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Pentagastrin liquid injection and preparation method thereof

A technology of pentagastrin and water injection, which is applied in the field of medicine and can solve problems such as easy precipitation of precipitates, unsatisfactory stability, and problems with product quality stability

Inactive Publication Date: 2012-06-27
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] 1) Adding Tween-80 in the preparation, although it can help dissolve, but because Tween-80 has adverse reactions such as hemolysis, the use of Tween-80 in injections is not recommended at present;
[0009] 2) The product obtained by the above-mentioned process has unsatisfactory stability after the accelerated investigation test, and precipitates are easily precipitated (or visible foreign matter is unqualified);
[0010] 3) After the accelerated test, the content of pentagastrin decreased significantly, reaching more than 8% (the labeled amount was 90.0%-110.0%), and there was a problem with the stability of product quality

Method used

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  • Pentagastrin liquid injection and preparation method thereof
  • Pentagastrin liquid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Pentagastrin Water Injection

[0035] 1. The prescription is: pentagastrin 200mg; cysteine ​​hydrochloride 0.4g; hydroxypropyl-β-cyclodextrin 20g; water for injection is added to 2000ml.

[0036] 2. Preparation method:

[0037] 1) Preparation:

[0038] Take 600ml of water for injection, first adjust the pH to 10.0 with concentrated ammonia water, then add the prescribed amount of pentagastrin to dissolve, and obtain the solution ①;

[0039] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add 400ml of water for injection, stir until completely dissolved, add 0.2% activated carbon for needles, stir at room temperature for 15 minutes, filter and decarbonize to obtain a solution②;

[0040] Take the prescribed amount of cysteine ​​hydrochloride and dissolve it in 300ml of water for injection; add 0.1% activated carbon for needles, heat to 72°C, stir for 20 minutes, filter and decarbonize to obtain a solution③;

[0041] Combine solution ①, solution ...

Embodiment 2

[0051] Example 2: Pentagastrin Water Injection

[0052] 1. Prescription: pentagastrin 300mg; cysteine ​​hydrochloride 0.6g; hydroxypropyl-β-cyclodextrin 30g; add water for injection to 2000ml.

[0053] 2. Preparation method

[0054] 1) Preparation:

[0055] Take 700ml of water for injection, first adjust the pH to 10.1 with concentrated ammonia water, then add the prescribed amount of pentagastrin to dissolve, and obtain the solution ①;

[0056] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add 400ml of water for injection, stir until completely dissolved, add 0.2% activated carbon for needles, stir at room temperature for 20 minutes, filter and decarbonize to obtain a solution②;

[0057] Take the prescribed amount of cysteine ​​hydrochloride and dissolve it in 400ml of water for injection; add 0.2% activated carbon for needles and heat to 74°C, stir for 20 minutes, filter and decarbonize to obtain a solution③;

[0058] Combine solution ①, solution ②, and sol...

Embodiment 3

[0068] Example 3: Pentagastrin Water Injection

[0069] 1. The prescription is: pentagastrin 400mg; cysteine ​​hydrochloride 0.8g; hydroxypropyl-β-cyclodextrin 40g; water for injection is added to 2000ml.

[0070] 2. Preparation method

[0071] 1) Preparation:

[0072] Take 800ml of water for injection, first adjust the pH to 10.1 with concentrated ammonia water, then add the prescribed amount of pentagastrin to dissolve, and obtain the solution ①;

[0073] Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add 500ml of water for injection, stir until completely dissolved, add 0.2% activated carbon for needles, stir at room temperature for 30min, filter and decarbonize to obtain a solution②;

[0074] Take the prescribed amount of cysteine ​​hydrochloride and dissolve it in 500ml of water for injection; add 0.2% activated carbon for needles and heat to 75°C, stir for 30 minutes, filter and decarbonize to obtain a solution③;

[0075] Combine solution ①, solution ②, ...

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PUM

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Abstract

The invention relates to a pentagastrin liquid injection and a preparation method thereof. The liquid injection is manufactured from components of: 200-400mg of pentagastrin, 0.4-0.8g of cysteine hydrochloride, and 20-40g of hydroxypropyl-beta-cyclodextrin. The volume of the injection is regulated to 2000ml by adding water for injection. The liquid injection provided by the invention is advantaged in improved stability. The effect of the liquid injection is better than that of prior art.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a pentagastrin aqueous injection and a preparation method thereof. Background technique [0002] Pentagastrin, chemical name: N-[(1,1-dimethylethoxy)carbonyl]-β-alanyl-L-tryptophanyl-L-methionyl-L- Aspartyl-L-phenylpropanamide. Molecular formula: C 37 h 49 N 7 o 9 S; molecular weight: 767.9. [0003] Pentagastrin can promote the secretion of gastric acid, pepsin and intrinsic factor. Its gastric acid secretion-promoting effect is equivalent to 1 / 4 of endogenous gastrin, but stronger than histamine phosphate and diethylpyrazole hydrochloride. Lasts 10-40 minutes. [0004] Pentagastrin injection is a sterilized aqueous solution of pentagastrin, containing pentagastrin (C 37 h 49 N 7 o 9 S) is 90.0%-110.0% of the labeled amount. Properties: It is a colorless clear liquid. Clinically, it is mainly injected subcutaneously or intramuscularly, 6 μg / Kg at a time, or intravenously inf...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/08A61K47/48A61K49/00A61P1/00
Inventor 尹双青刘永宏
Owner 蚌埠丰原涂山制药有限公司
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