A pharmaceutical composition for treating acne and a preparation method and use thereof

Abstract

The present application provides a kind of pharmaceutical composition for treating acne, which is prepared from the following weight ratio of raw materials: tea 20-30 parts, lemon 4-6 parts, olive leaf 16-24 parts, turmeric 8-12 parts, Sophora flavescens 8-12 parts, frankincense 8-12 parts, soap tree thorn 8-12 parts, loquat leaf 8-12 parts. The present application also provides a preparation method and use of the pharmaceutical composition. The pharmaceutical composition has the effects of clearing heat and drying dampness, eliminating swelling and pus, promoting blood circulation and removing blood stasis, and has good antibacterial, lipid-lowering and anti-inflammatory effects. The efficacy test proves that the external use of the pharmaceutical composition for treating acne has good curative effect, and the preparation has good application prospect and will produce significant social and economic benefits.

Description

TECHNICAL FIELD

[0001] The present application relates to a pharmaceutical composition for treating acne and its preparation method and use, belonging to the field of traditional Chinese medicine. BACKGROUND

[0002] Acne is a common chronic inflammatory disease of the pilosebaceous unit in dermatology, which often occurs in adolescents. The skin surface of patients often appears nodules, inflammatory papules, whiteheads, and even pustules. Due to the prolonged course of acne, it is prone to recurrence, and improper treatment can cause scar hyperplasia, pigmentation, and other symptoms, which not only affects the normal metabolism of the damaged skin, but also causes great psychological pressure to the patients. Therefore, active and effective treatment is of great significance to the physical and mental health of acne patients.

[0003] At present, there are many chemical drugs for treating acne on the market, which are effective but also have some defects and challenges. Topical drugs such as retinoids, benzoyl peroxide, salicylic acid, etc. may cause local irritation symptoms such as skin dryness, erythema, desquamation, itching, etc., affecting the medication adherence of patients. Long-term or improper use of antibiotic drugs may lead to antibiotic resistance of Propionibacterium acnes, reducing the therapeutic effect. Therefore, antibiotics should not be used alone for acne treatment, but should be combined with other drugs such as benzoyl peroxide or topical retinoids. Some drugs such as retinoids may increase the sensitivity of the skin to ultraviolet light, and strict sun protection is required during use. In addition, long-term use of oral antibiotics such as tetracyclines and macrolides may cause gastrointestinal reactions, increased photosensitivity, fungal infections, and other systemic side effects. Even some drugs such as retinoids may harm the fetus during pregnancy, which are contraindicated during pregnancy. Acne inflammation may lead to scarring, especially if not treated promptly or improperly.

[0004] TCM refers to acne as "acne", which belongs to the category of "acne". "Medical Canon · Surgical Heart Method" explains the causes and symptoms of acne, and believes that the cause of acne is "heat in the lung meridian", often "on the face and nose", shaped like "millet chaff", red and swollen, and painful. "Break out white powder juice", "long time all become white chaff", the cause of the disease is lung meridian wind heat; dampness and heat in the intestines, phlegm and blood stasis are related. The external treatment of traditional Chinese medicine has its own advantages in the treatment of skin diseases, and is an important way to treat acne. However, there are also the following difficulties in treating acne with traditional Chinese medicine, such as: the complexity of syndrome differentiation and treatment: TCM syndrome differentiation of acne is relatively complex, and it is necessary to comprehensively analyze the patient's constitution, etiology, symptoms and other factors to determine the treatment plan. For example, acne may be related to different TCM syndromes such as lung and stomach heat, dampness accumulation, and imbalance of chong and ren. Different treatment methods need to be used when treating. Long treatment cycle: Traditional Chinese medicine treatment usually needs a long time to take effect, and patients need to be patient and insist on treatment. At the same time, the decoction and taking of traditional Chinese medicine are relatively cumbersome, which may affect the patient's compliance. There are many kinds of traditional Chinese medicine, and the selection of appropriate drugs and reasonable compatibility is the key to treatment. At the same time, attention should also be paid to the dosage and decoction method of the drug to ensure the curative effect (such as Zheng Yachun, et al. Causes of acne and TCM syndrome differentiation and treatment, doi:10.53388 / CCMR2021018).

