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Palonosetron medicament composition and preparation method thereof

A technology of palonosetron and its composition, which is applied in the field of palonosetron pharmaceutical composition and its preparation, can solve the problems of inconvenient use, storage and transportation, and achieve market risk reduction, stable quality, and simple and easy method line effect

Inactive Publication Date: 2014-03-26
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The palonosetron pharmaceutical composition produced by the prior art has very strict requirements on storage and protection from light, and is inconvenient in use, storage and transportation

Method used

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  • Palonosetron medicament composition and preparation method thereof
  • Palonosetron medicament composition and preparation method thereof
  • Palonosetron medicament composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Every 1000 described palonosetron pharmaceutical compositions, its formula consists of:

[0052]

[0053]

[0054] Preparation process: Take 70% of the prescribed amount of water for injection, at a temperature of 50-60°C, add the prescribed amount of acetic acid and calcium sodium edetate, stir and dissolve; measure the initial pH value, and use 4% acetic acid solution according to the initial pH value Adjust the pH range to 3.0-4.0; add the prescribed amount of palonosetron, and stir until it is completely dissolved; add 0.05% medicinal charcoal to the solution, and stir for 30 minutes at 50-60°C; filter with suction, and add water for injection to The whole amount is mixed evenly; fine filtration; filling; autoclaving at 121° C. for 20 minutes; lamp inspection; storage; the palonosetron pharmaceutical composition is obtained.

Embodiment 2

[0056] Every 1000 described palonosetron pharmaceutical compositions, its formula consists of:

[0057]

[0058] Preparation process: with embodiment 1.

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PUM

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Abstract

The invention discloses a palonosetron medicament composition for injection. The palonosetron injection consists of palonosetron, acetic acid and sodium calcium edetate. The preparation method comprises the following steps: adding a prescription amount of acetic acid and sodium calcium edetate into injection water, stirring to dissolve, adjusting the pH value, adding palonosetron, stirring till complete dissolving, adding medicinal charcoal, stirring, performing suction filtration, compensating injection water till being full dose, uniformly mixing, finely filtering, filling, sterilizing, inspecting in light and storing in warehouses so as to obtain the palonosetron medicament composition. The palonosetron medicament composition is good in stability, the product yield is improved, the cost is lowered, industrialization is achieved, and the palonosetron medicament composition can be well applied to clinical treatment and has remarkable advantages.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a palonosetron pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Malignant tumors have become the leading cause of death among urban and rural residents in my country. The incidence of cancer in my country is 180 / 100,000, and there are 2 million new cancer patients every year. The most basic treatment for cancer is chemotherapy. Almost all anticancer drugs can cause nausea and vomiting during treatment, but the strength is different. Nausea and vomiting often lead to dehydration, acute renal failure (especially in patients with repeated use of cisplatin chemotherapy), electrolyte imbalance, esophageal damage, and even make patients give up further treatment. Therefore, the treatment of chemotherapy-induced nausea and vomiting has important clinical significance . [0003] Palonosetron is the latest highly efficient and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/473A61K47/18A61K47/12A61K9/08A61P1/08
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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