A traditional Chinese medicine composition for treating systemic sclerosis and a tablet thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition and its tablets for treating systemic sclerosis. The traditional Chinese medicine composition of this invention consists of 15-40 parts by weight of Centella asiatica, 2-8 parts by weight of Asarum heterotropoides, 8-22 parts by weight of Cinnamomum cassia, 15-40 parts by weight of Astragalus membranaceus, and 5-16 parts by weight of Ligusticum chuanxiong. Through the rational combination of Centella asiatica, Asarum heterotropoides, Cinnamomum cassia, Astragalus membranaceus, and Ligusticum chuanxiong, it achieves the effects of clearing heat and detoxifying, warming and unblocking the meridians, promoting blood circulation and removing blood stasis, and regulating immune function. The entire formula combines cold and warm properties, and integrates tonifying and purging effects, with a mild medicinal nature, and can address the three stages of systemic sclerosis: the swelling stage, the hardening stage, and the atrophy stage of the skin.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition and its tablets for treating systemic sclerosis. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease. It primarily affects the skin and internal organs, including the lungs, heart, kidneys, and digestive tract. One of the main characteristics of SSclerosis is the hardening and tension of the skin, caused by excessive collagen deposition. Patients may experience hardened, stiff, smooth, or plate-like skin. This hardening can affect the fingers and face, leading to finger bending, reduced facial expressions, etc. Furthermore, SSclerosis can also affect internal organs, causing various symptoms and complications. For example, lung involvement can lead to difficulty breathing and coughing; heart involvement can cause heart valve problems; kidney involvement can lead to high blood pressure and kidney damage; and digestive tract involvement can cause gastrointestinal motility disorders. Its onset may be related to genetic, environmental, and immune factors. The disease typically occurs in adults, with a higher incidence in women. In my country, scleroderma is the third most common autoimmune disease after rheumatoid arthritis and lupus erythematosus, with a higher incidence in women than men.

[0004] Chinese Patent CN104784634A discloses a traditional Chinese medicine preparation for treating diffuse systemic scleroderma. The selected raw materials and their weight components are as follows: Astragalus membranaceus 20-30g, Dioscorea opposita 10-20g, Angelica sinensis 10-20g, Citrus reticulata peel 10-20g, Aquilaria sinensis 10-20g, Citrus reticulata peel 10-20g, Curcuma zedoaria 10-20g, Lindera strychnifolia 10-20g, Liquidambar formosana 10-20g, Cinnamomum cassia twig 8-15g, Gleditsia sinensis thorn 8-12g, Pangolin scales 8-12g, Sargentodoxa cuneata 8-12g, Pinellia ternata 8-12g, Asarum heterotropoides 8-12g, and Aconitum carmichaelii 8-12g.

[0005] The existing technology discloses the following formula: Astragalus membranaceus 30g, deer antler glue (melted) 15g, Angelica sinensis 10g, Ligusticum chuanxiong 10g, peach kernel 10g, safflower 10g, Rehmannia glutinosa (processed) 10g, cinnamon twig 10g, Ephedra sinica 6g, Asarum sieboldii 3g, and licorice root 3g. Modifications: For patients with a long disease course, add Codonopsis pilosula and Dioscorea opposita; for patients with cold extremities, add Aconitum carmichaelii (processed). Decoct in water and take one dose daily. Used to treat systemic sclerosis.

[0006] Currently, Western medicine often uses corticosteroids, long-wave ultraviolet light therapy, carbon dioxide laser and other therapies, which have complex ingredients and high costs. In addition, plasters need to be made by boiling the medicine with vegetable oil or animal oil into a gel-like substance, which is also a complicated preparation method. Alternatively, pure Western medicine may have significant side effects.

