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Tanshinone IIA infusion solution and its preparation method

A technology of tanshinone and infusion solution, which is applied in the field of tanshinone IIA preparations, can solve the problems of unseen preparation process, poor intestinal absorption of tanshinone IIA, slow clinical onset of effect, etc., and achieve the effects of convenient use, elimination of cross-contamination, and guarantee of drug safety

Inactive Publication Date: 2006-02-15
GUANGZHOU DIHAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

From the 1930s to the early 1940s, Japanese scholars Nakao Manzo, Nakao and Takiura successively separated three kinds of red crystals from the ethanol or ether extracts of tanshinone, which were named as tanshinone I, IIA and III; Takiura confirmed that tanshinone II was A mixture of IIA and IIB; in the 1960s, Kakisawa determined the structural formula of tanshinone IIA; in 1968, Baidlre et al. synthesized tanshinone IIA. Due to the poor intestinal absorption of tanshinone IIA, the clinical onset was slow, so it was developed by Qian Mingkun et al. Sulfonation to water-soluble sodium salt
After inquiry, Tanshinone IIA Sodium Sulfonate Powder Injection and its preparation method were patented by Kunming Tongchi Pharmaceutical Research Co., Ltd. However, Tanshinone IIA series infusion preparations and their preparation process have not been reported on patent applications and administrative protection.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Formula: 40 g of sodium tanshinone IIA sulfonate (calculated as tanshinone IIA), 900 g of sodium chloride, 100 g of sodium bisulfite, an appropriate amount of 0.1 mol / L phosphoric acid solution (pH=6), and 100,000 ml of water for injection.

[0021] Preparation:

[0022] (1) Clean and sterilize the infusion bottle, rubber stopper, and aluminum cap respectively for later use;

[0023] Cleaning and sterilization of infusion bottles: the infusion bottles are first cleaned with a bottle washing machine, then cleaned with deionized water and water for injection, then dried with clean compressed air, and finally sterilized by an infrared tunnel oven with a temperature of 350°C for 5~ 8 minutes, let cool.

[0024] The cleaning and sterilization of the rubber stopper: the butyl rubber stopper is pre-washed with deionized water, then finely washed with water for injection, and sterilized at 125°C for 150 minutes.

[0025] Cleaning and sterilization of the aluminum cover: the a...

Embodiment 2

[0029] Formula: 50 g of sodium tanshinone IIA sulfonate (calculated as tanshinone IIA), 5000 g of glucose, 100 g of sodium sulfite, an appropriate amount of 0.1 mol / L phosphoric acid solution (pH=6), and 100000 ml of water for injection.

[0030] The preparation method is the same as in Example 1, and is divided into 1000 bottles.

Embodiment 3

[0032] Formula: 30 g of sodium tanshinone IIA sulfonate (calculated as tanshinone IIA), 20,000 g of mannitol, 200 g of vitamin C, an appropriate amount of 0.1 mol / L phosphoric acid solution (pH=6), and 100,000 ml of water for injection.

[0033] The preparation method is the same as in Example 1, and is divided into 1000 bottles.

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PUM

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Abstract

The invention discloses a tanshinone IIA infusion solution and its preparation method, wherein each 100ml of the transfusion agent contains water-soluble tanshinone II A 2-50mg, water for injection 100ml and medicinal carrier. The preparing process comprises the following steps, (1) cleaning transfusion bottles, plugs and aluminium caps, sterilizing for later use, (2) dissolving prescription amount of water-soluble tanshinone II A with water for injection, charging adjuvant proportionally, (3) subjectint the solution to active carbon decolouration, adjusting pH, passing through 0.22-0.45 um microporous filtering film, filtering and split charging, filling nitrogen, inserting plugs, sterilizing, inspecting and packaging.

Description

technical field [0001] The invention relates to a tanshinone IIA preparation, in particular to a tanshinone IIA infusion, and also relates to a preparation method of the infusion. Background technique [0002] Tanshinone IIA (also known as Tanshinone IIA, Tanshinone II, Tanshinone IIA, Tanshinone) is one of the main active ingredients in Danshen. This product is a cherry red needle-like crystal. From the 1930s to the early 1940s, Japanese scholars Nakao Manzo, Nakao and Takiura successively separated three kinds of red crystals from the ethanol or ether extracts of tanshinone, which were named as tanshinone I, IIA and III; Takiura confirmed that tanshinone II was A mixture of IIA and IIB; in the 1960s, Kakisawa determined the structural formula of tanshinone IIA; in 1968, Baidlre et al. synthesized tanshinone IIA. Due to the poor intestinal absorption of tanshinone IIA, the clinical onset was slow, so it was developed by Qian Mingkun et al. Sulfonated into water-soluble sod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K9/08A61P9/10A61P7/02
Inventor 武春风
Owner GUANGZHOU DIHAO PHARMA
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