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Injection solution of freezes dried powder of fibrauretine, and preparation method

A technology of freeze-dried powder injection and palmatine, which is applied in the field of palmatine powder injection and its preparation, can solve problems such as fragility, difficulty in fully dissolving mannitol, affecting product quality and dissolution speed, etc., to achieve stable and reliable products, good quality appearance

Inactive Publication Date: 2007-10-10
王锦
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

One is that the amount of water for injection is too small, making it difficult to fully dissolve mannitol, and it will precipitate when it is slightly cooled, resulting in crystallization of the product content, affecting product quality and dissolution rate
The other is that the pre-freezing time is not enough, resulting in poor appearance and fragile products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Take materials according to the following ratio:

[0024] Palmatine 20g

[0025] Mannitol 180g

[0026] Through the following method: under the condition of 10,000 grades, 20 g of the above-mentioned palmatine raw materials and 180 g of the mannitol auxiliary material are tested, and after the items such as its heat source, abnormal toxicity, and hemolytic property are qualified, they are dissolved together in 1600 ml of water for injection. After decolorization, add water for injection to dilute to a total volume of 2000ml, first filter with fast filter paper, and then filter the filtrate through filter paper and a filter membrane of 0.45 μm, and then filter it with a filter membrane below 0.2 μm under the condition of grade 100. The filtrate is sent to the packing machine, packed according to 2ml per tube, covered with a lid, sent to a freeze vacuum dryer, pre-frozen at -40°C for 14 hours → dried at -30°C for 2 hours → dried at -25°C for 4 hours →- Dry at 10°C for 8...

Embodiment 2

[0028] Take materials according to the following ratio:

[0029] Palmatine 40g

[0030] Mannitol 93g

[0031] Through the following method: under the condition of 10,000 grades, 40 g of the above-mentioned palmatine raw materials and 93 g of mannitol auxiliary materials are tested, and after the items such as heat source, abnormal toxicity, and hemolysis are qualified, they are dissolved together in 1000 ml of water for injection. After decolorization, add water for injection to dilute to a total volume of 1330ml, first filter with fast filter paper, and then filter the filtrate through filter paper and a filter membrane of 0.45 μm, and filter it with a filter membrane below 0.2 μm under the condition of grade 100. The filtrate is sent to the packing machine, packed according to 2ml per tube, covered with a lid, sent to a freeze vacuum dryer, pre-freezing at -40°C for 8h→drying at -30°C for 0.5h→drying at -25°C for 1h→ Dry at -10°C for 4h→dry at 0°C for 1h→dry at 10°C for 1h...

Embodiment 3

[0033] Take materials according to the following ratio:

[0034] Palmatine 20g

[0035] Mannitol 80g

[0036] Through the following method: under the condition of 10,000 grades, 20 g of the above-mentioned palmatine raw materials and 80 g of the mannitol auxiliary materials are tested, and after the items such as heat source, abnormal toxicity, and hemolysis are qualified, they are dissolved together in 800 ml of water for injection. After decolorization treatment, add water for injection to dilute to a total volume of 1000ml, first filter with fast filter paper, and then filter the filtrate through filter paper and a filter membrane of 0.45 μm, and then filter it with a filter membrane below 0.2 μm under the condition of grade 100. The filtrate is sent to the packaging machine, divided into 2ml per bottle, covered with a lid, and sent to a freeze vacuum dryer, pre-freezing at -40°C for 10h→drying at -30°C for 1h→drying at -25°C for 2h→- Dry at 10°C for 6 hours → dry at 0°C ...

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PUM

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Abstract

A freeze-dried powder injection of fibrauretin for treating the diseases in urinary system, especially woman's urinary tract, is proportionally prepared from fibrauretin and mannitol. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a palmatine powder injection with antibacterial and anti-inflammatory activity and a preparation method thereof. Background technique [0002] Palmatine, also known as rhizomatogenin, Fibranine, palmitine hydrochloride, palmatine hydrochloride, and Palmatine, is a plant antibiotic excavated from Pingbian Miao Autonomous County in Yunnan Province during the period of 1970-1972 when Chinese herbal medicine was promoted. The original medicinal material - Fibraureatinctoria Lour., a plant of the family Fangjiceae, is commonly used in folks to dye cloth and treat traumatic infections and chronic ulcers caused by sores. The existing palmatine preparations include oral tablets and injection water injections, which belong to heat-clearing and detoxifying drugs, and have the effect of enhancing the phagocytosis of leukocytes. For the treatment of gynecological inflammation, surgical infection, bacillary dysentery, enteritis, respirator...

Claims

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Application Information

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IPC IPC(8): A61K31/4375A61K9/19A61P13/00
Inventor 王锦
Owner 王锦
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