[0007] Currently, systemic sclerosis is often treated with oral hormones and immunosuppressants, which have adverse effects such as elevated blood sugar and high blood pressure. Furthermore, the skin hardening in some cases of systemic scleroderma does not respond well to hormone and immunosuppressant treatments. Currently available ointments require the addition of vegetable or animal oils to the medication and boiled into a gel-like substance, which is quite cumbersome to prepare, or pure Western medicine applications may have significant side effects. Topical medicated treatments often utilize traditional Chinese medicine compound formulas, but these often contain more than ten ingredients, making preparation complex and costly. Physical therapies such as long-wave ultraviolet light and carbon dioxide lasers are effective during the swelling phase, but are often ineffective during the hardening phase. Summary of the Invention

[0008] To overcome the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition that can address the three stages of systemic sclerosis: the swelling stage, the hardening stage, and the atrophy stage of the skin. It also improves the safety of medication.

[0009] Systemic sclerosis (SCSC) falls under the category of "skin paralysis" in Traditional Chinese Medicine (TCM). The etiology of this disease is congenital deficiency, spleen and kidney deficiency, insufficient qi and blood, and the inability of toxins to be internalized or expelled, leading to their lurking in the local skin. This is compounded by exposure to external pathogens such as wind, cold, and dampness, emotional distress, overexertion, or prolonged or mistreated illness, ultimately resulting in obstruction of the meridians, qi stagnation and blood stasis, leading to phlegm accumulation. The phlegm and blood stasis combine to obstruct the meridians, causing skin swelling, hardening, and eventually thinning and contracture. Blood stasis and phlegm accumulation are the basic pathogenesis. "The lungs govern the skin and hair, and the spleen governs the muscles," meaning the disease location is in the lungs and spleen, characterized by deficiency in the root and excess in the branch. The root deficiency is primarily lung, spleen, and kidney deficiency, while the branch excess is latent toxins, phlegm accumulation, blood stasis, and obstruction of the meridians. Treatment should focus on tonifying the spleen and lungs, clearing heat and detoxifying latent toxins, promoting qi and blood circulation for qi and blood stagnation, resolving phlegm and dispersing nodules for phlegm accumulation in the meridians, and warming and unblocking the meridians throughout the treatment.

[0010] This traditional Chinese medicine composition consists of 15-40 parts by weight of Centella asiatica, 2-8 parts by weight of Asarum heterotropoides, 8-22 parts by weight of Cinnamomum cassia, 15-40 parts by weight of Astragalus membranaceus, and 5-16 parts by weight of Ligusticum chuanxiong. Centella asiatica is the principal herb, possessing the effects of clearing heat and detoxifying, cooling blood and stopping bleeding. In the treatment of scleroderma, Centella asiatica can help clear heat and detoxify, regulate immune function, and improve skin symptoms. Asarum heterotropoides is the assistant herb, possessing the effects of warming yang and dispelling cold, dispelling wind and eliminating pathogens. In this formula, Asarum heterotropoides mainly plays the role of warming and unblocking the meridians and dispelling cold and dampness. Cinnamomum cassia is the adjuvant herb, possessing the effects of warming yang and transforming qi, activating blood and unblocking the meridians. It can assist Asarum heterotropoides in warming and unblocking the meridians, improving blood circulation, and promoting the flow of qi and blood. Astragalus membranaceus and Ligusticum chuanxiong are the guiding herbs. Astragalus membranaceus has the effects of tonifying qi and nourishing blood, and enhancing immunity. In this formula, Astragalus membranaceus can assist Centella asiatica in regulating immune function and enhancing the body's resistance; Ligusticum chuanxiong has the effects of activating blood and removing blood stasis, relaxing muscles and unblocking the meridians. In the treatment of scleroderma, Ligusticum chuanxiong can help improve blood circulation in the affected area and alleviate inflammatory response.

[0011] In one embodiment, the traditional Chinese medicine composition comprises the following traditional Chinese medicine ingredients: 15 parts by weight of Centella asiatica, 2 parts by weight of Asarum heterotropoides, 8 parts by weight of Cinnamomum cassia, 15 parts by weight of Astragalus membranaceus, and 5 parts by weight of Ligusticum chuanxiong.

