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CN-122005721-A - Preparation method of Xinxue pill preparation

CN122005721ACN 122005721 ACN122005721 ACN 122005721ACN-122005721-A

Abstract

The invention discloses a preparation method of a Xinxue pill preparation, and belongs to the technical field of traditional Chinese medicine preparations. The method comprises the steps of firstly, independently decocting magnetite, gypsum rubrum and talcum to obtain a mineral medicine decoction and dregs, adding common andrographis herb, bamboo leaf roll cores, gardenia, cloth-bagged agilawood and wide cimicifuga foetida into the dregs, decocting again to obtain a plant medicine decoction, combining the two decoctions, concentrating, adding mirabilite and saltpeter, continuously concentrating to obtain thick paste, drying and crushing the dregs in the cloth bag, crushing part of common andrographis herb leaves, mixing with the thick paste, pearl powder, artificial bezoar, starch and low-substituted hydroxypropyl cellulose, dissolving borneol with ethanol, spraying, pelleting, drying and coating. The invention obviously improves the transfer rate of mineral elements and heat-sensitive components and reduces the loss of volatile components through the processes of step extraction, recycling of dregs, adding of precious fine medicines and the like, and the prepared Xinxue pill has the advantages of quick disintegration, stable quality, wide applicable crowd, convenient carrying and the like.

Inventors

  • SUN WEIFANG
  • SI XIAOXIA

Assignees

  • 陕西康纳多药业有限公司

Dates

Publication Date
20260512
Application Date
20260329

Claims (10)

  1. 1. The preparation method of the Xinxue pill preparation is characterized by comprising the following steps: Step a, pretreatment, namely mixing four mineral medicines of magnetite, gypsum rubrum and talcum according to the prescription amount, adding water for decoction, and collecting mineral medicine decoction and mineral medicine residues; Step b, step a, adding the herba andrographitis, the bamboo leaf cores and the cape jasmine in the prescription amount into the mineral medicine residues obtained in the step a, decocting agilawood and rhizoma cimicifugae packaged by a cloth bag in water, and collecting plant medicine decoction; Combining and concentrating, namely combining the mineral medicine decoction obtained in the step a and the plant medicine decoction obtained in the step b, and concentrating to obtain a dilute paste with a first relative density; D, adding materials for concentration once, namely adding prescribed amounts of mirabilite and saltpeter into the dilute paste obtained in the step c, and continuing concentrating to obtain thick paste with second relative density; step e, dreg treatment, namely drying and crushing the dreg of the wide cimicifugae and the agilawood in the cloth bag in the step b to obtain dreg fine powder for standby, and meanwhile, reserving part of andrographis paniculata leaves with prescription amount and crushing the same into andrographis paniculata leaf fine powder for standby; And f, forming the preparation: mixing f1., namely uniformly mixing the thick paste obtained in the step d, the medicinal residue fine powder obtained in the step e, the common andrographis herb fine powder, the prescription amount of pearl powder, the artificial bezoar fine powder, the starch and the low-substituted hydroxypropyl cellulose to obtain mixed powder; step f2., wetting, namely dissolving the borneol with the prescription amount by using ethanol, uniformly spraying the solution into the mixed powder in the step f1, and airing to obtain a soft material; Making into pill by f3., namely making soft material into watered pill, and drying to obtain new snow pellets element pill; step f4, coating, namely coating the Xinxue pill with a film to obtain the Xinxue pill preparation.
  2. 2. The preparation method of the Xinxue pill preparation according to claim 1, wherein in the step a, the mineral medicine is decocted with water for 2-3 times, the water adding amount is 6-10 times of the weight of the medicine, and the time for each decoction is 2-4 hours.
  3. 3. The preparation method of the Xinxue pill preparation according to claim 1, wherein in the step b, the times of water adding and decoction are 2 times, the water adding amount is 8-10 times of the total weight of medicinal materials for 2.5-3.5 hours in the first time, the water adding amount is 5-7 times of the total weight of medicinal materials for 1.5-2.5 hours in the second time.
  4. 4. The method for preparing a Xinxue pill preparation according to claim 1, wherein in the step C, the first relative density is 1.20-1.30, the measurement temperature is 60 ℃, and in the step d, the second relative density is 1.50-1.70, and the measurement temperature is 60 ℃.
  5. 5. The preparation method of the Xinxue pill preparation according to claim 1, wherein in the step e, the dregs of the wide cimicifuga rhizome and the agilawood are dried at a temperature below 100 ℃, and the grain size of the fine powder of the andrographis paniculata leaves is 80-120 meshes.
  6. 6. The preparation method of the Xinxue pill preparation according to claim 1, wherein in the step f1, the starch is corn starch, the substitution degree of the low-substituted hydroxypropyl cellulose is 10% -15%, and in the step f2, the concentration of the ethanol is 90% -100% (v/v).
  7. 7. The method for preparing a Xinxue pill preparation according to claim 1, wherein in the step f3, the drying temperature is 50-70 ℃, the drying time is 2-6 hours, and the water content of the dried pill is controlled to be 3% -7%.
  8. 8. The preparation method of the Xinxue pill preparation according to claim 1, wherein in the step f4, a gastric-soluble film coating premix is adopted for the film coating, the coating weight is increased by 2% -5%, the hot air temperature is 50-70 ℃ in the coating process, and the pill core temperature is controlled at 35-45 ℃.
  9. 9. A new snow pill formulation, characterized in that it is prepared by a process for preparing a new snow pill formulation as claimed in any one of claims 1-8.
  10. 10. Use of a Xinxue pill formulation according to claim 9 in the manufacture of a medicament for the treatment of fever, sore throat or dysphoria symptoms caused by upper respiratory tract infections, tonsillitis, sphagitis, acute bronchitis or pneumonia.

