CN1500500A - Freeze-dry snow lotus powder for venous injection and its preparation method - Google Patents
Freeze-dry snow lotus powder for venous injection and its preparation method Download PDFInfo
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- CN1500500A CN1500500A CNA021340781A CN02134078A CN1500500A CN 1500500 A CN1500500 A CN 1500500A CN A021340781 A CNA021340781 A CN A021340781A CN 02134078 A CN02134078 A CN 02134078A CN 1500500 A CN1500500 A CN 1500500A
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- herba saussureae
- saussureae involueratae
- snow lotus
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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
The present invention relates to that a kind of rheumatism, waist knee joint are painful, the snow lotus medicine of traumatic injury and gynecological's slight illness, the present invention also is specifically related to be used for the preparation method of intravenous freeze-dry snow lotus powder.
Background technology
Herba Saussureae Involueratae, have another name called the snow Flos Nelumbinis, be Compositae phoenix hair Chrysanthemum herbaceos perennial, gain the name because of crouching to avenge to give birth at extremely frigid zones, mainly be distributed in Tianshan Mountains, the Kun Lun Mountain high and cold mountain area of Xinjiang of China, be grown among the high mountain glacial drift gravel hillside fields and stone crack soil seam of 2600 to 4000 meters height of height above sea level, against the cold wind, proud ice and snow, slim and graceful bursting forth; Be a kind of famous and precious medicinal plants of widely using among the people, its main component is flavone, lactone, sterol, phenols, volatile oil and alkaloid etc., is used for the treatment of that rheumatism, waist knee joint are painful, traumatic injury and gynecological's slight illness, and wherein the anti-inflammatory and analgesic effect of flavone is definite.
Function for Herba Saussureae Involueratae in Compendium of Material Medica and the supplementary Amplifications of the Compendium of Materia Medica is all on the books." the snow Flos Nelumbinis is first extremely hot in nature to produce the peak, Tianshan Mountains, energy nourishing YIN Yiyang, and expelling wind and dampness, the easypro network of strong muscle is controlled all sympotoms caused by cold factors." the present Herba Saussureae Involueratae injection that uses has tangible anti-inflammatory edema, pain relieving, and the effects such as interleukin I that have the inhibition macrophage to produce.
Because Herba Saussureae Involueratae has above-mentioned effect, domesticly in recent years developed Herba Saussureae Involueratae injection, Herba Saussureae Involueratae capsule in succession and be the compound preparation of Main Ingredients and Appearance with the Herba Saussureae Involueratae extract, with the Herba Saussureae Involueratae injection is example, its content that mainly contains effective constituent Herba Saussureae Involueratae flavone is very low, and other composition is comparatively complicated, therefore, this Herba Saussureae Involueratae injection be used for the human body post-absorption not exclusively, the reason of not high, the slow curative effect of bioavailability and the less stable of injection own, only be used for intramuscular injection at present.
Summary of the invention
The objective of the invention is to improve the purity of Herba Saussureae Involueratae flavone in the Herba Saussureae Involueratae injection, and make it to reach in the pharmacopeia requirement to intravenously administrable, finally make Herba Saussureae Involueratae injection can pass through intravenously administrable simultaneously, the raising curative effect of medication, make Herba Saussureae Involueratae injection more stable simultaneously, be beneficial to storage.
The objective of the invention is by following method realize: with Herba Saussureae Involueratae powder essence, coarse powder ethanol extraction, extracting solution are concentrated into no ethanol, concentrate dilutes with suitable quantity of water, last polyamide or macroporous resin column, absorption back suitable concentration ethanol elution, collect eluent, concentrate drying, concentrate add the dissolving of injection water, be mixed with 5mg Herba Saussureae Involueratae flavone/ml, use filtering with microporous membrane solution, transfer pH to 6～9, prop up packing by 2ml/, lyophilizing, capping.
At present, Herba Saussureae Involueratae injection is used for clinical with the aqueous solution form, but there are some shortcomings in this dosage form.At first, the composition complexity, injection products is stable bad in addition, therefore, has the needs to Herba Saussureae Involueratae flavone lyophilized preparation clinically.Preparation of the present invention overcomes above-mentioned shortcoming and pharmaceutically is being stable during Long-term Storage.Therefore, purpose of the present invention is exactly that the Herba Saussureae Involueratae preparation of the lyophilized form by pharmaceutically stable is provided overcomes these shortcomings.Herba Saussureae Involueratae lyophilized formulations of the present invention contains Herba Saussureae Involueratae flavone and pharmaceutically suitable carrier.
