Method for preparing tanshinone IIA sodium sulfonate preparation by using hydrotropic defoaming solvent

Abstract

The invention discloses a method for preparing a tanshinone IIA sodium sulfonate preparation by using a hydrotropic defoaming solvent. The method comprises the steps of: measuring the hydrotropic defoaming solvent in prescript amount and weighing water for injection which is 80% of prescript amount to a dosing tank, agitating and dissolving, adding tanshinone IIA sodium sulfonate, agitating till tanshinone IIA sodium sulfonate is completely dissolved; adding mannitol in prescript amount, agitating till the mannitol is completely dissolved, and adding water for injection to the prescript amount; adding active carbon and agitating, decarburizing by a titanium filter stick, adjusting pH by a hydrochloric liquid or a sodium hydroxide liquid, and filtering with 0.22 mu m millipore filter; and filling into an antibiotic bottle, freezing and drying to obtain a product. The alcohols solvent adopted has the main advantages of dissolubility in water, strong volatility and low toxicity and can serve as a latent solvent and a defoamer, and the crystalline state can be changed in the freezing process to form acicular crystals to facilitate sublimation of water, so that conduction in the freezing and drying process can be accelerated, the sublimation speed is improved, and nearly barely residues exist in a final product.

Description

technical field [0001] The invention relates to a preparation method of tanshinone IIA sodium sulfonate injection, in particular to a method for preparing tanshinone IIA sodium sulfonate injection by using a solvent. Background technique [0002] Sodium tanshinone IIA sulfonate is an essential drug commonly used in clinical practice. It can increase coronary blood flow, improve the collateral circulation and local blood supply of the myocardium in the ischemic area, improve the metabolic disorder of the hypoxic myocardium, improve the ability of the myocardium to withstand hypoxia, and inhibit platelets. Aggregation and anti-thrombosis, reducing the area of ​​ischemic myocardial infarction in experimental animals, and can also enhance myocardial contractility at a certain dose. Clinically used for the treatment of coronary heart disease angina pectoris and myocardial infarction, cerebral artery and retinal artery and peripheral vein thrombosis, Behcet's syndrome, erythema n...

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Problems solved by technology

[0008] When the applicant prepared the aseptic freeze-dried powder injection form, he found that according to the above prescription, when the raw drug was stirred and dissolved, a large amount of solid powder and bubble copolymer were likely to be produced, resulting in dissolution Slow; the structure of sodium tanshinone IIA sulfonate determines that it has the properties of a surfactant, and its crystal shape is similar to that of a colloid with swelling properties, so when the raw material is stirred and dissolved, it is easy to produce a large amount of copolymer of solid powder and air bubbles, resulting in slow dissolution. A large number of bubbles are generated due to liquid injection during filling, and the filling process is difficult to proceed smoothly. It is difficult to eliminate a large number of bubbles in the liquid during the freeze-drying process, resulting in uneven appearance of the freeze-dried preparation, which makes industrial production impossible.

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