[0012] In one embodiment, the traditional Chinese medicine composition comprises the following traditional Chinese medicine ingredients: 40 parts by weight of Centella asiatica, 8 parts by weight of Asarum heterotropoides, 22 parts by weight of Cinnamomum cassia, 40 parts by weight of Astragalus membranaceus, and 16 parts by weight of Ligusticum chuanxiong.

[0013] In one embodiment, the traditional Chinese medicine composition comprises the following traditional Chinese medicine ingredients: 30 parts by weight of Centella asiatica, 6 parts by weight of Asarum heterotropoides, 15 parts by weight of Cinnamomum cassia, 30 parts by weight of Astragalus membranaceus, and 9 parts by weight of Ligusticum chuanxiong.

[0014] Furthermore, the systemic sclerosis includes diffuse scleroderma, localized scleroderma, scleroderma without skin sclerosis, overlap syndrome, and undifferentiated connective tissue disease. The traditional Chinese medicine composition can be used to treat the swollen, sclerotic, and atrophic stages of systemic sclerosis, characterized by progressive skin hardening.

[0015] In the embodiments, the traditional Chinese medicine composition can be prepared into a topical preparation, which is a tablet.

[0016] This invention also provides a method for preparing the aforementioned traditional Chinese medicine composition:

[0017] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0018] (2) Grind Centella asiatica, cinnamon twig, astragalus membranaceus and chuanxiong into fine powder, mix with the asarum powder in step (1), and sieve.

[0019] The present invention also provides a method for preparing the tablets:

[0020] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0021] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0022] Compared with the prior art, the technical advantages of the present invention are as follows:

[0023] The formula of this invention mainly utilizes the combination of Centella asiatica, Asarum sieboldii, Cinnamomum cassia, Astragalus membranaceus, and Ligusticum chuanxiong to achieve the purposes of clearing heat and detoxifying, warming and unblocking the meridians, promoting blood circulation and removing blood stasis, and regulating immune function. Among them, Centella asiatica and Astragalus membranaceus are the principal herbs, playing a leading role in treating the disease; Asarum sieboldii and Cinnamomum cassia are the assistant herbs, assisting the principal herbs in exerting their effects; and Ligusticum chuanxiong is the guiding herb, assisting in promoting blood circulation and unblocking the meridians, allowing the medicine to exert its effects better. The entire formula combines cold and warm properties, and integrates tonification and purgation, with mild medicinal properties, and can address the three stages of systemic sclerosis: the swelling stage, the hardening stage, and the atrophy stage of the skin.

[0024] This invention also optimizes the processing method of Asarum, reduces the content of aristolochic acid I in the traditional Chinese medicine composition, and improves the safety of medication. Attached Figure Description

[0025] Figure 1 Skin fibrosis index of rats in each group.

[0026] Figure 2 : TGF-β content level in rat skin tissue.

[0027] Figure 3 Treatment outcomes for patients with scleroderma in the edematous, sclerotic, and atrophic stages.

[0028] Figure 4 Examples 1-3 tablets were compared with the aristolochic acid I content in Examples 1-5 tablets. Detailed Implementation

[0029] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention.

[0030] Example 1

[0031] formula:

[0032] Centella asiatica 15g, Asarum sieboldii 2g, Cinnamomum cassia 8g, Astragalus membranaceus 15g, Ligusticum chuanxiong 5g.

[0033] Preparation method:

[0034] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0035] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0036] Example 2

[0037] formula:

[0038] Centella asiatica 40g, Asarum heterotropoides 8g, Cinnamomum cassia 22g, Astragalus membranaceus 40g, Ligusticum chuanxiong 16g.

[0039] Preparation method:

[0040] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0041] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0042] Example 3

[0043] formula:

[0044] Centella asiatica 30g, Asarum sieboldii 6g, Cinnamomum cassia 15g, Astragalus membranaceus 30g, Ligusticum chuanxiong 9g.

