Traditional Chinese medicine preparation for treating skin diseases as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine preparation for treating skin diseases and a preparation method and application thereof. The medicament is prepared from 170 to 190 parts of herba artemisiae scopariae, 110 to 130 parts of schizonepeta spike, 80 to 100 parts of radix saposhnikoviae, 50 to 70 parts of rhizoma chuanxiong, 170 to 190 parts of raw radix astragali seu hedysari, 110 to 130 parts of radix angelicae sinensis, 80 to 100 parts of fructus arctii, 80 to 100 parts of rhizoma belamcandae, 80 to 100 parts of cortex moutan, 80 to 100 parts of radix clematidis, 80 to 100 parts of rhizoma smilacis glabrae, 110 to 130 parts of cornu bubali, 80 to 100 parts of cortex dictamni, 80 to 100 parts of fructus kochiae, 80 to 100 parts of fructus cnidii, 80 to 100 parts of raw rhizoma nelumbinis, 80 to 100 parts of rhizoma bistortae, 110 to 130 parts of fructus chaenomelis According to the invention, the skin disease formula II is developed into the water-bindered pill, so that the defects of inconvenience in taking, difficulty in controlling dosage, easiness in moisture absorption and deterioration and the like are overcome, and the water-bindered pill is easy to carry, low in dosage, higher in patient acceptance and capable of better meeting the requirements of clinical medication.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine for treating skin diseases, and a preparation method and application thereof. Background Art

[0002] Xuanlin Pills, originally named Dermatological Prescription No. Ⅱ, are derived from the experience prescription explored by Liu Tingxiang, a famous old expert at Shizuishan Traditional Chinese Medicine Hospital after years of clinical experience. As the agreed prescription of our hospital, it has reliable efficacy, with a total effective rate of more than 95%, and has been used clinically for many years. In the prescription, Astragalus, Angelica, and Chuanxiong nourish blood and moisten dryness, and are the main medicines. Raw Rehmannia, Peony Root, Buffalo Horn, Lotus Root, Saposhnikovia, and Nepeta Spike cool blood and dispel wind, and are the ministerial medicines. It is supplemented with heat-clearing and dampness-clearing medicines such as Artemisia capillaris, papaya, Stephania tetrandra, Smilax glabra, Clemati radix, Cnidium monnieri, Kochia scoparia, and Dictamni, and detoxifies and relieves itching, and is the guiding medicine; it has the effects of nourishing blood and moistening dryness, dispelling wind and dampness, cooling blood and detoxifying, and is mainly used to treat urticaria, eczema, acne, psoriasis, fish scales, scleroderma, etc. The prescription was initially used mainly as a decoction, and later it was mainly used in the clinic as a powder according to the needs of patients, and its efficacy is still stable and reliable.

[0003] However, due to the large dosage of powders, difficulty in swallowing, difficulty in controlling dosage, inconvenience in carrying, and easy absorption of moisture and deterioration, during clinical use, doctors and patients gradually began to reflect that powders were inconvenient to take and that patient acceptance was low. At the same time, the prescriptions contained drugs that were difficult to crush, such as Artemisia capillaris, Schizonepeta spicate, and buffalo horn. From a preparation process perspective, the drug powder extraction rate was low and some drugs were not fully utilized. Summary of the invention

[0004] In view of the above-mentioned problems, the present invention aims to provide a traditional Chinese medicine for treating skin diseases and its preparation method and application, so as to at least solve the problems of the existing tinea scale pills, such as inconvenience in taking, difficulty in controlling dosage and easy moisture absorption and deterioration.

[0005] In order to achieve the above object, the technical solution adopted by the present invention to solve the technical problem is:

[0006] A Chinese medicine for treating skin diseases, comprising the following raw materials: Artemisia capillaris, Nepeta spicata, Saposhnikovia divaricata, Chuanxiong, raw Astragalus, Angelica sinensis, Arctium lappa, Belamcanda chinensis, Paeonia suffruticosa, Clematis chinensis, Smilax glabra, Buffalo horn, Dictamni, Kochia scoparia, Cnidium monnieri, raw lotus root node, Polygonum multiflorum, Papaya, Stephania tetrandra and raw Rehmannia root;

[0007] The weight proportions of different raw materials are respectively: 170-190 parts of Artemisia capillaris, 110-130 parts of Schizonepeta spicate, 80-100 parts of Saposhnikovia divaricata, 50-70 parts of Chuanxiong, 170-190 parts of raw Astragalus, 110-130 parts of Angelica sinensis, 80-100 parts of Arctium lappa, 80-100 parts of Belamcanda chinensis, 80-100 parts of Paeonia suffruticosa, 80-100 parts of Clematidis, 80-100 parts of Smilax glabra, 110-130 parts of Buffalo Horn, 80-100 parts of Dictamni, 80-100 parts of Kochia scoparia, 80-100 parts of Cnidium monnieri, 80-100 parts of raw lotus nodes, 80-100 parts of Polygonum multiflorum, 110-130 parts of Papaya, 80-100 parts of Stephania tetrandra and 110-130 parts of raw Rehmannia root.

[0008] Further, the weight portions of different raw materials are respectively: Artemisia capillaris, Schizonepeta spicate, Saposhnikovia divaricata, Chuanxiong, raw Astragalus membranaceus, Angelica sinensis, Burdock fruit, Belamcanda chinensis, Peony bark, Clematidis, Smilax glabra, Buffalo horn, Dictamni peel, Kochia scoparia, Cnidium monnieri, raw lotus node, Polygonum aviculare, Papaya, Stephania tetrandra and raw Rehmannia glutinosa are respectively: 180 parts of Artemisia capillaris, 120 parts of Schizonepeta spicate, 90 parts of Saposhnikovia divaricata, 60 parts of Chuanxiong, 180 parts of raw Astragalus membranaceus, 120 parts of Angelica sinensis, 90 parts of Burdock fruit, 90 parts of Belamcanda chinensis, 90 parts of Peony bark, 90 parts of Clematidis, 90 parts of Smilax glabra, 120 parts of Buffalo horn, 90 parts of Dictamni peel, 90 parts of Kochia scoparia, 90 parts of Cnidium monnieri, 90 parts of raw lotus node, 90 parts of Polygonum aviculare, 120 parts of Papaya, 90 parts of Stephania tetrandra and 120 parts of raw Rehmannia glutinosa.

[0009] The pharmacology of different raw materials in the present invention are respectively:

[0010] Xuanlin Pills Recipe Explanation:

[0011] Main drug: Schizonepeta spicate can dispel wind and relieve exterior symptoms, clear rashes and relieve itching, and is targeted at wind evil in skin diseases.

