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CN-121987687-A - Xiang Lian tablet with heat clearing and dampness eliminating effects and preparation method thereof

CN121987687ACN 121987687 ACN121987687 ACN 121987687ACN-121987687-A

Abstract

The invention discloses a rhizoma coptidis tablet with the effects of clearing heat and drying dampness and a preparation method thereof, and relates to the technical field of medicines. The tablet comprises Coptidis rhizoma, radix aucklandiae, scutellariae radix, radix Paeoniae alba preparata, rhizoma Atractylodis extract, IL-12/IL-23 inhibitor with specific structure, filler, binder, disintegrating agent, and lubricant. The preparation method comprises extracting volatile oil from Chinese medicinal materials with water, mixing with the volatile oil, granulating, drying, adsorbing volatile oil, and tabletting. According to the invention, through the synergistic effect of specific chemical medicines and traditional Chinese medicines, the IL-12/IL-23 inflammatory pathway is accurately blocked, the anti-inflammatory activity and bioavailability are obviously improved, and the traditional Chinese medicine composition is used for treating dysentery, enteritis and ulcerative colitis caused by damp-heat accumulation.

Inventors

  • WANG BOLUN
  • XU YAHUI
  • WANG CHENG
  • PENG KEYUN

Assignees

  • 湖北香连药业有限责任公司

Dates

Publication Date
20260508
Application Date
20260319

Claims (10)

  1. 1. The rhizoma coptidis tablet with the effects of clearing heat and drying dampness is characterized by comprising the following raw materials, by weight, 30-50 parts of coptis chinensis, 15-25 parts of costustoot, 15-25 parts of radix scutellariae, 10-20 parts of stir-fried white paeony root, 10-20 parts of rhizoma atractylodis, 0.5-5 parts of anti-inflammatory interleukin 12 and interleukin 23 inhibitor, 20-40 parts of filler, 3-8 parts of adhesive, 2-6 parts of disintegrating agent and 0.5-2 parts of lubricant; the anti-inflammatory interleukin 12 and interleukin 23 inhibitor is N- (4- ((3, 3-difluoroazetidin-1-yl) sulfonyl) phenyl) -N- (4- (piperidin-1-ylsulfonyl) benzyl) imidazo [1,2-a ] pyridine-7-carboxamide; The structure of the N- (4- ((3, 3-difluoro azetidin-1-yl) sulfonyl) phenyl) -N- (4- (piperidine-1-ylsulfonyl) benzyl) imidazo [1,2-a ] pyridine-7-carboxamide is: 。
  2. 2. The invention of claim 1 wherein the filler is selected from one or more of microcrystalline cellulose, lactose, pregelatinized starch; the adhesive is one or more selected from povidone K30, hydroxypropyl methylcellulose and starch slurry.
  3. 3. The xianglian tablet with the efficacy of clearing heat and drying dampness according to claim 1, wherein the disintegrating agent is one or more selected from sodium carboxymethyl starch, crospovidone and low-substituted hydroxypropyl cellulose; The lubricant is one or more selected from magnesium stearate, silica gel micropowder and talcum powder.
  4. 4. A method for preparing a xianglian tablet with heat clearing and dampness eliminating effects according to any one of claims 1 to 3, comprising the following steps: Firstly, processing and extracting traditional Chinese medicine raw materials, namely weighing prescribed weight parts of costustoot, extracting volatile oil by adopting a steam distillation method, collecting the costustoot volatile oil for standby, collecting distilled aqueous solution and dregs, weighing prescribed weight parts of coptis chinensis, scutellaria baicalensis, fried white paeony root and rhizoma atractylodis, mixing the above-mentioned aqueous solution and dregs, adding water for decoction and extraction, mixing decoction, filtering, concentrating filtrate under reduced pressure to clear paste, spray-drying, crushing and sieving to obtain traditional Chinese medicine dry extract powder; Mixing the medicine with auxiliary materials, namely uniformly mixing the prescribed weight parts of anti-inflammatory interleukin 12 and interleukin 23 inhibitor with the prepared traditional Chinese medicine dry extract powder by an equivalent incremental method to obtain main medicine mixed powder, then adding the prescribed weight parts of filler and disintegrating agent, and mixing in a three-dimensional mixer to obtain a mixed material; thirdly, preparing soft materials and granulating, namely adding a specified weight part of adhesive into the mixed materials obtained in the second step to prepare soft materials, and preparing wet granules; And fourthly, absorbing volatile oil and tabletting, namely dissolving the costustoot volatile oil collected in the first step by using absolute ethyl alcohol, uniformly spraying the dissolved costustoot volatile oil on the dry particles obtained in the third step, sealing and moistening the dry particles to enable the volatile oil to be fully absorbed, adding a specified weight part of lubricant, uniformly mixing, and tabletting by using a rotary tablet press to obtain the xianglian tablet with the effects of clearing heat and drying dampness.
  5. 5. The method for preparing a xianglian tablet with the efficacy of clearing heat and drying dampness according to claim 4, wherein in the first step, the water is added in an amount which is 8 to 10 times of the total weight of the medicinal materials, and the decoction is carried out for 2 times, and the time for each decoction is 1.5 to 2 hours.
  6. 6. The method for preparing a xianglian tablet with the efficacy of clearing heat and drying dampness according to claim 4, wherein in the first step, the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.15 to 1.20 under the measurement condition of sixty degrees centigrade, and the clear paste is crushed and sieved to pass through a 80-mesh sieve.
  7. 7. The method of claim 4, wherein in the second step, the mixing time in the three-dimensional mixer is 20 minutes to 30 minutes.
  8. 8. The method according to claim 4, wherein in the third step, a 20 mesh sieve is used for preparing the wet granules, and the wet granules are dried at 50-60 ℃ until the moisture content is controlled to be three-five percent.
  9. 9. The method for preparing a xianglian tablet with the efficacy of clearing heat and drying dampness according to claim 4, wherein in the fourth step, the time of airtight moistening after spraying the volatile oil is 30 minutes to 60 minutes.
  10. 10. The method for preparing a xianglian tablet with heat clearing and dampness eliminating effects according to claim 4, wherein in the fourth step, the tablet weight difference is controlled within plus or minus three percent by compression.

