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Granisetron hydrochloride glucose injection and preparation method thereof

A technology for granisetron hydrochloride and glucose injection, which is applied to the field of granisetron hydrochloride and glucose injection and its preparation, can solve the problems of low sterility assurance level, complicated production process and high production cost, and achieves reduction of chance of contamination, The effect of reducing toxic side effects and improving quality stability

Inactive Publication Date: 2014-12-24
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese Patent Application Publication No. CN103340857 A (Application Publication Date: October 09, 2013) discloses a granisetron composition for injection and a preparation method thereof, which has a low level of sterility assurance, complicated production process, long production cycle and high production cost. high

Method used

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  • Granisetron hydrochloride glucose injection and preparation method thereof
  • Granisetron hydrochloride glucose injection and preparation method thereof
  • Granisetron hydrochloride glucose injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] prescription

[0020]

[0021]

[0022] craft

[0023] (1) Dissolve the prescribed amount of glucose in about 1 / 3 of water for injection, add an appropriate amount of activated carbon for needles, decarbonize and filter through a titanium rod filter, transfer it to a diluted tank and then use about 1 / 3 of the injection Rinse the concentrated tank with water and transfer to the thin tank.

[0024] (2) Add the prescribed amount of granisetron hydrochloride and add water for injection to the full amount, adjust the pH to 4.0 with 0.1mol / L HCl, stir evenly, filter, take a sample to detect the intermediate, and pour 50ml to 500ml of Nitrogen protection during the filling process in the infusion bottle.

[0025] (3) Plug and cover, sterilize at 115°C for 30 minutes with high temperature and humidity, and pack it into the warehouse after passing the light inspection.

Embodiment 2

[0027] prescription

[0028]

[0029] craft

[0030] (1) Dissolve the prescribed amount of glucose in about 1 / 3 of water for injection, add an appropriate amount of activated carbon for needles, decarbonize and filter through a titanium rod filter, transfer it to a diluted tank and then use about 1 / 3 of the injection Rinse the concentrated tank with water and transfer to the thin tank.

[0031] (2) Add the prescribed amount of granisetron hydrochloride and add water for injection to the full amount, adjust the pH to 4.5 with 0.1mol / L HCl, stir evenly, filter, take a sample to detect the intermediate, and pour 50ml to 500ml of Nitrogen protection during the filling process in the infusion bottle.

[0032] (3) Plug and cover, sterilize at 115°C for 30 minutes with high temperature and humidity, and pack it into the warehouse after passing the light inspection.

Embodiment 3

[0034] prescription

[0035]

[0036] craft

[0037] (1) Dissolve the prescribed amount of glucose in about 1 / 3 of water for injection, add an appropriate amount of activated carbon for needles, decarbonize and filter through a titanium rod filter, transfer it to a diluted tank and then use about 1 / 3 of the injection Rinse the concentrated tank with water and transfer to the thin tank.

[0038] (2) Add the prescribed amount of granisetron hydrochloride and add water for injection to the full amount, adjust the pH to 5.0 with 0.1mol / L HCl, stir evenly, filter, take a sample to detect the intermediate, and pour 50ml to 500ml of Nitrogen protection during the filling process in the infusion bottle.

[0039] (3) Plug and cover, sterilize at 115°C for 30 minutes with high temperature and humidity, and pack it into the warehouse after passing the light inspection.

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PUM

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Abstract

The invention relates to a granisetron hydrochloride glucose injection and a preparation method thereof. Single dose comprises 3.35 mg of granisetron hydrochloride, and the dosage of glucose is 5% of water for injection. The granisetron hydrochloride glucose injection and the preparation method thereof have the advantages that the production time is shortened greatly, contamination opportunities are reduced, and a large amount of energy can be saved; and prepared products have the advantages that toxic and side effects can be reduced, the quality is more stable, and higher safety and reliability are achieved.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a granisetron hydrochloride glucose injection and a preparation method thereof. Background technique: [0002] Granisetron hydrochloride is a potent and highly selective 5-HT3 receptor antagonist in peripheral neurons and central nervous system. It has good preventive and therapeutic effects on nausea and vomiting caused by chemotherapy, radiotherapy and surgery. This product is the second-generation 5-HT3 receptor antagonist listed after ondansetron. It was first listed in South Africa by Smith Kline-Beecham of the United States. At present, this product has been sold in the United States, France, Japan, Germany, and Italy. And more than a dozen countries and regions listed applications. In 1993, my country approved the import of the products of SmithKline - Beecham, and the second part of the Chinese Pharmacopoeia 2010 edition included the quality standards of grani...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/439A61K47/26A61K47/04
Inventor 赵志全吕永超张瑜石其德
Owner SHANDONG NEWTIME PHARMA
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