[0012] Assistant medicines: Artemisia capillaris and raw Astragalus membranaceus clear away heat and dampness, consolidate the exterior and stop sweating, and help the main medicine to relieve the dampness and heat.

[0013] Auxiliary drugs: Angelica sinensis, Ligusticum chuanxiong: tonify blood and activate blood circulation, harmonize qi and blood; Arctium lappa, Belamcanda chinensis: clear away heat and detoxify, relieve sore throat and reduce swelling; Paeonia suffruticosa, Rehmannia root: clear away heat and cool blood, activate blood circulation and remove blood stasis; Clematidis, Smilax glabra: dispel wind and dampness, detoxify and disperse nodules; Buffalo horn, Dictamni bark, cool blood and detoxify, dispel wind and relieve itching; Kochia scoparia, Cnidium monnieri: dry dampness and relieve itching, kill insects and treat tinea; Lotus root node, Polygonum multiflorum: astringent and hemostatic, clear away heat and detoxify; Papaya, Stephania tetrandra: relax muscles and tendons, dispel wind and relieve pain.

[0014] Assistant drug: Fangfeng dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain. It harmonizes all drugs and guides the drug power directly to the affected area.

[0015] This prescription is mainly used to dispel wind and relieve exterior symptoms, supplemented by methods such as clearing heat and dampness, replenishing blood and activating blood circulation, clearing heat and detoxifying. It targets the causes of skin diseases such as wind, dampness, heat, and blood stasis, harmonizes qi and blood, and treats both the symptoms and the root cause.

[0016] The efficacy of different components in traditional Chinese medicine and modern pharmacological research:

[0017] 1. Artemisia capillaris

[0018] Chinese medicine efficacy: clears dampness and heat, promotes bile secretion and relieves jaundice;

[0019] Pharmacological action: Reduces elevated transaminase levels caused by liver damage, resists pathogenic microorganisms, resists liver damage, and promotes choleresis.

[0020] 2. Nepeta spicata

[0021] Efficacy: dispel wind and relieve exterior symptoms, clear rashes and eliminate sores, and stop bleeding;

[0022] Pharmacological action: Enhances blood circulation in the skin, increases sweat gland secretion, has a slight antipyretic effect, and has an inhibitory effect on a variety of bacteria.

[0023] 3. Windproof

[0024] Efficacy: dispel wind and relieve exterior symptoms, eliminate dampness and relieve pain, stop spasms;

[0025] Pharmacological effects: antipyretic, analgesic, anti-inflammatory, diuretic, and has inhibitory effects on a variety of bacteria.

[0026] 4. Ligusticum chuanxiong

[0027] Efficacy: promoting blood circulation and removing blood stasis, promoting qi and relieving pain, dispelling wind and dampness;

[0028] Pharmacological effects: Promote blood circulation, improve microcirculation, anti-oxidation, anti-inflammatory, and anti-thrombotic.

[0029] 5. Astragalus

[0030] Efficacy: Strengthens the exterior and stops sweating, removes toxins and promotes tissue regeneration, replenishes qi and raises yang;

[0031] Pharmacological effects: Enhance the immune system, promote hematopoiesis, regulate blood pressure, and resist viruses.

[0032] 6. Angelica

[0033] Effects: Nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movements;

[0034] Pharmacological action: Increase coronary blood flow, anti-thrombotic, treat blood deficiency, blood stasis and cold coagulation and other diseases.

[0035] 7. Burdock

[0036] Effect: clearing away heat and detoxifying, clearing the liver and improving eyesight, diuresis and removing dampness;

[0037] Pharmacological action: Reduces fever and inflammation caused by infection, improves skin condition, and promotes hair growth.

[0038] 8.ejaculation

[0039] Efficacy: It has the effects of clearing away heat, detoxifying, removing phlegm and relieving sore throat;

[0040] The pharmacological effects are mainly antiviral, antibacterial, throat moisturizing and cough relieving. It is often used to treat respiratory diseases such as sore throat, cough and asthma.

[0041] 9. Peony bark

[0042] Efficacy: It has the effects of clearing away heat, cooling blood, promoting blood circulation and removing blood stasis. It can be used to treat symptoms such as heat entering the blood, warm toxins and spots;

[0043] Pharmacological effects: It has liver and kidney protection, anti-inflammatory, sedative, cooling and antipyretic effects.

[0044] 10. Clematis

[0045] Efficacy: It has the effects of removing rheumatism, unblocking meridians, relieving pain, and eliminating bone stagnation;

[0046] Pharmacological effects: Modern research shows that it also has analgesic, anti-inflammatory, anti-diuretic and other effects, and can be used to treat rheumatic pain, numbness of the limbs, bruises and other diseases.

[0047] 11. Smilax glabra

[0048] Efficacy: Reduce swelling and relieve pain, promote diuresis and eliminate dampness, clear away heat and detoxify;

[0049] Pharmacological action: It has a protective effect on brain and myocardial damage caused by ischemia, has a beta-receptor blocking effect and anti-atherosclerotic effect, protects the liver, has a diuretic effect, and is anti-gastric ulcer, etc.

[0050] 12. Buffalo Horn

[0051] Effects: Clearing away heat, cooling blood, detoxifying, calming the nerves;

[0052] Pharmacological action: It is used to treat high fever caused by febrile diseases, coma, delirium, convulsions, mania and other symptoms. It has a certain detoxification effect and can treat carbuncle, sore, blood heat and toxicity and other symptoms.

[0053] 13. Dictamni

[0054] Efficacy: clearing away heat and dampness, dispelling wind and detoxifying;

[0055] Pharmacological action: It has a strong inhibitory effect on fungi, enhances myocardial contractility, has a contractile effect on uterine and intestinal smooth muscles, enhances immunity, and has a certain anti-cancer effect.

[0056] 14. Kochia scoparia

[0057] Efficacy: clearing away heat and dampness, dispelling wind and relieving itching;

[0058] Pharmacological action: It is used to treat painful urination, vaginal itching and leucorrhea, urticaria, eczema, and skin itching. It has antibacterial and anti-allergic effects.

[0059] 15. Cnidium monnieri

[0060] Effects: Kill insects, relieve itching and dry dampness, warm the kidney and strengthen yang;

[0061] Pharmacological effects: anti-inflammatory, analgesic, antiarrhythmic, antihypertensive, expectorant, antiasthmatic, anti-aging, memory promoting, anti-mutagenic, anti-osteoporosis and other effects.

