Preparation method and quality detection method of coxtex moutan formula granules

A technology of formula granules and Moutan bark, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to achieve uniform quality, high degree of automation, and remarkable curative effect

Inactive Publication Date: 2017-07-25
吉林修正药业新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The preparation process of Moutan Cortex Formula Granules and its quality testing methods are less reported in the literature. Patent No. 201410429349.7 discloses a quality testing method of Moutan Cortex Formula Granules, which involves TLC identification and content determination of paeonol

Method used

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  • Preparation method and quality detection method of coxtex moutan formula granules
  • Preparation method and quality detection method of coxtex moutan formula granules
  • Preparation method and quality detection method of coxtex moutan formula granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Take 50kg of decoction pieces of Moutan cortex, add water to decoct twice, add 40kg of water for the first time, infiltrate for 0.5 hours, heat to boiling and decoct for 2 hours, filter the medicinal liquid, add 40kg of water for the second time, heat to boiling After decocting for 1 hour, the medicinal liquid was filtered, and the two filtrates were combined.

[0032] (2) Pump the filtrate into the liquid medicine storage tank, let it stand for 1 hour, and filter it with a 300-mesh filter cloth to obtain the liquid medicine. The liquid medicine is concentrated in a concentrator under reduced pressure until it is concentrated to a liquid extract with a relative density of 1.08 at 60°C. The vapor pressure of the concentrator is 0.08Mpa, the vacuum degree is -0.07Mpa, and the concentration temperature is 70°C.

[0033] (3) Mix the liquid extract with dextrin, stir evenly, and spray dry. The process parameters are: liquid medicine preheating temperature 50°C; air inlet...

Embodiment 2

[0040] (1) Take 40kg of decoction pieces of Moutan Cortex, add water to decoct twice, add 480kg of water for the first time, infiltrate for 1 hour, heat to boiling and decoct for 1.5 hours, filter the medicinal liquid, add 480kg of water for the second time, heat to boiling After decocting for 1.5 hours, the medicinal solution was filtered, and the two filtrates were combined.

[0041] (2) Pump the filtrate into the liquid medicine storage tank, let it stand for 1.5 hours, filter with a 300-mesh filter cloth to obtain the liquid medicine, place the liquid medicine in a concentrator to concentrate under reduced pressure, and concentrate to a fluid extract with a relative density of 1.10 at 60°C. The steam pressure of the concentrator is 0.08Mpa, the vacuum degree is -0.08Mpa, and the concentration temperature is 65°C.

[0042](3) Mix the liquid extract with auxiliary materials such as dextrin, the amount of auxiliary materials added is 12% of the quality of Moutan Cortex decoct...

Embodiment 3

[0049] (1) Take 90kg of decoction pieces of Moutan Cortex, add water to decoct twice, add 900kg of water for the first time, infiltrate for 1 hour, heat to boiling and decoct for 0.5 hour, filter the medicinal liquid, add 900kg of water for the second time, heat to boiling After decocting for 0.5 hour, the medicinal solution was filtered, and the two filtrates were combined.

[0050] (2) Pump the filtrate into the liquid medicine storage tank, let it stand for 2 hours, and filter it with a 300-mesh filter cloth to obtain the liquid medicine. The liquid medicine is concentrated in a concentrator under reduced pressure until it is concentrated to a fluid extract with a relative density of 1.12 at 60°C. The steam pressure of the concentrator is 0.09Mpa, the vacuum degree is -0.09Mpa, and the concentration temperature is 60°C.

[0051] (3) Mix the liquid extract with auxiliary materials such as dextrin, the amount of auxiliary materials added is 1% of the quality of Moutan cortex ...

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Abstract

The invention discloses a preparation method and a quality detection method of coxtex moutan formula granules. The preparation method comprises the following steps: (1) decocting decoction pieces of coxtex moutan with water and conducting extracting so as to obtain an extracting solution; (2) conducting decompressing and concentrating in a filtrate concentrator so as to obtain an extractum; and (3) mixing the obtained extractum with such adjuvants as dextrin or lactose or maltodextrin and the like, uniformly stirring the materials, and conducting spray-drying, so that the coxtex moutan formula granules are obtained. A fingerprinting determination method of the coxtex moutan formula granules comprises the following steps: (1) preparing a reference solution; (2) precisely adding ethanol to powder of the coxtex moutan formula granules and conducting ultrasonic treatment; and (3) injecting an obtained material into a high performance liquid chromatograph, and recording a chromatogram map. The preparation method provided by the invention has the beneficial effects that the produced formula granules are uniform, stable and controllable in quality, and the formula granules have the advantages of being decoction-free and instant, convenient to carry and the like. The adopted fingerprinting detection method is convenient, rapid, and excellent in high precision, repeatability and stability; therefore, a novel method is provided for enhancing quality control of the coxtex moutan formula granules.

Description

technical field [0001] The invention relates to a traditional Chinese medicine formula granule and a preparation method thereof, in particular to a preparation method of a moutan cortex formula granule and a quality detection method thereof, belonging to the field of traditional Chinese medicine pharmacy. Background technique [0002] Formula granules are aimed at the physical and chemical properties of the active ingredients of traditional Chinese medicine. Using modern production technology, taking Chinese herbal decoction pieces as raw materials, through appropriate extraction, concentration, drying, granulation and other steps, the active ingredients can be extracted to a greater extent, and impurities can be removed. Appropriate packaging and other methods are adopted to improve the stability of the traditional Chinese medicine preparation. [0003] At present, the quality control content of formula granules includes appearance identification, property inspection and co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/71A61K36/65A61K9/16A61K47/36A61K47/26A61P3/06A61P29/00G01N30/02
CPCA61K9/1623A61K9/1652A61K36/65A61K36/71A61K2236/331A61K2236/39A61K2236/51G01N30/02
Inventor 徐云任晶于艳辉石菊白冰徐建赵俞关丽丹
Owner 吉林修正药业新药开发有限公司
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