[0045] Preparation method:

[0046] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0047] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0048] Comparative Example 1

[0049] formula:

[0050] Centella asiatica 8g, Asarum sieboldii 1g, Cinnamomum cassia 30g, Astragalus membranaceus 10g, Ligusticum chuanxiong 20g.

[0051] Preparation method:

[0052] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0053] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0054] In this formula, the principal herb is Centella asiatica (8g), which has the effects of clearing heat and detoxifying, and promoting blood circulation and removing blood stasis. The assistant herbs are Asarum sieboldii (1g) and Cinnamomum cassia (30g), which enhance the efficacy of the principal herb and also have certain effects of relieving exterior syndromes, dispelling cold, and warming the meridians. The adjuvant herbs are Astragalus membranaceus (10g) and Ligusticum chuanxiong (20g), which enhance the effects of the principal and assistant herbs in dispelling wind-evil and promoting blood circulation and removing blood stasis, and also have the effects of tonifying qi and blood, and strengthening the spleen and stomach. Overall, this formula is based on Centella asiatica, supplemented by Asarum sieboldii and Cinnamomum cassia, with Astragalus membranaceus and Ligusticum chuanxiong added as adjuvant herbs.

[0055] Comparative Example 2

[0056] formula:

[0057] Asarum 2g, Cinnamon Twig 8g, Astragalus 15g, Ligusticum chuanxiong 5g.

[0058] Preparation method:

[0059] (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0060] (2) Grind cinnamon twig, astragalus root and chuanxiong into fine powder, mix with asarum powder from step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0061] Comparative Example 3

[0062] formula:

[0063] Centella asiatica 15g, Asarum sieboldii 2g, Cinnamomum cassia 8g, Astragalus membranaceus 15g, Ligusticum chuanxiong 5g.

[0064] Preparation method:

[0065] (1) Cut the Asarum into sections, boil it in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use;

[0066] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0067] Comparative Example 4

[0068] formula:

[0069] Centella asiatica 15g, Asarum sieboldii 2g, Cinnamomum cassia 8g, Astragalus membranaceus 15g, Ligusticum chuanxiong 5g.

[0070] Preparation method:

[0071] (1) Grind Asarum, Centella asiatica, Cinnamomum cassia, Astragalus membranaceus and Ligusticum chuanxiong into fine powder, mix with Asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0072] Comparative Example 5

[0073] formula:

[0074] Centella asiatica 15g, Asarum sieboldii 2g, Cinnamomum cassia 8g, Astragalus membranaceus 15g, Ligusticum chuanxiong 5g.

[0075] Preparation method:

[0076] (1) Cut the Asarum into sections, boil it in boiling water at 100℃ for 10-20 minutes, then soak it in ice water at 0℃ for 1-2 hours, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use.

[0077] (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

[0078] Pharmacodynamic experiments

[0079] The inventors conducted relevant pharmacodynamic studies to demonstrate the efficacy of the herbal composition of this invention in treating scleroderma. It should be noted that the drugs selected for the following pharmacodynamic studies are those obtained from representative formulations and dosage forms of this invention.

[0080] 1. Materials

[0081] 1.1 Experimental Drugs

[0082] The tablets obtained in Examples 1-3 of this invention;

[0083] The tablets obtained in Comparative Examples 1 to 5.

[0084] 1.2 Experimental animals

[0085] SD rats, SPF grade, 180 - 220 g, experimental animal license number: SYXK(Shandong)20180008, adaptively fed under standard conditions for 1 week before the experiment.

[0086] 2. Methods

[0087] 2.1 Modeling method and grouping

[0088] Take several rats, shave the back hair of the same area about 2 cm × 2 cm in the central area of the rat's back, subcutaneously inject 0.1 ml of bleomycin phosphate buffer solution (500 μg / ml) once a day, and continue subcutaneous injection for 4 weeks. The local skin of the injection shows fibrosis, the skin thickens and hardens, and the elasticity is poor. Histological observation shows that collagen fibers are significantly thickened, enlarged, increased in number, arranged closely, homogenized, etc. The dermis is significantly thickened, the blood vessels in the subcutaneous layer are thickened, the blood vessel walls are significantly thickened, and even the blood vessels are occluded. The rats with successful modeling are divided into model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group, with 10 rats in each group. Rats in the blank group (10 rats) are subcutaneously injected with 0.1 mL of phosphate buffer solution (PBS) in the depilated area of the back once a day.