[0062] 16. Lotus Root Festival

[0063] Effects: Cooling blood and stopping bleeding, removing blood stasis, clearing away heat and promoting body fluid production;

[0064] Pharmacological action: It is used to treat symptoms of blood heat and bleeding, such as vomiting blood, hemoptysis, hematuria, bloody stool, etc. It has the effects of astringing, stopping bleeding and removing blood stasis.

[0065] 17. Bistorta

[0066] Efficacy: clearing away heat and detoxifying, cooling blood and stopping bleeding, calming the nerves and calming the wind;

[0067] Pharmacological action: It has an inhibitory effect on various bacteria such as Staphylococcus aureus, can inhibit the growth of transplanted tumors in animals, and has a certain hemostatic effect when applied externally.

[0068] 18. Papaya

[0069] Effect: Relaxes muscles and tendons, soothes the stomach and eliminates dampness;

[0070] Pharmacological effects: Contains papain and papain, which have the effects of relieving pain, promoting digestion, enhancing immunity, and anti-tumor.

[0071] 19. Fangji

[0072] Efficacy: dispel wind and relieve pain, promote diuresis and reduce swelling;

[0073] Pharmacological action: It contains a variety of active ingredients, such as flavonoids and glycosides, which have diuretic, anti-inflammatory, anti-allergic, detoxification and other effects. It is often used to treat rheumatic pain, edema and other symptoms.

[0074] 20. Rehmannia root

[0075] Effect: Nourishes yin and kidney, nourishes blood and replenishes blood;

[0076] Pharmacological effects: Fresh Rehmannia root clears away heat and promotes the production of body fluid, cools blood and stops bleeding; Raw Rehmannia root clears away heat and cools blood, nourishes yin and promotes the production of body fluid; Cooked Rehmannia root nourishes blood and nourishes yin, replenishes essence and fills the marrow. Rehmannia root also has the effects of strengthening the heart and promoting diuresis, relieving fever and inflammation, promoting blood coagulation and lowering blood sugar.

[0077] Furthermore, the preparation method of a traditional Chinese medicine for treating skin diseases comprises the following steps:

[0078] S1: Grind fangfeng, chuanxiong, raw astragalus, angelica, belamcanda, moutan bark, smilax, baixianpi, clematis, quang, papaya, and fangji into fine powder, sieve, and mix well;

[0079] S2: separately take Artemisia capillaris, Nepeta spicata, Arctium lappa, Buffalo horn, Kochia scoparia, Cnidium monnieri, Raw lotus root node, and Raw Rehmannia root, add water and boil twice, the first time for 2 hours, the second time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.05-1.08;

[0080] S3: Take the above powder, coat it with decoction to make pills, dry them, and you have it.

[0081] Furthermore, the Chinese herbal medicine for treating skin diseases is used in the treatment of skin diseases including urticaria, eczema, acne, psoriasis, ichthyosis and scleroderma.

[0082] The beneficial effects of the present invention are as follows: compared with the prior art, the present invention has the following improvements:

[0083] 1. The present invention develops the Skin Disease No. II prescription into a water pill, thereby overcoming the defects of inconvenience in taking, difficulty in controlling the dosage, easy moisture absorption and deterioration, and the like. At the same time, the present invention is easy to carry, reduces the dosage, and has higher patient acceptance, thereby better meeting the needs of clinical medication. From the aspect of the preparation process of the water pill, some Chinese medicinal materials that are difficult to crush, such as Artemisia capillaris, Schizonepeta spicate, and Buffalo horn, are extracted and concentrated, and the concentrated medicine liquid is used to prepare the water pill, which can not only ensure the efficacy utilization of the medicine, but also concentrate the medicine content, thereby reducing the dosage of the original prescription. Therefore, developing the Skin Disease No. II prescription into the Tinea Scale Pill (water pill) can well overcome the dosage form defects of decoctions and powders, better serve patients, and meet the needs of clinical medication.

[0084] 2. The present invention makes the decoction of Skin Disease No. II into water pills through decoction and other procedures, thus avoiding the problems of swallowing difficulty, dosage control difficulty and carrying inconvenience caused by taking a large amount of powder, and is more practical.

[0085] 3. The present invention makes the decoction of Skin Disease No. II into water pills through decocting and other procedures, thereby enhancing its stability, making it more resistant to high temperature and strong light, and reducing the impact of high humidity environment on it, thereby avoiding the problems of deterioration of the original Skin Disease No. II due to easy moisture absorption. BRIEF DESCRIPTION OF THE DRAWINGS

[0086] Figure 1 The YMC chromatographic column 0.1% phosphoric acid-acetonitrile proposed by the present invention;

[0087] Figure 2 The T3 chromatographic column 0.1% phosphoric acid-acetonitrile proposed by the present invention;

[0088] Figure 3The peaks are obtained when the mobile phase proposed by the present invention is acetonitrile-0.2% phosphoric acid;

[0089] Figure 4 The peaks are obtained when the mobile phase proposed by the present invention is acetonitrile-0.2% formic acid;

[0090] Figure 5 The peak condition of the mobile phase proposed by the present invention is acetonitrile-0.2% glacial acetic acid;

[0091] Figure 6 Chromatograms of different wavelengths (274, 360) under the first condition proposed by the present invention;

[0092] Figure 7 Chromatograms of different wavelengths (274, 360) under the second condition proposed by the present invention;

[0093] Figure 8 The water extract acetonitrile (A)-0.2% formic acid aqueous solution (B) proposed by the present invention;

[0094] Fig. 9 The water extract acetonitrile (A)-0.2% phosphoric acid aqueous solution (B) proposed by the present invention;

[0095] Fig.10 The thin layer identification of Astragalus membranaceus proposed by the present invention;

[0096] Fig.11 The thin layer identification of angelica sinensis proposed by the present invention;

[0097] Fig.12 The invention provides a thin layer identification of the Rhizoma Chuanxiong;

[0098] Fig.13 The invention provides a thin layer identification of the peony bark;

[0099] Fig.14 The thin layer identification of Rehmannia root proposed by the present invention;

[0100] Fig.15 The chromatogram of the content determination of paeonol in Xuanlin pills proposed by the present invention;

[0101] Fig.16 The standard curve of the paeonol reference substance proposed by the present invention;

[0102] Fig.17 The quantitative limit of paeonol proposed in the present invention;

[0103] Fig.18 is the detection limit of paeonol proposed in the present invention;

[0104] Fig.19 The noise chromatogram proposed by the present invention;

[0105] Fig. 20 The HPLC chromatogram of the paeonol reference substance solution proposed by the present invention;

