Sustained release medicinal auxiliary material for improving stability of basic remedy

A technology for pharmaceutical excipients and stability, which is applied in the field of pharmaceutical excipients, can solve the problems such as the lack of L-arginine-α-ketoglutarate and the like, and achieves the effects of good release uniformity and controlled sustained-release behavior.

Active Publication Date: 2014-11-12
JIANGNAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the existing literature, there is no application of L-arginine-α-ketoglutarate as a sustained and controlled release excipient to improve the stability of the main drug

Method used

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  • Sustained release medicinal auxiliary material for improving stability of basic remedy
  • Sustained release medicinal auxiliary material for improving stability of basic remedy
  • Sustained release medicinal auxiliary material for improving stability of basic remedy

Examples

Experimental program
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Effect test

example 1

[0020] The crude drug human glucagon-like polypeptide-1 (GLP-1) was made into a sterile aqueous solution, which was equally divided into two parts, one of which was added as a test product with L-arginine-α-ketoglutarate (L -Arginine and α-ketoglutaric acid form a salt with a molar ratio of 2:1), the weight ratio of the added amount to the main drug is 10:1, after the dissolution is complete, carry out aseptic filling as usual, and freeze-dry Finally, it was sealed and made under aseptic conditions; the other was directly aseptically filled as a control product, and the rest of the operations were the same as the test product. After placing it for 12 months, measure its main drug content respectively, and the high-efficiency liquid phase diagram sees figure 2 , image 3 . figure 2 Compared with the liquid chromatogram of the raw material drug, the peak time and peak area are almost the same, and there is only one main peak at 12 minutes, and no other impurity peaks are see...

example 2

[0022] The crude drug human glucagon-like polypeptide-1 (GLP-1) was made into a sterile aqueous solution, which was equally divided into two parts, one of which was added as a test product with L-arginine-α-ketoglutarate (L -Arginine and α-ketoglutaric acid form a salt with a molar ratio of 2:1), the weight ratio of the added amount to the main drug is 10:1, after the dissolution is complete, carry out aseptic filling as usual, and freeze-dry Finally, it was sealed and made under aseptic conditions; the other was directly aseptically filled as a control product, and the rest of the operations were the same as the test product. Both the test product and the reference substance are dissolved with 5ml of water for injection, first adjust the pH to 10 with sodium hydroxide solution, mix well, then adjust the pH to 4 with hydrochloric acid solution, mix well, take samples respectively to measure the content of the main drug, the results are as follows: Figure 4 , Figure 5 shown....

example 3

[0024] Prepare curcumin sustained-release tablets according to the general tablet preparation process, L-arginine-α-ketoglutarate (L-arginine and α-ketoglutarate form a salt with a molar ratio of 2:1) ) and the weight ratio of raw material curcumin 50: 1, add an appropriate amount of filler starch in addition, disintegrant microcrystalline cellulose, mix uniformly, take polyvinylpyrrolidone K3010% (w / v, 80% ethanol solution) as Wetting agent, granulating, adding appropriate amount of lubricant magnesium stearate after drying, mixing evenly, and compressing into tablets. Refer to Appendix XC of Chinese Pharmacopoeia 2010 Edition, the first method to measure the in vitro drug release characteristics of preparations: 6 samples were randomly taken and placed in 200ml of deionized water degassed by ultrasonic, respectively, and kept at a constant temperature of (37±0.5)°C. The method speed is (100±5)r·min -1 , take 2.0ml of the receiving solution per hour, filter through a micropo...

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Abstract

The invention discloses an auxiliary material capable of being applied to medicament production, which can significantly improve the stability of a basic remedy, prolong the storage life of medicaments, and simultaneously play a role in sustained release. The auxiliary material is L-arginine-alpha-ketoglutarate, wherein L-arginine and alpha-ketoglutaric acid are prepared into a salt according to a mole ratio of 2:1, and the weight ratio of the L-arginine-alpha-ketoglutarate added into a medicament to the basic remedy is 10:1-50:1.

Description

technical field [0001] The invention relates to a pharmaceutical auxiliary material, in particular to a pharmaceutical auxiliary material capable of improving the stability of the main drug and providing the effect of sustained and controlled release. Background technique [0002] L-Arginine-α-ketoglutarate, the English name is L-Arginine-alpha-Ketoglutarate, English abbreviation AAKG, it is different from the crystalline mixture of L-arginine and α-ketoglutarate, the common mixture is two There is no salt bond between them. L-arginine-α-ketoglutarate is white or light yellow crystal, easily soluble in water, HCl and NaOH solution, slightly soluble in ethanol, insoluble in acetone, ether, etc. [0003] L-arginine-α-ketoglutarate is an amino acid salt health product with increasing sales in the international market. As a functional nutritional enhancer and liver-protecting drug, it is mainly used Rapid muscle growth and recovery, promote the absorption of nutrients and ener...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/18C07C279/14
Inventor 史劲松许正宏钱建瑛陆震鸣
Owner JIANGNAN UNIV
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