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Sodium tashinone II A sulfonate injection and preparation method thereof

The technology of sodium sulfonate and tanshinone is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of easy turbidity and poor stability of the aqueous solution of sodium tanshinone IIA sulfonate, etc. achieve high yield

Inactive Publication Date: 2006-12-13
JILIN SIHUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are many patent publications related to tanshinone IIA sodium sulfonate injection, such as CN200310111509.5, CN200510064376.X, CN200310125178, CN200410002103.8, CN200310121026.3, CN200510040386.X, CN200510035691. There are CN200410002103.8, CN200510040386.X and CN200510035691.X, but adopting the technology of these 3 patent documents still can not effectively solve the poor stability of tanshinone IIA sodium sulfonate aqueous solution, the problem of easily becoming turbid

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Tanshinone IIA sodium sulfonate 100g is pulverized by a QWJ airflow vortex micronizer to obtain tanshinone IIA sodium sulfonate of 5-8 microns, which is made into 10,000 small-capacity injections (the specification is 2ml / branch).

[0017] Add an appropriate amount of water for injection into the concentrated preparation tank, add 100 g of ultra-finely pulverized sodium tanshinone IIA sulfonate with a particle size of 5-8 microns to the concentrated preparation tank, stir well, and add activated carbon according to 0.04% of the total volume of the preparation , heat to 90°C, keep warm for 20 minutes, cool down to 50°C, decarbonize and filter the medicinal solution into the dilute tank, add 5g alanine and 0.5g Tween-80 into the dilute tank, stir well to dissolve completely , add activated carbon according to 0.02% of the total volume of the preparation, let it stand for 20 minutes, add water for injection to the dosing volume, adjust the pH to 4.5±0.2, decarbonize and fil...

Embodiment 2

[0019] Tanshinone IIA sodium sulfonate 100g is pulverized by a QWJ airflow vortex micronizer to obtain 8-50 micron tanshinone IIA sodium sulfonate and made into 10,000 small-capacity injections (2ml / bottle).

[0020] Add an appropriate amount of water for injection in the concentrated preparation tank, add the superfine crushing particle size of the prescribed amount to the concentrated preparation tank, and add tanshinone IIA sodium sulfonate with a particle size of 5-8 microns, fully stir, add activated carbon by 0.04% of the total volume of the preparation, Heat to 90°C, keep it warm for 20 minutes, cool down to 50°C, decarbonize and filter the medicinal liquid into the dilute preparation tank, add 5g sodium chloride and 3g sodium sulfite into the dilute preparation tank and stir thoroughly to dissolve completely, according to the total volume of the preparation Add activated carbon at 0.02%, let it stand for 20 minutes, add water for injection to the dosing volume, adjust t...

Embodiment 3

[0022] 42 g of sodium tanshinone IIA sulfonate was pulverized by a QWJ airflow vortex micronizer to obtain sodium tanshinone IIA sulfonate of 5-8 microns.

[0023] Formula: 40g of tanshinone IIA sodium sulfonate of 5-8 microns, 900g of sodium chloride, 100g of sodium bisulfite, an appropriate amount of 0.1mol / L phosphoric acid solution (pH=6), and 100,000ml of water for injection.

[0024] Preparation:

[0025] (1) Clean and sterilize the infusion bottle, rubber stopper and aluminum cap respectively for later use; among them, cleaning and sterilization of the infusion bottle: the infusion bottle is first cleaned with a bottle washing machine, then cleaned with deionized water and water for injection, and then cleaned with deionized water and water for injection. Blow dry with clean compressed air, and finally pass through an infrared tunnel oven with a temperature of 350°C for 5-8 minutes and cool down. The cleaning and sterilization of the rubber stopper: the butyl rubber st...

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Abstract

The invention relates to a sodium tanshinone IIA silate injection and process for preparation, wherein the raw material comprises superfine sodium tanshinone IIA silate and medicinal auxiliary materials for injections. The injection has the advantages of high yield and good stability.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine injections, in particular to a tanshinone IIA sodium sulfonate injection and a preparation method thereof. Background technique [0002] Ultra-fine crushing is a new technology developed in recent years. This technology adopts the special impact target Thomson effect in the fluidized bed jet crushing mill, which can strengthen the effect of ultra-fine crushing on tough materials, and adopts backward inclined blades , The ultra-fine classification system that makes the grading turbine suitable for low specific gravity Chinese medicinal material powder also adopts anti-static structure and explosion-proof design, these measures effectively ensure the ultra-fine effect of medicine. The dissolution rate of solid drugs is closely related to the degree of micronization in the preparation process. Quantitative changes in particle size will bring about qualitative changes in powder properties ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/58A61K47/02A61K47/18A61K47/26A61P9/10A61P9/00
Inventor 张玉梅
Owner JILIN SIHUAN PHARM CO LTD
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