CN101417105B - Zedoary turmeric oil glucose injection and preparation method thereof - Google Patents
Zedoary turmeric oil glucose injection and preparation method thereof Download PDFInfo
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- CN101417105B CN101417105B CN2008101858527A CN200810185852A CN101417105B CN 101417105 B CN101417105 B CN 101417105B CN 2008101858527 A CN2008101858527 A CN 2008101858527A CN 200810185852 A CN200810185852 A CN 200810185852A CN 101417105 B CN101417105 B CN 101417105B
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Abstract
The invention relates to a turmeric oil and glucose injection which is prepared by the following method: proper injection water is taken and glucose is added to prepare a liquid with certain concentration; then mosatil is added and stirred for dissolving; proper active carbon is added and boiled for a certain time and then filtered; then turmeric oil is additionally taken and proper vitamin E is added, fully stirred and added into Tween-80; proper injection water is taken; the mixed liquor of the turmeric oil and the Tween-80 is slowly added and continuously heated to a certain temperature and stirred until the mixed liquor is milky white. The turmeric oil liquor is mixed with the glucose liquor; the injection water is added until the full dose; the pH is regulated by citric acid liquor and the mixed liquor is stirred for a certain time, filtered, filled and sterilized by a terminal. The medicine composition and the preparation method thereof can obtain the stable turmeric oil and glucose injection, are better than the prior art, ensure the safety of clinical application and can reduce the safety risk.
Description
Invention field
The present invention relates to a kind of ejection preparation, particularly a kind of Zedoary turmeric oil glucose injection and preparation method thereof.
Background technology
Oleum Curcumae is the volatile oil that extracts by in zingiberaceous plant Rhizoma Curcumae, RADIX CURCUMAE or the Guangxi zedoary rhizome, show through pharmacological research, Oleum Curcumae has antiviral, antibiotic, antitumor, antithrombotic, protects the liver, treatment psoriasis, cervical erosion, peptic ulcer, and effect such as raise immunity.Zedoary turmeric oil glucose injection is the sterile water solution that Oleum Curcumae, glucose and suitable cosolvent are made, wherein cosolvent is poly-three pear esters 80 (tween 80), but during as injection, tween 80 has certain toxicity and haemolysis (Heilungkiang medical science, 2001,24 (4): 40), it is more that Zedoary turmeric oil glucose injection impurity trap is raise, and in put procedure, curcumenol content descends fast, causes effect duration to shorten.(Chinese Pharmaceutical such as Zhang Qingsheng, 2008,17 (6): 42) prepare Zedoary turmeric oil glucose injection behind the employing HP-enclose Oleum Curcumae, behind the HP-enclose Oleum Curcumae, the quality of the Zedoary turmeric oil glucose injection of making is subjected to the scale effect of HP-and Oleum Curcumae bigger, the ratio of HP-and Oleum Curcumae is 10: 1, changes of contents is little before and after made Zedoary turmeric oil glucose injection semi-finished product and the finished product sterilization, curcumenol stable content in the Zedoary turmeric oil glucose injection, 3 batches of test specimens are made accelerated test to be investigated, in 1,2,3, sampling detects the changes of contents of its Oleum Curcumae in the time of 6 months, the total fall of content is 3.0% in the time of 6 months, and is basicly stable.But the untoward reaction of intravenous injection hydroxypropyl mainly concentrates on nephrotoxicity and hemolytic, and may have certain teratogenesis and carcinogenecity.Under the intravenous injection approach, 0.02mol/L promptly slight haemolysis can occur, (State Food and Drug Administration evaluates the center, electronic publication: the problem that hydroxypropyl need be considered as the solubilizing agent of intravenous formulations) to occur tangible haemolysis when 0.04mol/L.Patent (number of patent application: 03146102.6) disclose adding citric acid or sodium citrate in Zedoary turmeric oil glucose injection, disodium edetate is to solve the problem that the rising of impurity trap is more and the decline of curcumenol content is fast, wherein kept adding in the former Zedoary turmeric oil glucose injection 0.4% weight portion tween 80, this scheme raises more to the impurity trap and curcumenol content descends, and fast problem has obtained certain solution, but the tween 80 amount does not reduce, the existing safety hidden danger of tween 80 is not solved, simultaneously the problem of the unresolved high-capacity injection terminal sterilization of this patent (F0 〉=8).
Summary of the invention
One object of the present invention is to provide a kind of Zedoary turmeric oil glucose injection.
Another object of the present invention is to provide a kind of Zedoary turmeric oil glucose injection preparation method.
The invention solves the problem that the rising of impurity trap is more and the decline of curcumenol content is fast, realized terminal sterilization simultaneously, reduced the safety hidden danger of clinical use.
The present invention seeks to be achieved through the following technical solutions:
A kind of Zedoary turmeric oil glucose injection, the raw material in per 1000 parts by volume of this injection consists of:
Oleum Curcumae 0.2～0.9 weight portion, glucose 30～120 weight portions, tween 80 1.2-3.5 weight portion, calcium disodium edetate 0.1～0.3 weight portion, vitamin E 0.01～0.5 weight portion.
