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Irinotecan hydrochloride injection and preparation method thereof

A technology of irinotecan hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, and can solve problems such as reducing adverse reactions of delayed diarrhea, safety risks of injections, and complicated preparation processes. Achieve the effect of drug dependence and treatment effect promotion, adverse reaction reduction, and simple production method

Active Publication Date: 2012-09-19
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of the above two liposome preparations is complicated, and organic solvents are introduced, which may bring safety risks to injections
[0010] In summary, the prior art discloses only how to solve the stability problem of irinotecan hydrochloride preparations, and there is no report on how to reduce the adverse reaction of delayed diarrhea produced by irinotecan through preparation means

Method used

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  • Irinotecan hydrochloride injection and preparation method thereof
  • Irinotecan hydrochloride injection and preparation method thereof
  • Irinotecan hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
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Embodiment 1-5

[0026] The preparation of embodiment 1-5 irinotecan hydrochloride injection

[0027]

[0028] The preparation technology of above-mentioned embodiment is as follows:

[0029] (1) Take water for injection of 75%-85% of the total volume of the prescribed amount in the batching tank, add the prescribed amount of sorbitol, stir to dissolve and mix evenly, then add the prescribed amount of irinotecan hydrochloride, at 70℃±5 Stirring and mixing under the temperature condition of ℃;

[0030] (2) Cool down the solution obtained in step (1) to below 30°C, add phosphoric acid to adjust the pH value of the solution to 3.0-3.8, and add the remaining amount of water for injection below 30°C to volume;

[0031] (3) Add activated carbon for needles accounting for 0.1% of the total weight of the solution to the solution obtained in step (2), stir for 15-45 minutes and then filter for decarbonization;

[0032] (4) The medicinal solution obtained in step (3) is filtered through one 0.45 μ...

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Abstract

The invention relates to an irinotecan hydrochloride injection consisting of irinotecan hydrochloride (15-25g / L), sorbierite (17.5-22.5g / L), and the balance of phosphoric acid and injection water, wherein the phosphoric acid adjusts the pH of the injection to 3.0-3.8. The invention also relates to a preparation method of the irinotecan hydrochloride injection. Compared with the prior art, the irinotecan hydrochloride injection disclosed by the invention has the following beneficial effects: (1) the untoward effect is reduced; as shown in an animal test, the irinotecan hydrochloride injection disclosed by the invention can greatly reduce the untoward effect of delayed-onset diarrhea caused by irinotecan, which has an active promotion effect on the drug dependency and treatment effect of cancer patients; (2) the stability is high, as shown in an acceleration test, the character, acidity, solution clarity and color, insoluble particles, visible foreign matters, moisture, related substance and content of the irinotecan hydrochloride injection meet the regulations; and (3) the preparation method is simple and is favorable to the industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, in particular to an irinotecan hydrochloride injection and a preparation method thereof. Background technique [0002] Cancer is a common and frequently-occurring disease that seriously endangers people's lives and health. Due to the different parts of the cancer, there can be various cancers, such as gastric cancer, esophageal cancer, lung cancer, bone cancer, skin cancer, intestinal cancer, gastric cancer, etc. wait. The death rate caused by cancer in my country ranks second among all causes (accounting for 17.9%), and the incidence rate is on the rise, among which the incidence rates of lung cancer and intestinal cancer are relatively high. [0003] Irinotecan hydrochloride (Irinotecan hydrochloride) is a semi-synthetic derivative of camptothecin that can specifically inhibit DNA topoisomerase I, thereby achieving anti-tumor effects. It is metabolized in most tissues by...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4745A61P35/00
Inventor 郭昭
Owner NANJING CHENGONG PHARM CO LTD
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