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Freeze-dry snow lotus powder for venous injection and its preparation method

A technology of freeze-dried powder injection and snow lotus, applied in the field of preparation of snow lotus freeze-dried powder injection, can solve the problems of poor stability of injection, low content, complicated other components, etc., and achieve the effect of high stability

Inactive Publication Date: 2004-06-02
CHONGQING LUMMY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the above-mentioned effects of Saussurea involucrata, Saussurea involucrata injection, Saussurea involucrata capsules and compound preparations with Saussurea involucrata extract as the main component have been developed successively in China in recent years. Taking Saussurea involucrata injection as an example, the content of the main active ingredient Saussurea involucrata flavonoids is very low, while Other ingredients are more complex, therefore, the Saussurea involucrata injection is only used for intramuscular injection due to incomplete absorption, low bioavailability, slow curative effect and poor stability of the injection itself after being used in the human body

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Take 1000g of dried snow lotus, crush it into a coarse powder by conventional methods, reflux extract with 10 times the amount of 70% ethanol for 3 times, each time for 100 minutes, concentrate and dry the combined extracts until there is no ethanol, add 4 times the amount of water to dilute, filter, and filtrate Adsorb on a polyamide resin column (Φ8cm×40cm), elute with water 3 times the volume of the resin, discard the eluate, then elute with 2 times the volume of 30% ethanol, collect the eluate, concentrate and dry to obtain concentrated Material 10.2g, wherein the content of Saussurea flavonoids (with rutin juice) is 40.1%.

[0013] Take 10.0g of snow lotus extract, mix it with 5g of mannitol, dissolve it with 800ml of water for injection, filter it with a microporous membrane, adjust the pH of the solution to 6-9, divide it into 2ml / vials, freeze-dry, seal the cap, and obtain freeze-dried snow lotus Powder injection, each preparation unit contains Saussurea flavono...

Embodiment 2

[0015] Take 2000g of dried snow lotus, crush it into coarse powder by conventional method, reflux extract with 10 times the amount of 70% ethanol for 3 times, each time for 100 minutes, combine the extracts to concentrate and dry to no ethanol, add 4 times the amount of water to dilute, filter, and filtrate Adsorbed on a macroporous resin column (Φ10cm×40cm), eluted with 3 times the amount of water, then eluted with 2 times the amount of 20% ethanol, and finally eluted with 80% ethanol to obtain 38.7g of concentrate, of which Saussurea flavonoids (with Rutin juice) content is 19.4%.

[0016] Take 25.8g of snow lotus extract, mix it with 12.5g of mannitol, dissolve it with 1000ml of water for injection, filter it with a microporous membrane, adjust the pH of the solution to 6-9, divide it into 2ml / vials, lyophilize it, and seal it to get snow lotus jelly Dry powder injection, each preparation unit contains Saussurea flavonoids 10mg.

experiment example

[0017] Experimental example Comparative test on the stability of Snow Lotus freeze-dried powder injection and Saussurea involucrata injection

[0018] The snow lotus injection sold on the market and the snow lotus freeze-dried powder injection of the present invention are configured into an injection form for clinical use by passengers, and stored at room temperature; samples are analyzed according to the predetermined sampling time for the total flavonoid content, clarity and bacterial endotoxin index of the snow lotus , using the stipulations in the General Rules for Injections in the Chinese Pharmacopoeia 2000 Edition as the analysis index.

[0019] time

[0020] time

[0021] time

[0022] Conclusion: From the results of Table 1, Table 2, Table 3 and Table 4, it can be seen that under the test conditions of 6 months at room temperature and 12 months at 40°C, the content of total flavonoids in Snow Lotus freeze-dried powder injection has ob...

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Abstract

The freeze dried Saussurea involucrata powder for intravenous injection is used in treating rheumatism, pain waist and knee, traumatic injury and women's diseases. Compared with available technology, the present invention has raised Saussurea involucrata flavone purity. The present invention also includes the preparation process of the freeze dried Saussurea involucrata powder for intravenous injection, and the preparation process includes crushing Saussurea involucrata into coarse powder, extracting with proper solvent, dissolving the initial extractive, adsorption with adsorbing column, solvent elution, concentration and drying of the eluted liquid to obtain Saussurea involucrata extractive, mixing with proper amount of freeze drying supporting agent, dissolving in injection water, sterilizing, filtering, regulating pH to 6-9, packing and freeze drying.

Description

technical field [0001] The invention relates to a preparation medicine of snow lotus for rheumatism, waist and knee pain, bruises and gynecological pain, and specifically relates to a preparation method of snow lotus freeze-dried powder injection for intravenous injection. Background technique [0002] Snow lotus, also known as snow lotus, is a perennial herb of the family Asteraceae and is named after being born in the snow in the alpine area. It is mainly distributed in the Tianshan Mountains and Kunlun Mountains in Xinjiang, my country. It grows at an altitude of 2600 to 4000 In the ice-stained gravel slopes and rock crevices of high mountains with a height of 1.5 meters, against the cold wind, proud of the ice and snow, Yuli blooms; it is a precious medicinal plant widely used by the people, and its main components are flavonoids, lactones, and sterols , phenols, volatile oils and alkaloids, etc., are used to treat rheumatism, waist and knee pain, bruises and gynecological...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61P29/00
Inventor 邱宇安林王英
Owner CHONGQING LUMMY PHARMA
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