Description

Xiang Lian tablet with heat clearing and dampness eliminating effects and preparation method thereof Technical Field The invention relates to the technical field of medicines, in particular to a xianglian tablet with the effects of clearing heat and drying dampness and a preparation method thereof. Background The xianglian tablet is used as a classical Chinese medicinal preparation and is used for treating digestive system diseases such as diarrhea, abdominal pain, diarrhea, enteritis and the like caused by damp-heat accumulation in clinic for a long time in traditional Chinese medicine. The traditional pharmacological mechanism of the traditional Chinese medicine mainly depends on the effects of clearing heat and drying dampness of coptis chinensis and promoting qi circulation and relieving pain of costustoot, and along with the development of modern preparation technology, the traditional Chinese medicine is often supplemented with medicinal materials such as scutellaria baicalensis, fried white paeony root, rhizoma atractylodis and the like in the formula so as to enhance the comprehensive curative effect. In recent years, in order to cope with increasingly complex inflammatory bowel diseases and immune-related digestive tract diseases, an improvement scheme is proposed in the prior art, namely, on the basis of raw material medicines consisting of coptis chinensis, costustoot, scutellaria baicalensis, fried white paeony root and rhizoma atractylodis, an anti-inflammatory interleukin 12 and interleukin 23 inhibitor are introduced, and an attempt is made to block related inflammatory pathways by using the inhibitor in a mode of combining Chinese medicines and western medicines, so that the anti-inflammatory activity of the preparation is improved. However, despite the prior art proposing the concept of introducing such inhibitors, there are still significant technical drawbacks in practical applications. First, the prior art describes the inhibitors employed only in a generic conceptual way, without specifying the specific chemical structure. Because the inhibitor contains a huge compound library, molecules with different structures have great differences in pharmacokinetic properties, target binding affinity and bioavailability, the uniformity and stability of the preparation on anti-inflammatory effect cannot be ensured in the prior art due to the generalization of the general system, so that the clinical curative effect has larger uncertainty, and the requirement of accurate treatment is difficult to meet. Secondly, the traditional Chinese medicine extract has complex components, and berberine in coptis chinensis, volatile oil in costustoot and the like are easy to interact with exogenous chemical substances in the in-vitro and in-vivo environment. The general inhibitors which are not screened in the prior art are difficult to achieve optimal compatibility with specific traditional Chinese medicine matrixes, which may not only cause stability problems in the preparation process of the medicines, but also are more critical to ensure that expected synergy is generated between chemical medicines and active ingredients of the traditional Chinese medicines. In some cases, the structurally mismatched inhibitors may even interfere with the absorption or metabolism of the traditional Chinese medicine components, thereby weakening the inherent heat-clearing and dampness-drying effects of the rhizoma coptidis. Therefore, there is a need in the art to develop an improved form of the xianglian tablet containing a highly effective inhibitor with a specific structure, so as to solve the technical problems of weak anti-inflammatory pertinence, limited curative effect and ambiguous synergistic effect of the components of the traditional Chinese medicine and the western medicine. Disclosure of Invention Aiming at the problems of general structure, poor compatibility with traditional Chinese medicine matrixes and unclear synergistic effect of anti-inflammatory inhibitors adopted by the improved type of the invention, the invention aims to provide the invention for clearing heat and drying dampness and a preparation method thereof. The invention improves the accurate anti-inflammatory activity and the clinical comprehensive curative effect of the medicine obviously while ensuring the stability of the preparation by introducing the IL-12/IL-23 inhibitor with a specific structure to carry out scientific compatibility with the traditional Chinese medicine components. The invention provides a rhizoma coptidis tablet with the effects of clearing heat and drying dampness, which comprises the following raw materials, by weight, 30-50 parts of coptis chinensis, 15-25 parts of elecampane, 15-25 parts of baikal skullcap root, 10-20 parts of stir-fried white paeony root, 10-20 parts of rhizoma atractylodis, 0.5-5 parts of anti-inflammatory interleukin 12 and interleukin 23 inhibitor, 20-40 parts of filling agent, 3-8 parts of adhesi