Urapidil hydrochloride injection and preparation method thereof

A technology of urapidil hydrochloride and injection, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. It can improve the stability, reduce the probability of deterioration, and promote the effect of large-scale industrial production.
CN113876705AInactive Publication Date: 2022-01-04SHIJIAZHUANG NO 4 PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SHIJIAZHUANG NO 4 PHARMA
Publication Date
2022-01-04
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses an urapidil hydrochloride injection and a preparation method thereof. In the urapidil hydrochloride injection, every 1000 mL of the urapidil hydrochloride injection comprises the following raw materials: 5 g of urapidil hydrochloride, 100 g of an osmotic pressure regulator and an acid-base buffer pair, and the pH value of the urapidil hydrochloride injection is 5.9-6.5. According to the invention, citric acid-sodium citrate, acetic acid-sodium acetate, citric acid-disodium hydrogen phosphate or phosphoric acid-sodium phosphate are used as acid-base buffer pairs, and the pH value of the injection is adjusted to 5.9-6.5, so that the stability of the injection is remarkably improved. In the preparation process of the injection, the adding and mixing sequence of the main drug urapidil hydrochloride and other auxiliary materials is adjusted, and the temperature in the preparation process is controlled to be lower than 60 DEG C, so that the deterioration probability of urapidil hydrochloride is effectively reduced, and the stability of the injection is remarkably improved.
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Description

technical field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to urapidil hydrochloride injection and a preparation method thereof. Background technique

[0002] Urapidil hydrochloride is a uracil derivative substituted by phenylpiperazine. It is currently an effective and safe vasodilator for the treatment of hypertensive crisis, severe hypertension, control of hypertension during surgery, and treatment of congestive heart failure. It is a national essential drug. In addition, urapidil hydrochloride generally does not cause reflex tachycardia while lowering blood pressure.

[0003] At present, the pharmaceutical preparations mainly include injections, freeze-dried powder injections, tablets, capsules, etc. Among them, tablets and capsules are all oral preparations, and the drug efficacy is reduced due to the unavoidable first-pass effect; freeze-dried powder injections need to be reconstituted after reconstitution. Reuse ...

Claims

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