Preparation method of tanshinone IIA sodium sulphonate small volume injection

A technology of tanshinone and sodium sulfonate, applied in the directions of pharmaceutical formulations, cardiovascular system diseases, drug combinations, etc., can solve the problems of instability of tanshinone IIA sodium sulfonate, poor product quality stability, high unqualified rate of clarity, and achieve The effect of improving collateral circulation and local blood supply, increasing stability and increasing coronary blood flow

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are mainly problems such as poor product quality stability, high failure rate of clarity, strong irritation of liquid medicine, decreased pH value, decreased content, deepened color, etc.
The main reason is that some impurities such as protein, tannin, oxalate, etc. are not completely removed during the preparation process of tanshinone IIA sodium sulfonate, and the instability of tanshinone IIA sodium sulfonate itself causes

Method used

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  • Preparation method of tanshinone IIA sodium sulphonate small volume injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A) Take fresh water for injection with a preparation amount of 25% at 80°C, add tanshinone IIA sodium sulfonate in the prescription in the dark, stir and dissolve thoroughly, place it at room temperature, seal it in shading, refrigerate at 8°C for 12 hours, and use tanshinone IIA sodium sulfonate with a molecular weight cut-off of 10,000 Ultrafiltration with ultrafiltration membrane to obtain ultrafiltrate I.

[0022] B) Take 10% fresh water for injection at 80°C, add edetate disodium in the prescription to dissolve, adjust the pH value to 3.8, place it at room temperature, refrigerate at 6°C for 12 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 10,000 Ultrafiltration to obtain ultrafiltrate II.

[0023] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 3.8. After the intermediate product is qualified, the liquid is sterilized and filtered by the terminal, filled with nitrogen under dark...

Embodiment 2

[0025] A) Take fresh water for injection with a preparation volume of 15% at 60°C, add Tanshinone IIA sodium sulfonate in the prescription away from light, fully stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 4°C for 24 hours, and use water with a molecular weight cut-off of 10,000 Ultrafiltration with ultrafiltration membrane to obtain ultrafiltrate I.

[0026] B) Take 20% fresh water for injection at 60°C, add edetate disodium in the prescription to dissolve, adjust the pH value to 5.0, place it at room temperature, refrigerate at 4°C for 24 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 10,000 Ultrafiltration to obtain ultrafiltrate II.

[0027] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 5.0. After the intermediate product is qualified, the liquid is sterilized and filtered at the terminal, filled with nitrogen under dark conditions, sterilized, an...

Embodiment 3

[0029] A) Take fresh water for injection with a preparation volume of 10% at 70°C, add Tanshinone IIA sodium sulfonate in the prescription in the dark, stir and dissolve thoroughly, place it at room temperature, seal it in shading, refrigerate at 6°C for 36 hours, and use tanshinone IIA sodium sulfonate with a molecular weight cut-off of 10,000 Ultrafiltration with ultrafiltration membrane to obtain ultrafiltrate I.

[0030] B) Take 30% fresh water for injection at 70°C, add edetate disodium in the prescription to dissolve, adjust the pH value to 4.5, place it at room temperature, refrigerate at 10°C for 36 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 10,000 Ultrafiltration to obtain ultrafiltrate II.

[0031] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 4.5. After the intermediate product is qualified, the liquid is sterilized and filtered by the terminal, filled with nitrogen under dar...

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Abstract

A low-dosage injection of tanshinone IIA-sodium sulfonate for treating coronary heart disease, angina pectoris, myocardial infarction and ventricular premature contraction is prepared from the tanshinone IIA-sodium sulfonate through depositing in water, cold storage, ultrafiltration, adding additives in dark condition, pouring in containers in Na atmosphere, sterilizing and lamp examining.

Description

technical field [0001] The present invention relates to a preparation method of anti-angina drugs, in particular to a small-capacity injection with sodium tanshinone IIA sulfonate as the main component, which is prepared by water sinking, cold storage and ultrafiltration technology, and then protected from light , filling with nitrogen, final sterilization, light inspection, packaging, and making small-capacity injections, which belong to the field of chemical preparations. The product can be injected intravenously, can expand coronary artery, increase coronary blood flow, improve collateral circulation and local blood supply of ischemic myocardium, improve metabolic disorder of hypoxic myocardium, improve myocardial hypoxia tolerance, inhibit platelet aggregation and anti Thrombosis, reducing the size of ischemic myocardial infarction in experimental animals. It is mainly used for the treatment of coronary heart disease, angina pectoris, myocardial infarction and premature v...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K9/08A61P9/10
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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