[0106] Fig.21 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (0 day);

[0107] Fig. 22 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (high temperature for 5 days);

[0108] Fig.23 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (high temperature for 10 days);

[0109] Fig.24 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (illumination for 5 days);

[0110] Fig.25 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (10 days of illumination);

[0111] Fig.26 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (high humidity for 5 days);

[0112] Fig. 27 This is the HPLC chromatogram of the test solution of the pills of the product 190201 batch proposed by the present invention (high humidity for 10 days);

[0113] Fig.28 This is a process flow chart of the pharmaceutical preparation proposed in the present invention. DETAILED DESCRIPTION

[0114] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0115] Example 1

[0116] A traditional Chinese medicine for treating skin diseases, prepared from the following raw materials: Artemisia capillaris, Nepeta spicate, Saposhnikovia divaricata, Chuanxiong, raw Astragalus, Angelica sinensis, Arctium lappa, Belamcanda chinensis, Paeonia suffruticosa, Clematis chinensis, Smilax glabra, Buffalo horn, Dictamni bark, Kochia scoparia, Cnidium monnieri, raw lotus root node, Polygonum multiflorum, Papaya, Stephania tetrandra and raw Rehmannia root;

[0117] The weight portions of different raw materials are respectively: Artemisia capillaris, Nepeta spicate, Saposhnikovia divaricata, Chuanxiong, raw Astragalus, Angelica sinensis, Burdock fruit, Belamcanda chinensis, Peony bark, Clematidis, Smilax glabra, Buffalo horn, Dictamni peel, Kochia scoparia, Cnidium monnieri, raw lotus node, Polygonum aviculare, Papaya, Stephania tetrandra and raw Rehmannia glutinosa are respectively: 180 parts of Artemisia capillaris, 120 parts of Nepeta spicate, 90 parts of Saposhnikovia divaricata, 60 parts of Chuanxiong, 180 parts of raw Astragalus, 120 parts of Angelica sinensis, 90 parts of Burdock fruit, 90 parts of Belamcanda chinensis, 90 parts of Peony bark, 90 parts of Clematidis, 90 parts of Smilax glabra, 120 parts of Buffalo horn, 90 parts of Dictamni peel, 90 parts of Kochia scoparia, 90 parts of Cnidium monnieri, 90 parts of raw lotus node, 90 parts of Polygonum aviculare, 120 parts of Papaya, 90 parts of Stephania tetrandra and 120 parts of raw Rehmannia glutinosa.

[0118] Furthermore, the fingerprint of Xuanlin pills was studied;

[0119] Instruments: 1 / 100,000 electronic molecular balance (CPA225D, Beijing Satori Scientific Instrument Co., Ltd.); ultrasonic cleaning machine (15C4390, Ningbo Xinzhi Biotechnology Co., Ltd.); high performance liquid chromatograph (LC-2030C, Shimadzu, Japan);

[0120] Experimental solvent: methanol (AR, Tianjin Damao Chemical Reagent Factory, 20210701)

[0121] All liquid chromatography reagents: phosphoric acid (chromatographic grade, Tianjin Damao Chemical Reagent Factory, 20180105001); methanol (HPLC, Fisher, LOT211781); acetonitrile (HPLC, Fisher, LOT212314); Wahaha water (Hangzhou Wahaha Feichang Cola Beverage Co., Ltd., 20210916);

[0122] Sample: Xuanlin Pills are produced by Shizuishan Traditional Chinese Medicine Hospital;

[0123] Preparation of Xuanlin Pills Test Solution: Take Xuanlin Pills Test Sample, grind it, accurately weigh 2.0g of the powder, add 20mL of 80% methanol as extraction solvent, sonicate for 30min, cool, dilute to 25ml with corresponding solvent, filter, take 5ml of the filtrate, add the same solvent to dilute to 10ml, shake well, take the filtrate at 13000r / min, centrifuge for 10min, take the supernatant for sampling and determination. 3.3.2 Preparation of Xuanlin Pills Water Extract Solution Take seven herbs, including Artemisia capillaris, Nepeta spicata, Buffalo Horn, Radix Rehmanniae, Fructus Cnidii, Fructus Kochiae, and Node of Lotus Root, decoct and extract, soak for 30min, extract twice, each time for 1.5 hours, 10 times water for the first time, 8 times water for the second time, concentrate the extract to 250ml, take 1ml and add 80% methanol to dilute to 5ml, take the filtrate at 13000r / min, centrifuge for 10min, take the supernatant for sampling and determination.

[0124] The test solution was scanned at the full wavelength of UV, and the maximum absorption wavelength of the test solution was at 274nm. Therefore, the optimization of the liquid phase conditions of Xuanlin Pills can be carried out by using high performance liquid chromatography as a reference at 274nm.

[0125] In this experiment, the chromatographic columns YMC-Triart C18 (250×4.6mml.D.) and XSelect HSS T3 C18 (250×4.6mm.5μm.) were selected for investigation under the same elution conditions, which are collectively referred to as the first elution conditions (see Table 1). The results show that the difference between YMC-TriartC18 (250×4.6mml.D.) and XSelect HSS T3 C18 (250×4.6mm.5μm.) is not too big, so XSelect HSS T3 C18 (250×4.6mm.5μm.) was selected. The results are shown in Table 1. Figure 1 ; Mobile phase A was acetonitrile, and mobile phase B was 0.1% phosphoric acid;

[0126] Table 1 First mobile phase elution gradient conditions

[0127]

[0128] This experiment investigated the mobile phase system. When selecting the mobile phase, the same mobile phase elution conditions were used. Acetonitrile-0.2% phosphoric acid aqueous solution, acetonitrile-0.2% formic acid aqueous solution, and acetonitrile-0.2% glacial acetic acid aqueous solution were used as the mobile phases. The results are shown in the attached figure. Figure 3 , 4 , 5, Figure 3-5 The results showed that acetonitrile-0.2% phosphoric acid aqueous solution and acetonitrile-0.2% formic acid aqueous solution had more peaks and poor separation effect during gradient elution, while acetonitrile-0.2% formic acid aqueous solution had the best separation effect and a stable baseline, but the peak shape and separation degree of each chromatographic peak still needed to be explored.