The Herba Saussureae Involueratae flavone is present in the preparation of the present invention with the amount of 5～20mg aptly, pharmaceutically suitable carrier is meant all kinds of solvents that can be used for preparing the preceding solution of lyophilizing of the present invention, water normally, one or more other suitable solvent, the perhaps mixture of water and one or more suitable solvent, preferred carrier is a mannitol.
Lyophilized formulations of the present invention is to provide with an active dose unit, and it is designed as intravenously administrable, and according to the concentration of administration pharmaceutically, is made into the Herba Saussureae Involueratae lyophilized preparation of the Herba Saussureae Involueratae flavone that contains 5～20mg.
The freeze-dried powder of Herba Saussureae Involueratae flavone of the present invention pharmaceutically is being stable, and pH value also keeps stablizing constant.And the aqueous solution of the lyophilized injectable powder that disposes during use keeps clarification, colourless, and clarity meets the Chinese Pharmacopoeia regulation.When room temperature and 40 ℃ 12 months detection determined that the stability of Herba Saussureae Involueratae flavone lyophilized injectable powder is higher.
The specific embodiment
Embodiment 1
Get Herba Saussureae Involueratae dry product 1000g, be ground into coarse powder, measure 70% alcohol reflux 3 times with 10 times with conventional method, each 100 minutes, the merge extractive liquid, concentrate drying added 4 times of water gaging dilutions to there not being ethanol, filter, (Φ 8cm * 40cm) absorption is with the water elution of 3 times of amount resin volumes for polyamide resin column on the filtrate, discard eluent, 2 times of amounts of reuse, 30% ethanol elution is collected eluent, concentrate drying, get concentrate 10.2g, wherein Herba Saussureae Involueratae flavone (with rutin juice) content is 40.1%.
Get Herba Saussureae Involueratae extract 10.0g, mix with 5g mannitol, with the dissolving of 800ml water for injection, microporous membrane filtration is transferred pH value of solution 6～9, divides 2ml/ bottle in the cillin bottle of packing into, lyophilizing, and capping gets the freeze-dry snow lotus powder agent, and every preparation unit contains Herba Saussureae Involueratae flavone 10mg.
Embodiment 2
Get Herba Saussureae Involueratae dry product 2000g, be ground into coarse powder, measure 70% alcohol reflux 3 times with 10 times with conventional method, each 100 minutes, the merge extractive liquid, concentrate drying adds 4 times of water gaging dilutions to there not being ethanol, filters, macroporous resin column absorption on the filtrate (Φ 10cm * 40cm), with 3 times of water gaging eluting, 2 times of amounts of reuse, 20% ethanol elution is used 80% ethanol elution at last, get concentrate 38.7g, wherein Herba Saussureae Involueratae flavone (with rutin juice) content is 19.4%.
Get Herba Saussureae Involueratae extract 25.8g, mix with 12.5g mannitol, with the dissolving of 1000ml water for injection, microporous membrane filtration is transferred pH value of solution 6～9, divides 2ml/ bottle in the cillin bottle of packing into, lyophilizing, and capping gets the freeze-dry snow lotus powder agent, and every preparation unit contains Herba Saussureae Involueratae flavone 10mg.
Experimental example freeze-dry snow lotus powder and the comparative test of Herba Saussureae Involueratae injection stability
The injection form of the clinical use of passenger is disposed in the Herba Saussureae Involueratae injection and the freeze-dry snow lotus powder agent of the present invention of selling on the present market, put under the room temperature and preserve; According to predetermined sample analysis Saussurea involucrate general flavone content sample time, clarity and bacterial endotoxin index, adopt in the Chinese Pharmacopoeia 2000 editions the analysis indexes that is defined as in the injection general rule.
The stability experiment of table 1 freeze-dry snow lotus powder (room temperature, 6 months)
| Time | Clarity | Content (sign percentage amounts) | Bacterial endotoxin |
| 0 month | Up to specification | ????101.4 | Up to specification |
| January | Up to specification | ????100.7 | Up to specification |
| March | Up to specification | ????98.5 | Up to specification |
| June | Up to specification | ????99.4 | Up to specification |
The stability experiment (room temperature, 6 months) of the Herba Saussureae Involueratae injection that use in table 2 market
Annotate: content is meant in the preparation Saussurea involucrate general flavone content in rutin.
