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CN-122005736-A - Preparation process of traditional Chinese medicine external composition

CN122005736ACN 122005736 ACN122005736 ACN 122005736ACN-122005736-A

Abstract

The invention discloses a preparation process of a traditional Chinese medicine external composition, which consists of a medicinal powder bag and an infiltration liquid, wherein the medicinal powder comprises 13 medicinal materials of scorpion, chinese starjasmine stem, divaricate saposhnikovia root, astragalus root, pubescent angelica root, giant knotweed rhizome, asarum herb, tetrandra root, szechuan lovage rhizome, dahurian angelica root, medicinal cyathula root, suberect spatholobus stem, turmeric root-tuber and the like, and the infiltration liquid is the infiltration liquid of safflower in 45% sorghum liquor. The preparation process comprises the steps of medicinal material cleaning and classified parching, mixing and low-temperature drying, superfine grinding and sieving, aseptic bagging, safflower screening, 30 times of 45% sorghum liquor soaking, sealing and constant temperature control, multilayer filtering, standing and removing sediment, aseptic filling and the like. The invention optimizes the medicine property of the medicinal materials through a classified stir-frying process, combines low-temperature drying and superfine grinding to keep the activity of the active ingredients, and simultaneously obviously shortens the production period and ensures the dissolution quantity and stability of the active ingredients through accurate control of parameters of the soaking liquid. The topical Chinese medicinal composition has effects of warming channels, dredging collaterals, and relieving pain.

Inventors

  • ZHANG JUNFANG

Assignees

  • 山西新太常健康产业发展有限公司

Dates

Publication Date
20260512
Application Date
20260401

Claims (10)

  1. 1. A preparation process of a traditional Chinese medicine external composition is characterized by comprising a medicine powder bag and an infiltration liquid, and comprises the following steps: step 1, preparing medicinal powder, namely cleaning medicinal materials with formula amount, performing classified parching treatment, wherein the whole worm is slightly fried to remove fishy smell, and the Chinese starjasmine stem is fried to be slightly yellow; Step 2, preparing soaking liquid, namely screening and cleaning safflower, mixing the safflower with 30 times of 45% sorghum liquor, sealing, soaking for 72 hours at the constant temperature of 25 ℃, taking out the soaking liquid, performing multi-layer filtration, primarily filtering by gauze, finely filtering by a filter membrane, standing the filtrate for 24 hours to remove sediment to obtain the soaking liquid, and aseptically filling the soaking liquid to prepare a finished product of the soaking liquid.
  2. 2. The preparation process of the external traditional Chinese medicine composition according to claim 1, wherein the prescription of the medicine powder bag comprises, by weight, 30g of scorpion, 120g of Chinese starjasmine stem, 100g of divaricate saposhnikovia root, 120g of astragalus root, 100g of pubescent angelica root, 80g of giant knotweed, 50g of asarum herb, 80g of stephania tetrandra root, 80g of szechuan lovage rhizome, 80g of dahurian angelica root, 60g of medicinal cyathula root, 50g of suberect spatholobus stem and 50g of turmeric root tuber, and the total weight of the medicine powder bag is 1000g, and the medicine powder bag is packaged into 70 g/bag.
  3. 3. The process for preparing the external traditional Chinese medicine composition according to claim 1, wherein in the classifying and frying step, the micro-frying temperature of the whole worm is 80-100 ℃, the frying time is 5-8 minutes until the surface of the whole worm is yellowish and the fishy smell is weakened, and the frying temperature of the Chinese starjasmine stem is 100-120 ℃ and the frying time is 10-15 minutes until the surface of the Chinese starjasmine stem is yellowish and the texture becomes crisp.
  4. 4. The process for preparing a composition for external use according to claim 1, wherein the low temperature drying step is performed by vacuum drying equipment at a drying temperature of 50-60 ℃ for 4-6 hours to reduce the water content of the medicinal materials to below 8%.
  5. 5. The process for preparing a composition for external use according to claim 1, wherein the superfine pulverizing step is carried out by using a jet mill, the pulverizing fineness is 60-80 meshes, and the passing rate of a 60-mesh sieve is more than 95%.
  6. 6. The process for preparing a composition for external use according to claim 1, wherein the aseptic bagging step is carried out by cutting and sewing medical grade cotton cloth into bags, the size of the bags is 15cm x 20cm, the drug loading amount is 70 g/bag, the sealing is carried out by adopting a hot-press sealing mode, and the sealing width is not less than 1.0cm.
  7. 7. The preparation process of the external traditional Chinese medicine composition according to claim 1, wherein in the preparation of the infiltration liquid, the weight-to-volume ratio of safflower to sorghum liquor is 1:30, namely 1500ml of 45% sorghum liquor is used for every 50g of safflower, and the alcoholic strength of the sorghum liquor is strictly controlled at 45+/-1%, and the pH value is 5.5-6.5.
  8. 8. The process for preparing a composition for external use according to claim 1, wherein in the sealed constant temperature soaking step, the soaking container is a stainless steel closed container, the constant temperature control precision is ± 1 ℃, and the soaking process is performed by shaking or stirring every 12 hours for 2-3 minutes.
  9. 9. The process for preparing a composition for external use according to claim 1, wherein the multi-layer filtration step comprises the steps of first performing primary filtration with 200 mesh gauze to remove safflower residue and large particle impurities, then performing fine filtration with 0.45 μm microporous filter membrane to remove microorganisms and small particles, and controlling the filtration pressure at 0.1-0.2MPa.
  10. 10. The use of a topical Chinese medicinal composition according to any one of claims 1-9 in the preparation of topical Chinese medicinal composition for relieving arthralgia, soreness, and stretching disorder caused by pathogenic wind-cold-dampness.

