Preparation method of tropisetron hydrochloride oral liquid

A technology for tropisetron hydrochloride oral liquid and tropisetron hydrochloride, which is applied in directions such as pharmaceutical formulations, testing pharmaceutical preparations, and material inspection products, and can solve problems such as unreasonable process design, high process condition requirements, and poor product stability. , to achieve high-quality long-term stability, low process conditions, and reasonable pH design.

Inactive Publication Date: 2015-07-22
NANJING REAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The prior art Tropisetron Hydrochloride Oral Liquid has relatively high production equipment and process conditions, high cost, unreasonable process design, poor product stability, etc.

Method used

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  • Preparation method of tropisetron hydrochloride oral liquid
  • Preparation method of tropisetron hydrochloride oral liquid
  • Preparation method of tropisetron hydrochloride oral liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1）

[0024] (Example 1) A method for preparing tropisetron hydrochloride oral liquid, comprising weighing tropisetron hydrochloride, citric acid, sodium citrate, stevia, and water for injection.

[0025] (1) Weigh the raw and auxiliary materials, add 4 / 5 water for injection into the batching tank, and cool to 40±5°C;

[0026] (2) Add tropisetron hydrochloride, citric acid, sodium citrate, and stevioside in order to dissolve in the batching tank, rinse the container with 200ml of water for injection after adding each raw material, and pour the cleaning water into the batching tank Inside;

[0027] (3) Add the remaining prescription amount of water for injection, and reflux for 15 minutes;

[0028] (4) Take samples to measure the pH value and content, and adjust the pH value to 4.5 with HCL or NaOH;

[0029] (5) Install the cleaned filter and filter membrane after disinfection, and filter the liquid medicine into the buffer bottle;

[0030] (6) Check the clarity, fill after passin...

Embodiment 2）

[0033] (Example 2) A method for preparing tropisetron hydrochloride oral liquid, comprising weighing tropisetron hydrochloride, citric acid, sodium citrate, stevia, and water for injection.

[0034] (1) Weigh the raw and auxiliary materials, add 4 / 5 water for injection into the batching tank, and cool to 38°C;

[0035] (2) Add tropisetron hydrochloride, citric acid, sodium citrate, and stevioside in order to dissolve in the batching tank, rinse the container with 200ml of water for injection after adding each raw material, and pour the cleaning water into the batching tank Inside;

[0036] (3) Add the remaining prescription amount of water for injection, and reflux for 15 minutes;

[0037] (4) Take a sample to measure the pH value and content, and adjust the pH value to 4.2 with HCL or NaOH;

[0038] (5) Install the cleaned filter and filter membrane after disinfection, and filter the liquid medicine into the buffer bottle;

[0039] (6) Check the clarity, fill after passing...

Embodiment 3）

[0042] (Example 3) A method for preparing tropisetron hydrochloride oral liquid, comprising weighing tropisetron hydrochloride, citric acid, sodium citrate, stevia, and water for injection.

[0043] (1) Weigh the raw and auxiliary materials, add 4 / 5 water for injection into the batching tank, and cool to 45°C;

[0044] (2) Add tropisetron hydrochloride, citric acid, sodium citrate, and stevioside to the batching tank in order to dissolve, rinse the container with 200ml of water for injection after adding each raw material, and pour the cleaning water into the batching tank Inside;

[0045] (3) Add the remaining prescription amount of water for injection, and reflux for 15 minutes;

[0046] (4) Take a sample to measure the pH value and content, and adjust the pH value to 4.2 with HCL or NaOH;

[0047] (5) Install the cleaned filter and filter membrane after disinfection, and filter the liquid medicine into the buffer bottle;

[0048] (6) Check the clarity, fill after passing...

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PUM

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Abstract

The invention relates to a preparation method of a tropisetron hydrochloride oral liquid. the preparation method comprises the following steps: (1) weighing raw materials and auxiliary materials, adding 4 / 5 of injection water into a material dosing tank and cooling to 40+ / -5 DEG C; (2) successively adding tropisetron hydrochloride, citric acid, sodium citrate and steviosin into the material dosing tank and dissolving; (3) adding the rest of injection water and carrying out reflux for 15 min; (4) sampling and measuring pH value and content, and adjusting pH value to 4.2-5.8 by the use of HCl or NaOH; (5) installing sterilized clean filter and filter membrane, and filtering a liquid medicine into a buffer bottle; (6) checking clarity, filling after qualified, starting a meshbelt machine and a filing and sealing machine for bottle-sending, filling and sealing; (7) placing a filled and sealed tropisetron hydrochloride oral liquid semi-finished product upside down into a sterilizing cabinet and sterilizing; and (8) carrying out light inspection. According to the invention, processing steps are concise and clear and easy to operate. In addition, requirements on technological conditions are low, and the technology is easy to control; processing costs are low, and pH value of tropisetron hydrochloride is reasonably designed; and the product has excellent long-term stability.

Description

technical field [0001] The invention relates to a medical preparation containing organic active ingredients, in particular to a preparation method of tropisetron hydrochloride oral liquid. Background technique [0002] Tropisetron hydrochloride, chemical name: endo-1H-indole-3-carboxylic acid-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride, which is a A potent and highly selective competitive antagonist of peripheral neurons and central nervous system 5-hydroxytryptamine 3 (5-HT3) receptors. Certain substances, including some chemotherapeutic drugs, stimulate the release of serotonin from chromaffin-like cells in the visceral mucosa, which induces the gag reflex with nausea. Tropisetron hydrochloride inhibits the gag reflex mainly by selectively blocking the presynaptic 5-HT3 receptors of peripheral neurons. In addition, its antiemetic effect may also be related to its direct blockade of central 5-HT3 receptors. Stimulation of the vagus nerve that inhibits the are...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/46A61P1/08G01N33/15
Inventor 时文祥于居超李玉凤
Owner NANJING REAL PHARMA
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