Formulation of mildronate injection and preparation method

A technology of meldonium and injection, which is applied in the field of pharmaceutical preparations and can solve problems such as the inability to adopt terminal sterilization technology to sterilize

Active Publication Date: 2011-09-21
JIANGSU SKYRUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, this prescription cannot be sterilized by terminal sterilization process

Method used

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  • Formulation of mildronate injection and preparation method
  • Formulation of mildronate injection and preparation method
  • Formulation of mildronate injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Preparation of Meldonium Injection

[0035] Weigh meldonium [3-(2,2,2-trimethylhydrazine) propionate dihydrate] 100g into the mixing tank, add 750ml of water for injection into the mixing tank, stir to make the main ingredient dissolve completely, Weigh 1.97g of disodium hydrogen phosphate into the mixing tank, stir and mix until completely dissolved, then weigh 0.23g of potassium dihydrogen phosphate, add it into the mixing tank, stir and mix until completely dissolved, add water for injection to 1000ml, mix well, Add 0.05% (W / V) activated carbon to the solution, stir for 15 minutes, pressurize the liquid to pass through 1 μm and 0.45 μm titanium rod filters wrapped with neutral filter paper, filter the activated carbon into the dilute tank, and take samples Check the pH value of the solution. If the pH value is within the acceptable range, no adjustment is required. Take the qualified filtrate and use a 0.45μm filter membrane for coarse filtration, and then use a 0.22...

Embodiment 2

[0037] Preparation of Meldonium Injection

[0038] Take by weighing Meldonium [3-(2,2,2-trimethylhydrazine) propionate dihydrate] 105g to the mixing tank, add 750ml of water for injection to the mixing tank, stir to make the main ingredient dissolve completely, Weigh 5.6g of dipotassium hydrogen phosphate and add it to the mixing tank, stir and mix until completely dissolved, then weigh 0.4g of potassium dihydrogen phosphate and add it to the mixing tank, stir and mix until completely dissolved, add water for injection to 1000ml, mix well, Add 0.05% (W / V) activated carbon to the solution, stir for 15 minutes, pressurize the liquid to pass through a 1 μm and 0.45 μm titanium rod filter wrapped with neutral filter paper, filter the activated carbon into the diluted tank, and take a sample Check the pH value of the solution. If the pH value is within the acceptable range, no adjustment is required. Take the qualified filtrate and use a 0.45μm filter membrane for coarse filtration...

Embodiment 3

[0040] Preparation of Meldonium Injection

[0041] Weigh meldonium [3-(2,2,2-trimethylhydrazine) propionate dihydrate] 90g into the mixing tank, add 750ml of water for injection into the mixing tank, stir to make the main ingredient dissolve completely, Weigh 6.8g of potassium dihydrogen phosphate and add it to the mixing tank, stir and mix until it is completely dissolved, then weigh 1.7g of sodium hydroxide and add it to the mixing tank, stir and mix until it is completely dissolved, add water for injection to 1000ml, mix well, and add Add 0.05% (W / V) activated carbon to the solution, stir for 15 minutes, pressurize the liquid to pass through 1 μm and 0.45 μm titanium rod filters wrapped with neutral filter paper, filter the activated carbon into the dilute tank, and take samples for inspection The pH value of the solution, the pH value is within the qualified range, no adjustment is required, the qualified filtrate is firstly filtered with a 0.45 μm filter membrane, and then ...

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Abstract

The invention relates to a formulation of mildronate injection and a preparation method. The formulation mainly comprises active component of mildronate, phosphate buffer solution, and water for injection. The preparation method for the formulation comprises the following steps: weighing each component, stirring and decomposing the components, adding 0.05 percent of active carbon in weight-volumeratio into the components, pressurizing and filtering liquid medicine to remove pyrogen, adjusting the pH value of the solution within a range of 7.0 to 8.5, preliminarily filtering the solution by using a filter membrane of 0.45mu m, then fine filtering the solution by using a filter membrane of 0.22mu m, filling the solution into a penicillin bottle of 5 milliliters after passing quality inspection, and capping and sealing the bottle; and finally a temperature of 121 DEG C, sterilizing the bottle for 20 minutes under terminal sterilizing condition to obtain the injection. The mildronate injection produced by the method has high sterility assurance degree, each index accords with the prescription after being stored for three years, and the safety is fully ensured for clinical application.

Description

technical field [0001] The invention relates to a prescription and a preparation method of meldonium injection, in particular, the prescription can be sterilized by adopting terminal sterilization conditions, which can ensure the sterility of the product, and belongs to the field of pharmaceutical preparations. Background technique [0002] Meldonium Injection It was synthesized and developed by the Latvian Academy of Sciences Institute of Organic Synthesis and its factory, the predecessor of the Latvian JSC Grindeks company. It belongs to the original research product of JSC Grindeks. The Latvian JSC Grindeks company pushed Meldonium to the former Soviet Union market in the late 1980s. Registered in Latvia in 1992, it is currently on the market in Latvia, Lithuania, Russia, Belarus, Georgia, Ukraine, Moldova, Azerbaijan, Kazakhstan, Uzbekistan, Armenia, and other countries. The marketed dosage forms include injection (500mg / 5ml), capsule (250mg, 500mg) and syrup (250ml, 5...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/205A61K47/02A61P9/00A61P9/04A61P9/10A61P39/00
Inventor 燕立波王丽黄迎春陶义华
Owner JIANGSU SKYRUN PHARMA CO LTD
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