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High-capacity pulse-activating injection and preparation method thereof

A high-volume technology for Shengmai injection, which can be used in blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., and can solve problems such as short shelf life, quantitative errors, and complex components.

Active Publication Date: 2013-11-20
常熟雷允上制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] And the Shengmai injection of prior art is the injection of small capacity, can use after must diluting with glucose solution liquid or sodium chloride injection before clinical use, and this has brought the inconvenience in the clinical use, and existing preparation simultaneously There are following deficiencies:
[0004] (1) The chance of the liquid medicine being contaminated is increased during liquid preparation, which is likely to cause secondary pollution and affect the safety of the medicine;
[0005] (2) The dosing process is cumbersome, prone to quantitative errors, affecting drug efficacy and drug safety;
[0006] (3) After the diluent is added to the medicine in the prior art, the stability of the medicine is not good, and the shelf life is short;
[0007] (4) It is inconvenient to use, which also brings inconvenience to transportation and storage; the use of a large amount of packaging materials brings unnecessary waste
[0008] At the same time, due to the complex ingredients of prescription drugs, when making small-volume injections, the efficacy of the original prescription cannot be guaranteed.

Method used

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  • High-capacity pulse-activating injection and preparation method thereof
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  • High-capacity pulse-activating injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] A large-capacity Shengmai injection, which is prepared by the following method:

[0043] (1) Extraction of total ginseng saponins:

[0044] Take 1000g red ginseng, add red ginseng weight 7 times the concentration of 85% ethanol to reflux extract 3 times, each time for 2 hours, combine the extracts, refrigerate at 0-4°C, press filter to obtain the filtrate, then apply macroporous adsorption resin, use The concentration is 30 to 60% ethanol elution, near-infrared spectrum online tracking, the ethanol eluent with a concentration of 40% to 50% is combined, concentrated, and the total ginseng saponins extract is obtained; then the total ginseng saponins extract is added to activated alumina , stirred, adsorbed for 30 minutes, suction filtered the medicinal solution, recovered ethanol from the filtrate, adjusted the pH of the concentrated solution to 7.5-8.0 with 10% NaOH, then steamed until there was no alcohol smell, adjusted the pH to 6.5-7.0, added appropriate amount of w...

Embodiment 2

[0051] A large-capacity Shengmai injection, which is prepared by the following method:

[0052] (1) Extraction of total ginseng saponins:

[0053] Take 1000 g of red ginseng, add 80% ethanol at a concentration 6 times the weight of red ginseng, and reflux for extraction twice, each time for 2 hours. The concentration is 30 to 60% ethanol elution, near-infrared spectrum online tracking, the ethanol eluent with a concentration of 40% to 50% is combined, concentrated, and the total ginseng saponins extract is obtained; then the total ginseng saponins extract is added to activated alumina , stir, absorb for 30 to 50 minutes, suction filter the medicinal solution, recover ethanol from the filtrate, adjust the pH of the concentrated solution to 7.5-8.0 with 10% NaOH, then steam until there is no alcohol smell, adjust the pH to 6.5-7.0, add an appropriate amount for injection Continue heating with water for 1 hour, add water for injection until each 1ml is equivalent to 0.6g of medi...

Embodiment 3

[0060] A large-capacity Shengmai injection, which is prepared by the following method:

[0061] (1) Extraction of total ginseng saponins:

[0062] Take 1000g of red ginseng, add 85% ethanol at a concentration 8 times the weight of red ginseng, and reflux for extraction 3 times, each time for 3 hours, combine the extracts, refrigerate at 0-4°C, press filter to obtain the filtrate, and then apply macroporous adsorption resin, use The concentration is 30 to 60% ethanol elution, near-infrared spectrum online tracking, the ethanol eluent with a concentration of 40% to 50% is combined, concentrated, and the total ginseng saponins extract is obtained; then the total ginseng saponins extract is added to activated alumina , stir, absorb for 30 to 50 minutes, suction filter the medicinal solution, recover ethanol from the filtrate, adjust the pH of the concentrated solution to 7.5-8.0 with 10% NaOH, then steam until there is no alcohol smell, adjust the pH to 6.5-7.0, add an appropriate...

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Abstract

The invention discloses a high-capacity pulse-activating injection and a preparation method thereof. The preparation method comprises the following steps of with red ginseng, radix ophiopogonis and schisandra chinensis as raw materials, preparing by using a modern extracting and purifying method to obtain an active part with high effective ingredient content and low impurity component content; then, adding glucose or sodium chloride; and diluting the active part into the injection with the specification of 100-500ml by using water for injection. The high-capacity pulse-activating injection provided by the invention can be directly used for infusion, can be used for avoiding secondary pollution during liquid preparation, and is particularly good in stability and high in safety performance in clinic application; and the preparation method is reasonable in process design and suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a large-capacity Shengmai injection and a preparation method thereof. Background technique [0002] Shengmai Injection is a pure traditional Chinese medicine preparation extracted from red ginseng, Ophiopogon japonicus and Schisandra chinensis. It has the functions of regulating qi and resuscitation, replenishing qi and strengthening the heart, promoting body fluid and rejuvenating the pulse, restoring yang and rescuing adverse events, strengthening the body and eliminating pathogens, promoting blood circulation and removing blood stasis, and anticoagulation. It is mainly used clinically for the treatment of coronary heart disease, myocardial infarction, heart failure, various shocks and adjuvant chemotherapy for cancer patients. In recent years, reports of adverse reactions of Shengmai Injection have been increasing. Therefore, it is ne...

Claims

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Application Information

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IPC IPC(8): A61K36/8968A61K9/08A61P9/10A61P9/04A61P7/08A61P35/00
Inventor 顾治平王恒斌陈力建
Owner 常熟雷允上制药有限公司
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