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Preparation method of manganese chloride tetrahydrate bulk drug

A technology of manganese chloride tetrahydrate and raw materials, applied in the direction of manganese halide, etc., can solve the problem of low safety of manganese chloride tetrahydrate and achieve high safety effect

Active Publication Date: 2021-06-11
合肥市未来药物开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The specifications of manganese chloride tetrahydrate used in domestic trace element preparations are all non-pharmaceutical grade analytical reagents. Although its purity can reach 99.99%, it still contains 0.01% of impurities, and there is no guarantee that these impurities can reach ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, International Conference on Harmonization of Technical Requirements for Human Use, Human Drug Registration Technical Requirements) standards, such as cobalt and nickel are more than 5ppm, etc., which makes the current manganese chloride tetrahydrate less safe

Method used

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  • Preparation method of manganese chloride tetrahydrate bulk drug

Examples

Experimental program
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Effect test

Embodiment

[0029] The embodiment of the present invention provides a kind of preparation method of manganese chloride tetrahydrate crude drug, and this preparation method comprises:

[0030] Mix manganese monoxide and water to obtain a suspension, the mass ratio of manganese monoxide to water is 1:3; in this example, manganese monoxide was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd., with a content of ≥99.5% , the grade is M105457.

[0031] Slowly add hydrochloric acid dropwise into the suspension, the molar ratio of manganese monoxide and hydrochloric acid is 1: (1.8-2.0), to obtain the first reaction solution;

[0032] Heating the first reaction solution to 70-100°C for 3.5-4.5 hours, cooling to room temperature after heating to obtain the second reaction solution;

[0033] After adding food-grade diatomite to the second reaction solution and stirring, the first mixed solution is obtained. The quality of food-grade diatomite is 20% to 30% of the mass of manganese ...

Embodiment 1

[0056]Drop into 300.00g purified water and 100.00g manganese monoxide in the 1L four-neck flask (still) that is equipped with mechanical stirring device, open mechanical stirring device, make manganese monoxide and water mix, obtain suspension, then Add 256.98g of hydrochloric acid with a mass fraction of 37% into the constant pressure dropping funnel, control the molar ratio of manganese monoxide and hydrochloric acid to 1:1.85, slowly open the valve of the constant pressure dropping funnel, and let the hydrochloric acid drop slowly at room temperature In the four-necked flask (still), because the reaction exotherm is obvious, it is necessary to control the temperature in the four-necked flask (still) below 90°C. After the hydrochloric acid is dripped, record the temperature in the four-necked flask (still), and when the temperature in the four-necked flask (still) begins to drop, place the four-necked flask (still) in a preheated water bath with a water bath temperature of 10...

Embodiment 2

[0060] Drop into 300.00g purified water and 100.00g manganese monoxide in the 1L four-neck flask (still) that is equipped with mechanical stirring device, open mechanical stirring device, make manganese monoxide and water mix, obtain suspension, then Add 250.03g of hydrochloric acid with a mass fraction of 37% into the constant pressure dropping funnel, control the molar ratio of manganese monoxide and hydrochloric acid to 1:1.80, slowly open the valve of the constant pressure dropping funnel, and let the hydrochloric acid drop slowly at room temperature into a four-necked flask (still), because the reaction exotherm is obvious, so it is necessary to control the temperature in the four-necked flask (still) below 70°C. After the hydrochloric acid is dripped, record the temperature in the four-necked flask (still), and when the temperature in the four-necked flask (still) begins to drop, place the four-necked flask (still) in a preheated water bath with a water bath temperature o...

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Abstract

The invention provides a preparation method of a manganese chloride tetrahydrate bulk drug. The preparation method comprises the following steps: mixing manganese monoxide with water to obtain turbid liquid; slowly dropwise adding hydrochloric acid into the turbid liquid to obtain a first reaction liquid; heating the first reaction solution to obtain a second reaction solution; adding food-grade diatomite into the second reaction solution, and stirring to obtain a first mixed solution; filtering the first mixed solution to obtain a first filtrate; adjusting the pH value of the first filtrate; adding manganese powder into the first filtrate, and heating to obtain a third reaction solution; adding the food-grade diatomite into the third reaction solution, and stirring to obtain a second mixed solution; filtering the second mixed solution to obtain a second filtrate; adjusting the pH value of the second filtrate; and purifying the second filtrate to obtain the manganese chloride tetrahydrate bulk drug. The product prepared by the method has very high safety.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a preparation method of manganese chloride tetrahydrate crude drug. Background technique [0002] Manganese is one of the essential trace elements for human body. Part of manganese is used as a component of metalloenzymes in the body, and the other part is used as an enzyme activator. The lack of manganese in the human body will not only affect the growth and development of human bones, but also affect the normal metabolism of sugar and fat in the human body, and the lack of manganese will also cause neurasthenia syndrome and affect intellectual development; in addition, the lack of manganese will also affect reproductive ability, It is possible to cause congenital deformities in offspring. Therefore, proper intake of manganese is necessary for the human body, and manganese can be supplemented in the form of manganese chloride tetrahydrate. [0003] Currently, manganese chl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C01G45/06
CPCC01G45/06C01P2006/80
Inventor 赵立军彭松徐国义金秋肖垒吴海林
Owner 合肥市未来药物开发有限公司
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