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Procaine hydrochloride injection and its production technology

A technology of procaine hydrochloride and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as being unsuitable for topical anesthesia and weak mucosal penetration, and achieve the effects of improving stability and curbing hydrolysis

Inactive Publication Date: 2012-03-07
HENAN FUREN HUAIQINGTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Procaine hydrochloride is an ester local anesthetic, which can temporarily block the conduction of nerve fibers and has an anesthetic effect. This product has weak penetration into the skin and mucous membranes, so it is not suitable for surface anesthesia

Method used

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Embodiment Construction

[0019] The procaine hydrochloride injection provided by the invention is made up of procaine hydrochloride, medicinal charcoal and fresh water for injection, wherein, every 1000ml procaine hydrochloride injection contains 20g procaine hydrochloride, 9g chloride Sodium, and 0.5g medicinal charcoal, the rest are fresh water for injection.

[0020] The production process of the present invention is as follows: unscrambling→washing, drying, bottle extinguishing→preparation→filling→sterilization, leak detection→light inspection→packing→storage.

[0021] 1. Washing, drying, and extinguishing bottles: put the sorted bottles in a bottle washing machine, use purified water (water temperature 50°C to 60°C) for rough washing with ultrasonic waves, finely wash with water for injection, and place them in a tunnel oven at 300°C to 320°C, sterilization time ≥ 4 minutes.

[0022] 2. Preparation: Calculate the usage of raw materials according to the marked amount of 100%, measure the water fo...

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Abstract

The invention belongs to the field of medicinal preparations, and provides a procaine hydrochloride injection and its preparation method. 1000 ml of the procaine hydrochloride injection provided by the invention contains 20g of procaine hydrochloride, 9g of common salt, 0.5g of medicinal charcoal and the balance being fresh injection water. The preparation method of the procaine hydrochloride injection is characterized by comprising the following steps of: a, adding common salt into injection water for dissolution, adding procaine hydrochloride, and stirring for dissolution; b, adjusting pH of a liquid medicine obtained from the step a to 4.0-4.5 by the use of 1 mol / L of hydrochloric acid; c, adding injection water into a liquid medicine obtained from the step b up to the full amount, adding medicinal charcoal, stirring for 10 minutes, standing for 20 minutes, and filtering through a titanium rod filter and 0.45 micron and 0.22 micron of a cartridge type filter; d, placing a sealed intermediate product into a sterilization cabinet, using circulating vapor of 100 DEG C, and sterilizing for 30 minutes. The procaine hydrochloride injection provided by the invention is more stable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and provides a procaine hydrochloride injection and a preparation method. Background technique [0002] Procaine hydrochloride, a local anesthetic, is one of the clinical drugs widely used at home and abroad, and has been included in the pharmacopoeias of China, the United States, Britain, Japan, Germany, France, Italy, and Switzerland. [0003] Procaine hydrochloride is an ester local anesthetic, which can temporarily block the conduction of nerve fibers and has an anesthetic effect. This product has weak penetrating power to the skin and mucous membranes, so it is not suitable for topical anesthesia. This product has poor diffusion and permeability, and its hydrochloride combined form releases free base in the tissue to exert local anesthetic effect. This product has constant inhibition and excessive excitement on the central nervous system. First, it causes sedation, dizziness, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/245A61K47/02A61K47/04A61P23/02
Inventor 陈水库白宗锋朱永杰
Owner HENAN FUREN HUAIQINGTANG PHARMA
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