodextrin aqueous solution. After no water flows out, collect the inclusion complex precipitate, dry, and grind into powder to obtain a white powdery inclusion complex. Mix the inclusion complex and dry extract evenly to obtain the composition.

[0086] Formula 1: According to the prescribed dosage, weigh out 12g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 8g of Angelica sinensis, 6g of Cinnamomum cassia, 10g of Glycyrrhiza uralensis, and 10g of Gracilaria pulveratum. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0087] Formula 2: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Phellodendron chinense, 8g of Angelica sinensis, 6g of Cinnamomum cassia, 10g of Glycyrrhiza uralensis, and 10g of Gracilaria pulveratum. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0088] Formula 3: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Anemarrhena asphodeloides, 8g of Angelica sinensis, 6g of Cinnamomum cassia, 10g of Glycyrrhiza uralensis, and 10g of Gracilaria pulveratum. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0089] Formula 4: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 6g of Cinnamomum cassia, 10g of Glycyrrhiza uralensis, and 10g of Alopecuroides oryzae. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0090] Formula 5: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 8g of Angelica sinensis, 10g of Glycyrrhiza uralensis, and 10g of Gracilaria pulveratum. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0091] Formula 6: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 6g of Angelica sinensis, 10g of Cinnamomum cassia, and 10g of Gracilaria pulveratum. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0092] Formula 7: According to the prescribed dosage, weigh out 30g of Astragalus membranaceus, 12g of Anemarrhena asphodeloides, 12g of Phellodendron chinense, 8g of Angelica sinensis, 6g of Cinnamomum cassia, and 10g of Glycyrrhiza uralensis. Soak in 10 times the volume of water for 0.5 hours, then reflux twice, each time for 1.5 hours. During extraction, collect twice the volume of aromatic water. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 60℃ to 0.65 g crude drug / ml, with a density of 1.08-1.10. Spray dry at 150℃ to obtain a dry extract sample. Mix the inclusion complex and the dry extract thoroughly to obtain the final composition.

[0093] Preparation method of the disassembled drug: It was prepared according to the method in Example 1.

[0094] Experimental Methods: Following the method described in Example 3, the expression of inflammatory factors after administration of the disassembled drug to a cell model was investigated. The results are shown in Table 8. After treatment with LPS (1 μg / mL), the levels of IL-6, IL-1β, and TNF-α were significantly increased compared to the blank control group. Compared to the LPS model group, both the disassembled drug group and the traditional Chinese medicine composition group inhibited the expression of inflammatory factors in the supernatant. The traditional Chinese medicine composition group showed stronger inhibitory effects on IL-6, IL-1β, and TNF-α than the disassembled drug group. The inhibitory effect was weakest when the principal drug was removed, indicating that the traditional Chinese medicine composition group had a better anti-inflammatory effect.

[0095] Table 8. Effects of traditional Chinese medicine compositions and literature prescriptions on the expression of cellular inflammatory factors.

[0096]

[0097] Note: * Compared with the LPS group, P < 0.05. ** Compared with the LPS group, P < 0.01; # Compared with the traditional Chinese medicine composition group, P < 0.05. ## Compared with the traditional Chinese medicine composition group, P < 0.01 (mean ± SD, n=3).

[0098] (2) The effect of the dissected drugs on NO expression in cell supernatant was investigated according to the method in Example 3. The results are shown in Table 9. After treating cells with LPS (1 μg / mL), the content of nitric oxide increased significantly compared with the blank control group. Compared with the LPS model group, both the dissected drug group and the traditional Chinese medicine composition group could inhibit the content of NO in cell supernatant. In addition, there was a significant difference between the dissected drug group 1 and the traditional Chinese medicine composition group (P < 0.01).

[0099] Table 9. Effects of Traditional Chinese Medicine Compositions and Literature Formulas on Cellular NO Release Content

[0100]

[0101] Note: * Compared with the LPS group, P < 0.05. ** Compared with the LPS group, P < 0.01; # Compared with the traditional Chinese medicine composition group, P < 0.05. ## Compared with the traditional Chinese medicine composition group, P < 0.01 (mean ± SD, n=3).

