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Irinotecan hydrochloride liquor type injection and preparation method thereof

A technology of irinotecan hydrochloride and injections, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of increasing the risk of patients' medication, high production costs, non-terminal sterilization, etc., and achieve reduction Effects of medication risk, production cost reduction, and stable product quality

Active Publication Date: 2011-01-26
SHANGHAI ACEBRIGHT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with aqueous solution, freeze-dried powder has the following disadvantages: 1. High production cost; 2. Non-terminal sterilization, low level of sterility assurance, complex process, high requirements for production environment and equipment; 3. Inconvenient to use, need to inject solution to dissolve , increasing the chance of contamination
[0004] At present, the irinotecan hydrochloride injections produced by domestic and foreign manufacturers all contain a considerable amount of sorbitol as a stabilizer in their prescriptions, which not only increases the cost, but also increases the risk of medication for patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] In a glass container, dissolve 40g of irinotecan hydrochloride in 1600ml water for injection, add 0.5M lactic acid-sodium lactate solution (40ml) with a concentration of 0.5M and pH 2.5 to adjust the pH to 3.0, add water to make the volume to 2000ml, filter, and package , Moist heat sterilization to obtain the product.

[0019] Detected by HPLC, the long-term stability data is as follows:

[0020] index

Embodiment 2

[0022] In a glass container, dissolve 45g of irinotecan hydrochloride with 1800ml water for injection, add 0.5M acetic acid-sodium acetate solution (25ml) with a pH of 3.0 to adjust the pH to 3.5, add water to make the volume up to 2000ml, filter, and package , Damp heat sterilization.

[0023] Detected by HPLC, the long-term stability data is as follows:

[0024] index

Embodiment 3

[0026] Dissolve 30g of irinotecan hydrochloride in 1100ml water for injection (glass container), add 1M citric acid-sodium citrate solution (30ml) with a concentration of 1M and pH 4.5 to adjust the pH to 4.2, add water to make the volume up to 2000ml, Filter, encapsulate, and sterilize by moist heat.

[0027] Detected by HPLC, the long-term stability data is as follows:

[0028] index

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PUM

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Abstract

The invention discloses an irinotecan hydrochloride liquor type injection and a preparation method thereof, which is characterized in that the injection contains buffer salt, no stabilizing agent, i.e. sorbierite. In addition, the invention also discloses a preparation method of the irinotecan hydrochloride injection. The irinotecan hydrochloride injection obtained by utilizing the method has stable quality, pharmacy safety and low production cost.

Description

Technical field [0001] The invention relates to the field of irinotecan hydrochloride preparations, in particular to an irinotecan hydrochloride injection and a preparation method thereof. Background technique [0002] Irinotecan hydrochloride (Irinotecan, CPT-11) is a water-soluble camptothecin derivative jointly developed by Daiichi Seiyaku and YakultHonsha in Japan. The chemical name is (+)-(4S)-4, 11-diethyl- 4-Hydroxy-9[(4-piperidinylpiperidine)carbonyl]-1H-pyrano[3′,4′:6,7]indolazine[1,2-b]quinoline-3,14 -(4H, 12H)-Diketone hydrochloride trihydrate. Irinotecan hydrochloride is a modified natural camptothecin derivative. It is an anti-cancer drug with definite curative effect and less toxic and side effects. It is a specific drug for advanced colorectal cancer. For patients who have failed chemotherapy with 5-fluorouracil, this product can be used as a second-line treatment. It is also effective for small cell and non-small cell lung cancer, cervical cancer and ovarian can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4745A61P35/00
Inventor 刘蔚张静李小强马素伟
Owner SHANGHAI ACEBRIGHT PHARMA CO LTD
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