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Stable pharmaceutical composition containing sodium tanshinone IIA sulfonate

A composition and technology of tanshinone, applied in the field of small-volume injections, can solve the problems of poor stability, easily turbid chemical stability and the like

Inactive Publication Date: 2014-03-12
广东岭南制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability of the preparation of tanshinone IIA sodium sulfonate injection still needs special attention, the aqueous solution of tanshinone IIA sodium sulfonate has poor stability, easily becomes turbid and / or has poor chemical stability

Method used

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  • Stable pharmaceutical composition containing sodium tanshinone IIA sulfonate
  • Stable pharmaceutical composition containing sodium tanshinone IIA sulfonate
  • Stable pharmaceutical composition containing sodium tanshinone IIA sulfonate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0126] formula:

[0127] Sodium Tanshinone IIA Sulfonate 0.5g

[0128] Glucose 5g

[0129] Add water for injection to 100ml

[0130] Formula parameters: pH=4.5; dissolved oxygen value=1.45mg / L.

[0131] Preparation Process:

[0132] (i) Take water for injection (at room temperature, freshly prepared and stored for no more than 48 hours), and replace the gas with air until the dissolved oxygen value reaches the specified value;

[0133] (ii) Take water for injection of about 95% of the formula, add an osmotic pressure regulator, dissolve, add active ingredients, stir to dissolve;

[0134] (iii) measure the pH value of the solution obtained in step (ii), adjust the pH value to a specified value with 1M hydrochloric acid solution or 1M sodium hydroxide solution if necessary, add water for injection to 100ml and stir evenly; test the dissolved oxygen of the solution, if necessary The dissolved oxygen in the solution reaches the prescribed dissolved oxygen range in step (i) by...

Embodiment 2

[0137] formula:

[0138] Sodium Tanshinone IIA Sulfonate 0.5g

[0139] Glucose 5g

[0140] Add water for injection to 100ml

[0141] Formula parameters: pH=4.5; dissolved oxygen value=0.55mg / L.

[0142] Carbon dioxide is used as the air replacement gas, and the others are the same as in Example 1.

Embodiment 3

[0144] formula:

[0145]

[0146] Formula parameters: pH=5.5; dissolved oxygen value=2.50mg / L.

[0147] Carried out with reference to the method of Example 1.

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Abstract

The invention relates to a stable pharmaceutical composition containing sodium tanshinone IIA sulfonate, and in particular relates to a composition. The composition comprises (a) sodium tanshinone IIA sulfonate, (b) osmotic pressure regulator and (c) water. The pharmaceutical composition containing sodium tanshinone IIA sulfonate, provided by the invention, has excellent pharmaceutical properties, such as excellent physical stability and / or chemical stability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of a stable pharmaceutical composition of sodium tanshinone IIA sulfonate, in particular to a small-capacity injection prepared by adding specific auxiliary materials with sodium tanshinone IIA sulfonate as the main component. technical background [0002] Sodium tanshinone IIA sulfonate is obtained by extracting tanshinone IIA from Danshen and sulfonating it. Compared with tanshinone IIA, its water solubility has been enhanced and its curative effect is better. Sodium tanshinone IIA sulfonate is mainly used clinically for adjuvant treatment of coronary heart disease, angina pectoris and myocardial infarction. [0003] Because tanshinone IIA sulfonate sodium is easily oxidized in aqueous solution, antioxidants are added to the tanshinone IIA sulfonate sodium injection to prevent oxidative degradation, but because antioxidants often cause adverse reactions in patients, it increases the number of pati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/58A61K47/26A61K9/08A61P9/10
Inventor 徐文凯陈良强王荣
Owner 广东岭南制药有限公司