[0005] Application No. 201410099025.1, Invention Name: A kind of conditioning acne enzyme and its preparation method, disclose a kind of conditioning acne enzyme and its preparation method;Its raw material component is: A1: yiyi 40%, safflower 3%, cockscomb flower 5%, chrysanthemum 5%, rose flower 5%, honeysuckle 3%, dandelion 3%, diting 8%, day 10%, loquat leaf 10%, licorice 5%, smilax 3%;Probiotics are: chestnut wine yeast 2%, sticky red yeast 2%, white ground mold 2%, film-producing yeast 2%, wine yeast 2%, fine yellow streptomyces 1%, plant lactobacillus 3%, lactobacillus 2% composition of streptococcus lactis. It has the advantages of clearing liver, moistening lung, invigorating spleen and regulating intestine, removing dampness and clearing heat, and improving acne caused by dampness and heat constitution. However, due to the complexity of the causes of acne, the current drugs cannot meet the needs of clinical practice, so it is particularly important to select a safe and effective external preparation of traditional Chinese medicine to treat acne. SUMMARY

[0006] The technical scheme of the present application provides a new drug composition for treating acne, and another technical scheme of the present application provides a preparation method and use of the drug composition.

[0007] The present application provides a drug composition for treating acne, which is prepared from the following raw materials in the following weight ratio:

[0008] Tea 20-30 parts, lemon 4-6 parts, olive leaves 16-24 parts, turmeric 8-12 parts, Sophora flavescens 8-12 parts, frankincense 8-12 parts, soapstick 8-12 parts, loquat leaves 8-12 parts.

[0009] Further preferably, it is prepared from the following raw materials in the following proportions:

[0010] Tea 25 parts, lemon 5 parts, olive leaves 20 parts, turmeric 10 parts, Sophora flavescens 10 parts, frankincense 10 parts, soapstick 10 parts, loquat leaves 10 parts.

[0011] The pharmaceutical composition of the present application is prepared from the raw material of the crude drug powder, water or organic solvent extract, or the fermentation product of the raw material as the active ingredient, and the addition of pharmaceutically acceptable adjuvants or auxiliary ingredients into the commonly used external preparation in pharmacy.

[0012] The external preparation is ointment, cream, gel, solution, lotion, spray, tincture, and coating agent.

[0013] The present application provides a preparation method of the pharmaceutical composition for treating acne, which comprises the following steps:

[0014] a. weighing the raw materials in the following proportions;

[0015] b. the raw material of the crude drug powder, water or organic solvent extract, or the fermentation product of the raw material as the active ingredient, and the addition of pharmaceutically acceptable adjuvants or auxiliary ingredients into the commonly used external preparation in pharmacy.

[0016] The preparation method of the fermentation product is as follows:

[0017] a. weighing the raw materials in the following proportions, soaking, washing, and powdering;

[0018] b. putting the crushed powder into the sterilized fermentation barrel; adding purified water according to the ratio of 1:5 of Chinese herbal medicine powder to purified water; adding honeycomb honey to promote the fermentation process; after stirring evenly, the fermentation barrel is sealed and placed in a dark and cool place; after one month, the supernatant is extracted;

[0019] c. repeating step b twice, a total of three times of supernatant extraction;

[0020] d. combining the three times of extracted supernatant, filtering and concentrating to obtain the fermentation product.

[0021] The soaking time of step a is at least 12 hours; the fineness of powdering is at least 100 mesh;

[0022] The addition amount of honeycomb honey in step b is 50-100g per kilogram of Chinese herbal medicine powder.

[0023] The application provides use of the medicine composition in preparation of an external medicine for treating acne.

[0024] Acne is a common chronic inflammatory disease of skin follicle sebaceous glands. According to traditional Chinese medicine, the cause and pathogenesis of acne are that: at the time of youth, heat of Yangming is in excess, dampness and heat accumulate, phlegm is formed by liquid, phlegm and blood stasis are combined, and the meridians are blocked; diet and living habits are disordered, heat of lung and stomach is accumulated, and the chest and face are infected; external evil and internal blood stasis are combined in the chest and face, and the disease is caused after a long time. The tea and lemon mixture has the effects of clearing heat and drying dampness, eliminating swelling and pus, and promoting blood circulation and removing blood stasis, and can treat the pathogenesis of acne.