[0089] 2.2 Drug administration

[0090] Rats in Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group are given the corresponding tablet drugs with a thickness of 1 mm, applied on the back, 3 times a day, and continuously administered for 4 weeks. Rats in the blank group and the model group are not intervened and are conventionally fed for 4 weeks.

[0091] 3. Statistical processing

[0092] The obtained data are statistically analyzed using SPSS 22.0 software. Measurement data are expressed as (x±s), one-way ANOVA is used for comparison between multiple groups, and independent sample T-test is used for analysis between two groups. P < 0.05 is considered statistically significant.

[0093] 4. Observation indicators

[0094] 4.1 Skin fibrosis index

[0095] Rat skin was fixed in 10% formaldehyde solution, embedded in paraffin, and stained with Masson's stain to calculate the fibrosis index. The staining results were interpreted as follows: collagen fibers appeared bright green, muscle fibers appeared red, and cell nuclei appeared black. Images of the Masson-stained skin tissue sections were acquired under high magnification using a cytoimmunohistochemical quantitative analysis system. Ten fields of view (260,000 pixels each) were randomly selected from each rat's skin section. Bright green (collagen fibers) was considered positive, and the positive area and mean positive intensity were calculated. Multiplying these two values ​​yielded the collagen fiber histochemical index, which was then used to calculate the skin fibrosis index for each rat.

[0096] 4.2 TGF-β content in skin tissue

[0097] Skin tissue was collected, minced, and ground with physiological saline to form a 2% tissue paste. The paste was centrifuged at 3000 rpm for 10 min, and a portion of the supernatant was collected. The procedure was strictly followed according to the kit instructions, and the TGF-β content in the skin was determined by ELISA.

[0098] 5. Analysis of Experimental Results

[0099] Figure 1 The skin fibrosis index of rats in each group was calculated. Compared with the model group, groups 1-3 showed statistically significant differences (P < 0.01), indicating that the herbal composition of this invention, when applied topically to the skin of rats with systemic sclerosis, directly targets the lesion and has a good therapeutic effect on scleroderma.

[0100] Figure 2 The levels of TGF-β in rat skin tissue were measured. Compared with the model group, groups 1-3 showed statistically significant differences (P < 0.01). Cells around blood vessels in scleroderma lesions showed strong expression of TGF-β. The herbal composition of this invention can inhibit the expression of TGF-β in scleroderma lesions.

[0101] Comparative Example 1, a traditional Chinese medicine tablet, had its prescription modified, resulting in a lower efficacy compared to Examples 1-3 of this invention. Comparative Examples 3-5, on the other hand, had their processing methods modified, leading to some loss of effective components such as asarin, resulting in lower efficacy compared to Examples 1-3 of this invention.

[0102] Clinical Cases

[0103] We collected clinical cases of scleroderma patients treated with the tablets of Example 1 of this invention in our hospital, classified them into swelling stage, hardening stage and atrophy stage according to clinical symptoms, and statistically analyzed the treatment effects of patients in each stage.

[0104] Figure 3The treatment efficacy of this traditional Chinese medicine composition for patients in the swollen, sclerotic, and atrophic stages of scleroderma was analyzed according to the statistical principle of effective = cure + significant effect + improvement. The results show that the effective rate of this composition is 90.0% for patients in the swollen stage, 96.6% for patients in the sclerotic stage, and 86.6% for patients in the atrophic stage. Furthermore, no patients reported adverse reactions during treatment with this composition. This composition combines cooling and warming properties, and integrates tonifying and purging methods, resulting in a mild effect that can address the progressive hardening of the skin in the swollen, sclerotic, and atrophic stages of systemic sclerosis.

