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Method for preparing anhydrous potassium aspartate crude drugs and tablets thereof

A technology of potassium aspartate and raw materials, which is applied in the preparation of organic compounds, pharmaceutical formulations, cyanide reaction preparation, etc., and can solve problems such as mixing, tablet impact, unsatisfactory effect, and large drug loading

Active Publication Date: 2018-07-10
LIAONING YAOLIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The commonly used specification of potassium aspartate tablet is 300 mg, and the drug loading capacity is relatively large, while the conventionally used potassium aspartate raw material containing 1 / 2 crystal water has strong hygroscopicity, and the The environmental humidity and equipment requirements are high. Under the normal laboratory humidity, the main steps in the pharmaceutical process, such as mixing and tableting, are greatly affected.
Although there are also patents to optimize and improve the prescription and process of potassium aspartate tablets, the effect is not satisfactory and the cost is high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Add an appropriate amount of purified water to the liquid preparation tank, add 80kg of potassium hydroxide to dissolve under stirring, add aspartic acid to react according to the molar equivalent of 1:1; adjust the pH value to 6.5, add 0.1% activated carbon and stir for 30 minutes, and replenish after decarbonization Add purified water to 384kg, and the amount of purified water is 0.6 times the amount of aspartic acid to prepare water feed liquid; the water feed liquid is sprayed into the drying room through the atomizer to form mist droplets, and the inlet air temperature is controlled at 240 °C, and the outlet air temperature 150°C, the frequency of the atomizer was adjusted to 40Hz, and the pressure inside the tower was kept at -0.25kpa; after spray drying, the material was discharged, and the finished product was 228kg, with a yield of 93.4%.

Embodiment 2

[0060] Add an appropriate amount of purified water to the liquid preparation tank, add 80kg of potassium hydroxide to dissolve under stirring, add aspartic acid to react according to the molar equivalent of 1:1; adjust the pH value to 8.0, add 0.1% activated carbon and stir for 30 minutes, and replenish after decarbonization Add purified water to 460kg, the amount of purified water is 1.0 times the amount of aspartic acid to prepare the water feed liquid; spray the water feed liquid through the atomizer to form droplets into the drying room, control the inlet air temperature at 250°C, and the outlet air temperature 160°C, the frequency of the atomizer was adjusted to 50Hz, and the pressure inside the tower was maintained at -0.1kpa; after spray drying, the material was discharged to obtain 220kg of finished product, with a yield of 90.2%.

Embodiment 3

[0062] Add an appropriate amount of purified water to the liquid preparation tank, add 80kg of potassium hydroxide to dissolve under stirring, add aspartic acid to react according to the molar equivalent of 1:1; adjust the pH value to 7.0, add 0.1% activated carbon and stir for 30 minutes, and replenish after decarbonization Add purified water to 346kg, and the amount of purified water is 0.4 times the amount of aspartic acid to prepare water feed liquid; the water feed liquid is sprayed into the drying room through the atomizer to form mist droplets, and the inlet air temperature is controlled at 250°C, and the outlet air temperature 150°C, the frequency of the atomizer was adjusted to 35Hz, and the pressure inside the tower was maintained at -0.3kpa; after spray drying, the material was discharged, and the finished product was 222kg, with a yield of 91.0%.

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PUM

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Abstract

The invention relates to a method for preparing anhydrous potassium aspartate crude drugs and tablets thereof. A novel spray drying process is adopted, the prepared anhydrous potassium aspartate crudedrugs do not contain crystal water, and the product quality is stable and controllable. The crude drugs prepared by the process are directly compressed to prepare the potassium aspartate tablets, which effectively reduces the control requirement of a preparation process for the environmental humidity during the tableting process, the process is reliable, the method is simple and easy to operate,and the obtained potassium aspartate tablets have a good dissolution effect in vitro. The preparation method significantly improves the preparation yield, greatly reduces the production cost, solves the situation that the environment humidity requirement of potassium aspartate tablet production is high for a long time, and is a low-cost process which can be popularized.

Description

technical field [0001] The present invention relates to a preparation method for preparing anhydrous potassium aspartate raw material drug and tablet thereof in the field of pharmaceutical technology, in particular, anhydrous potassium aspartate raw material drug is prepared by spray drying, and anhydrous potassium aspartate raw material drug is prepared from the prepared anhydrous potassium aspartate Potassium aspartate crude drug adopts the mode of direct compression to prepare tablet. Background technique [0002] Aspartate is the precursor of oxaloacetate in the human body and plays an important role in the Krebs cycle. At the same time, it also participates in the ornithine cycle, promotes the metabolism of ammonia and carbon dioxide, and makes it generate urea, thereby reducing the content of ammonia and carbon dioxide in the blood. Aspartic acid has a strong affinity with cells and can be used as a carrier of potassium ions, allowing potassium ions to return to cells...

Claims

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Application Information

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IPC IPC(8): C07C229/24C07C227/18C07C227/40A61K31/198A61K9/28A61P3/12A61P9/06
CPCA61K9/28A61K31/198C07C227/18C07C227/40C07C229/24
Inventor 于航李爽
Owner LIAONING YAOLIAN PHARMA
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