Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

L-oxiracetam hydro-acupuncture for injection and preparation method thereof

A water-for-injection, injection-use technology, applied in pharmaceutical formulations, drug delivery, nervous system diseases, etc., can solve problems such as obvious pain, easy oxidation, and increased impurities, and achieve good patient compliance, not easy to be oxidized, pain, etc. sense-reducing effect

Inactive Publication Date: 2017-09-01
CHONGQING RUNZE PHARM CO LTD
View PDF7 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing Levoxiracetam water injection for injection mainly has a large change in solution pH and increased impurities during the sterilization process, poor solubility of the main drug of the product, poor product stability and easy oxidation, and obvious pain during the injection process. , poor compliance and other issues

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
  • L-oxiracetam hydro-acupuncture for injection and preparation method thereof
  • L-oxiracetam hydro-acupuncture for injection and preparation method thereof
  • L-oxiracetam hydro-acupuncture for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A levoxiracetam water injection for injection is prepared according to the following steps:

[0023]

[0024]

[0025] Preparation process:

[0026] 1. Concentrated preparation: Add 2 / 3 of the prescription amount of sterile water for injection into the batching tank, add the prescription amount of raw and auxiliary materials, stir, dissolve, and obtain a concentrated liquid preparation;

[0027] 2. Dilute preparation: Take the concentrated preparation, add sodium phosphate buffer solution (precisely weigh 65.697g of disodium hydrogen phosphate and 2.346g of sodium dihydrogen phosphate, put it in a 1000ml volumetric flask, add purified water to dissolve, dilute to the scale , to obtain) adjust the pH to 6.5, add mass fraction of 0.1% to 0.3% activated carbon, absorb and decolorize, filter with a 0.45 μm filter membrane, collect the filtrate, add sterilized water for injection to the prescribed amount, pass the intermediate product inspection , you can;

[0028] 3...

Embodiment 2

[0077] A levoxiracetam water injection for injection is prepared according to the following steps:

[0078]

[0079] Preparation process: prepared according to the preparation process of Example 1.

[0080] By the test method of embodiment 1, the sample stability test result of embodiment 2 shows that the sample quality is stable in accelerated June, and the quality is stable in long-term 18 months, so this product is valid for at least 18 months. The test results of the effect of sterilization process on the increase of impurities show that the prescription of Example 2, combined with a specific sterilization process, increases the related substances significantly better than that of the control sample. The results of the mouse writhing method to observe the pain during the injection process showed that the pain of the sample of Example 2 was significantly weaker than that of the control sample during the left injection. Experiments on the influence of different pH regula...

Embodiment 3

[0082] A levoxiracetam water injection for injection is prepared according to the following steps:

[0083]

[0084] Preparation process: prepared according to the preparation process of Example 1.

[0085] By the test method of embodiment 1, the sample stability test result of embodiment 3 shows that the sample quality is stable in accelerated June, and the long-term quality is stable in 18 months, so this product is valid for at least 18 months. The test results of the effect of sterilization process on the increase of impurities show that the prescription of Example 3, combined with a specific sterilization process, has significantly better increase of related substances than the control sample. The results of the mouse writhing method to observe the pain during the injection process showed that the pain of the sample of Example 3 was significantly weaker than that of the control sample during the left injection. Experiments on the influence of different pH regulators o...

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

No PUM Login to View More

Abstract

An L-oxiracetam hydro-acupuncture for injection is disclosed. According to the invention, 58-72% of L-oxiracetam, 8-22% of glycerin, 13-25% of glycine, 3-8% of vitamin C, 2-5% of ethylene diamine tetraacetic acid and 1-3% of benzyl alcohol which are used as raw materials and auxiliary materials undergo steps of concentrated mixing, diluted mixing, encapsulation, sterilization, inspection and packaging to prepare the L-oxiracetam hydro-acupuncture for injection. During the sterilization process of the L-oxiracetam hydro-acupuncture for injection, pH value of the solution is barely changed, the product is not easy to oxidize, and impurity increasing amount is only 0.02% during the sterilization process. Dissolvability of main drug of the product is good. Insoluble particles are lower than 25 microns. Stability is good. The period of validity is as long as 18 months and above. The product has less impurity during the period of validity, and the total impurity content is lower than 0.28%. Pains of patients are obviously reduced during the injection process, and patients' compliance is good. The product is worthy of market promotion.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam water injection for injection and a preparation method thereof. Background technique [0002] Oxiracetam was launched in Italy in 1987 in the form of tablet, 800mg; capsule, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei et al mentioned in the patent publication No. CN 103735545 A that levoxiracetam has an obvious wake-promoting effect on coma caused by alcoholism, while dextro-oxiracetam has basically no effect. The wake-up effect is twice that of racemic oxiracetam; levo-oxiracetam has significant awakening effects on trauma and coma induced by anesthesia. Zhang Feng et al disclosed in the patent with the publication number CN 103599101 A that levoxiracetam can significantly improve the learning, memory and cognitive dysfunction in rats...

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): A61K9/08A61K31/4015A61K47/10A61K47/18A61K47/22A61P25/28
CPCA61K9/0019A61K9/08A61K31/4015A61K47/10A61K47/183A61K47/22
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com