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Palonosetron preparation for injection and preparation method thereof

A technology for palonosetron and injection, which is applied in the field of medicine, can solve problems such as general solubility, impact on safety, and impact on convenience, and achieve the effects of good reconstitution, smooth surface, and stable product quality

Inactive Publication Date: 2014-06-11
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-dried preparation made by the general method has average solubility. After adding water for injection, it needs to be shaken for a few minutes before it can be completely dissolved, which affects the convenience of use, and the solution is slightly cloudy, which affects the safety of use, and it is also inconvenient.

Method used

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  • Palonosetron preparation for injection and preparation method thereof
  • Palonosetron preparation for injection and preparation method thereof
  • Palonosetron preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The formula of the described palonosetron hydrochloride freeze-dried preparation of every 1000 bottles consists of:

[0022] Palonosetron Hydrochloride 0.25g

[0023] β-cyclodextrin 10g

[0024] Mannitol 20g

[0025] Water for injection 1L

[0026] Preparation process: 1. Weigh palonosetron hydrochloride and β-cyclodextrin, add 80% water for injection and stir to dissolve, then add mannitol, stir to dissolve completely, and use citrate-disodium phosphate buffer solution (pH4.0) adjust the pH value to 4.0-6.0, add water for injection to the full amount, add a needle with a total volume of 0.05-0.1% (g / ml), stir and absorb with carbon for 20 minutes, and decarburize by filtration.

[0027] 2. Fine filter with 0.22μm microporous membrane.

[0028] 3. Inspection of semi-finished products.

[0029] 4. Filling, press half stopper.

[0030] 5. Freeze-drying: first cool down the freeze-drying box to -40°C ~ -50°C, then put the sample into it to make it freeze quickly, the...

Embodiment 2

[0032] The formula of the described palonosetron hydrochloride freeze-dried preparation of every 1000 bottles consists of:

[0033] Palonosetron Hydrochloride 0.25g

[0034] Hydroxypropyl-β-cyclodextrin 15g

[0035] Mannitol 18g

[0036] Water for injection 1L

[0037] Preparation process: 1. Weigh palonosetron hydrochloride and hydroxypropyl-β-cyclodextrin, add 80% water for injection and stir to dissolve, then add mannitol, stir to dissolve completely, and use citric acid-phosphoric acid Disodium buffer solution (pH 4.0) was used to adjust the pH value to 4.0-6.0, add water for injection to the full amount, add needles with a total volume of 0.05-0.1% (g / ml), stir and adsorb with carbon for 20 minutes, and decarburize by filtration.

[0038] 2. Fine filter with 0.22μm microporous membrane.

[0039] 3. Inspection of semi-finished products.

[0040] 4. Filling, press half stopper.

[0041] 5. Freeze-drying: first cool down the freeze-drying box to -40°C~-50°C, then put in ...

Embodiment 3

[0043] The formula of the described palonosetron hydrochloride freeze-dried preparation of every 1000 bottles consists of:

[0044] Palonosetron Hydrochloride 0.5g

[0045] β-cyclodextrin 20g

[0046] Mannitol 25g

[0047] Water for injection 2L

[0048] Preparation process: 1. Weigh palonosetron hydrochloride and β-cyclodextrin, add 80% water for injection and stir to dissolve, then add mannitol, stir to dissolve completely, and use citrate-disodium phosphate buffer solution (pH 4.0) adjust the pH value to 4.0-6.0, add water for injection to the full amount, add a needle with a total volume of 0.05-0.1% (g / ml), stir and adsorb with carbon for 20 minutes, and decarburize by filtration.

[0049] 2. Fine filter with 0.22μm microporous membrane.

[0050] 3. Inspection of semi-finished products.

[0051] 4. Filling, press half stopper.

[0052] 5. Freeze-drying: first cool down the freeze-drying box to -40°C~-50°C, then put in the sample to make it freeze quickly, the time i...

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PUM

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to palonosetron hydrochloride freeze-dried powder injection. The invention also relates to preparation of the freeze-dried powder injection. By adding beta-cyclodextrin or hydroxypropyl beta-cyclodextrin and mannitol, the palonosetron preparation has the characteristics of being smooth in surface, delicate, uniform, free of cracks, breakage and adhesion to a bottle, white in color, shaped like a loose piece, good in formation, also good in dissolubility, quite easy to dissolve, clear and transparent in solution and stable in product quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried preparation of palonosetron hydrochloride, which can be used for nausea and vomiting caused by anti-tumor chemotherapy. Background technique [0002] With the improvement of the status of chemotherapy in tumor treatment and the application of more and more new chemotherapy drugs, people have a deeper understanding of the adverse reactions of chemotherapy. The adverse reactions of chemotherapy can temporarily or long-term affect the quality of life of patients, may limit the dose and course of treatment, and even endanger life in severe cases. Nausea and vomiting caused by chemotherapy are the most feared adverse reactions of cancer patients. Insufficient control of nausea and vomiting will produce a series of related complications. Severe nausea and vomiting will make patients fearful of future chemotherapy, and even have the idea of ​​reluctance or g...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/473A61K47/40A61P1/08
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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