A kind of Zedoary turmeric oil glucose injection, the raw material composition in per 1000 parts by volume of this injection is preferably:
Oleum Curcumae 0.27～0.5 weight portion, glucose 40～100 weight portions, tween 80 1.5-3.0 weight portion, calcium disodium edetate 0.1～0.2 weight portion, vitamin E 0.01～0.5 weight portion.
Described Zedoary turmeric oil glucose injection, the raw material composition in per 1000 parts by volume of this injection is preferably:
Oleum Curcumae 0.4 weight portion, glucose 50 weight portions, tween 80 2.0 weight portions, calcium disodium edetate 0.15 weight portion, vitamin E 0.08 weight portion.
Tween 80 also can be replaced by the poloxamer that waits weight portion in the Zedoary turmeric oil glucose injection of the present invention.
Calcium disodium edetate of the present invention can substitute with disodium edetate.
Zedoary turmeric oil glucose injection preparation method of the present invention is:
Step 1: get water for injection 80-200 parts by volume, adding glucose 40-100 weight portion, add calcium disodium edetate 0.1～0.2 weight portion, stir and make dissolving, add active carbon 0.04～0.4 weight portion, boiled 5～30 minutes, filter, get solution 1;
Step 2: get Oleum Curcumae 0.3～0.5 weight portion, add vitamin E 0.01-0.5 weight portion, stir evenly, add tween 80 1.5-3.0 weight portion, stir evenly;
Step 3: get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2;
Step 4: solution 1 and solution 2 is mixed, add injection water to 1000 parts by volume, lid, is rolled at filtration, fill in citric acid solution adjusting pH to 4.0～5.0 with 1～20%, sterilize Zedoary turmeric oil glucose injection.
Described step 3 also can for: get proper amount of water for injection, slowly join in the mixed liquor of Oleum Curcumae and tween 80, stir evenly, solution 2.
Sterilizing methods is in the step 4: sterilized 30 minutes in 8 minutes or 115 ℃ through 121 ℃ of sterilizations.
Described Zedoary turmeric oil glucose injection preparation method is preferably:
Step 1: get water for injection 100 parts by volume, adding glucose 50 weight portions, add calcium disodium edetate 0.15 weight portion, stir and make dissolving, add active carbon 0.1 weight portion, boiled 15 minutes, filter, get solution 1;
Step 2: get Oleum Curcumae 0.4 weight portion, add vitamin E 0.08 weight portion, stir evenly, add tween 80 2.0 weight portions, stir evenly;
Step 3: get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2;
Step 4: solution 1 and solution 2 are mixed, add injection water to 1000 parts by volume, lid, is rolled at filtration, fill in citric acid solution adjusting pH to 4.0～5.0 with 10%, sterilized 30 minutes in 8 minutes or 115 ℃ through 121 ℃ of sterilizations, promptly get Zedoary turmeric oil glucose injection.
Weight portion of the present invention and parts by volume correspond to grams per milliliter.
Pharmaceutical composition of Zedoary turmeric oil glucose injection of the present invention and preparation method thereof, not only solved the problem that the rising of impurity trap is more and the decline of curcumenol content is fast, and solved prior art and can not adopt the problem of terminal sterilization (F0 〉=8), can adopt 121 ℃ of sterilization 8 minutes or 115 ℃ of sterilization sterilizations in 30 minutes down down, reduce the safety hidden danger of clinical use.
The contrast of experimental example 1 Zedoary turmeric oil glucose injection of the present invention and No. 03146102.6 patent application technology
1, description of test
According to the embodiment of the invention 1 pharmaceutical composition and the prepared Zedoary turmeric oil glucose injection sample of preparation method A, and prepare Zedoary turmeric oil glucose injection sample B according to optimum ratio of adjuvant and method in the patented method (03146102.6).Every index and the every index of study on the stability were analyzed before and after two kinds of composition prescriptions and the prepared sample of preparation method sterilized respectively.(adopt operation simultaneously to be to increase the comparability of two inventions, eliminate error)
2, the preparation of No. 03146102.6 patent Zedoary turmeric oil glucose injection
Getting Oleum Curcumae is equivalent to curcumenol 1.6g (is 100% to feed intake with curcumenol content) and adds the warm composition emulsifying of 17.6g tween 80 and get mixed liquor; Get the 180g anhydrous glucose and be made into 60% solution, 1% hydrochloric acid and the active carbon 2g that add 0.5ml stir, and boil 30 minutes, take out, and are cooled to 50～60 ℃, filter to such an extent that remove the charcoal mixed liquor; With the emulsifying mixed liquor with go the charcoal mixed liquor to merge, add water to about 4000ml, add 1g sodium citrate and 0.2g disodium edetate, dissolving, with 5%HCl pH value is adjusted to 4.0～4.5, adds water to 4000ml, filtration, fill, roll lid, respectively: (1) promptly gets Zedoary turmeric oil glucose injection B1 through 105 ℃ of sterilizations 30 minutes; (2) through 121 ℃ of sterilizations 8 minutes, promptly get Zedoary turmeric oil glucose injection B2.