Description

Preparation process of traditional Chinese medicine external composition Technical Field The invention relates to the technical field of external traditional Chinese medicine preparations, in particular to a preparation process of an external traditional Chinese medicine composition, and especially relates to an external traditional Chinese medicine set consisting of a medicine powder bag and an infiltration liquid and a preparation method thereof. Background The external preparation of the traditional Chinese medicine is an important component in the traditional Chinese medicine treatment system, and has the advantages of high local medicine concentration, small systemic side effect, convenient use and the like. The traditional Chinese medicine external preparation is usually in the forms of plaster, patch, tincture, lotion and the like, and is mainly used for treating wind-cold-dampness arthralgia, muscular soreness and other symptoms. A plurality of external traditional Chinese medicine compositions and a preparation method thereof are available in the prior art. For example, chinese patent CN106692252a discloses a topical Chinese medicinal composition comprising honeysuckle stem and honeysuckle flower, prepared by alcohol impregnation method, for treating infectious skin disease and aseptic arthritis of heat toxin syndrome. The technology adopts 60-95% alcohol by volume fraction, and the soaking time is 5-7 days. However, the technology has the problems of long soaking time, inaccurate technological parameters, lack of optimization of pretreatment of medicinal materials and the like. Specifically, the alcohol concentration range is too wide, so that the dissolution behavior of the active ingredients is unstable, the soaking time is described as 5-7 days, but key parameters such as temperature are not clear, the actual production reproducibility is poor, the medicinal materials are not processed or pretreated, and the stimulatory ingredients or impurities in the medicinal materials can directly enter the preparation, so that the safety and the tolerance of patients are affected. Another chinese patent CN02109326.1 discloses a traditional Chinese medicine composition for treating acne, which is composed of dahurian angelica root, green tangerine peel, licorice, peppermint, chinese angelica, ginseng, etc., and can be taken orally or applied externally. The composition has effects of removing oil, relieving inflammation, stopping bleeding, astringing pores, and whitening skin when it is used for external application, but its preparation process is simple, and lacks systematic technological parameter control and quality control means. The patent simply describes the conventional steps of crushing, mixing or extracting medicinal materials, does not give specific limitation to crushing fineness, extraction solvent proportion, temperature, time and the like, belongs to simple superposition of conventional technology in the field, cannot ensure uniformity and stability of product quality among different batches, and is more difficult to realize accurate control of industrial production. In addition, the World Traditional Medicine Patent Database (WTMPD) records a large number of externally-applied related patents of traditional Chinese medicines, and covers various preparation forms and application fields. These prior art techniques have the following general shortcomings: The process parameters are not accurate enough, the preparation process description of most external traditional Chinese medicine preparations is more general, and accurate parameter control such as soaking time, temperature, material proportion and the like is lacked, so that the quality of the product is unstable. For example, in the soaking and extracting step, the process is often described as "soaking with ethanol for several days", wherein the concentration of ethanol is unknown, and the range of ethanol for several days is fuzzy, so that the process window in actual operation is too large, production staff depend on experience, the content of active ingredients in each batch of products is difficult to be ensured to be consistent through standardized operation, and the reliability and reproducibility of clinical curative effects are finally affected. The prior art mostly uses raw medicinal materials directly, and lacks a targeted pretreatment process, such as classified stir-frying, special drying and the like, which influences the dissolution of active ingredients and the exertion of the efficacy. The traditional Chinese medicine has complex ingredients, and the raw materials and the prepared medicines (such as stir-baking, calcining and the like) have obvious differences in medicinal properties, efficacy and toxic and side effects. For example, the whole worm (scorpion) has heavy smell and strong irritation, and the direct administration of the medicine can cause skin discomfort, the vein Dan Tengsheng has tough quality, and the activ