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Gemcitabine hydrochloride for injection as well as preparation method thereof

A technology for gemcitabine hydrochloride and injection, which is applied in the field of gemcitabine hydrochloride for injection and its preparation, which can solve the problems of introducing allergens and the safety of preparations cannot be guaranteed, so as to increase stability, avoid water degradation, and improve product quality Effect

Inactive Publication Date: 2013-05-08
NANJING ZHENGKUAN MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the freeze-dried powder injection has the advantages of simple process route, short freeze-drying time, and convenient operation, due to the addition of lactose as an additive, it is easy to introduce allergens caused by residual proteins and miscellaneous sugars and other related substances during production. security is not guaranteed

Method used

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  • Gemcitabine hydrochloride for injection as well as preparation method thereof
  • Gemcitabine hydrochloride for injection as well as preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Dissolve 1kg of gemcitabine hydrochloride and 1.6kg of gelatin in 25L of water, dissolve and mix well as the inner water phase (phase W1); 75 / 25, molecular weight 6000) was dissolved in 180L dichloromethane as the oil phase (O phase); 22kg polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 1.0% (w / v), as the external water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsify at a high speed of 18000r / min for about 4min, cool to 10°C, use it as colostrum, and add it to the W2 phase, 15000r / min high-speed oscillating emulsification for about 5 minutes, 5000r / min for 3-5h to evaporate dichloromethane, 10000r / min high-speed centrifugation, use water for injection to wash 3-5 times to remove polyvinyl alcohol, sub-package, half stopper, sample into the box, Freeze drying is carried out as follows:

[0031] (1) After putting the product into the freeze dryer, first lower the temper...

Embodiment 2

[0035] Dissolve 1kg of gemcitabine hydrochloride and 1.8kg of gelatin in 30L of water, dissolve and mix well as the inner water phase (W1 phase); 75 / 25, molecular weight 6000) was dissolved in 200L dichloromethane as the oil phase (O phase); 25kg polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 0.98% (w / v), as the external water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsify at a high speed of 15000r / min for about 5min, cool to 10°C, use it as colostrum, and add it to the W2 phase, 15000r / min high-speed oscillating emulsification for about 5 minutes, 5000r / min for 3-5h to evaporate dichloromethane, 15000r / min high-speed centrifugation, use water for injection to wash 4-7 times to remove polyvinyl alcohol, sub-package, half stopper, sample into the box, Freeze-drying was carried out according to the steps of Example 1.

Embodiment 3

[0037]Dissolve 1kg gemcitabine hydrochloride and 1kg gelatin in 20L water, dissolve and mix well as the inner water phase (W1 phase); mix 15kg polylactic acid-glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is 75 / 25, molecular weight 6000) was dissolved in 100L dichloromethane as the oil phase (O phase); 16kg polyvinyl alcohol was dissolved in water for injection at 80°C, so that the mass volume concentration of polyvinyl alcohol was 1.05% (w / v ), as the external water phase (W2 phase); slowly drop the W1 phase into the O phase, emulsify at a high speed of 15000r / min for about 5min, cool to 10°C, and add it to the W2 phase, 20000r / min Min high-speed oscillation emulsification for about 3 minutes, 4000r / min for 3-5h to evaporate dichloromethane, 10000r / min high-speed centrifugation, use water for injection to wash 3-5 times to remove polyvinyl alcohol, subpackage, half stopper, sample into the box, press The steps of Example 1 were freeze-drie...

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Abstract

The invention discloses gemcitabine hydrochloride for injection. The gemcitabine hydrochloride for injection is frozen and dried by an emulsion prepared from components in parts by weight as follows: 1 part of gemcitabine hydrochloride, 10-15 parts of polylactic acid-hydroxyacetic acid and 1-2 parts of gelatin. According to the invention, gemcitabine hydrochloride dissolved in an oil phase is wrapped in PLGA [Poly(Lactic-co-Glycolicacid)] to avoid degradation in the presence of water, so that the product quality is improved and the stability is enhanced. When the product is redissolved, microballoon particles are uniformly distributed, the drug carrying capacity reaches over 65% and the encapsulation efficiency reaches over 87%, and the drug is continuously and stably released.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to gemcitabine hydrochloride for injection and a preparation method thereof. Background technique [0002] Gemcitabine hydrochloride (Gemcitabine hydrochloride) is a difluoronucleoside antineoplastic drug that destroys cell replication synthesized by Eli Lilly Company of the United States in 1983. It can be metabolized into triphosphate compounds in cells, preventing DNA synthesis. It was launched in Sweden, Netherlands, Finland and South Africa in 1995, and was approved for the treatment of pancreatic cancer and non-small cell lung cancer. Now FDA's Oncology Drug Advisory Committee has recommended this product for advanced and metastatic non-small cell lung cancer, pancreatic cancer, Bladder cancer, breast cancer and other solid tumors. Gemcitabine is one of the most effective first-line drugs for the treatment of non-small cell lung cancer, and is...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7068A61K47/42A61K47/34A61P35/00
Inventor 不公告发明人
Owner NANJING ZHENGKUAN MEDICAL TECH
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