[0102] (3) The antioxidant activity of the disassembled drugs was evaluated using the method described in Example 4. The results showed that the traditional Chinese medicine composition had stronger antioxidant capacity, with an IC50 value of [missing value].50 The value was 50.2 ± 6.3 μg / mL, indicating that the traditional Chinese medicine composition had the greatest antioxidant capacity compared to the seven individual formulations.

[0103] Table 10 Results of antioxidant activity determination of traditional Chinese medicine compositions and literature prescriptions

[0104]

[0105] Example 7: Preparation of a lip balm for anti-inflammatory and antioxidant effects on the skin.

[0106] This embodiment provides a composition for anti-inflammatory and antioxidant effects on the skin and a method for preparing a lipstick, wherein the lipstick is composed of mixture A and mixture B.

[0107] Mixture A contains the following components by weight percentage: 8% jojoba oil, 18% camellia oil, 15% hydrogenated polyisobutylene, 0.5% ethylhexylglycerin, and 13% aqueous solution of traditional Chinese medicine composition (the traditional Chinese medicine composition is first dispersed evenly in water before being added to the mixture, wherein the weight ratio of the traditional Chinese medicine composition to water is 10:3).

[0108] Mixture B contains the following components by weight percentage: 1% squalane, 12% shea butter, 6% bis-diglyceride polyacryladiate-2, 10% beeswax, 8% carnauba wax, 5% candelilla wax, 1% synthetic wax, and 2.5% tocopheryl acetate.

[0109] The preparation process is as follows: All components of mixture A are stirred at 40℃ and 40 rpm for 30 minutes; all components of mixture B are melted at 80℃ and mixed evenly at this temperature, with a stirring speed of 40 rpm for 30 minutes; the mixture B is cooled to 55℃, and preheated mixtures A and B are slowly added sequentially, maintaining the temperature at 55℃, with a stirring speed of 40 rpm for 30 minutes. The liquid is then poured into lipstick molds, cooled to room temperature, and allowed to set for 20 minutes. The lipsticks are then demolded, sterilized, and packaged.

[0110] Quality assessment:

[0111] (1) Physicochemical properties: The lipstick was tested for physicochemical properties according to standard QB / T1977-2004. The results showed that the sensory indicators of the prepared lipstick were all good, the appearance was smooth and without bubbles, the color of the lipstick was uniform, there was no layering, and it had a slight fragrance.

[0112] (2) Cold resistance test: Take 6 lipsticks, 3 of which are placed at room temperature as controls, and the other 3 are placed in a -10℃ refrigerator. After 24 hours, take them out and observe their properties after they return to room temperature. There is no softening or cracking, and the application and use feel is unchanged.

[0113] (3) Heat resistance test: Take 6 lipsticks, 3 of which are placed at room temperature as controls, and the other 3 are placed in a 45℃ constant temperature chamber. After 24 hours, take them out and observe their properties after they return to room temperature. There is no softening or cracking, and the application and use feel is unchanged.

[0114] Therefore, it can be seen that the lipstick prepared by the method of the present invention has good cold resistance and heat resistance.

[0115] Example 8: Anti-inflammatory effect test of lipstick

[0116] The lipstick prepared in Example 7 was tested, with desonide cream as a positive control. Approximately 30 subjects were selected for each test. The subjects were non-allergic, aged between 20 and 50 years old, and mainly presented with dry, peeling, cracked, oozing, bleeding, or thickened lip skin, unclear vermilion border, and subjective symptoms of itching, pain and discomfort in the lips.

[0117] Usage: 15 minutes after cleansing the face, the test subjects applied lip balm (treatment group) or desonide cream (control group) to their lips, once after breakfast, once after lunch, once after dinner, and once before bedtime.

[0118] The efficacy of the treatment was observed and scored before treatment and during weeks 1, 2, and 3 of treatment. This observation mainly included the observation of the patient's subjective symptoms (pain) and objective symptoms of skin lesions (dryness, scaling, and fissures). Subjective symptom scores are shown in Table 11, and clinical manifestations and scoring details are shown in Table 12.