[0129] This experiment explored the gradient of the mobile phase system. XSelect HSS T3 C18 (250×4.6mm.5μm.) chromatographic column was selected, and the mobile phase was acetonitrile (A)-0.2% formic acid aqueous solution (B), which is collectively referred to as the second mobile phase elution condition. The first mobile phase elution gradient condition and the second mobile phase elution condition (see Tables 1 and 2) were used for injection respectively. The results are shown in the attached figure. Figure 6 , 7 The results show that the conditions shown in Table 1 have more peaks than those shown in Table 2. Considering that there are many components with low polarity, a high proportion of organic phase should be added to flush the column. Under the 360nm condition, the peaks of both conditions are relatively reduced. If the components are complex and the peaks are not good in the later stage, consider optimizing the conditions at a wavelength of 360nm in combination with the prescription.

[0130] Table 2 Second mobile phase elution conditions

[0131]

[0132] This experiment also explored the HPLC conditions of the water extract of Xuanlin Pills. XSelectHSST3 C18 (250×4.6mm.5μm.) chromatographic column was selected, and the mobile phase was acetonitrile (A)-0.2% formic acid aqueous solution (B) and the mobile phase was acetonitrile (A)-0.2% phosphoric acid aqueous solution (B) with the third mobile phase gradient injection, as shown in Table 3. Figure 8 , 9 shown.

[0133] Table 3 Elution conditions of the third mobile phase

[0134]

[0135] Furthermore, the thin layer chromatography identification of Xuanlin pills was studied;

[0136] Instruments: Four-purpose UV analyzer (ZF-B, Shanghai Jingke Industrial Co., Ltd.); 1 / 100,000 electronic molecular balance (CPA225D, Beijing Saiduoli Scientific Instrument Co., Ltd.); ultrasonic cleaning machine (15C4390, Ningbo Xinzhi Biotechnology Co., Ltd.); thin layer heater (TH-Ⅱ, Shanghai Kezhe Biochemical Technology Co., Ltd.), electric constant temperature blast drying oven (101-2-S, Shanghai Yuejin Medical Equipment Factory);

[0137] Reference substances: Astragalus reference medicinal material (China Food and Drug Inspection Institute, 120974-201311, 1g / piece); Chuanxiong reference medicinal material (China Food and Drug Inspection Institute, 120918-201411); Paeonol reference substance (China Food and Drug Inspection Institute, 110708-201908, 50mg); Ferulic acid reference substance (China Food and Drug Inspection Institute, 110773-201915, 50mg); Catalpol reference substance (China Food and Drug Inspection Institute, 110808-201711, 20mg);

[0138] Sample: Provided by Shizuishan Traditional Chinese Medicine Hospital.

[0139] Thin layer identification of Astragalus: Take 10g of this product, grind it, add 50ml of ethanol, heat and reflux for 20 minutes, filter, evaporate the filtrate, add 20ml of 0.3% sodium hydroxide solution to the residue to dissolve it, filter, adjust the pH value of the green leaves to 5-6 with dilute hydrochloric acid, extract with 20ml of ethyl acetate by shaking, separate the ethyl acetate filtrate, filter with filter paper covered with an appropriate amount of anhydrous sodium sulfate, and evaporate the filtrate. Add 2ml of ethyl acetate to dissolve the residue as the test solution. Take another Astragalus control medicinal material and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use chloroform-methanol (10:1) as the developing solvent, develop, take out, dry, fumigate in ammonia vapor, and inspect under ultraviolet light (365nm). In the chromatogram of the test sample, at the corresponding position in the chromatogram of the control medicinal material, a main fluorescent spot of the same color appears, as shown in the attached Fig.10 shown.

[0140] Thin layer identification of Angelica sinensis: Take 10g of this product, grind it into powder, add 50ml of 1% sodium bicarbonate solution, ultrasonically treat it for 10 minutes, centrifuge it, take the supernatant and adjust the pH value to 2-3 with dilute hydrochloric acid, shake and extract it with ether twice, 20ml each time, combine the ether solution, evaporate it, add 1ml of methanol to the residue to dissolve it, and use it as the test solution. Take another ferulic acid reference substance, add methanol to make a solution containing 1mg per 1ml, and use it as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions, and spot them on the same silica gel G thin layer plate, use cyclohexane-dichloromethane-ethyl acetate-formic acid (4:1:1:0.1) as the developing agent, develop it, take it out, dry it, and examine it under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference substance, a fluorescent spot of the same color appears, such as the attached Fig.11 shown.

[0141] Thin layer identification of Chuanxiong: Take 10g of the powder of this product, add 50ml of ether, heat and reflux for 1 hour, filter, evaporate the filtrate, add 2ml of ethyl acetate to the residue to dissolve it, and use it as the test solution. Take another 1g of Chuanxiong as a reference medicinal material, and prepare a reference medicinal solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above solutions and spot them on the same silica gel G thin layer plate, use n-hexane-ethyl acetate (3:1) as the developing agent, develop, take out, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference medicinal material, a fluorescent spot of the same color appears, such as the attached Fig.12 shown.

[0142] Thin layer identification of peony bark: Take 10g of this product, grind it into powder, add 100ml of ether, plug it, shake it for 10 minutes, filter it, evaporate the filtrate, add 2ml of acetone to the residue to dissolve it, and use it as the test solution. Take another paeonol reference substance, add acetone to make a solution containing 2mg per 1ml, and use it as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions, spot them on the same silica gel G thin layer plate, use cyclohexane-ethyl acetate-glacial acetic acid (4:1:0.1) as the developing agent, develop it, take it out, dry it, spray it with 2% vanillin sulfuric acid ethanol solution, and heat it at 105℃ until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding position of the chromatogram of the reference substance, such as the attached Fig.13 shown.

[0143] Thin layer identification of Rehmannia glutinosa Take 10g of this product, grind it into powder, add 50ml of methanol, heat and reflux for 1 hour, cool, filter, and concentrate the filtrate to 5ml as the test solution. Take another catalpol reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 5μl of each of the above two solutions, spot them on the same silica gel G thin layer plate, use chloroform-methanol-water (14:6:1) as the developing agent, develop, take out, dry, spray with anisaldehyde test solution, and heat at 105°C until the spots are clearly colored. In the chromatogram of the test sample, at the corresponding position of the chromatogram of the reference substance, a spot of the same color appears, such as the attached Fig.14 shown.