[0025] In the raw materials of the medicine composition, tea dregs, lemon and olive leaves are the monarchs, the tea dregs are natural powder residues left after pressing wild camellia oil, also known as tea bran and tea seed cake, and have the effects of clearing heat and resolving toxins, and removing dampness and killing insects. The lemon has the effect of clearing heat and removing dampness, and the olive leaf has the effects of clearing heat and resolving toxins, and relieving a sore throat and eliminating swelling; the sophora flavescens, kadsura longipedunculata and loquat leaves are the ministers, the sophora flavescens has the effects of clearing heat and drying dampness, and killing insects and stopping itching. The kadsura longipedunculata has the effects of eliminating swelling and removing toxins, and removing pus and killing insects. The Bencao Huiyan states: the kadsura longipedunculata can remove toxins and dispel wind, can cause the unformed abscesses to dissipate, can cause the broken abscesses to grow out of the head, and can cause the ulcerated abscesses to drain pus. It is the first important agent among agents for treating abscesses. The loquat leaf has the effect of clearing heat of lung and stomach. The frankincense is the assistant, and has the effects of promoting blood circulation and relieving pain, eliminating swelling and promoting tissue regeneration. The curcuma is the guide, and has the effects of clearing heat and resolving toxins, promoting blood circulation and removing dampness, and promoting qi circulation and relieving pain.

[0026] The medicine composition has good antibacterial, lipid-lowering and anti-inflammatory effects, and the pharmacodynamic test proves that the external use of the medicine composition for treating acne has good curative effect, and aims to create a safe external preparation of pure traditional Chinese medicine. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 The preparation process flow chart of the application;

[0028] Figure 2 HE staining pictures of left auricle tissues of rats in each group (x200);

[0029] Figure 3 IL-1alpha, IL-1beta, IL-6 and TNF-alpha protein banding pictures of left auricle tissues of rats in each group. DETAILED DESCRIPTION

[0030] Example 1: Preparation of the medicine composition of the application (hereinafter referred to as tea and lemon mixture)

[0031] The present application adopts the microorganism brewing fermentation technology and its preparation method: 2500g of tea dregs, 500g of lemon, 2000g of olive leaves, 1000g of turmeric, 1000g of sophora flavescens, 1000g of frankincense, 1000g of soapstick, and 1000g of loquat leaves, totally 10kg, and the preparation method is as follows:

[0032] The above Chinese herbal medicines are soaked, cleaned, and crushed.

[0033] The treated Chinese herbal medicines are put into a sterilized fermentation barrel, purified water and honeycomb honey are added, and stirred uniformly.

[0034] The fermentation barrel is placed in a dark and cool place for about one month, and about 40kg of supernatant is extracted.

[0035] Purified water and honeycomb honey are added again, stirred for the second time, and then placed for one month again, and the second supernatant is extracted.

[0036] The third time, the above steps are repeated, and the third supernatant is extracted.

[0037] The three times of extracted supernatants are synthesized to obtain the final Chinese herbal medicine fermentation extract.

[0038] Among them, the purified water is used to soak the Chinese herbal medicines for at least 12 hours; the Chinese herbal medicines are crushed to a fineness of at least 100 meshes; the addition amount of honeycomb honey is 50g to 100g per kilogram of Chinese herbal medicine powder; the sterilization treatment of the fermentation barrel includes wiping sterilization with 75% alcohol; and the step of extracting the supernatant includes filtering with filter paper. Figure 1 )

[0039] Example 2 Preparation of the medicine of the present application

[0040] Tea dregs 20g, lemon 4g, olive leaves 16g, turmeric 8g, sophora flavescens 8g, frankincense 8g, soapstick 8g, and loquat leaves 8g are weighed, water decocting and extraction, concentrated, and added with a commonly used emulsion base to prepare an emulsion.