Description

Preparation method of Xinxue pill preparation Technical Field The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a preparation method of a Xinxue pill preparation and the Xinxue pill preparation prepared by the preparation method. The preparation method of the invention is particularly aimed at the traditional Chinese medicine compound preparation containing mineral medicines, plant medicines and precious fine medicines, and solves the technical problems of low raw material utilization rate, large loss of active ingredients, poor quality stability, limited applicable crowd and the like of the existing Xinxue series preparation by optimizing the extraction, concentration, drying and forming processes. Background The Xinxue series preparations, such as Xinxue particles, xinxue tablets, xinxue capsules, and the like, are Chinese patent medicines for clearing heat, detoxicating, purging fire and cooling blood commonly used in clinic. The core prescription is derived from traditional experience and is usually composed of mineral antipyretics (such as magnetite, gypsum rubrum and talcum), plant antidotes (such as herba Andrographitis, herba Lophatheri, fructus Gardeniae and rhizoma cimicifugae), heat-purging and hardness-softening herbs (such as Natrii sulfas and Sal Nitri), and precious and fine antipyretic and resuscitating herbs (such as artificial bezoar, borneolum Syntheticum and Margarita powder). The series of preparations are mainly applied to diseases such as high fever, dysphoria, sore throat, tonsillitis, upper respiratory tract infection and the like caused by exogenous febrile disease and excessive heat toxin, and play an important role in clinical practice. However, although the Xinxue series preparation has definite curative effect, the existing dosage forms and preparation process have a plurality of common problems, and the convenience, safety and stable and controllable quality of clinical application are severely restricted. The traditional formulation of the Xinxue series preparation has similar medicinal flavor composition, but the formulation is mainly based on the extensive compatibility thought of the traditional pill powder, namely, the formulation is simply piled up according to the efficacy, and the formulation lacks of a fine design based on the modern pharmaceutical theory. For example, the mineral medicines (magnetite, gypsum, etc.) in the prescription have hard textures, the active ingredients are difficult to dissolve out, the thermosensitive ingredients (such as andrographolide and geniposide) in the plant medicines are easy to damage in the long-time high-temperature extraction process, and the volatile ingredients in the precious fine medicines (such as artificial bezoar and borneol) are easy to lose in the subsequent process. In terms of preparation technology, the prior art generally adopts a one-pot decocting mixed extraction mode. Adding all the medicinal materials (including mineral medicines and plant medicines) into an extraction tank, and decocting with water for 2-4 times, each time for 2-3 hr. This extensive process has the following significant drawbacks: However, with the development of the traditional Chinese medicine pharmaceutical technology, although some improved extraction ideas appear, for example, patent document CN102600235A discloses a preparation method of a new snow preparation, which is to extract herba andrographitis by ethanol alone, grind artificial bezoar and borneol, add, and extract other medicinal herbs (including mineral medicines and most of plant medicines) by adopting aqueous solution mixing. Although the technology reduces the component loss of individual medicinal materials to a certain extent, the main process still belongs to the category of mixing and frying mineral medicines and other plant medicines for a long time, and the fundamental problem caused by mixing and frying can not be fundamentally solved. This prior art has at least the following disadvantages: 1. The fundamental problem of low dissolution rate of mineral medicines is not solved, in the technical scheme of CN102600235A, the rest of mineral medicines (magnetite, gypsum rubrum and talcum) except common andrographis herb and most of plant medicines (bamboo leaf roll core, gardenia, largetrifoliolious bugbane rhizome and the like) are still in a mixed decoction state. The mineral medicine has hard texture, and the dissolution of the active ingredients requires stronger extraction conditions (such as longer time, higher temperature or specific pH environment), and the existence of the plant medicine often adsorbs the dissolved mineral elements or changes the microenvironment of the decoction system, thereby disturbing the continuous dissolution of the mineral medicine. Therefore, the dissolution rate of the mineral medicines is still not ideal under the technical scheme. 2. The loss of heat sensitivity and volatile compo