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Papaverine hydrochloride for injection and preparation method thereof

A technology of papaverine hydrochloride and injection, which is applied in the field of medicine, can solve problems such as poor stability, high water content in medicines, and affect the efficacy of medicines, and achieve the effect of enhancing stability

Active Publication Date: 2021-07-23
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. effective technical issues

Method used

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  • Papaverine hydrochloride for injection and preparation method thereof
  • Papaverine hydrochloride for injection and preparation method thereof

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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: take by weighing papaverine hydrochloride and mannitol of the prescription amount in the liquid preparation tank, add 80% of the prescription water to the liquid preparation 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 inje...

Embodiment 2

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

[0039] (1) Process pre-treatment: Clean the antibiotic glass bottle with ultrasonic waves, rinse it with purified water and water for injection again, and sterilize it at 350°C for later use; clean the medicinal butyl rubber stopper 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 papaverine hydrochloride and mannitol of the prescribed amount in 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; use citric acid to adjust the pH value to 2.8, 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 solu...

Embodiment 3

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

[0045] (2) Dosing: take by weighing papaverine hydrochloride and mannitol of the prescription amount in the liquid preparation tank, add 80% of the prescription water to the liquid preparation tank and stir for 25 minutes to fully dissolve the papaverine hydrochloride and mannitol, 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 medicinal liquid through a 5 μm titanium rod filter for 5 minutes, and then coarsely filtering 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 takes mannitol as a low-temperature protective agent and excipient to protect the papaverine hydrochloride from deterioration in a low-temperature freeze-drying environment and enhance the stability of the papaverine hydrochloride. The invention also provides a preparation method of the papaverine hydrochloride for injection. The papaverine hydrochloride has better stability and solubility by adjusting a proper pH value and the temperature of water for injection; appropriate pre-freezing time and temperature and an appropriate sublimation drying method are selected, so that papaverine hydrochloride is completely dried, the stability is improved, the solubility of a medicine is better, a product is convenient to use, the medicine effect is ensured, and the use safety of the product is improved. The invention is used for solving the technical problems that: existing papaverine hydrochloride is easily degraded into papaverinol in the long-term storage process, the stability is poor, the medicine contains much water, and the medicine effect of the medicine is affected.

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 Applications(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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