[0041] Example 3 Preparation of the medicine of the present application

[0042] Tea dregs 30g, lemon 6g, olive leaves 24g, turmeric 12g, sophora flavescens 12g, frankincense 12g, soapstick 12g, and loquat leaves 12g are prepared into a fermentation extract according to Example 1.

[0043] The beneficial effects of the present application are proved by the following specific pharmacodynamic tests.

[0044] Test Example 1 Animal experiment of the medicine of the present application

[0045] 1 Experimental materials

[0046] 1.1 Experimental animals: 32 SPF-grade SD rats, with a body weight of (180 ± 20) g, male, purchased from Shanghai Slack Experimental Animal Co., Ltd. (Production License: SCXK(Beijing)2019-0008). They were housed in the SPF breeding room of the SPF-grade Medical Experimental Animal Center of Fujian University of Traditional Chinese Medicine (Certificate of Conformity: SYXK(Fujian)2019-0007). This study was reviewed and approved by the Animal Ethics Committee of Fujian University of Traditional Chinese Medicine, and the ethical review number is FJTCM IACUC 2023149.

[0047] 1.2 Experimental drugs and reagents: Tea catechin citrate mixture (prepared by Example 1); 0.1% tretinoin cream (Shandong Liangfu Pharmaceutical Co., Ltd., batch number: H37023768); Propionibacterium acnes solution (Beijing Beina Biotechnology Co., Ltd., batch number: BNCC362517); Rat interleukin 1β (IL-1β) ELISA kit, rat interleukin 1α (IL-1α) ELISA kit, rat interleukin 6 (IL-6) ELISA kit, and rat tumor necrosis factor α (TNF-α) ELISA kit were all purchased from Shanghai Zhuocai Biotechnology Co., Ltd. (batch numbers: ZC-36391-96T, ZC-36337-96T, ZC-3​​​​

[0049] 2 Experimental Methods

[0050] 2.1 Preparation of Propionibacterium acnes suspension: Lyophilized Propionibacterium acnes was dissolved in sodium thioethanolate to form a suspension, inoculated onto anaerobic blood agar plates, and placed in an anaerobic container for incubation at 37°C for 24 hours. The concentration of Propionibacterium acnes was adjusted to 6 × 10⁻⁶ with physiological saline. 7 CFU / mL, inactivated in a 95℃ water bath for 15 min, and ready for use.

[0051] 2.2 Preparation of an auricular acne rat model: Thirty-two male SD rats were randomly divided into a normal group (n=8) and a model group (n=24). The auricular acne model was established in the model group rats using the following specific steps. [3] Anesthesia was administered via intraperitoneal injection of 3% sodium pentobarbital (1 mL / kg body weight), and Propionibacterium acnes solution (6 × 10⁻⁶) was injected intradermally into the left auricle. 7 50 μL of CFU / mL solution was administered once daily for 3 consecutive days. On day 3, each rat was injected intraperitoneally with Propionibacterium acnes solution (6 × 10⁻⁶ CFU / mL). 7 Administer 1 mL of sterile saline (cfu / mL) once daily for 7 consecutive days. At the same time, rats in both the normal and model groups received an intradermal injection of 50 μL of sterile saline in the left ear and an intraperitoneal injection of 1 mL of sterile saline. After modeling, the skin condition of the left ear was observed in each group of rats. A rat with an acne model grade ≥1 was considered a successfully established model. Acne model grading criteria. [4] Grade 1 is characterized by localized skin color changes, capillary dilation, and slight thickening of the auricle; Grade 2 is characterized by rough and dry skin surface, thickened and hardened auricle with mild redness and swelling; Grade 3 is characterized by rough skin surface, aggravated thickening of the auricle, hardness to the touch, obvious redness and swelling of the skin, and increased skin temperature.

[0052] 2.3 Experimental Grouping and Drug Administration Rats with successfully established acne models were randomly divided into three groups according to acne model grading: model group, retinoic acid group, and tea-lemon mixture group, with 8 rats in each group. Eight male SD rats were also included in the normal control group. Physiological saline was applied topically to both sides of the left ear of rats in the normal and model groups, 0.2 mL of 0.1% retinoic acid cream was applied topically to the retinoic acid group, and 0.5 mL of tea-lemon mixture was applied topically to the tea-lemon mixture group. All treatments were administered once daily for 14 consecutive days.

