Preparation method of urapidil hydrochloride injection

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses a preparation method of an urapidil hydrochloride injection, which comprises the following steps: every 5000mL of injection contains the following components by weight: 27.35 g of urapidil hydrochloride, 500g of 1, 2-propylene glycol, 2.1 g of disodium hydrogen phosphate dihydrate and 11.1 g of sodium dihydrogen phosphate dihydrate; the preparation method comprises the following steps: cooling water for injection to below 30 DEG C, and adding a prescription amount of 1, 2-propylene glycol for dissolving while continuously charging nitrogen and stirring; adding the disodium hydrogen phosphate dihydrate and the sodium dihydrogen phosphate dihydrate according to the prescription dosage under continuous nitrogen charging and stirring, and stirring to dissolve the disodium hydrogen phosphate dihydrate and the sodium dihydrogen phosphate dihydrate; under continuous nitrogen charging and stirring, adding the urapidil hydrochloride raw material according to the prescription dosage to dissolve the urapidil hydrochloride raw material, and measuring the pH value (5.5-6.5); supplementing the water for injection (below 30 DEG C) to full dose; and filtering with a 0.22 mu m microporous filter membrane, filling and sterilizing. The preparation method is simple in process and stable in product quality.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations and relates to a preparation method of pharmaceutical preparations for treating cardiovascular and cerebrovascular diseases, and in particular to a preparation method of urapidil hydrochloride injection. Background technique [0002] Hypertension is a common disease and frequently-occurring disease. Hypertension affects people's work and life, and hypertension is the most important risk factor for coronary heart disease and cerebrovascular disease. 50% of patients with myocardial infarction are hypertensive, and 76% of patients with sudden cerebral death have a history of hypertension. The risk of high blood pressure is therefore sudden death or disability. At this stage, with the improvement of people's living standards, the number of patients with hypertension is increasing, especially the number of patients with hypertensive crisis and severe disease. Hypertensive crisis ...

AI Technical Summary

Problems solved by technology

However, the patent still does not fundamentally solve the problems of poor stability and easy decomposition and deterioration of urapidil hydrochloride in the injection solution, which greatly limits the wide application of the drug in the injection form

[0011] Patent CN104173281 A discloses a kind of urapidil hydrochloride injection and its preparation method. The preparation method is complicated, the process takes a long time, and it also needs to add activated carbon for decolorization. The activated carbon is filtered and removed during the production process. There are often leakages and residues, and there are potential safety risks. According to the technical requirements for the consistency evaluation of generic drugs (injections), it is clearly stated that the use of activated carbon is not recommended.

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