Pemetrexed disodium freeze-dried powder injection for injection and preparation method thereof

A technology for pemetrexed disodium and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of increasing drug safety hazards, existing safety hazards, and insignificant improvement effects, and meets the requirements, types and dosages suitable for large-scale production. Less, pH-constant effect

Active Publication Date: 2013-12-11
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the stability problem of pemetrexed disodium freeze-dried preparations, the current technology has done a lot of work through prescription screening and process research, including: CN101411710A discloses a kind of pemetrexed disodium freeze-dried powder injection and its preparation method , the prescription is 50 parts of pemetrexed disodium, 10-50 parts of mannitol, 0.1-1 part of sodium sulfite, pH7-8; however, the addition of antioxidants increases the hidden dangers of drug safety
CN102266298A discloses a pharmaceutical composition of pemetrexed disodium, the prescription is 110 parts of pemetrexed disodium, 60-105 parts of trehalose, and 0-40 parts of lyophilized excipient; but there is no approval at home and abroad The above injection grade excipient trehalose
CN102106833A discloses a pemetrexed disodium freeze-dried powder injection and a preparation method thereof, the prescription of which is pemetrexed disodium: mannitol ratio of 1:0.6-2.0, this technology improves the problem of poor stability of the main drug The effect is not obvious
CN102846563A discloses a pemetrexed disodium injection composition and a preparation method thereof, the composition is made of pemetrexed disodium, mannitol, and β-cyclodextrin; yet cyclodextrin itself has certain Nephrotoxicity, injected into the body, there are potential safety hazards
CN103040834A discloses a pemetrexed disodium for injection, the pemetrexed disodium for injection is prepared from raw materials comprising the following components in parts by weight: pemetrexed disodium compound 50-60 20-40 parts of mannitol and 2-4 parts of arginine; however, arginine itself has certain pharmacological activity, which may bring unexpected adverse consequences to clinical medication
CN102525955A discloses a preparation process of pemetrexed disodium for injection. The prescription is 200 g of pemetrexed disodium, 200 g of mannitol, an appropriate amount of hydrochloric acid or sodium hydroxide, and 10 L of water for injection. After preparing the liquid medicine, it is freeze-dried However, the improvement effect of this technology on the problem of poor stability of the main drug is not obvious
[0005] In addition, the existing technology solves the problem of poor drug stability by adding various freeze-dried proppants and antioxidants and other components

Method used

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  • Pemetrexed disodium freeze-dried powder injection for injection and preparation method thereof
  • Pemetrexed disodium freeze-dried powder injection for injection and preparation method thereof
  • Pemetrexed disodium freeze-dried powder injection for injection and preparation method thereof

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Effect test

Embodiment 1

[0033] Embodiment 1 Pemetrexed disodium freeze-dried powder injection and its preparation process

[0034]

[0035] Process preparation:

[0036] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0037] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 20 minutes, and dried for later use.

[0038] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0039] Preparation of medicinal solution: Weigh the prescribed amount of pemetrexed disodium, add it to water for injection cooled to 15-30°C, stir to dissolve, add the prescribed amount of disodium hydrogen phosphate and potassium dihydrogen phosphate, stir to dissolve, hydrogen A...

Embodiment 2

[0042] Embodiment 2 Pemetrexed disodium freeze-dried powder injection and its preparation process

[0043]

[0044] Process preparation:

[0045] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0046] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 20 minutes, and dried for later use.

[0047] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0048] Preparation of medicinal solution: Weigh the prescribed amount of pemetrexed disodium, add it to water for injection cooled to 15-30°C, stir to dissolve, add the prescribed amount of disodium hydrogen phosphate and potassium dihydrogen phosphate, stir to dissolve, hydrogen Sod...

Embodiment 3

[0051] Embodiment 3 pemetrexed disodium freeze-dried powder injection and its preparation process

[0052]

[0053] Process preparation:

[0054] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0055] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 20 minutes, and dried for later use.

[0056] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0057] Preparation of medicinal solution: Weigh the prescribed amount of pemetrexed disodium, add it to water for injection cooled to 15-30°C, stir to dissolve, add the prescribed amount of disodium hydrogen phosphate and potassium dihydrogen phosphate, stir to dissolve, hydrogen A...

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Abstract

The invention discloses a pemetrexed disodium freeze-dried powder injection for injection and a preparation method thereof. The pemetrexed disodium freeze-dried powder injection contains disodium hydrogen phosphate and dipotassium hydrogen phosphate buffer salt, wherein the weight ratio of disodium hydrogen phosphate to dipotassium hydrogen phosphate is (8-10):1, and the pH value of liquid medicine is 6.5-7.5 before freeze-drying. The pemetrexed disodium freeze-dried powder injection disclosed by the invention enhances the pharmaceutical stability, has the advantages of less auxiliary material variety and usage amount, more safety and reliability and simple preparation process, and meets the requirement for mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried powder injection of pemetrexed disodium for injection and a preparation method thereof. Background technique [0002] The chemical name of pemetrexed disodium is N-(4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrole[2,3 -d]pyrimidin-5-yl)ethyl]benzoyl)-L-glutamate disodium, which is a new anti-tumor drug acting on multiple targets in the folic acid metabolism process. Preclinical and clinical studies have confirmed that it has clear anti-multiple solid tumor activity, including lung cancer, breast cancer, pancreatic cancer, ovarian cancer, etc., and is particularly effective for the treatment of malignant pleural mesothelioma (MPM). [0003] As an anticancer drug, pemetrexed disodium is very irritating to the gastrointestinal tract, so the drug is preferably administered by injection. Lilly, the original manufacturer, has launched a freeze-dried preparation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/519A61K47/02A61P35/00
Inventor 张玮冯军明
Owner NANJING CHIA TAI TIANQING PHARMA
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