Preparation of Dandengtongnao medicinal formulation and quality control method

A quality control method and a technology of pharmaceutical preparations, applied in the direction of drug combination, drug delivery, and pharmaceutical formulations, can solve problems such as incomplete quality control methods and unreasonable extraction and preparation processes, so as to monitor drug quality, shorten production cycle, and ensure The effect of the treatment effect

Inactive Publication Date: 2008-11-12
胡传良
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the shortcomings of unreasonable extraction and preparation process and incomplete quality control method of the existing Dandeng Tongnao preparation, the present invention provides a Dandeng Tongnao preparation with reasonable process, low production cost, suitable for large-scale industrial production, and comprehensive quality control

Method used

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  • Preparation of Dandengtongnao medicinal formulation and quality control method
  • Preparation of Dandengtongnao medicinal formulation and quality control method
  • Preparation of Dandengtongnao medicinal formulation and quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078]Ligusticum chuanxiong 555g, extract the volatile oil by steam distillation for later use, or wrap the extracted volatile oil with β-cyclodextrin with 3 times the weight of the volatile oil to form an inclusion complex, dry and pulverize to obtain the volatile oil inclusion complex powder; then extract the residue after extracting the volatile oil Merge with 835g of Pueraria lobata root, add water and decoct 3 times, 1 hour for the first time, 0.5 hours for the second and third times, the amount of water used is 10, 8, and 6 times the total weight of Rhizoma Chuanxiong and Pueraria lobata root respectively, combine the decoction, filter, and concentrate the filtrate to The relative density is 1.08 (60°C), add ethanol to make the alcohol content in the solution 70% (v / v), stir well, heat to 60°C, let it stand for 24 hours, filter, recover ethanol from the filtrate and concentrate to a relative density of 1.20 (60°C) concentrated solution (concentrated solution A); then take...

Embodiment 2

[0080] Ligusticum chuanxiong 555g, extract volatile oil by steam distillation for later use, or wrap the extracted volatile oil with β-cyclodextrin of 4 times the weight of volatile oil to synthesize clathrate, dry, and pulverize (to obtain volatile oil inclusion complex powder); Combine the residue with 835g of Pueraria lobata root, add water and decoct twice, 1 hour each time, the amount of water used is 10 and 8 times the total weight of Rhizoma Chuanxiong and Pueraria lobata root, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.10 (60°C) , add ethanol so that the alcohol content in the solution is 75%, stir evenly, heat to 60°C, let stand for 48h, filter, recover ethanol from the filtrate and concentrate it into a concentrated solution (concentrated solution A) with a relative density of 1.25 (60°C); Then take 555g of Salvia miltiorrhiza and 555g of Erigeron breviscapine and add 80% ethanol to heat and reflux to extract twice, each tim...

Embodiment 3

[0081] Embodiment 3: tablet

[0082] Add 240 grams of starch to dry powder of the extract obtained in Example 1 or 2, mix well, pass through a No. 5 sieve, granulate with 95% ethanol, dry below 60°C, granulate, add 0.5% magnesium stearate, mix well , pressed into 1000 tablets, each 0.5g, coated with film, is the tablet of the present invention.

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PUM

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Abstract

The invention belongs to the medicine preparation field and discloses a method for preparing Dandeng Tongnao pharmaceutical preparation and a quality control method. The preparation method is as follows: firstly, volatile oil extracted from hemlock parsley is standby or cladded and then residue and kudzu root are extracted water and precipitated alcohol, filtered and concentrated into concentrated solution A; secondly, Salvia miltiorrhiza and Erigeron breviscapus are extracted alcohol, filtered and concentrated into concentrated solution B; thirdly, the concentrated solution A and the concentrated solution B are mixed, concentrated into thick paste and then dried and crushed; volatile oil clathrate powder is added into the mixture, and extracted dry medicinal powder is obtained; fourthly, or the concentrated solution A and the concentrated solution B are mixed; the standby volatile oil is added into the mixture which is then uniformly mixed and filtered, and extracted liquid medicine is obtained; fifthly, the corresponding pharmaceutical preparation is prepared by addition of auxiliary materials which can be accepted pharmaceutically by the extracted dry medicinal powder or the extracted liquid medicine. The quality control method comprises the following steps of content test and content discrimination, wherein, the content test takes puerarin and tanshinone II A as the index, and the content discrimination takes hemlock parsley contrast medicine, puerarin and scutellarin as the contrast. The method is simple in preparation technique and short in production period and is suitable for industrial production; and the quality control method comprehensively guarantees the product quality.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a preparation method and a quality control method of a medicinal preparation of Dandeng Tongnao. Background technique [0002] "Stroke" is the main killer of cardiovascular disease, and more than two million people die of stroke every year. Cerebrovascular accidents are the leading cause of death and disability in different regions of the world or in different species clusters. In my country, 1.2 to 1.5 million people suffer from complete cerebral apoplexy every year, 800,000 to 1,000,000 people die, about 75% of the survivors become disabled, and the recurrence rate within 5 years is as high as 41%. Every year, 500,000 people in the United States get sick, 150,000 of them die, and more than 2 million survivors need medical attention. [0003] In recent years, many inventors and companies have done a lot of research on it, and also provided some therapeutic products and invention patents....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/537A61K9/06A61K9/08A61K9/10A61K9/16A61K9/20A61K9/48A61P9/10G01N30/02G01N30/90G01N21/33
Inventor 秦勇胡传良周自桂金春徐成苏晋景瑞
Owner 胡传良
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