Prescription and preparation process for irinotecan hydrochloride injection

A technology of irinotecan hydrochloride and preparation process, which can be applied in directions such as pharmaceutical formulation, drug delivery, and drug combination, can solve problems such as lack of effective drugs, and achieve the effects of good sterilization effect, convenient use and easy production.

Inactive Publication Date: 2013-05-15
HARBIN PHARMA GROUP BIOLOGICAL ENG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although the curative effect can be improved by prolonging the infusion time of 5-FU or adding bio

Method used

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  • Prescription and preparation process for irinotecan hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Take precisely weighed lactic acid, add 20%-30% of the proportioned amount of water for injection at 75°C to 85°C, stir to dissolve, then slowly pour the precisely weighed irinotecan hydrochloride into the lactic acid solution and stir evenly, then quickly Add 60% to 70% of the dosed water for injection at 75°C to 85°C and fully stir until completely dissolved, then add precisely weighed sorbitol, and stir at a speed of 1200-1500rpm for more than 20 minutes until completely dissolved. Add 0.1% activated carbon (W / V), stir and adsorb at 900-1100rpm for 30 minutes. Decarbonize with a 0.45μm metal filter. Add water for injection to a dosage of 95% (mass percentage), adjust the pH value to 3.2-3.6 with a concentration of about 0.2 mol / L sodium hydroxide solution or hydrochloric acid, add water for injection to 30L, and stir at a speed of 900-1100 rpm for 5 ~15 minutes. 0.22μm microporous membrane filtration. Filling, stoppering and capping, sterilization (sterilization i...

Embodiment 2

[0031] Take precisely weighed lactic acid, add 20%-30% of the proportioned amount of water for injection at 75°C to 85°C, stir to dissolve, then slowly pour the precisely weighed irinotecan hydrochloride into the lactic acid solution and stir evenly, then quickly Add 60% to 70% of the dosed water for injection at 75°C to 85°C and fully stir until completely dissolved, then add precisely weighed sorbitol, and stir at a speed of 1200-1500rpm for more than 20 minutes until completely dissolved. Add 0.1% activated carbon (W / V), stir and adsorb at 900-1100rpm for 30 minutes. Decarbonize with a 0.45μm metal filter. Add water for injection to a dosage of 95% (mass percentage), adjust the pH value to 3.2-3.6 with a concentration of about 0.2 mol / L sodium hydroxide solution or hydrochloric acid, add water for injection to 30L, and stir at a speed of 900-1100 rpm for 5 ~15 minutes. 0.22μm microporous membrane filtration. Filling, stoppering and capping, sterilization (moist heat ster...

Embodiment 3

[0033] The accelerated stability study of irinotecan hydrochloride injection prepared by two sterilization methods is carried out, and the experimental results are compared as follows:

[0034]

[0035] Conclusion: From the above comparative experiments, the results show that the sterilization effect of rotating water is good, which can effectively control the increase of related substances in irinotecan hydrochloride injection, prolong the validity period, and make the drug quality and safety controllable.

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Abstract

The invention provides a prescription and a preparation process for an irinotecan hydrochloride injection. The preparation process comprises the following steps: weighing and re-checking; preparation of a soup; removal of bacteria through filtration; sterile filling; and terminal sterilization. The invention is characterized in that since the process employs rotating water-bath for terminal sterilization, fast production is realized, the amount of related substances can be effectively controlled, the period of validity is prolonged and irinotecan hydrochloride in the injection is allowed to be more stable.

Description

technical field [0001] The invention relates to the field of irinotecan hydrochloride preparations, in particular to a prescription of irinotecan hydrochloride injection and a preparation process thereof. Background technique [0002] Due to the change of living environment and lifestyle, as well as the influence of objective factors such as the aging of the population and the increase of living pressure, the incidence of malignant tumors in my country has continued to rise, becoming the first fatal disease. Colorectal cancer is one of the most common malignant tumors. Among digestive tract tumors, the incidence of colorectal cancer ranks third after gastric cancer and esophageal cancer. The number of new cases of colorectal cancer in the world reaches 940,000 every year, and nearly 500,000 people die of colorectal cancer every year. Colorectal cancer is the third leading cause of cancer death. [0003] Colorectal cancer is also one of the most common malignant tumors in...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4745A61P35/00
Inventor 张玉华王忠孙照英陈玉军苏宏健
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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