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Anti-hydrolysis injection aspirin-dl-lysine composition and preparation method thereof

A technology for lysine and injection, which is applied in the field of lysine for injection and its preparation, can solve the problems of easy decomposition and poor stability, and achieve the effects of stable content, improved stability and reduced risk.

Inactive Publication Date: 2018-05-04
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to: overcome the problems of easy decomposition and poor stability of existing lysine-pirin, and provide a hydrolysis-resistant lysine-pirin composition for injection and a preparation method thereof

Method used

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  • Anti-hydrolysis injection aspirin-dl-lysine composition and preparation method thereof
  • Anti-hydrolysis injection aspirin-dl-lysine composition and preparation method thereof
  • Anti-hydrolysis injection aspirin-dl-lysine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Eight groups of hydrolysis-resistant lysine-pirin compositions for injection and one group of lysine-pirin injections prepared by a freeze-drying process were prepared, and the components and dosages are as follows. According to the components and dosage of groups A-H below, dissolve lysine-pirin and stabilizer in 1000ml water for injection, add activated carbon for adsorption and decolorization, and then filter for decarburization. Adjust the pH value to 4.5-7.5 with a pH regulator, and filter 2-3 times with a sterile microporous membrane of 0.22 μm-0.45 μm. The filtered medicinal solution is dehydrated and dried, and each component is packed in 1000 glass bottles to obtain the common powder injection of the anti-hydrolysis lysine-pirin composition, each drug containing 0.25 or 0.9g of lysine-pirin .

[0025] The component consumption of the injection lysine-pirin prepared by freeze-drying process is shown in group I in table 1, and the preparation method is as follow...

Embodiment 2

[0029] Stability under different conditions is carried out to the common powder injection of the lysine-pirin composition for injection of the A-H group anti-hydrolysis in embodiment 1 and the lyophilized powder of the lysine-pirin composition for injection prepared by the freeze-drying process in group I study. Take the lysine-pirin composition for injection in Group A-I, place it under the conditions of high temperature 60°C or light of 4500 lx for 10 days, and measure the appearance, solution color, pH value, and related substances of the ordinary powder injection on the 0th day, 5th day, and 10th day (salicylic acid), content indicators. When detecting solution color, pH value, related substance (salicylic acid), content index, dissolve a bottle (lysine pirin content 0.25,0.9g) in embodiment 1 with water for injection 5 or 18ml, be mixed with lysine pirin Lin injection 50mg / ml. The test results of Group A-I preparations in Example 1 are shown in Table 2. Among the prepa...

Embodiment 3

[0034] Dissolve the Example 1A-I group in 0.9% sodium chloride injection, and the prepared lysine-pirin injection can be directly administered clinically. As shown in Table 3, after the A-I group was compatible with 0.9% sodium chloride injection, the pH decrease rate of the solution slowed down. After 15 minutes of compatibility, the solution pH was all around 4.0, and the content changed little, and the related substances of the A-I group all met the requirements; After 15 minutes of compatibility of commercially available lysine-pirin, the content changes greatly, wherein the pH changes and content changes of groups A-C and I are all small; commercially available lysine-pirin has a large change in related substances after 1 hour of compatibility , and the related substances of A-I group are lower than the commercially available group. After 1 hour, the pH of the solution in group A-B was still greater than 4, which reduced the risk of phlebitis; the content of the solution ...

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Abstract

The invention discloses an anti-hydrolysis injection aspirin-dl-lysine composition and a preparation method thereof. The anti-hydrolysis injection aspirin-dl-lysine composition comprises the followingcomponents in percentage by mass: 64-74% of aspirin-dl-lysine, 6-10% of a pH value adjusting agent and 20-35% of a stabilizer. The anti-hydrolysis injection aspirin-dl-lysine composition disclosed bythe invention can be used as a common powder injection, has the advantages of being not liable to bond surface, good in flowability, low in hygroscopicity in the air, small in content of related substances and good in stability, is capable of effectively preventing aspirin-dl-lysine from hydrolysis, reducing occurrence rates of adverse reactions and improving clinical application security, has good application prospects and market values, and is applicable to industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy. More specifically, the invention relates to a hydrolysis-resistant injection lysine-pirin composition which can be made into common powder injections and a preparation method thereof. Background technique [0002] Lysinepirin, chemical name DL-lysine mono[2-(acetoxy) benzoic acid potassium] salt, is the DL-lysine salt of acetylsalicylic acid, as a derivative of aspirin, it is produced by Egic Pharmaceuticals of France An antipyretic and analgesic drug first launched by the company in the 1970s. The drug can be administered intramuscularly or intravenously, and is mainly used clinically for fever and mild to moderate pain. [0003] Lyspirin has good solubility in water and can be administered by injection, thereby avoiding gastrointestinal side effects caused by oral administration and improving curative effect. The content of salicylic acid exceeds the limit requirement of the quality standard, which di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/616A61K31/198A61K47/12A61K47/02A61K47/22A61K47/26A61P29/00
CPCA61K9/0019A61K9/143A61K9/145A61K31/198A61K31/616A61K2300/00
Inventor 郑朝武陈雪君温国标
Owner HAINAN HUALON PHARM
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