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Pharmaceutical composition containing granisetron hydrochloride compound

A technology of granisetron hydrochloride and its composition, which is applied in the field of freeze-dried powder injection of granisetron hydrochloride and its preparation, can solve the problems of unsatisfactory dissolution speed, easy fluctuation of pH value, insufficient content, etc., and achieve rapid dissolution, The effect of good stability and small fluctuation range

Active Publication Date: 2014-08-13
姚云
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, adding active carbon to decolorize and filter after the production process will easily lead to insufficient content, and the pH value in the product storage process is easy to fluctuate, has instability, and the dissolution rate is not ideal. The present invention provides a new prescription and preparation method to overcome the above defect

Method used

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  • Pharmaceutical composition containing granisetron hydrochloride compound
  • Pharmaceutical composition containing granisetron hydrochloride compound
  • Pharmaceutical composition containing granisetron hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Granisetron hydrochloride 3g;

[0055] Mannitol 150g;

[0056] Sodium hydroxide 2g;

[0057] Vitamin C 1.5g,

[0058] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4;

[0059] Preparation

[0060] (1) Weigh the raw and auxiliary materials according to the prescription quantity

[0061] (2) Add mannitol, sodium hydroxide, and vitamin C to 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4, and stir to dissolve.

[0062] (3) Add the prescribed amount of granisetron hydrochloride into the solution and stir to dissolve completely. Stir to combine.

[0063] (4) Measure the pH value of the solution, which is 7.0.

[0064] (5) Fine filter with a 0.2 μm microporous membrane to check the clarity of the solution.

[0065] (6) According to the measurement results, fill the liquid medicine into a vial with a volume of about 2ml.

[0066] (7) Put the sample into a freeze dry...

Embodiment 2

[0069] Granisetron hydrochloride 3g;

[0070] Mannitol 100g;

[0071] Sodium hydroxide 1g;

[0072] Vitamin C 1g,

[0073] 2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4; preparation method

[0074] Same as Example 1

Embodiment 3

[0076] Granisetron hydrochloride 3g;

[0077] Mannitol 200g;

[0078] Sodium hydroxide 3g;

[0079] Vitamin C 2g,

[0080]2000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4; preparation method

[0081] With embodiment 1.

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Abstract

The invention relates to a pharmaceutical composition containing a granisetron hydrochloride compound, and in particular to a freeze-dried injection preparation of granisetron hydrochloride and a preparation method thereof. For every 1000 injections, the pharmaceutical composition comprises the following components: 3g of granisetron hydrochloride, 100-200g of mannitol, 1-3g of sodium hydroxide, 1-2g of vitamin C, and 2000ml of sodium hydrogencitrate and trisodium citrate buffer liquor with molar ratio of 1:4.

Description

technical field [0001] The invention relates to a freeze-dried powder injection preparation of granisetron hydrochloride and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Granisetron hydrochloride, English name: Granisetron Hydrochloride, is a potent and highly selective peripheral and central nervous system 5-HT3 receptor antagonist, through the upper end and intestinal abdominal centripetal nerve fibers and the nucleus of the solitary tract or the chemoreceptive area of ​​vomiting The blocking effect of 5-HT3 receptor inhibits the nausea and vomiting caused by antineoplastic drugs and radiotherapy. Compared with traditional antiemetic drugs, this product has the following two characteristics: (1) high curative effect and good antiemetic effect; (2) less side effects. The main reason is that the affinity of this product with 5-HT3 receptor is 4000-40000 times higher than that of other receptors (such as dopamine). [0003]...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/439A61K47/26A61K47/22A61P1/08
Inventor 姚云
Owner 姚云
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