| Time | Clarity | Content (sign percentage amounts) | Bacterial endotoxin |
| 0 month | Up to specification | ????103.5 | Up to specification |
| January | Up to specification | ????98.3 | Up to specification |
| March | Up to specification | ????100.4 | Up to specification |
| June | Up to specification | ????88.1 | Up to specification |
The stability experiment of table 3 freeze-dry snow lotus powder (40 ℃, 12 months)
The stability experiment (40 ℃, 12 months) of the Herba Saussureae Involueratae injection that use in table 4 market
| Time | Clarity | Content (sign percentage amounts) | Bacterial endotoxin |
| 0 month | Up to specification | ????101.1 | Up to specification |
| January | Up to specification | ????100.5 | Up to specification |
| June | Up to specification | ????99.7 | Up to specification |
| December | Up to specification | ????99.9 | Up to specification |
| Time | Clarity | Content (sign percentage amounts) | Bacterial endotoxin |
| 0 month | Up to specification | ????100.5 | Up to specification |
| January | Up to specification | ????98.3 | Up to specification |
| June | Up to specification | ????95.5 | Up to specification |
| December | Show muddy slightly | ????90.1 | Up to specification |
Conclusion: by table 1, table 2, table 3 and table 4 result as can be seen, room temperature 6 months and 40 ℃, under 12 months two kinds of experimental conditions, the stable content of the Saussurea involucrate general flavone of freeze-dry snow lotus powder obviously is better than the Herba Saussureae Involueratae injection that use in market.
Claims (8)
1, a kind ofly is used for intravenous freeze-dry snow lotus powder agent, contains the Herba Saussureae Involueratae flavone, frozen-dried supporting agent, pH regulator agent and pharmaceutical carrier.
2,, contain Herba Saussureae Involueratae flavone (in rutin) 5～20mg according to the freeze-dry snow lotus powder agent of claim 1.
3, according to the freeze-dry snow lotus powder agent of claim 1, frozen-dried supporting agent is mannitol, gelatin, sorbitol, and concentration is 10～50% (w/w).
4, according to the freeze-dry snow lotus powder agent of claim 1, its pharmaceutical carrier is a water for injection, glucose for injection solution, sodium chloride for injection solution.
5, according to the freeze-dry snow lotus powder agent of claim 1, the pH regulator agent is Na0H or other alkali, and the pH value scope is 6～9.
6, the preparation method of freeze-dry snow lotus powder agent according to claim 1: the Herba Saussureae Involueratae pulverizing medicinal materials is become coarse powder,, get primary extract with the solvent extraction of suitable concentration, after primary extract is used the Sq water dissolution, with the adsorption column absorption of appropriate materials, reuse suitable solvent eluting, the eluent concentrate drying gets Herba Saussureae Involueratae extract, and Herba Saussureae Involueratae extract is mixed with the Sq frozen-dried supporting agent, add an amount of water for injection dissolving, adjust pH 6～9 is filtered in degerming, packing, lyophilizing and getting.
7, according to the preparation method of claim 6, suitable solvent can be water, ethanol, methanol or other can be used as the solvent of plant extract.
8, according to the preparation method of claim 6, adsorbing material can be polyamide, macroporous resin, silica gel or other are suitable for the material of purification plant extract.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021340781A CN100444829C (en) | 2002-11-15 | 2002-11-15 | Freeze-dry snow lotus powder for venous injection and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021340781A CN100444829C (en) | 2002-11-15 | 2002-11-15 | Freeze-dry snow lotus powder for venous injection and its preparation method |
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| CN1500500A true CN1500500A (en) | 2004-06-02 |
| CN100444829C CN100444829C (en) | 2008-12-24 |
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| CNB021340781A Expired - Lifetime CN100444829C (en) | 2002-11-15 | 2002-11-15 | Freeze-dry snow lotus powder for venous injection and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100391482C (en) * | 2005-03-25 | 2008-06-04 | 张海峰 | Saussurea involucrate powder injection and its preparation method |
| CN103330728A (en) * | 2013-07-17 | 2013-10-02 | 贾正平 | Preparation method and application of saussurea involucrate flavonoid capsule |
-
2002
- 2002-11-15 CN CNB021340781A patent/CN100444829C/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100391482C (en) * | 2005-03-25 | 2008-06-04 | 张海峰 | Saussurea involucrate powder injection and its preparation method |
| CN103330728A (en) * | 2013-07-17 | 2013-10-02 | 贾正平 | Preparation method and application of saussurea involucrate flavonoid capsule |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100444829C (en) | 2008-12-24 |
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Owner name: CHONGQING LAIMEI PHARMACY CO., LTD. Free format text: FORMER OWNER: YAOYOU SCIENCE AND TECHNOLOGY DEVELOPMENT CO., LTD., CHENDU CITY Effective date: 20080215 |
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Effective date of registration: 20080215 Address after: No. 8, Rose Road, Nan'an District, Chongqing, China: 401336 Applicant after: CHONGQING LUMMY PHARMACEUTICAL Co.,Ltd. Address before: No. 8, hi tech Road, hi tech Zone, Sichuan, Chengdu Province, China: 610041 Applicant before: CHENGDU PHARMMATE TECHNOLOGY Co.,Ltd. |
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