[0053] 2.4 Samples were collected 2 hours after the last administration of the drug. Rats were anesthetized, and blood was collected from the abdominal aorta. The blood was allowed to stand at room temperature for 1 hour, then centrifuged at 3000 rpm for 15 minutes to separate the serum. One-quarter of the auricular tissue was fixed in 4% paraformaldehyde for 24 hours, routinely dehydrated, embedded in paraffin, and then used for HE staining. The remaining auricular tissue was placed in liquid nitrogen and then transferred to a -80°C refrigerator for storage.

[0054] 2.5 Observation Indicators

[0055] 2.5.1 General observation of the left auricle skin of each group of rats.

[0056] 2.5.2 Measurement of rat ear swelling degree The thickness of the auricle before modeling was measured using a vernier caliper before modeling, and the thickness of the auricle was measured using a vernier caliper before sampling, the ear swelling degree was calculated, and the formula was:

[0057] Auricle swelling degree = (thickness after modeling - thickness before modeling) / thickness before modeling.

[0058] 2.5.3 Detection of serum IL-1α, IL-1β, IL-6, TNF-α content in rats ELISA method was used to detect the content of IL-1α, IL-1β, IL-6, TNF-α in rat serum according to the instructions of the kit.

[0059] 2.5.4 Observation of pathological morphology of left auricle tissue of rats The left auricle tissue paraffin-embedded block was made into 4 μm section, and the conventional xylene was deparaffinized, and the gradient ethanol was deparaffinized and rehydrated, and the HE staining was performed, and the pathological changes of auricle tissue were observed under 200 times microscope and the images were collected.

[0060] 2.5.5 Detection of IL-1α, IL-1β, IL-6, TNF-α protein expression level in left auricle tissue of rats 5 rats were randomly selected from each group, about 100 mg of left auricle tissue was taken, and liquid nitrogen was ground into powder, and 1:10 was added to high-efficiency tissue lysis solution containing protease inhibitor and phosphatase inhibitor, and total protein was extracted. The protein concentration was determined by BCA kit, and the protein sample was prepared by adding SDS loading buffer. The denatured protein sample was subjected to SDS-PAGE gel electrophoresis, and then transferred to PVDF membrane. The corresponding band was cut, blocked with 5% skim milk for 70 min, and washed with TBST. The primary antibody (β-actin dilution ratio was 1:5000, IL-1α, IL-1β, IL-6, TNF-α dilution ratio was 1:1000) was incubated at 4℃ overnight, and the secondary antibody (HRP labeled goat anti-mouse secondary antibody, HRP labeled goat anti-rabbit secondary antibody dilution ratio was 1:3000) was incubated at room temperature for 70 min, and TBST was washed thoroughly. The special hypersensitive ECL was developed, and the image was formed on ChemiDoc XRS+ chemiluminescence imaging system and the image was collected. The Image Lab 6.0 software was used to analyze the gray value of the band, and β-actin was used as the internal reference to calculate the relative expression amount of the target protein, and the relative expression amount of the target protein = target protein gray value / internal reference protein gray value, and the value of the relative expression amount of the target protein was normalized according to the value of the normal group.

[0061] 2.6 Statistical processing of experimental data The experimental data were analyzed by SPSS29.0 software, and the measurement data belonged to normal distribution The results showed that the single factor analysis of variance was used for the comparison among groups, and the LSD test was used for the variance homogeneity, and the Games-Howell test was used for the variance heterogeneity.

[0062] 3. Results

[0063] 3.1 General state The skin color of the left auricle of the normal group was normal, and the capillary was clear. The touch feeling was soft and light. The skin of the model group was rough and dry, and the skin was obviously red and swollen. The touch feeling was hard and thick, and the skin temperature was increased. There were scattered papules and pustules. The acne model was judged to be≥2 grade. After the drug treatment, the skin state of the left auricle of the rats was improved to different degrees.