[0144] Furthermore, the content of paeonol in Xuanlin pills was determined;

[0145] Instruments: 1 / 100,000 electronic molecular balance (CPA225D, Beijing Satori Scientific Instrument Co., Ltd.); 1 / 100,000 electronic molecular balance (XPE26, METTLERTOLEDO); ultrasonic cleaning machine (15C4390, Ningbo Xinzhi Biotechnology Co., Ltd.); high performance liquid chromatograph (LC-2030C, Shimadzu, Japan); high performance liquid chromatograph (Agilent 1260); ultraviolet spectrophotometer (UV-1780, Shimadzu, Japan); electric constant temperature blast drying oven (101-2-S, Shanghai Yuejin Medical Equipment Factory); electric drying oven (KWY-HW 500-1, Wuhan Wuchang Experimental Instrument Factory);

[0146] All liquid chromatography reagents: methanol (HPLC, Fisher, LOT211781); acetonitrile (HPLC, Fisher, LOT213448); phosphoric acid (chromatographic grade, Tianjin Saifului Chemical Reagent Factory, 20180105001); purified water (Hangzhou Wahaha, 20210612).

[0147] Reference substance: Paeonol reference substance (China Food and Drug Control Institute, 110708-201908, about 50 mg, purity: 99.8%);

[0148] Sample: provided by Shizuishan Traditional Chinese Medicine Hospital;

[0149] Preparation of test solution: Grind the product into powder, accurately weigh 1.0 g of sample and place it in a 25 ml volumetric flask, add 20 ml of 80% methanol, ultrasonically treat (power 200 W, frequency 42 kHz) for 30 minutes, cool, then add 80% methanol to the scale, shake well, filter, take 2 ml of the filtrate, centrifuge at 13000r for 10 min, and take the supernatant.

[0150] Preparation of reference solution: Take an appropriate amount of paeonol reference substance, weigh it accurately, and add methanol to prepare a solution containing 50 μg of paeonol per 1 ml.

[0151] Preparation of negative control solution: Weigh the remaining medicinal ingredients of Xuanlin Pills excluding Mudan Cortex according to the prescription ratio of Xuanlin Pills, prepare a negative sample according to the preparation process of Xuanlin Pills, and then prepare a negative control solution according to the method under "Preparation of test solution".

[0152] Chromatographic column: XSelect HSS T3 C18 (250×4.6mm.5μm.); mobile phase A is acetonitrile, mobile phase B is 0.1% phosphoric acid-water; flow rate is 1.0ml / min; injection volume is 10μl; wavelength is 274nm; column temperature is 30℃; gradient elution program is shown in Table 4.

[0153] Table 4 Determination of paeonol mobile phase elution gradient conditions

[0154]

[0155] Under this chromatographic condition, the reference solution and the test solution were respectively injected into the liquid chromatograph for determination. Paeonol and other components were separated by baseline. Fig.15 shown.

[0156] Linear relationship and range Take the paeonol stock solution (concentration: 2275.04μg / ml) and prepare it into concentrations of 568.76, 426.57, 284.38, 142.19, 71.10, 35.55, 17.77, 8.89, and 4.44μg / ml, respectively. Determine at 274nm, and use the paeonol peak area integral value A to regress the concentration C of the paeonol reference substance. The regression equation is: A=68233C-39882, and the correlation coefficient r=0.9995; The results show that the concentration and peak area of ​​paeonol are in a good linear relationship within the range of 4.44 to 568.76μg / ml. The linear relationship data are shown in Table 5, and the standard curve is as shown in the attached Fig.16 shown.

[0157] Table 5 Linearity and range of paeonol

[0158]

[0159] Quantitative limit, detection limit: Take an appropriate amount of paeonol reference solution (concentration: 0.04μg / ml), inject 10μl, and determine according to the method. The corresponding amount of paeonol is 0.0004μg, and the signal-to-noise ratio is 11:1, that is, the quantitative limit of this content determination method is 0.0004μg. Fig.17 , 18 shown.

[0160] Take an appropriate amount of paeonol reference solution (concentration: 0.01 μg / ml), inject 10 μl, and determine according to the method. The corresponding amount of paeonol is 0.0001 μg, and the signal-to-noise ratio is 4:1, that is, the detection limit of this content determination method is 0.0001 μg.

[0161] Repeatability test: Take 6 samples of the same batch of Xuanlin pills in parallel, prepare them according to the method under "Preparation of test solution", inject them separately according to the above chromatographic conditions, process the obtained data, and calculate the average content and RSD of paeonol, as shown in Table 6. The results show that the analytical method has good repeatability.

[0162] Table 6 Repeatability test of paeonol content determination in Xuanlin pills

[0163]

[0164] Sample addition recovery rate: Accurately weigh an appropriate amount of Xuanlin pills sample with measured paeonol content (average content 0.7352 mg / g, moisture: 2.37%), and accurately add high, medium and low concentrations of paeonol reference substances into 9 parallel portions, respectively. Follow the procedures under "Preparation of test solution" and determine according to the law to calculate the recovery rate, as shown in Table 7. The results show that this method has a good recovery rate.

[0165] Table 7 Recovery rate of paeonol content determination in Xuanlin pills

[0166]

[0167] Note: Original amount (mg) = sample weight (mg) × (1-water content) × content (mg / g)

[0168] Intermediate precision: Take the same sample of Xuanlin Pills, and operate according to the "Preparation of Test Solution" under different dates, different analysts, different equipment and other variable conditions, and determine according to the law to calculate the relative average deviation of the paeonol content, as shown in Table 8. The results show that the intermediate precision of this method is good.

[0169] Table 8 Intermediate precision of paeonol content determination in Xuanlin pills

[0170]

[0171] Durability: Take the same Xuanlin pills and investigate the effects of column temperature, flow rate, and column changes on the determination. (1) Change column temperature chromatographic conditions: chromatographic column: XSelectHSST3C18 (250×4.6mm.5μm.); mobile phase: 0.1% phosphoric acid aqueous solution, acetonitrile; flow rate: 1.0ml / min; detection wavelength: 274nm; injection volume: 10μl; column temperature: 28℃, 32℃. (2) Change flow rate chromatographic conditions: chromatographic column: XSelectHSST3C18 (250×4.6mm.5μm.); mobile phase: 0.1% phosphoric acid aqueous solution, acetonitrile; column temperature: 30℃; detection wavelength: 274nm; injection volume: 10μl; flow rate: 1.2ml / min, 0.8ml / min. (3) Change the chromatographic column conditions: mobile phase: 0.1% phosphoric acid-water solution, acetonitrile; flow rate: 1.0 ml / min; column temperature: 30°C; detection wavelength: 274 nm; injection volume: 10 μl. Chromatographic columns: YMC-PackODS-A, 250×4.6 mml.D, S-5 μm, 12 nm and XSelectHSST3C18 (250×4.6 mm.5 μm.), as shown in Table 9.

