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A kind of papaverine hydrochloride for injection and preparation method thereof

A technology for papaverine hydrochloride and injection, which is applied in the field of medicine, can solve the problems of poor stability, high water content of medicines, influences the efficacy of medicines and the like, and achieves the effect of enhancing stability

Active Publication Date: 2022-04-12
海南久常制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a papaverine hydrochloride for injection and a preparation method thereof, which are used to solve the problem that the existing papaverine hydrochloride is easily degraded into papaverine during long-term storage, has poor stability, and contains more water in the medicine, which affects the quality of the medicine. technical issues of efficacy

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0027] An embodiment of papaverine hydrochloride for injection and its preparation method provided by the present invention, the types of components and the weight ratio of each component included in every thousand bottles of papaverine hydrochloride for injection are: papaverine hydrochloride 30g; mannitol 100g ; Dilute to 2000ml with water for injection.

[0028] The preparation process steps are as follows:

[0029] (1) Process pre-treatment: Clean the antibiotic glass bottle and the medicinal butyl rubber stopper with ultrasonic waves, and sterilize them at high temperature for later use;

[0030] (2) Dosing: Weigh the prescribed amount of papaverine hydrochloride and mannitol into the liquid mixing tank, add 80% of the prescribed amount of water for injection to the mixing tank and stir to fully dissolve papaverine hydrochloride and mannitol, and the temperature of the water for injection 9~15°C; use citric acid to adjust the pH value to 2.8~3.5, add water for injection ...

Embodiment 2

[0038] As a further improvement to embodiment 1, the difference from embodiment 1 is:

[0039] (1) Process pre-treatment: Clean antibiotic glass bottles with ultrasonic waves, rinse them again with purified water and water for injection, and sterilize them at 350°C for later use; clean the medicinal butyl rubber stoppers with ultrasonic waves, then Rinse with water for injection, sterilize at 121°C for 30 minutes, dry with hot air and set aside;

[0040] (2) Dosing: Weigh the prescribed amount of papaverine hydrochloride and mannitol into the liquid mixing tank, add 80% of the prescribed amount of water for injection to the liquid mixing tank, stir for 20 minutes to fully dissolve papaverine hydrochloride and mannitol, and add water for injection The temperature of the solution is 9°C; adjust the pH value to 2.8 with citric acid, add water for injection to the full amount, and the temperature of the added water for injection is 4°C; then add 0.02% of the total weight of the so...

Embodiment 3

[0044] The difference between this embodiment and embodiment 2 is:

[0045] (2) Dosing: Weigh the prescribed amount of papaverine hydrochloride and mannitol into the liquid mixing tank, add 80% of the prescribed amount of water for injection to the mixing tank and stir for 25 minutes to fully dissolve papaverine hydrochloride and mannitol, and the water for injection The temperature is 10°C; use citric acid to adjust the pH value to 3.0, add water for injection to the full amount, and the temperature of the added water for injection is 5°C; then add 0.02% of the total weight of the solution to absorb with activated carbon for 30 minutes and then perform decarbonization treatment; The carbon treatment includes circulating the liquid medicine through a 5 µm titanium rod filter for 5 minutes, and then coarsely filtering it through a 0.45 µm cartridge filter to obtain a filtrate.

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Abstract

The invention discloses papaverine hydrochloride for injection and a preparation method thereof, and provides papaverine hydrochloride for injection, which uses mannitol as a cryoprotectant and excipient to protect papaverine hydrochloride from deterioration in a low-temperature freeze-drying environment , enhancing its stability. On the other hand also provides a kind of preparation method of papaverine hydrochloride for injection, by adjusting suitable pH value and temperature of water for injection, papaverine hydrochloride has better stability and solubility; The temperature and the appropriate sublimation drying method make the papaverine hydrochloride dry completely, the stability is improved, the solubility of the drug is better, the product is convenient to use, the drug effect is guaranteed, and the use safety of the product is improved. The invention is used to solve the technical problems that the existing papaverine hydrochloride is easily degraded into papaverine hydrochloride during long-term storage, has poor stability, and the drug contains more water, which affects the efficacy of the drug.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to papaverine hydrochloride for injection and a preparation method thereof. Background technique [0002] Papaverine hydrochloride is an isoquinoline alkaloid with the molecular formula C 20 h 21 NO 4 , is one of the main alkaloids in poppy. It has a relaxing effect on smooth muscles such as blood vessels, bronchi, gastrointestinal tract, and bile ducts. By relaxing vascular smooth muscles, coronary artery dilation, peripheral resistance and cerebrovascular resistance are reduced. It is mainly used in the brain Thrombosis, pulmonary embolism, extremity arterial spasm and arterial embolism pain, etc. This drug is mainly used to relieve brain and peripheral vascular diseases accompanied by arterial spasm, treat cerebral thrombosis, pulmonary embolism, extremity arterial spasm and arterial embolism pain, etc. And as one of the components of compound bronchodilator spray; it can a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/472A61K47/26A61P1/06A61P9/06A61P9/08A61P9/10A61P9/12A61P9/14A61P11/08A61P13/06
CPCA61K31/472A61K9/19A61K9/0019A61K47/26A61P1/06A61P9/08A61P11/08A61P9/14A61P13/06A61P9/12A61P9/10A61P9/06
Inventor 魏雪纹戴宏旭苏凌彭琪
Owner 海南久常制药有限公司
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