[0119] Table 11 Subjective Symptoms and Scoring Rules

[0120]

[0121] Table 12 Clinical Manifestations and Scoring Details

[0122]

[0123] Data analysis was performed using SPSS software. Clinical efficacy indicators were presented as ordinal data. The Wilcoxon rank-sum test was used to compare the pre- and post-treatment results between the two groups. A p-value < 0.05 was considered statistically significant. Table 13 shows a comparison of the lip condition of the two groups before treatment. No statistically significant differences were found between the groups, indicating that the clinical manifestations of the patients were relatively consistent and suitable for comparing positive drug administration and lip balm administration.

[0124] Table 13 Subjective symptom and clinical manifestation scores before treatment (mean±SD)

[0125]

[0126] Table 14 shows the results of the autonomous symptom scores at each treatment time point. Wilcoxon rank-sum test showed statistically significant changes in autonomous symptom scores in both the treatment and control groups before treatment and after week 3 of treatment. At week 1, week 2, and week 3 of treatment, there was no statistically significant difference in post-treatment scores between the two groups, indicating that the pain-relieving effect of the lip balm was comparable to that of the positive control drug.

[0127] Table 14 Subjective symptom scores before and after treatment (mean±SD)

[0128]

[0129] Note: * Compared with before treatment, P < 0.05. ** Compared with before treatment, P < 0.01.

[0130] The clinical symptom scores at each treatment time point are shown in Table 15. At the 3rd week of treatment, the clinical symptom scores of the treatment group and the control group showed significant differences in dryness, cracking, and peeling symptoms compared with before treatment, indicating that the lip balm was as effective as desonide cream in improving these symptoms. At the 1st, 2nd, and 3rd weeks of treatment, there was no significant difference in the different symptom scores between the two groups, indicating that the lip balm was as effective as the positive control drug in improving dryness, cracking, and peeling symptoms of the lips.

[0131] Table 15 Subjective symptom scores before and after treatment (mean±SD)

[0132]

[0133] Note: * Compared with before treatment, P < 0.05. ** Compared with before treatment, P < 0.01.

[0134] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition with anti-inflammatory and antioxidant functions, characterized in that, The following raw materials were prepared by the following method using the following weight proportions: 15 parts Astragalus membranaceus, 6 parts Anemarrhena asphodeloides, 6 parts Phellodendron chinense, 4 parts Angelica sinensis, 3 parts Cinnamomum cassia, 5 parts Glycyrrhiza uralensis, and 5 parts Ampelopsis japonica. Water was added in a volume 10 times the total weight of the raw materials, and the mixture was soaked for 0.5 hours. The mixture was then refluxed twice, each time for 1.5 hours. During the extraction, aromatic water equivalent to twice the volume of the prescription was collected for later use. The aqueous extract was concentrated under reduced pressure at 60-80℃ and dried to obtain a dry extract. An inclusion complex was prepared from the aromatic water using β-cyclodextrin, dried, and pulverized. The dry extract and the aromatic water β-cyclodextrin inclusion complex were mixed thoroughly.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition contains astragaloside A, anemarrhena saponin BII, mangiferin, berberine hydrochloride, berberine hydrochloride and dihydromyricetin.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the aromatic water β-cyclodextrin inclusion complex is as follows: take aromatic water, heat to 40~50℃, add β-cyclodextrin with a concentration of 20g / L for inclusion, keep warm and stir at 300~700 r / min for 30~40 min, after stirring, let it cool to room temperature, refrigerate at 4℃ for 24h, wait for the inclusion complex to precipitate, filter, wait for no water to flow out, wash with saturated β-cyclodextrin aqueous solution, wait for no water to flow out, collect the inclusion complex precipitate, dry, and grind into powder.

4. A lipstick with anti-inflammatory and antioxidant functions, characterized in that, The lipstick contains the traditional Chinese medicine composition as described in claim 1.

5. The lipstick as described in claim 4, characterized in that, The lipstick is made from mixture A and mixture B. Mixture A contains the following components by weight percentage: 8% jojoba oil, 18% camellia oil, 15% hydrogenated polyisobutylene, 0.5% ethylhexylglycerin, and 13% aqueous solution of the traditional Chinese medicine composition of claim 1. Mixture B contains the following components by weight percentage: 1% squalane, 12% shea butter, 6% bis-diglyceride polyacryladiate-2, 10% beeswax, 8% carnauba wax, 5% candelilla wax, 1% synthetic wax, and 2.5% tocopheryl acetate.

6. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of anti-inflammatory and antioxidant products.

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