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Injetio for treating coronary heart disease and preparation process thereof

A technology for coronary heart disease and extraction liquid, which is applied in the field of preparation of Guanxinning freeze-dried powder for injection, can solve the problems of increasing coronary flow, unscientific extraction process of Guanxinning injection, and low preparation quality standard, etc. The effect of strengthening myocardial contractility, controllable quality of extraction process, and high quality standard of preparations

Active Publication Date: 2009-04-08
YABAO PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The currently commercially available Guanxinning injection is a water injection prepared from Danshen and Chuanxiong as raw materials. After the two are mixed, they are decocted in water and alcohol-settled to extract the active ingredients. , for the treatment of cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, heart failure, hypertension, ischemic cerebrovascular disease, chronic hepatitis and other diseases. Unscientific extraction process, incomplete extraction of active ingredients, high difficulty in product quality control, low and imperfect preparation quality standards; in addition, the drug concentration of Guanxinning injection is low, and the clinical dosage is large (each dosage is 50-100ml ), and the transportation and storage of Guanxinning Injection are also inconvenient
According to literature reports (Huang Xi et al., the influence of Chuanxiong Wuyong Danshen decoction on the pharmacokinetics of Ligustrazine, Chinese Journal of Integrated Traditional Chinese and Western Medicine, 1994, 14(5): 288-291): one of the main active ingredients of Chuanxiong is Chuanxiong. Ligustrazine has a wide range of biological activities, such as expanding coronary arteries, increasing coronary flow, and reducing oxygen consumption. Decoction affected the extraction of Ligustrazine
Another scholar found that the main active ingredients of Chuanxiong, such as ferulic acid and adenosine, had a low extraction rate by decoction, while the extraction rate of the two was significantly increased when the ethanol reflux and ultrasonic extraction were performed (Sun Yi et al., Chuanxiong Medicinal Materials Research on HPCE-FP methodology, Chinese Journal of Traditional Chinese Medicine, 2003, 28(2): 167-171)
The currently commercially available Guanxinning injection only uses the mixture of Salvia miltiorrhiza and Chuanxiong, decoction and alcohol precipitation to extract the active ingredients. It is obviously difficult to extract the active ingredients completely, and this process does not have the alcohol extraction ingredients of the two; Extracting after mixing Danshen and Chuanxiong, the components are too complex and the intermediates are difficult to control; the current quality standard for Guanxinning injection only quantifies the main component of Danshen, protocatechualdehyde, and lacks the quantification of the main effective parts of Chuanxiong. indicators; in addition, the stability of Guanxinning injection is also poor, and after long-term storage, the color will become darker and precipitate

Method used

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  • Injetio for treating coronary heart disease and preparation process thereof
  • Injetio for treating coronary heart disease and preparation process thereof
  • Injetio for treating coronary heart disease and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0024] Experimental example 1: Screening of Extraction Technology of Active Components from Salvia Miltiorrhiza and Chuanxiong

[0025] It is reported in the literature that the active ingredients of Salvia miltiorrhiza and Chuanxiong are extracted in Guanxinning injection. The weak point of this extraction process is: the extraction of the effective components of Rhizoma Chuanxiong is affected, the two are mixed and extracted, the composition is too complicated, the intermediate control is difficult, and the extraction of active components is incomplete. Adenosine, etc., the extraction rate of decoction and alcohol precipitation method is low. For this reason, this experiment conducted a comparative study on the optimal process conditions for the extraction of active ingredients from Rhizoma Chuanxiong, which is summarized as follows:

[0026] Sample preparation:

[0027] (1) Ethanol reflux extraction combined with water decoction and alcohol precipitation method to extrac...

experiment example 2

[0034] Experimental example 2: Excipient selection

[0035] See Table 2 for the appearance results of the lyophilized powder injection prepared by adding different types of excipients to the medicinal component extract obtained by the above separate extraction process and freeze-dried.

[0036] Table 2 Effect of different excipients

[0037]

[0038] Each treatment was repeated 3 times. Table 2 shows that mannitol is the best excipient.

experiment example 3

[0039] Experimental example 3: Comparison with the original quality standard of Guanxinning Injection

[0040] Guanxinning for injection of the present invention has improved compared with the quality standard of the original Guanxinning injection, and the comparison under its "content determination" item is shown in Table 3:

[0041] Table 3 Comparison of "content determination" methods and indicators

[0042]

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Abstract

The invention provides a method for preparing freeze dried injection for stable angina pectoris of coronary heart disease, which comprises the significant part of radix salvia miltiorrhiza, Ligusticum wallichii and excipient, wherein the preparing process comprises stirring, dissolving, filtrating, charging water for injection and adjusting pH, an extraction method integrating ethanol backflow and water grilling is employed to extract the significant part of the root of red-rooted salvia, and the method integrating ultrasonic abstraction and water grilling is employed to extract the significant part of the root of chuanxiong rhizome. The invention also discloses the method of quality control for the freeze dried injection.

Description

technical field [0001] The invention belongs to the field of medicines, and relates to a preparation method of Guanxinning freeze-dried powder for injection, which uses plant crude drugs salvia miltiorrhiza and chuanxiong as raw materials. Background technique [0002] The currently commercially available Guanxinning injection is a water injection prepared from Danshen and Chuanxiong as raw materials. After the two are mixed, they are decocted in water and alcohol-settled to extract the active ingredients. , for the treatment of cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, heart failure, hypertension, ischemic cerebrovascular disease, chronic hepatitis and other diseases. Unscientific extraction process, incomplete extraction of active ingredients, high difficulty in product quality control, low and imperfect preparation quality standards; in addition, the drug concentration of Guanxinning injection is low, and the clinical dosage is ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/53A61K36/236A61K9/19A61P9/10A61P9/04A61P9/12
Inventor 李亚平任武贤李亚政冯伟马晓军
Owner YABAO PHARMA GRP CO LTD