[0172] Table 9 Determination of Paeonol Content in Xuanlin Pills Durability Test

[0173]

[0174] Stability test: Take appropriate amount of the same Xuanlin Pill sample and reference substance, treat them according to the method under "Preparation of test solution", and determine the content according to the above-mentioned chromatographic conditions, inject 10 μl at 0, 2, 4, 8, 12, 24, and 48 hours, determine the peak area of ​​paeonol and calculate the RSD value, as shown in Table 10. The results show that the Xuanlin Pill test solution and paeonol solution have good stability within 8 hours.

[0175] Table 10 Xuanlin pill content determination stability test

[0176]

[0177] Example 2

[0178] Example 2 provides a method for preparing a Chinese medicine for treating skin diseases as described in Example 1, comprising the following steps: Fig.28 As shown:

[0179] S1: Take 12 parts each of fangfeng, chuanxiong, raw astragalus, angelica, belamcanda, moutan bark, smilax, baixianpi, clematis, quangshen, papaya, and fangji, grind them into fine powder, sieve and mix well;

[0180] S2: Take 8 portions each of Artemisia capillaris, Nepeta spicata, Arctium lappa, Buffalo horn, Kochia scoparia, Cnidium monnieri, Raw lotus root node, and Raw Rehmannia root, add water and boil twice, the first time for 2 hours, the second time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.05-1.08;

[0181] S3: Take the above powder, coat it with decoction to make pills, dry them, and you have it.

[0182] Furthermore, a stability test was conducted on the Xuanlin pills prepared by the method;

[0183] Influencing factor test: (1) High temperature test Take the pilot sample batch number 190201 pills for testing, remove the simulated commercial packaging, place in a sealed clean container, and place at 60℃ for 10 days. Take samples for testing at 0, 5, and 10 days to examine the effect of high temperature on Xuanlin pills, observe their properties, inspections, and changes in paeonol content. If the content of the test sample is lower than the specified limit, conduct the test at 40℃ in the same way.

[0184] (2) Strong light irradiation test: The pilot sample pills with batch number 190201 were taken for testing, the simulated commercial packaging was removed, and the pills were placed in a sealed clean container and placed under a light intensity of 4500 lx for 10 days. Samples were taken for testing at 0, 5, and 10 days to examine the effect of strong light on the pills, and to examine their properties, inspections, and changes in paeonol content.

[0185] (3) High humidity test Take the pills with batch number 190201 from the pilot sample, remove the simulated commercial packaging, and place them at 25°C and relative humidity (RH) 92.5%±5% for 10 days. Take samples for testing at 0, 5, and 10 days to examine the effect of humidity on Xuanlin Pills, and examine their properties, inspections, and changes in paeonol content. At the same time, accurately weigh the weight of the test sample before and after the test to examine the hygroscopic and deliquescent properties of the test sample. If the weight gain due to moisture absorption is more than 5%, the test is carried out in the same manner under a relative humidity of 75%±5%; if the weight gain due to moisture absorption is less than 5%, and other inspection items meet the requirements, this test is no longer carried out. The chromatogram of the content determination of Xuanlin Pills in the test of influencing factors is attached. Figures 20 to 27 The content determination results are shown in Table 11. It can be seen from Table 11 that under the influencing factors of high temperature 60℃, high humidity 92.5% and light 4500lx, except that the humidity is too high under high humidity conditions causing the water pills to stick together, the properties, moisture, dissolution time and paeonol content of the Xuanlin pills have no obvious changes compared with those on day 0, indicating that high humidity and light have no effect on the test sample, but high humidity has an effect on the test sample.

[0186] Table 11 Experimental results of factors affecting tinea scale pills

[0187]

[0188] Accelerated test: Three batches of pilot samples of Xuanlin Pills were taken and placed at a temperature of 40°C for testing. Samples were taken at the end of the 0th, 1st, 2nd, 3rd and 6th month during the experiment to observe the changes in properties, inspection and paeonol content. The results are shown in Tables 12 to 16. The results show that under the conditions of the accelerated test, the properties, moisture, dissolution time and paeonol content of Xuanlin Pills did not change significantly compared with those in the 0th month, indicating that the pills were stable under the conditions of the accelerated test.

[0189] Table 12 October test report

[0190]

[0191] Table 13 Accelerated 1-month test report

[0192]

[0193] Table 14 Accelerated February Test Report

[0194]

[0195] Table 15 Accelerated 3-month test report

[0196]

[0197] Table 16 Accelerated June Test Report

[0198]

[0199] Long-term test: Three batches of pilot samples of Xuanlin Pills were taken and placed at a constant temperature of 25°C for testing. Samples were taken at the end of 3, 6, 9, and 12 months to observe the changes in properties, inspections, and paeonol content. The results are shown in Tables 17 to 20. The results show that under long-term test conditions, the properties, moisture, dissolution time, and paeonol content of Xuanlin Pills did not change significantly compared with those in 0 month, indicating that the pills are stable under long-term test conditions.

[0200] Table 17 Long-term 3-month test report

[0201]

[0202] Table 18 Long-term 6-month test report

[0203]

[0204] Table 19 Long-term 9-month test report

[0205]

[0206] Table 20 Long-term 12-month test report

[0207]

[0208] Further, the identification method of this product is:

[0209] (1) Take 10g of this product, grind it into powder, add 50ml of ethanol, heat and reflux for 20 minutes, filter, evaporate the filtrate, add 20ml of 0.3% sodium hydroxide solution to the residue to dissolve it, filter, adjust the pH value of the green leaves to 5-6 with dilute hydrochloric acid, extract with 20ml of ethyl acetate by shaking, separate the ethyl acetate filtrate, filter it with filter paper covered with an appropriate amount of anhydrous sodium sulfate, and evaporate the filtrate to dryness. Add 2ml of ethyl acetate to dissolve the residue and use it as the test solution. Take another reference herb Astragalus and prepare the reference herb solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use chloroform-methanol (10:1) as the developing solvent, develop, take out, dry, fumigate with ammonia vapor, and examine under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference herb, a main fluorescent spot of the same color appears.

[0210] (2) Take 10g of this product, grind it into powder, add 50ml of 1% sodium bicarbonate solution, ultrasonically treat it for 10 minutes, centrifuge it, take the supernatant, adjust the pH value to 2-3 with dilute hydrochloric acid, extract it twice with ether by shaking, 20ml each time, combine the ether solution, evaporate it, add 1ml of methanol to dissolve the residue, and use it as the test solution. Take another ferulic acid reference substance, add methanol to make a solution containing 1mg per 1ml, and use it as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use cyclohexane 47 dichloromethane-ethyl acetate-formic acid (4:1:1:0.1) as the developing solvent, develop it, take it out, dry it, and examine it under ultraviolet light (365nm). In the chromatogram of the test substance, at the corresponding position of the chromatogram of the reference substance, a fluorescent spot of the same color appears.