[0064] 3.2 Comparison of the auricle swelling degree of the rats in each group Compared with the normal group, the auricle swelling degree of the rats in the model group was significantly increased (P<0.01). Compared with the model group, the auricle swelling degree of the rats was significantly reduced after the treatment with the tea and lemon mixture and the tretinoin cream for 14 days (P<0.05). See Table 1.

[0065] Table 1 Comparison of the auricle swelling degree of the rats in each group

[0066]

[0067]

[0068] Note: Compared with the normal group, ** P<0.01; compared with the model group, # P<0.05.

[0069] 3.3 Observation of the pathological morphology of the left auricle HE results showed that: the dermis layer of the left auricle tissue of the normal group was clear with the epidermis and subcutaneous tissue, and no inflammatory cell infiltration was observed. The dermis layer of the left auricle tissue of the model group was blurred with the epidermis and subcutaneous tissue, the epidermis was thickened with hyperkeratosis, a large number of inflammatory cells infiltrated in the dermis layer, and the capillary was obviously expanded. After the intervention of the tea and lemon mixture and tretinoin, the auricle tissue structure was obviously improved, the epidermis keratinization and thickness were reduced to different degrees, and the inflammatory cells were obviously reduced. See Figure 2 .

[0070] 3.4 Comparison of the serum IL-1α, IL-1β, IL-6, and TNF-α contents of the rats in each group Compared with the normal group, the serum IL-1α, IL-1β, IL-6, and TNF-α contents of the rats in the model group were significantly increased (P<0.01). After the treatment with the tea and lemon mixture and the tretinoin cream for 14 days, the serum IL-1α, IL-1β, IL-6, and TNF-α contents of the rats were significantly reduced (P<0.01). See Table 2.

[0071] Table 2 Comparison of IL-1α, IL-1β, IL-6, TNF-α contents in serum of rats in each group

[0072]

[0073] Note: compared with the normal group, ** P<0.01; compared with the model group, ##P<0.01.

[0074] 3.5 Comparison of IL-1α, IL-1β, IL-6, TNF-α protein expression levels in left auricle tissues of rats in each group Compared with the normal group, the IL-1α, IL-1β, IL-6, TNF-α protein expression levels in auricle tissues of rats in the model group were significantly increased (P<0.05 or 0.01); after treatment with the tea-citrus mixture and tretinoin cream, the IL-1α, IL-1β, IL-6, TNF-α protein expression levels in auricle tissues of rats were significantly decreased (P<0.05 or 0.01). See Table 4. Figure 3 and Table 4.

[0075] Table 4 Comparison of IL-1α, IL-1β, IL-6, TNF-α protein expression levels in left auricle tissues of rats in each group

[0076]

[0077] Note: compared with the normal group, *P<0.05, **P<0.01; compared with the model group, #P<0.05, ##P<0.01.

[0078] 4. Discussion

[0079] The pathogenesis of acne is relatively complex, mainly including increase of androgens, increase of sebaceous gland secretion, hyperkeratosis of the follicular orifice, and infection of Propionibacterium acnes, among which the skin inflammation caused by infection of Propionibacterium acnes is closely related to the onset of acne. Therefore, in this experiment, local infection was caused by intradermal injection of Propionibacterium acnes in the auricle of rats, and abdominal injection of Propionibacterium acnes solution was added to simulate the pathogenesis process of external manifestations and inflammatory reactions of acne, and the model was maintained for not less than 14 days after modeling. After modeling in this experiment, the left auricle of rats showed rough and dry epidermis, obvious skin redness and swelling, hard and thick touch, increased skin temperature, scattered papules and pustules, and the acne model judgment grade was ≥2 grade, and pathological examination showed that the left auricle skin tissue showed obvious inflammatory damage, indicating that the model was successfully prepared.

[0080] Traditional Chinese medicine believes that acne is mainly caused by external evils such as wind, dampness, heat, phlegm, and blood stasis. The tea-citrus mixture has the effects of clearing heat and removing dampness, reducing swelling and pus discharge, and promoting blood circulation to remove blood stasis, and has good curative effect in the clinical treatment of acne.

