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Preparation method of pralidoxime chloride injection

A technology of phosphonium chloride and injection, which is applied in the field of preparation of phosphonium chloride injection, and can solve the problem that the material item does not meet the national standard, the phosphonium chloride injection cannot meet the quality standard of phosphonium chloride injection, etc. question

Inactive Publication Date: 2012-10-17
CHENGDU LIST PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] 6. The pralidoxime injection prepared according to the above-mentioned original production process cannot meet the revised WS-10001(HD-1031)-2002-2011 quality standard for pralidoxime injection
The main reason is that the relevant substance items in the production and storage process of the product do not meet the national standards

Method used

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  • Preparation method of pralidoxime chloride injection
  • Preparation method of pralidoxime chloride injection
  • Preparation method of pralidoxime chloride injection

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Embodiment Construction

[0022] The beneficial effect of this production process invention is illustrated below by the preparation, storage and product quality stability investigation of pralidoxime chloride injection.

[0023] 1. Test material

[0024] 1.1 Raw material

[0025] Pradoxime Chloride: Chengdu Lisite Pharmaceutical Co., Ltd.

[0026] 1.2 Ampoule: low borosilicate ampoule

[0027] 2. Production prescription and preparation process

[0028] 2.1 Prescription and production volume of pralidoxime chloride injection (2ml:0.5g):

[0029] Pradoxime Chloride 500g

[0030] Add water for injection to 2000ml

[0031] 2.2 Preparation process of pralidoxime chloride injection:

[0032] Measure 80% of the water for injection <40°C in the liquid mixing tank, add the prescribed amount of pralidoxime chloride and stir to dissolve, add water for injection <40°C to the full amount, and stir evenly. Adjust the pH of the drug solution to 2.5-4.5, sterilize and filter,...

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Abstract

The invention relates to a preparation method of pralidoxime chloride injection, belonging to the pharmaceutical field. The method comprises the steps of weighing 500g of pralidoxime chloride, then adding the pralidoxime chloride into 1600ml injection water which is less than 40 DEG C, repplenishing the injection water which is less than 40 DEG C to reach 2000ml, and then mixing well, adjusting the pH of the solution to 2.5 to 4.5, sterilizing, filtering, implementing sterile filling, inspecting the leakage, and storing the finished product under the lightproof refrigeration condition of 2 DEG C to 8 DEG C. According to the method specified in the invention, by controlling and optimizing the production process and the storage conditions of following chlorine pralidoxime injection, the products are in line with the national quality standards, and the quality stability of the products in the storage period is guaranteed at the same time.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a preparation method and storage conditions of pralidoxime chloride injection. Background technique [0002] 1. Pradoxime Chloride Injection belongs to the national essential medicine. It is a colorless or slightly yellow clear liquid. It can revive the activity of cholinesterase inhibited by acute organophosphate insecticides to different degrees. It is used to rescue various Poisoning by organophosphate insecticides. However, the poisoning effect on malathion, trichlorfon, dichlorvos, dimethoate, dimefox, mipafox and schradan is poor; it is insecticidal to carbamate The cholinesterase inhibited by the agent has no revival effect. [0003] 2. The original implementation standard of pralidoxime chloride injection is Volume 5 of the Second Ministry of Standards issued by the Ministry of the People's Republic of China. [0004] 3. On September 30, 2012, the State Food and Dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4425A61P39/02
Inventor 张浩刘新春
Owner CHENGDU LIST PHARMA