Magnesium isoglycyrrhizinate freeze dried powder injection for injection and preparation method thereof

A technology of magnesium isoglycyrrhizinate and freeze-dried powder injection, which can be applied in freeze-dried delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. It is not conducive to large-scale production and other problems, and achieves the effects of easy transportation and long-term storage, small batch differences, and easy industrialized large-scale production.

Active Publication Date: 2011-08-17
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In addition, injections have safety and stability problems, which are not conducive to drug transportation and long-term storage. In addition, the traditional practice of injection solution preparation is to first add raw materials to water for injection, stir to make a uniform suspension, and then add other excipients. However, in the preparation process of magnesium isoglycyrrhizinate injection, since magnesium isoglycyrrhizinate is slightly soluble in water and is easy to float on the water surface, it takes a long time to stir to uniformly suspend, and then add a pH regulator to adjust to a suitable pH value to dissolve the raw materials, and Because the regulator uses a strong alkali or a concentrated alkali solution, it is easy to cause an irreversible reaction to form magnesium hydroxide precipitation when the local concentration is too high, so it is generally adjusted gradually with a dilute alkali solution, which not only takes a long time, but also increases the production cost. The difference between batches of obtained products is large, and the quality is relatively unstable, which is not conducive to large-scale industrial production

Method used

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  • Magnesium isoglycyrrhizinate freeze dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Preparation formula:

[0028] formula

per bottle (mg)

1000 bottles (g)

Magnesium isoglycyrrhizinate

50

50

Disodium phosphate

38

38

Add water for injection to

1ml

1000ml

[0029] The preparation method is as follows:

[0030] 1) Solution preparation

[0031] Dissolve disodium hydrogen phosphate in 800ml water for injection, add magnesium isoglycyrrhizinate, stir to dissolve.

[0032] 2) Removal of pyrogens

[0033] Heat to about 50°C, add 0.8g of activated carbon and stir for 15 minutes, cool to room temperature, and decarbonize by filtration. Take the filtrate and add water for injection to a sufficient amount, pass through a 0.22 μm filter membrane to obtain the intermediate.

[0034] 3) Packing

[0035] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0036] 4) freeze-dried

[0037] The eutectic poi...

Embodiment 2

[0039] Preparation formula:

[0040] formula

per bottle (mg)

1000 bottles (g)

Magnesium isoglycyrrhizinate

250

250

sodium hydroxide

5

5

lactose

25

25

Add water for injection to

4ml

4000ml

[0041] The preparation method is as follows:

[0042] 1) Solution preparation

[0043] Dissolve sodium hydroxide in 3200ml water for injection, add magnesium isoglycyrrhizinate and lactose, stir to dissolve.

[0044] 2) Removal of pyrogens

[0045]Heat to about 50°C, add 10g of activated carbon and stir for 20 minutes, cool to room temperature, and decarbonize by filtration. Take the filtrate and add water for injection to a sufficient amount, pass through a 0.22 μm filter membrane to obtain the intermediate.

[0046] 3) Packing

[0047] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0048] 4) freeze-dri...

Embodiment 3

[0051] Preparation formula:

[0052] formula

per bottle (mg)

1000 bottles (g)

Magnesium isoglycyrrhizinate

50

50

ammonia

108

108

glucose

200

200

Add water for injection to

4ml

4000ml

[0053] The preparation method is as follows:

[0054] 1) Solution preparation

[0055] Add ammonia water to 3200ml water for injection, stir evenly, add magnesium isoglycyrrhizinate and glucose, stir to dissolve.

[0056] 2) Removal of pyrogens

[0057] Heat to about 50°C, add 7.2g of activated carbon and stir for 30 minutes, cool to room temperature, and decarbonize by filtration. Take the filtrate and add water for injection to a sufficient amount, use G 6 Filter through a fused glass filter to obtain the intermediate.

[0058] 3) Packing

[0059] After the intermediates pass the inspection, they are divided into vials according to the content of the intermediates and half-pressed.

[0060] 4) fr...

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PUM

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Abstract

The invention relates to a magnesium isoglycyrrhizinate frozen-dried powder injection and a preparation method of the injection. The frozen-dried powder injection comprises magnesium isoglycyrrhizinate, cosolvent and frozen-dried excipient. When in preparation, the cosolvent is dissolved first and other substances are added and dissolved, and then the freezing and drying process is carried out, so as to get the magnesium isoglycyrrhizinate frozen-dried powder injection which has the advantages of better dissolving capability, safety, efficiency and stability, being suitable for conveying and a long-term conservation, simple operation technique, small difference among manufacturing batches, and being easy for an industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a magnesium isoglycyrrhizinate freeze-dried powder for injection and a preparation method thereof. technical background [0002] Viral hepatitis is a common infectious disease caused by a variety of hepatitis viruses. It is highly contagious and has a high incidence rate. The etiology, pathogenesis and symptoms are complex and varied. It is difficult to cure and seriously endangers people's health. Glycyrrhizic acid has a wide range of anti-inflammatory and anti-allergic effects, and has immune regulation effects. It can achieve an ideal effect of preventing and treating chronic hepatitis through anti-inflammatory and immune methods. Long-term clinical practice has proved that intravenous administration of glycyrrhizic acid preparations is an effective way to treat chronic hepatitis. It can significantly reduce serum transaminases, improve liver inflammation, realize th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/12A61K9/19A61P31/14A61P1/16A61K31/704A61P31/20A61K47/02A61K47/16
Inventor 张来芳程艳菊沈静
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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