Papaverine hydrochloride powder injection for injection and quality detection method thereof

A technology of papaverine hydrochloride and papaverine, applied in the field of medicine, can solve the problems of insignificant curative effect and so on

Active Publication Date: 2020-10-20
山东北大高科华泰制药有限公司
View PDF8 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has no significant curative effect on hypertension, angina pectoris, pyloric spasm, biliary colic, intestinal colic, bronchial asthma, etc.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Papaverine hydrochloride powder injection for injection and quality detection method thereof
  • Papaverine hydrochloride powder injection for injection and quality detection method thereof
  • Papaverine hydrochloride powder injection for injection and quality detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0157] Embodiment 1: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0158] formula:

[0159]

[0160] Preparation method:

[0161] (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;

[0162] (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;

[0163] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0164] (d) Freeze-drying to remove moisture, and stoppering, to obtain. This powder injection sample can be recorded as Ex1.

Embodiment 2

[0165] Embodiment 2: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0166] formula:

[0167]

[0168]

[0169] Preparation method:

[0170](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;

[0171] (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;

[0172] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0173] (d) Freeze-drying to remove moisture, and stoppering, to obtain. This powder injection sample can be recorde...

Embodiment 3

[0174] Embodiment 3: Preparation of papaverine hydrochloride powder injection pharmaceutical composition

[0175] formula:

[0176]

[0177] Preparation method:

[0178] (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;

[0179] (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;

[0180] (c) The medicinal liquid is sterilized and filtered with a microporous membrane, and filled in vials;

[0181] (d) Freeze-drying to remove moisture, and stoppering, to obtain. The powder injection sample can be recorded as ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
wavelengthaaaaaaaaaa
pore sizeaaaaaaaaaa
Login to view more

Abstract

The invention relates to a papaverine hydrochloride powder injection for injection and a quality detection method thereof, in particular to a method for determining the content of impurities A, B, C,D, E and F in the powder injection by using a high performance liquid chromatography. The method comprises the following steps that determination is carried out according to the specification of '0512high performance liquid chromatography' in the fourth part of Chinese Pharmacopoeia 2015 edition; an Eclipse XDB-C8 column is used as a chromatographic column, and mobile phases as follows are adopted: the mobile phase A is 3.4 g / L monopotassium phosphate solution of which the pH is adjusted to 3.0 by dilute phosphoric acid, the mobile phase B is acetonitrile, and the mobile phase C is methanol;a gradient elution program is adopted, and the detection wavelength is 238 nm; and in a system suitability test, the separation degree between an impurity A peak and a papaverine peak is not less than1.5. The invention also relates to a papaverine hydrochloride powder injection for injection. The method and the papaverine hydrochloride powder injection for injection have excellent technical effects as shown 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 invention also relates to a quality detection method of the papaverine freeze-dried powder injection, especially a method for determining the content of specific impurities therein. 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 vasodilat...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74A61K9/19A61K31/472A61K47/10A61K47/18A61P9/08A61P7/02A61P11/00A61P29/00
CPCG01N30/06G01N30/74A61K9/19A61K9/0019A61K31/472A61K47/10A61K47/183A61P9/08A61P7/02A61P11/00A61P29/00
Inventor 姜长通满春兰李明慧周雨汐
Owner 山东北大高科华泰制药有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap