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Cinepazide maleate injection and preparation method thereof

A technology of cinepazide maleate and injection, which can be applied in the field of medicine and can solve the problems of increasing cis isomer of cinepazide maleate and the like

Active Publication Date: 2011-10-19
HAINAN SIHUAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of this invention is to provide a new cinepazide maleate injection and preparation method thereof, which effectively solves the problem of cinepazide maleate in the related substances of cinepazide maleate injection during storage. The problem that the content of the special cis isomer is significantly increased, which improves the safety of clinical medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] 1. Prescription

[0084] Cinepazide Maleate 80g

[0085] D-Sorbitol 50.8g

[0086] Disodium hydrogen phosphate (as Na2HPO4) 5.4g

[0087] Add water for injection to 2000ml

[0088] A total of 1000 sticks were prepared

[0089] 2. Preparation process:

[0090] 1) Pre-use ampoules and equipment for liquid preparation, make disodium hydrogen phosphate into a 10% solution for later use;

[0091] 2) Add the prescribed amount of D-sorbitol into 1200ml water for injection, and stir to dissolve;

[0092] 3) adding cinepazide maleate to the above-mentioned D-sorbitol solution, stirring and partially dissolving;

[0093] 4) Stir 1 / 3 of the 10% disodium hydrogen phosphate solution into the above cinepazide maleate solution, stir to completely dissolve the cinepazide maleate, and then slowly add the remaining 2 / 3 of 10% For the disodium hydrogen phosphate solution, the total time of addition should be more than 30 minutes, and the pH should be adjusted within the range of 4....

Embodiment 2

[0103] 1. Prescription

[0104] Cinepazide Maleate 160g

[0105] D-Sorbitol 101.6g

[0106] Disodium hydrogen phosphate (as Na2HPO4) 10.8g

[0107] Add water for injection to 5000ml

[0108] A total of 1000 sticks were prepared

[0109] 2. Preparation process: refer to Example 1.

Embodiment 3

[0111] 1. Prescription

[0112] Cinepazide Maleate 320g

[0113] D-Sorbitol 203.2g

[0114] Disodium hydrogen phosphate (as Na2HPO4) 21.6g

[0115] Add water for injection to 10000ml

[0116] A total of 1000 sticks were prepared

[0117] 2. Preparation process: refer to Example 1.

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PUM

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Abstract

The invention belonging to the field of medicine technology discloses a cinepazide maleate injection and a manufacturing method thereof. In every 1000ml of injection, 35-45g of cinepazide maleate is contained, 20-30g of D-sorbierite, 2-3.5g of disodium hydrogen phosphate, and proper water for injection are contained. The manufacturing method includes the following steps: dissolving the D-sorbierite in water; adding the cinepazide maleate into the D-sorbierite solution, mingling in order to partially dissolve; adding part of disodium hydrogen phosphate solution in order to fully dissolve the cinepazide maleate; then slowly adding the rest disodium hydrogen phosphate solution to adjust the pH value; finally filtering and preparing into injection preparation. The cinepazide maleate injectionof the invention effectively reduces the content of cinepazide maleate cis-isomer for the long-term storage.

Description

1. Technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection containing an active ingredient cinepazide maleate and a preparation method thereof. 2. Background technology [0002] Cinepazide Maleate Injection (Klinao) is a new type of cardiovascular and cerebrovascular drug developed by the Institute of Materia Medica, Chinese Academy of Medical Sciences after years of hard work. It is produced by Beijing Sihuan Pharmaceutical Co., Ltd. and is currently the exclusive product in China. , cinepazide maleate (national drug approval H20020124, approved for production on April 9, 2002); cinepazide maleate injection (national drug approval H20020125, approved for production on April 9, 2002), and Cinepazide maleate injection has national drug standards. [0003] The unique pharmacological characteristics of cinepazide maleate injection are manifested in the synergistic effect of endogenous adenosine. It is a calcium...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/08A61P9/00
Inventor 车冯升
Owner HAINAN SIHUAN PHARMA
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