Pharmaceutical composition of paclitaxel and ranitidine hydrochloride

A technology of ranitidine hydrochloride and paclitaxel, which is applied in the field of medicine and can solve problems such as unresolved side effects

Inactive Publication Date: 2013-11-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The prior art has taught that paclitaxel can be used in combination with ranitidine, but th

Method used

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  • Pharmaceutical composition of paclitaxel and ranitidine hydrochloride
  • Pharmaceutical composition of paclitaxel and ranitidine hydrochloride
  • Pharmaceutical composition of paclitaxel and ranitidine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Preparation of paclitaxel injection

[0045] prescription:

[0046]

[0047] making process

[0048] (1) First add 2000ml propylene glycol, 250ml povidone K30 and 30g Span 20 into the container, stir and mix well;

[0049] (2) Add 30g paclitaxel, stir to dissolve completely, add water for injection to 4500ml, adjust pH to 4.6 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0050] (3) Add 2.5g of activated carbon for injection, add the remaining water for injection, set the volume to 5000ml, stir and absorb for 30 minutes;

[0051] (4) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0052] (5) Fill, 5ml / bottle, seal, sterilize, and get paclitaxel injection

Embodiment 3

[0062] Example 3 Preparation of Ranitidine Hydrochloride Injection

[0063] prescription:

[0064]

[0065] Preparation Process

[0066] (1) First add 1600ml water for injection into the container; add 50g ranitidine hydrochloride, 11.32g disodium hydrogen phosphate and 6.44g sodium dihydrogen phosphate, stir to dissolve completely, and use 1mol / L sodium hydroxide solution or 1mol / L Phosphoric acid solution to adjust the pH to 6.9; add 1.0g of activated carbon for injection, add the remaining water for injection, set the volume to 2000ml, stir and absorb for 30 minutes; decarbonize the solution through a 0.45μm cartridge filter, and then use a 0.22μm Sterilize and filter with a microporous membrane until visible foreign matter is qualified; fill, 2ml / bottle, seal, and sterilize to obtain ranitidine hydrochloride injection.

[0067] (2) First add 4000ml water for injection into the container; add 50g ranitidine hydrochloride, 11.32g disodium hydrogen phosphate and 6.44g ...

Embodiment 4

[0070] Example 4 Preparation of ranitidine hydrochloride for injection

[0071] prescription:

[0072]

[0073]

[0074] Preparation Process

[0075] (1) First add 4800ml of water for injection into the container;

[0076] (2) Add 150g ranitidine hydrochloride, 450g mannitol, 33.96g disodium hydrogen phosphate and 19.32g sodium dihydrogen phosphate, stir to dissolve completely, adjust the pH with 1mol / L sodium hydroxide solution or 1mol / L phosphoric acid solution to 7.0;

[0077] (3) Add 3g of activated carbon for injection, add the remaining water for injection, set the volume to 6000ml, stir and absorb for 30 minutes;

[0078] (4) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0079] (5) Filling, 2ml / bottle or 4ml / bottle, freeze-dried to obtain ranitidine hydrochloride for injection.

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Abstract

The invention relates to a pharmaceutical composition of paclitaxel and ranitidine hydrochloride, and especially relates to an application product of the pharmaceutical composition, wherein the application product comprises paclitaxel injection and an injection containing ranitidine hydrochloride. Administration comprises following steps, the injection containing ranitidine hydrochloride is applied firstly by intravenous injection, the paclitaxel injection is dissolved and diluted by normal saline or 5% glucose and sodium chloride solution, and then the diluted paclitaxel injection is applied by intravenous drop infusion.

Description

technical field [0001] The invention relates to a pharmaceutical composition of paclitaxel and ranitidine hydrochloride, in particular to a combined application package of paclitaxel injection and the injection containing ranitidine hydrochloride, belonging to the technical field of medicine. Background technique [0002] Paclitaxel is a new type of anti-microtubule drug, by promoting tubulin polymerization, inhibiting depolymerization, maintaining tubulin stability, and inhibiting cell mitosis. In vitro experiments have shown that paclitaxel has a significant radiosensitizing effect, which may cause cells to stop in the G2 and M phases that are sensitive to radiotherapy. [0003] Paclitaxel is a mitosis inhibitor or spindle poison (Spindle poison), and its mechanism of action is different from that of commonly used chemotherapeutic drugs. It induces and promotes the assembly of microtubules. Paclitaxel has the function of polymerizing and stabilizing microtubules, causing ...

Claims

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Application Information

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IPC IPC(8): A61K31/341A61K9/08A61K9/19A61P35/00A61P37/08A61K31/337
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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