[0105] Determination of aristolochic acid I content

[0106] Aristolochic acid I is a toxic chemical that may cause symptoms such as skin redness and itching. It is found in Asarum. Therefore, reducing the content of aristolochic acid I in the composition of this invention and improving the safety of medication is one of the innovations of this invention.

[0107] The tablets of Examples 1-3 and Comparative Examples 1-5 were used as test samples, and the content of aristolochic acid I was determined according to the high performance liquid chromatography (General Rule 0512) method of the 2020 edition of the Chinese Pharmacopoeia. Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase; acetonitrile was used as mobile phase A, and 0.05% phosphoric acid solution was used as mobile phase B, with gradient elution performed according to the specifications in Table 1; the detection wavelength was 260 nm. The theoretical plate number, calculated based on the aristolochic acid I peak, should not be less than 5000. Preparation of the reference solution: An appropriate amount of aristolochic acid I reference standard was accurately weighed and dissolved in methanol to prepare a solution containing 0.2 μg per ml. Preparation of the test solution: Accurately weigh approximately 0.5 g of the test sample and place it in a stoppered conical flask. Accurately add 25 ml of 70% methanol, seal tightly, and weigh. Sonicate (500 W, 40 kHz) for 40 minutes, cool, and weigh again. Replenish the lost weight with 70% methanol, shake well, filter, and collect the filtrate. Assay: Accurately pipette 10 μl each of the reference solution and the test solution into the liquid chromatograph and determine the results.

[0108] Table 1 Gradient elution program

[0109]

[0110] Figure 4 The content of aristolochic acid I in the tablets of Examples 1-3 and Comparative Examples 1-5 shows that the present invention optimizes the processing method of Asarum, reduces the content of aristolochic acid I in the traditional Chinese medicine composition, and improves the safety of medication.

Claims

1. A traditional Chinese medicine composition for treating systemic sclerosis, characterized in that, The traditional Chinese medicine composition is made from the following ingredients: Centella asiatica 15-40 parts by weight, Asarum heterotropoides 2-8 parts by weight, Cinnamomum cassia 8-22 parts by weight, Astragalus membranaceus 15-40 parts by weight, and Ligusticum chuanxiong 5-16 parts by weight; the traditional Chinese medicine composition is prepared into an external preparation; the preparation method of the traditional Chinese medicine composition is as follows: (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use; (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), and sieve.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following traditional Chinese medicine ingredients: Centella asiatica 15 parts by weight, Asarum heterotropoides 2 parts by weight, Cinnamomum cassia 8 parts by weight, Astragalus membranaceus 15 parts by weight, and Ligusticum chuanxiong 5 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following traditional Chinese medicine ingredients: 40 parts by weight of Centella asiatica, 8 parts by weight of Asarum heterotropoides, 22 parts by weight of Cinnamomum cassia, 40 parts by weight of Astragalus membranaceus, and 16 parts by weight of Ligusticum chuanxiong.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following traditional Chinese medicine ingredients: Centella asiatica 30 parts by weight, Asarum heterotropoides 6 parts by weight, Cinnamomum cassia 15 parts by weight, Astragalus membranaceus 30 parts by weight, and Ligusticum chuanxiong 9 parts by weight.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The systemic sclerosis includes diffuse scleroderma, localized scleroderma, and scleroderma without skin sclerosis.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition can be used to treat the swelling, hardening, and atrophy stages of the skin in systemic sclerosis.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, The topical preparation is in the form of lozenges.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, The preparation method of the tablets is as follows: (1) Cut the Asarum into sections, soak in ice water at 0℃ for 1-2 hours, then boil in boiling water at 100℃ for 10-20 minutes, filter out the Asarum, dry it, grind it into fine powder, and obtain Asarum powder for later use; (2) Grind Centella asiatica, cinnamon twig, astragalus and chuanxiong into fine powder, mix with the asarum powder in step (1), sieve, and press into external tablets. When using, mix with vinegar to form a paste and apply to the affected area.

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