Gemcitabine hydrochloride or gemcitabine composition

A technology of gemcitabine hydrochloride and gemcitabine, which is applied in the directions of drug combination, non-active components of polymer compounds, drug delivery, etc., can solve the problems of reduced stability, clinical efficacy, small molecular weight, etc., so as to improve drug tolerance and improve stability , Simple and convenient clinical use

Inactive Publication Date: 2009-05-13
常州安孚立德药业技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is still difficult to encapsulate gemcitabine hydrochloride or gemcitabine stably in the liposome system in the current traditional liposome technology, because gemcitabine has a small molecular weight and can freely enter and exit the liposome quickly when the pH value is neutral in the body. Layer film
Therefore, shortly after the preparation of gemcitabine hydrochloride or gemcitabine liposomes, gemcitabine hydrochloride or gemcitabine can quickly diffuse out of the liposome bilayer membrane, thereby reducing the stability and clinical utility of the product

Method used

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  • Gemcitabine hydrochloride or gemcitabine composition

Examples

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preparation Embodiment 1

[0034] Preparation Example 1: 100ml gemcitabine hydrochloride solution and 100mg / bottle gemcitabine hydrochloride lyophilized powder

[0035] Preparation Composition: Gemcitabine Hydrochloride 1000mg

[0036] Human serum albumin (~MW66K) 10000mg

[0037] Polyvinylpyrrolidone (K17) 10000mg

[0038] Disodium hydrogen phosphate 1420mg

[0039] Mannitol 3000mg

[0040]Vitamin C 0.5mg

[0041] appropriate amount of water for injection

[0042] Hydrochloric acid or sodium hydroxide appropriate amount

[0043] Preparation method: Dissolve disodium hydrogen phosphate in water for injection, adjust the pH value to 7.5 and prepare disodium hydrogen phosphate buffer solution. Dissolve human serum albumin, polyvinylpyrrolidone, mannitol, and vitamin C in disodium hydrogen phosphate buffer solution, add gemcitabine hydrochloride after complete dissolution, adjust the pH value to 7.5 after complete dissolution, and dilute to ...

preparation Embodiment 2

[0044] Preparation Example 2: 10ml gemcitabine hydrochloride solution

[0045] Preparation Composition: Gemcitabine Hydrochloride 150mg

[0046] Bovine serum albumin (~MW69K) 600mg

[0047] Polyvinylpyrrolidone (K17) 1000mg

[0048] Sodium dihydrogen phosphate 120mg

[0049] Sucrose 300mg

[0050] EDTA0.05mg

[0051] appropriate amount of water for injection

[0052] Hydrochloric acid or sodium hydroxide appropriate amount

[0053] Preparation method: Dissolve sodium dihydrogen phosphate in water for injection, adjust the pH value to 7.4, and prepare sodium dihydrogen phosphate buffer solution. Dissolve bovine serum albumin, polyvinylpyrrolidone, sucrose and EDTA in sodium dihydrogen phosphate buffer solution, add gemcitabine hydrochloride after complete dissolution, adjust the pH value to 7.4 after complete dissolution, dilute to volume with the prepared buffer solution, and filter to sterilize Finally, the solution is filled in type ...

preparation Embodiment 3

[0054] Preparation Example 3: 10ml gemcitabine hydrochloride solution

[0055] Preparation Composition: Gemcitabine Hydrochloride 50mg

[0056] Human serum albumin (~MW66K) 1000mg

[0057] Polyvinylpyrrolidone (K17) 500mg

[0058] Citric acid 154mg

[0059] Sodium chloride 500mg

[0060] Vitamin C 0.05mg

[0061] Mannitol 100mg

[0062] appropriate amount of water for injection

[0063] Hydrochloric acid or sodium hydroxide appropriate amount

[0064] Preparation method: Dissolve citric acid in water for injection, adjust the pH value to 7.0, and prepare a citric acid buffer solution. Dissolve human serum albumin, polyvinylpyrrolidone, sodium chloride, vitamin C and mannitol in citric acid buffer solution, add gemcitabine hydrochloride after complete dissolution, adjust the pH value to 7.0 after complete dissolution and use the prepared buffer solution to volume After filter sterilization, ...

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Abstract

The invention belongs to the field of pharmacy, which discloses hydrochloric gemcitabine or gemcitabine composition. The composition comprises components in the following weight ratio: the ratio of hydrochloric gemcitabine or gemcitabine, polymer and protein is 0.1 to 20:0.00 to 50:0.00 to 20, wherein, the weight of polymer and protein is not zero at the same time. The composition can effectively prevent hydrochloric gemcitabine or gemcitabine from loosing the activity in vivo, and has the advantages of good stability, low toxicity and good efficacy.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to an anti-tumor gemcitabine hydrochloride or a gemcitabine composition with good stability, low toxicity and high curative effect. Background technique [0002] Gemcitabine hydrochloride or gemcitabine is an antitumor compound. In 1996, the U.S. FDA approved gemcitabine hydrochloride produced by Lilly Company of the United States as a first-line drug for the treatment of pancreatic cancer. Approved in 1998 as a drug for the treatment of non-small cell lung cancer. In 1999, my country approved the import of gemcitabine hydrochloride anti-tumor drug, and the domestic imitation product was approved for marketing in 2003. [0003] US Patent 4,808,614 records gemcitabine hydrochloride or gemcitabine as an anti-filtering pathogen compound, and its antitumor properties are recorded in US Patent 5,464,826, both of which are hereby incorporated by reference. The formulation technology of gemcitabine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7068A61K47/42A61K9/08A61K9/19A61P35/00
Inventor 贺欣贺明
Owner 常州安孚立德药业技术有限公司
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