[0081] Acne is one of the common skin diseases, its pathogenesis is related to many factors, and bacterial infection induced inflammation plays an important role in the pathogenesis of acne, and the inflammatory response runs through the entire process of acne pathogenesis. Propionibacterium acnes is the most important pathogenic bacteria, which can stimulate human peripheral blood mononuclear cells and macrophages to produce pro-inflammatory cytokines, and then the inflammatory factors bind to the corresponding receptors in the epidermis, hair follicle and sebaceous gland, and participate in the inflammatory response. In the development of acne inflammation, immune response and pro-inflammatory cytokines are involved. IL-1α, IL-1β, IL-6 and TNF-α are pro-inflammatory cytokines, which are produced by mononuclear macrophages, mediate innate immunity, are the key to initiate innate immune response, and can promote the excessive keratinization of the follicle orifice and the characteristic inflammatory lesions of acne. The results of this experiment show that the tea and lemon mixture can significantly reduce the content and protein expression level of IL-1α, IL-1β, IL-6 and TNF-α in the serum and left auricle tissue of ear acne model rats (P<0.05 or 0.01), and alleviate the inflammatory response state induced by Propionibacterium acnes.

[0082] In summary, the tea and lemon mixture can reduce the expression level of inflammatory mediators to achieve the purpose of reducing the inflammatory cascade reaction of acne.

Claims

1. A pharmaceutical composition for treating acne, characterized by comprising: It is an external preparation prepared from the following weight ratio of raw materials: ​ Tea 20-30 parts, lemon 4-6 parts, olive leaves 16-24 parts, turmeric 8-12 parts, Sophora 8-12 parts, frankincense 8-12 parts, soapstick 8-12 parts, loquat leaves 8-12 parts.

2. The pharmaceutical composition for treating acne according to claim 1, characterized by: It is an external preparation prepared from the following weight ratio of raw materials: Tea 20-30 parts, lemon 4-6 parts, olive leaves 16-24 parts, turmeric 8-12 parts, Sophora 8-12 parts, frankincense 8-12 parts, soapstick 8-12 parts, loquat leaves 8-12 parts.

3. The pharmaceutical composition for treating acne according to claim 1 or 2, characterized in that: It is an external preparation prepared from the following weight ratio of raw materials:

4. The pharmaceutical composition for treating acne according to claim 3, characterized by: Tea 20-30 parts, lemon 4-6 parts, olive leaves 16-24 parts, turmeric 8-12 parts, Sophora 8-12 parts, frankincense 8-12 parts, soapstick 8-12 parts, loquat leaves 8-12 parts.

5. A process for the preparation of a pharmaceutical composition for the treatment of acne according to any one of claims 1 to 4, characterized in that: It is an external preparation prepared from the following weight ratio of raw materials: The external preparation is ointment, cream, gel, lotion, spray, tincture. It includes the following steps:

6. The method for preparing the pharmaceutical composition for treating acne according to claim 5, characterized in that: a. Weigh the raw materials in the following weight ratio; b. The raw material of the crude drug powder, water or organic solvent extract, or the fermentation product of the raw material is used as the active ingredient, and the pharmaceutically acceptable adjuvant is added to prepare the commonly used external preparation in pharmacy. The preparation method of the fermentation product is: a. Weigh each weight ratio of raw materials, soak, wash, and powder; b. Put the crushed powder into the sterilized fermentation barrel; add purified water according to the ratio of Chinese herbal medicine powder to purified water 1:5; add honeycomb honey to promote the fermentation process; after stirring evenly, seal the fermentation barrel and place it in a dark and cool place; after one month, extract the supernatant; 7. The method for preparing the pharmaceutical composition for treating acne according to claim 6, characterized in that: c. Repeat step b twice, a total of three times; d. Combine the three times of supernatant, filter and concentrate to obtain the fermentation product. The soaking time of step a is at least 12h; the fineness of the powder is at least 100 mesh; The addition amount of honeycomb honey in step b is 50-100g per kilogram of Chinese herbal medicine powder.

8. The use of the pharmaceutical composition of any one of claims 1-4 in the preparation of an external medicine for treating acne.

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