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Pharmaceutical composition containing aceglutamide and safflower effective ingredients and formulation thereof

A technology of acetylglutamine and active ingredients, which is applied in the field of pharmaceutical compositions containing acetylglutamine and safflower active ingredients and its preparations, can solve problems such as unstable content of active ingredients, pesticide residues, and difficulty in strict quality control, and achieve The content of active ingredients is clear and the effect is quick

Inactive Publication Date: 2007-05-23
北京天新园医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the frequent reports of adverse reactions of compound drugs of chemical drugs and traditional Chinese medicines, the China Food and Drug Administration issued on February 2, 2005 "About suspending the acceptance of applications for the registration of 117 varieties of Ginkgo Damo injection and other drugs that have national standards." From this point of view, the research and development and production of chemical drugs with definite curative effect and stable quality and compound drugs of traditional Chinese medicine still have certain difficulties.
Due to the shortcomings of the extraction process and the characteristics of Chinese medicinal materials, the quality of safflower is difficult to be strictly controlled
The quality of raw medicinal materials in different origins and different picking seasons is quite different, resulting in preparations, especially the active ingredient content, clarity, and color of injections are not stable enough
The original drug extract contains unpredictable impurities, which are likely to cause adverse reactions, and there are problems of heavy metals and pesticide residues
The content of active ingredients in safflower extract is unstable and there are impurities, which lead to hidden dangers in the safety of its compound preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 - the preparation of the injection of pharmaceutical composition

[0030] [Prescription] Acetyl Glutamine 100g

[0031] Kaempferol-3-Rutinoside 50g

[0032] Glycerin 250ml

[0033] Appropriate amount of water for injection

[0034] Makes 1000ml

[0035][Preparation method] The kaempferol-3-rutinoside of the prescription is dissolved by adding 5 times the amount of water for injection, the pulp is filtered, the filtrate is adjusted to pH, and left to stand for 4 hours. Membrane filtration, add prescribed amount of glycerin and acetylglutamine to the filtrate, stir well, adjust the pH value, constant volume, and finally ultrafilter with an ultrafilter with a molecular weight cut-off of 100,000, fill the filtrate into a 5ml ampoule after passing the test, Sterilize at 100°C for 30 minutes.

Embodiment 2

[0036] Embodiment 2 - the preparation of the injection of pharmaceutical composition

[0037] [Prescription] Acetyl Glutamine 100g

[0038] Neosafflower glycosides 50g

[0039] Saffron quinone 50g

[0040] Glycerin 250ml

[0041] Appropriate amount of water for injection

[0042] Makes 1000ml

[0043] [Preparation method] Add 3 times the amount of water for injection to dissolve the prescribed amount of neosafflower glycosides and safflower quinone glycosides, filter the pulp, adjust the pH value of the filtrate, let it stand for 4 hours, filter the filtrate pulp, and then use a 0.45 μm micropore Membrane filtration, adding prescribed amount of glycerin and acetylglutamine to the filtrate, stirring well, adjusting the pH value, constant volume, and finally ultrafiltering with an ultrafilter with a molecular weight cut-off of 100,000, filling the filtrate into a 5ml ampoule after passing the test , 100 ℃ steril...

Embodiment 3

[0044] Embodiment 3——Preparation of pharmaceutical composition freeze-dried powder injection

[0045] [Prescription] Acetyl Glutamine 100g

[0046] 6-Hydroxykaempferol-3,6,7-triglucoside 50g

[0047] Dextran-40 50g

[0048] Appropriate amount of water for injection

[0049] Makes 200 bottles

[0050] [Preparation method] Add an appropriate amount of water for injection at 80°C to 90°C in the concentrated preparation tank, add 6-hydroxykaempferol-3,6,7-triglucoside into the concentrated preparation tank, stir well, and prepare according to the total volume Add activated carbon at 0.04%, heat at 90°C, keep warm for 20 minutes, cool down to 50°C, decarbonize the liquid medicine and filter it into the dilute tank, add acetylglutamine dissolved with an appropriate amount of NaOH into the dilute tank, stir well to make it completely Dissolve, add dextran-40 excipient, add activated carbon according to 0.02% of the total volu...

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PUM

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Abstract

The invention discloses a pharmaceutical composition and preparation comprising active constituents of aceglutamide and safflower, which can be used for preparing medicaments for treating cardiovascular and cerebrovascular diseases, and can be prepared into tablets, capsules, drop pills, injections, pills, syrups, granules, oral liquids, orally administered turbid liquors or oral emulsions.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a pharmaceutical composition containing acetylglutamine and safflower active ingredients and a preparation thereof. Background technique [0002] Acetylglutamine is N2-acetyl-L-glutamine (C 7 h 12 N 2 o 4 ), which is a white crystalline powder, is often used clinically as a drug for improving brain function. The drug can pass through the blood-cerebrospinal fluid barrier, and after passing through the blood-cerebrospinal fluid barrier, it can be decomposed into glutamic acid and gamma-aminobutyric acid (GABA) to play a role. Glutamic acid participates in the information transmission of the central nervous system. γ-aminobutyric acid can antagonize the excitatory toxicological effect of glutamic acid, improve nerve cell metabolism, maintain nerve stress ability and reduce blood ammonia, and improve brain function. The drug is commonly used clinically for hepatic ...

Claims

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Application Information

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IPC IPC(8): A61K36/286A61K31/7048A61K9/00A61P9/00
Inventor 魏海关
Owner 北京天新园医药科技开发有限公司
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