[0211] (3) Take 10g of the powder of this product, add 50ml of ether, heat and reflux for 1 hour, filter, evaporate the filtrate, add 2ml of ethyl acetate to the residue to dissolve it, and use it as the test solution. Take another 1g of Chuanxiong reference medicinal material and prepare the reference medicinal material solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above solutions and spot them on the same silica gel G thin layer plate, use n-hexane-ethyl acetate (3:1) as the developing agent, develop, take out, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference medicinal material, a fluorescent spot of the same color appears.

[0212] (4) Take 10g of this product, grind it into powder, add 100ml of ether, seal it, shake it for 10 minutes, filter it, evaporate the filtrate, add 2ml of acetone to the residue to dissolve it, and use it as the test solution. Take another paeonol reference substance, add acetone to make a solution containing 2mg per 1ml, and use it as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 10μl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use cyclohexane-ethyl acetate-glacial acetic acid (4:1:0.1) as the developing agent, develop it, take it out, dry it, spray it with 2% vanillin sulfuric acid ethanol solution, and heat it at 105℃ until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions of the chromatogram of the reference substance.

[0213] (5) Take 10g of this product, grind it into powder, add 50ml of methanol, heat and reflux for 1 hour, cool it, filter it, and concentrate the filtrate to 5ml as the test solution. Take another catalpol reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference solution. According to the thin layer chromatography method (General Rule 0502), take 5μl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use chloroform-methanol-water (14:6:1) as the developing solvent, develop it, take it out, dry it, spray it with anisaldehyde test solution, and heat it at 105℃ until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions of the chromatogram of the reference substance.

[0214] Moisture content: not more than 9.0% (General Rule 0601);

[0215] Melting time limit: should be completely melted within 2 hours (General rule 0631);

[0216] Microbiological limit test: should comply with the regulations (General Rules 1105, 1106 and 1107);

[0217] Others: Should comply with relevant provisions under pills (General Rule 0181).

[0218] Content determination: Paeonol was determined according to high performance liquid chromatography (General Rule 0512). The chromatographic conditions and system suitability test were as follows: Chromatographic column: XSelect HSS T3 C18 (250×4.6mm.5μm.); mobile phase A was acetonitrile, and mobile phase B was 0.1% phosphoric acid-water; flow rate was 1.0mL / min; injection volume was 10μL; detection wavelength was 274nm; column temperature was 30°C; gradient elution program was shown in Table 21 below.

[0219] Table 21 Gradient elution program

[0220]

[0221] Preparation of reference solution: Take an appropriate amount of paeonol reference substance, weigh it accurately, and add methanol to prepare a solution containing 45.50 μg of paeonol per 1 ml.

[0222] Preparation of test solution: Grind the product, accurately weigh 1.0 g of the sample and place it in a 25 mL volumetric flask, add 20 mL of 80% methanol, and treat it by ultrasound (power 200 W, frequency 42 kHz) for 30 minutes. Cool, make up to volume with 80% methanol, shake well, and filter to obtain the solution.

[0223] Determination method: Accurately pipette 10 μL of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0224] The above description of the embodiments is to facilitate the understanding and application of the present invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to the above embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention should be within the scope of protection of the present invention.

Claims

1. A Chinese medicine for treating skin diseases, characterized in that: Including the following ingredients: Artemisia capillaris, Nepeta tenuifolia, Saposhnikovia divaricata, Ligusticum chuanxiong, raw Astragalus, Angelica sinensis, Burdock fruit, Belamcanda chinensis, Peony bark, Clematis chinensis, Smilax glabra, Buffalo horn, Dictamni bark, Kochia scoparia, Cnidium monnieri, raw lotus root node, Polygonum multiflorum, Papaya, Stephania tetrandra, and raw Rehmannia root; The weight proportions of different raw materials are respectively: 170-190 parts of Artemisia capillaris, 110-130 parts of Schizonepeta spicate, 80-100 parts of Saposhnikovia divaricata, 50-70 parts of Chuanxiong, 170-190 parts of raw Astragalus, 110-130 parts of Angelica sinensis, 80-100 parts of Arctium lappa, 80-100 parts of Belamcanda chinensis, 80-100 parts of Paeonia suffruticosa, 80-100 parts of Clematidis, 80-100 parts of Smilax glabra, 110-130 parts of Buffalo Horn, 80-100 parts of Dictamni, 80-100 parts of Kochia scoparia, 80-100 parts of Cnidium monnieri, 80-100 parts of raw lotus nodes, 80-100 parts of Polygonum multiflorum, 110-130 parts of Papaya, 80-100 parts of Stephania tetrandra and 110-130 parts of raw Rehmannia root.

2. A Chinese medicine for treating skin diseases according to claim 1, characterized in that: The weight proportions of different raw materials are respectively: 180 parts of Artemisia capillaris, 120 parts of Schizonepeta spicate, 90 parts of Saposhnikovia divaricata, 60 parts of Ligusticum chuanxiong, 180 parts of raw Astragalus, 120 parts of Angelica sinensis, 90 parts of Burdock seeds, 90 parts of Belamcanda chinensis, 90 parts of Paeonia suffruticosa, 90 parts of Clematidis, 90 parts of Smilax glabra, 120 parts of Buffalo Horn, 90 parts of Dictamni, 90 parts of Kochia scoparia, 90 parts of Cnidium monnieri, 90 parts of raw lotus nodes, 90 parts of Polygonum multiflorum, 120 parts of Papaya, 90 parts of Stephania tetrandra and 120 parts of raw Rehmannia root.

3. The method for preparing the medicament according to claim 1 or 2, characterized in that: The following steps are involved: S1: Grind fangfeng, chuanxiong, raw astragalus, angelica, belamcanda, moutan bark, smilax, baixianpi, clematis, quang, papaya, and fangji into fine powder, sieve, and mix well; S2: separately take Artemisia capillaris, Nepeta spicata, Arctium lappa, Buffalo horn, Kochia scoparia, Cnidium monnieri, Raw lotus root node, and Raw Rehmannia root, add water and boil twice, the first time for 2 hours, the second time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.05-1.08; S3: Take the above powder, coat it with decoction to make pills, dry them, and you have it.

4. Application of the Chinese medicinal preparation for treating skin diseases as claimed in claim 1 or 2 in drugs for treating skin diseases including urticaria, eczema, acne, psoriasis, ichthyosis and scleroderma.

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