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Red-rooted-salvia-root chuanxiong-rhizome azine injecta, its preparation method and use

A technology of ligustrazine and injection, which is applied in the field of traditional Chinese medicine preparations, can solve problems such as difficulty in research and development and production, large loss of active ingredients, and impact on product quality, and achieve the effects of less adverse reactions, high bioavailability, and avoiding turbidity of the liquid medicine

Active Publication Date: 2006-05-24
吉林四长制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional Chinese medicine preparations according to the above standards, due to the large loss of active ingredients by the stone sulfur method and alcohol precipitation method in traditional process operations, there are more residual impurities such as protein, tannin, and polysaccharides, and due to differences in the origin and harvest season of medicinal materials , the components of residual impurities are prone to turbidity, precipitation, and discoloration of the liquid during the preservation of the injection, affecting product quality, and adverse reactions are reported [Shi Zhen Guoyao Research 2004, 15(8): 542]
[0004] Due to the frequent reports of adverse reactions of compound drugs of chemical drugs and traditional Chinese medicines, the China Food and Drug Administration issued on February 2, 2005 "About suspending the acceptance of applications for the registration of 117 varieties of Ginkgo Damo injection and other drugs that have national standards." From this point of view, the research and development and production of chemical drugs with definite curative effect and stable quality and compound drugs of traditional Chinese medicine still have certain difficulties.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The preparation of embodiment 1-Salvia miltiorrhiza and Ligustrazine injection

[0027][Prescription] Danshen 200g

[0028] Ligustrazine Hydrochloride 20g

[0029] Glycerin 250ml

[0030] Appropriate amount of water for injection

[0031] Makes 1000ml

[0032] [Preparation method] Take the pre-treated Danshen medicinal material, add 2 times the amount of water to soak for 12 hours, decoct and extract three times with 8 times the amount, 6 times the amount, and 6 times the amount of water respectively, and the time is 3 hours, 2 hours, and 2 hours respectively. hours, filter, combine the filtrate, concentrate the filtrate to a relative density of 1.15, stir and add 0.03% clarifier, centrifuge with a high-speed centrifuge after standing for 6 hours, collect the supernatant, concentrate the supernatant to a relative density of 1.20, add Ethanol to make the alcohol content 70%, refrigerated at 4...

Embodiment 2

[0033] The preparation of embodiment 2-Salvia miltiorrhiza and Ligustrazine injection

[0034] [Prescription] Danshen 100g

[0035] Ligustrazine Hydrochloride 1.00g

[0036] Glucose 50g

[0037] Glycerin 12ml

[0038] Appropriate amount of water for injection

[0039] Makes 1000ml

[0040] [Preparation method] Take the pretreated Danshen medicinal material, add 2 times the amount of water to soak for 12 hours, decoct with 6 times the amount, 5 times the amount, and 5 times the amount of water to extract three times, the time is 3 hours, 2 hours, and 1 hour respectively. hours, filter, combine the filtrate, concentrate the filtrate to a relative density of 1.15, stir and add 0.05% clarifier, centrifuge with a high-speed centrifuge after standing for 6 hours, collect the supernatant, concentrate the supernatant to a relative density of 1.20, add Ethanol to make the alcohol content 70%...

Embodiment 3

[0041] The preparation of embodiment 3-Salvia miltiorrhiza and Ligustrazine injection

[0042] [Prescription] Danshen 40.0g

[0043] Ligustrazine Hydrochloride 0.400g

[0044] Glucose 50g

[0045] Glycerin 12ml

[0046] Appropriate amount of water for injection

[0047] Makes 1000ml

[0048] [Preparation method] Take the pretreated Danshen medicinal material, add 2 times the amount of water to soak for 12 hours, decoct with 6 times the amount, 5 times the amount, and 5 times the amount of water to extract three times, the time is 3 hours, 2 hours, and 1 hour respectively. hours, filter, combine the filtrate, concentrate the filtrate to a relative density of 1.15, stir and add 0.05% clarifier, centrifuge with a high-speed centrifuge after standing for 6 hours, collect the supernatant, concentrate the supernatant to a relative density of 1.20, add Ethanol to make the alcohol cont...

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Abstract

The present invention relates to a salvia ligustrazine injection, its preparation and application. Said preparation method includes the following steps: decocting salvia root, concentrating, adding clearer, centrifugalizing, alcohol precipitation, water precipitation and ultrafiltering so as to obtain salvia active component, mixing said salvia active component with ligustrazine, filling and sterilizing 20 as to obtain the invented injection preparation. Said preparation can be used for intramuscular injection and intravenous injection.

Description

technical field [0001] The invention relates to a salvia miltiorrhiza and ligustrazine injection, a preparation method thereof and an intravenous administration of the salvia miltiorrhiza and ligustrazine injection, belonging to the field of traditional Chinese medicine preparations. The injection can be widely used in the treatment of cardiovascular and cerebrovascular diseases. Background technique [0002] Ligustrazine is an alkaloid extracted from the traditional Chinese medicine Ligusticum Chuanxiong, and its chemical structure is tetramethylpyrazine. Modern pharmacological studies have shown that Ligustrazine has the functions of expanding the crown, lowering blood pressure, improving myocardial hypoxia resistance, reducing blood viscosity, and improving neurotrophic status. Salvia (Radix Salviae Miltiorrhiza Bge) is a plant of the genus Salvia in the Labiatae family. Salvia is also known as: Purple Salviae, Red Root, Blood Ginseng, Dahongpao, etc. Salvia miltiorrhiz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/53A61P9/10A61P11/00
Inventor 张玉梅
Owner 吉林四长制药有限公司
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