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Transfusion contg. tanshinone II A sodium sulfonate and its prepn. method

A technology of sodium sulfonate and tanshinone, which is applied in drug delivery, blood diseases, pharmaceutical formulations, etc., can solve the problems of preparation clarity, production, storage and transportation difficulties, and can not solve the problems of tanshinone IIA sodium sulfonate, etc., so as to reduce the workload , to ensure the effect of safety

Inactive Publication Date: 2006-06-14
南京都药医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] During the sterilization process of tanshinone IIA sodium sulfonate injection (small injection), a small amount of tanshinone IIA sulfonate sodium decomposes to produce tanshinone IIA, and tanshinone IIA is insoluble in water, which will affect the clarity of the preparation, and then affect the drug use of the product Safety
This brings certain difficulties to production, storage and transportation. Tanshinone IIA sodium sulfonate injection (small injection) needs to be diluted in the middle of the infusion to use during clinical use, which also brings inconvenience to clinical medication.
Previously, Kunming Seagate Pharmaceutical Research and Development Co., Ltd. announced a tanshinone IIA sulfonate sodium glucose injection (CN1640391). According to its method, it could not solve the problem that tanshinone IIA sulfonate sodium was decomposed at high temperature to form water-insoluble tanshinone IIA, resulting in insoluble particles visible to the naked eye. , so that the clarity of the preparation cannot meet the requirements of injections, thereby affecting the drug safety of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Tanshinone IIA sodium sulfonate transfusion, the components are as follows (all by weight percentage)

[0031] Sodium Tanshinone IIA Sulfonate 0.04g

[0032] Sodium chloride 0.45g

[0033] Thioglycerol 0.02

[0034] Tween 80 0.4g

[0035] Add water for injection to 50ml

[0036] The preparation method is as follows:

[0037] (1) Treat the infusion bottle, rubber stopper, and polyester film according to the routine requirements for injections, and keep them for later use;

[0038] (2) Preparation of medicinal solution: take 80% water for injection in a liquid preparation tank, add main drug and auxiliary materials and stir to dissolve. Adjust the pH to 4.3, add 0.1‰ activated carbon for needles, stir the carbon for 15 minutes, filter and decarbonize with a titanium filter stick, add water for injection to the full amount, and stir well.

[0039] (3) Intermediate product detection: get the liquid and measure the pH value and the content of sodium tansh...

Embodiment 2

[0043] Embodiment 2: Tanshinone IIA sodium sulfonate transfusion, the components are as follows (all by weight percentage)

[0044] Sodium Tanshinone IIA Sulfonate 0.04g

[0045] Sodium chloride 0.9g

[0046] Potassium metabisulfite 0.02g

[0047] Poloxamer 0.5

[0048] Water for injection 100ml same as above

[0049] Made infusion solution according to the method of embodiment 1

Embodiment 3

[0050] Embodiment 3: Tanshinone IIA sodium sulfonate transfusion, the components are as follows (all by weight percentage)

[0051] Sodium Tanshinone IIA Sulfonate 0.04g

[0052] Sodium chloride 0.9g

[0053] Potassium metabisulfite 0.3g

[0054] Poloxamer 0.5

[0055] Water for injection 100ml

[0056] Made infusion solution according to the method of embodiment 1

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PUM

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Abstract

A perfusion of tanshinone IIA-sodium sulfonate for treating coronary heart disease, angina pectoris, myocardiac infarction and ventricular early heartbeat contains tanshinone IIA sodium sulfonate (0.002-0.16 Wt%), antioxidizing agent (0-20), solubilizer (0-20), osmosis pressure regulator (0.3-75) and the water for perfusion. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a medicine with good curative effect on cardiovascular diseases and a preparation method thereof. More precisely, the invention relates to a sodium tanshinone IIA sulfonate infusion solution and a preparation method thereof, belonging to the technical field of medicine and its preparation. Background technique [0002] Salvia miltiorrhiza has the effects of dispelling vibration and stopping bleeding, promoting blood circulation and regulating menstruation, clearing the heart and eliminating troubles. There is a saying in traditional Chinese medicine that "one flavor of Danshen drink has the same effect as Siwu Decoction", and its efficacy can be seen. Salvia miltiorrhiza protects the myocardium, can expand blood vessels, resist atherosclerosis, and resist thrombosis. The improvement of salvia miltiorrhiza on the peripheral and visceral microcirculation is one of its basic functions of promoting blood circulation and reducing ph...

Claims

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Application Information

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IPC IPC(8): A61K31/343A61K9/08A61P7/02A61P7/04A61P9/10A61P15/00
Inventor 张广明庄红艳朱存平
Owner 南京都药医药科技有限公司
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