Papaverine hydrochloride pharmaceutical composition for injection and preparation method

A technology of papaverine hydrochloride and a composition, applied in the field of medicine, can solve problems such as insignificant curative effect and the like

Active Publication Date: 2020-10-20
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has no significant curative effect on hypertension, angina pectoris,

Method used

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  • Papaverine hydrochloride pharmaceutical composition for injection and preparation method
  • Papaverine hydrochloride pharmaceutical composition for injection and preparation method
  • Papaverine hydrochloride pharmaceutical composition for injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Embodiment 1: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0136] formula:

[0137]

[0138] Preparation method:

[0139] (a) Take by weighing papaverine hydrochloride and pharmaceutical excipients of the prescribed amount, add an appropriate amount (accounting for 65% of the prescription volume) of water for injection to dissolve, then add 0.5% of the volume of the medicinal liquid with active carbon for needles, stir, filter and decarbonize;

[0140] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0141] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0142] (d) Freeze-drying to remove moisture, and stoppering, to obtain. This powder injection sample can be recorded as Ex1.

Embodiment 2

[0143] Embodiment 2: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0144] formula:

[0145]

[0146]

[0147] Preparation method:

[0148] (a) Take by weighing papaverine hydrochloride and pharmaceutical excipients of the prescribed amount, add an appropriate amount (accounting for 50% of the prescription volume) of water for injection to dissolve, then add 0.5% of the volume of the medicinal liquid with active carbon for needles, stir, filter and decarbonize;

[0149] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0150] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0151] (d) Freeze-drying to remove moisture, and stoppering, to obtain. This powder injection sample can be record...

Embodiment 3

[0152] Embodiment 3: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0153] formula:

[0154]

[0155] Preparation method:

[0156] (a) Take by weighing papaverine hydrochloride and pharmaceutical excipients of the prescribed amount, add an appropriate amount (accounting for 90% of the prescription volume) of water for injection to dissolve, then add 0.8% of the volume of the medicinal liquid with active carbon for needles, stir, and decarbonize by filtration;

[0157] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0158] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0159] (d) Freeze-drying to remove moisture, and stoppering, to obtain. The powder injection sample can be recorded as ...

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PUM

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Abstract

The invention relates to a papaverine hydrochloride pharmaceutical composition for injection and a preparation method. Specifically, the pharmaceutical composition provided by the invention comprisespapaverine hydrochloride and pharmaceutic adjuvants, wherein the pharmaceutic adjuvant comprises mannitol and edetate, and the weight ratio of the papaverine to the mannitol to the edetate is 30: (15-500): (2-10); the pharmaceutical composition further comprises an acid-base regulator, and the dosage of the acid-base regulator is that when the freeze-dried powder injection is dissolved into a solution containing papaverine hydrochloride with the concentration of 15mg/ml by using water for injection, the pH value of the solution is within the range of 2.5-4.0, the acid-base regulator is selected from sodium hydroxide, potassium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, monopotassium phosphate, dipotassium phosphate, hydrochloric acid, phosphoric acid, nitric acid,sulfuric acid or a combination thereof, especially a 1M hydrochloric acid solution or a 1M sodium hydroxide solution. The invention also provides a preparation method of the papaverine hydrochloridepharmaceutical composition for injection. The papaverine hydrochloride pharmaceutical composition for injection is prepared by a method for freeze-drying powder injection. The papaverine hydrochloridepharmaceutical composition disclosed by the invention has excellent technical effects as described in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to an opiate alkaloid used as a vasodilator, in particular to a freeze-dried powder injection of papaverine. The freeze-dried powder injection of papaverine of the present invention exhibits excellent technical effects as described herein. Background technique [0002] Papaverine, its hydrochloride is commonly used clinically, the English name is Papaverine Hydrochloride, the molecular formula of papaverine hydrochloride is C20H21NO4·HCl, the molecular weight is 375.85, and the chemical name is 1-[(3,4-dimethoxyphenyl)methyl] -6,7-dimethoxyisoquinoline hydrochloride, the chemical structural formula of papaverine hydrochloride is as follows: [0003] [0004] Papaverine hydrochloride is a vasodilator, which is a non-specific smooth muscle detoxifier, especially for pulmonary arteries, sinus arteries, and large blood vessels to produce non-specific arterial dilation and smooth muscl...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/472A61K47/10A61K47/18A61P9/08
CPCA61K31/472A61K9/0019A61K9/19A61K47/10A61K47/183A61P9/08
Inventor 徐愈富路艳君李杨马艳艳
Owner 山东北大高科华泰制药有限公司
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