3, the contrast of Zedoary turmeric oil glucose injection of the present invention and No. 03146102.6 patent application technology
1, before and after the sterilization
(number of patent application: 03146102.6) preparation Zedoary turmeric oil glucose injection (B1, B2), every index testing result relatively the results are shown in Table 1 before and after sterilizing according to the embodiment of the invention 1 preparation Zedoary turmeric oil glucose injection (A) and according to patent.
The comparison of every index before and after the sterilization of the different prescription preparation of table 1 Zedoary turmeric oil glucose injection
Result of the test shows: adopt the decline of the Zedoary turmeric oil glucose injection sterilization back inhibition curcumenol content of the present invention's preparation.Adopting 8 minutes terminal sterilization gained sample of 121 ℃ of sterilizations can satisfy prescription, and (number of patent application: it is consistent that 03146102.6) method adopts nonterminal sterilization (sterilizing 30 minutes for 105 ℃) gained sample quality with patent for quality, patent (number of patent application: 03146102.6) the obtained sample of method adopt 8 minutes terminal sterilization gained samples of 121 ℃ of sterilizations then curcumenol content and pH value obviously descend, 5-hydroxymethyl furfural content obviously raises.Therefore, the inventive method and adjuvant prescription have clear superiority.
2,30 ℃ of accelerated stability test results
Prepare Zedoary turmeric oil glucose injection (A) and (number of patent application: 03146102.6) preparation Zedoary turmeric oil glucose injection (B1) through the every index testing result of accelerated tests 6 months relatively, the results are shown in Table 2 according to patent according to the embodiment of the invention 1 the present invention.
The comparison of 6 months every indexs of accelerated tests of the different prescription preparation Zedoary turmeric oil glucose injections of table 2
Result of the test shows: adopt the decline of the Zedoary turmeric oil glucose injection sterilization back inhibition curcumenol content of the present invention's preparation.(number of patent application: it is consistent that 03146102.6) method adopts nonterminal sterilization (sterilizing 30 minutes for 105 ℃) gained Zedoary turmeric oil glucose injection with patent for the Zedoary turmeric oil glucose injection of the present invention's preparation.
3, long-term stable experiment result
According to the embodiment of the invention 1 the present invention prepare Zedoary turmeric oil glucose injection (A) with according to patent (number of patent application: 03146102.6) preparation Zedoary turmeric oil glucose injection (B), through 6 months every index testing results of long-term stable experiment relatively, the results are shown in Table 3.
The comparison of the every index of the different prescription preparation Zedoary turmeric oil glucose injection long-term stable experiments of table 3
Result of the test shows: adopt the decline of the Zedoary turmeric oil glucose injection sterilization back inhibition curcumenol content of the present invention's preparation.(number of patent application: it is consistent that 03146102.6) method adopts nonterminal sterilization (sterilizing 30 minutes for 105 ℃) gained Zedoary turmeric oil glucose injection with patent for the Zedoary turmeric oil glucose injection of the present invention's preparation.
Following embodiment all can realize the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1: the preparation of Zedoary turmeric oil glucose injection
Get water for injection 100ml, adding glucose 50g, add calcium disodium edetate 0.15g, stir and make dissolving, add active carbon 0.1g, boiled 15 minutes, filter, get solution 1; Get Oleum Curcumae 0.4g (is 100% to feed intake with curcumenol content), add vitamin E 0.08g, stir evenly, add tween 80 2.0g, stir evenly; Get water for injection 100ml, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2; Solution 1 and solution 2 is mixed, add the injection water to 1000ml, the citric acid solution with 10% is regulated pH to 4.0～5.0, filtration, fill, rolls lid, sterilizes 8 minutes through 121 ℃, promptly gets Zedoary turmeric oil glucose injection A.
Embodiment 2: the preparation of Zedoary turmeric oil glucose injection
Get water for injection 200ml, adding glucose 100g, add calcium disodium edetate 0.1g, stir and make dissolving, add active carbon 0.4g, boiled 30 minutes, filter, get solution 1; Get Oleum Curcumae 0.3g, add vitamin E 0.5g, stir evenly, add tween 80 1.5g, stir evenly; Get proper amount of water for injection, slowly join in the mixed liquor of Oleum Curcumae and tween 80, stir evenly, get solution 2; Solution 1 and solution 2 is mixed, add the injection water to 1000ml, the citric acid solution with 20% is regulated pH to 4.0～5.0, filtration, fill, rolls lid, sterilizes 30 minutes through 115 ℃, promptly gets Zedoary turmeric oil glucose injection.
Embodiment 3: the preparation of Zedoary turmeric oil glucose injection
Get water for injection 80ml, adding glucose 50g, add calcium disodium edetate 0.2g, stir and make dissolving, add active carbon 0.04g, boiled 5 minutes, filter, get solution 1; Get Oleum Curcumae 0.5g, add vitamin E 0.01g, stir evenly, add tween 80 3.0g, stir evenly; Get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2; Solution 1 and solution 2 is mixed, add the injection water to 1000ml, the citric acid solution with 1% is regulated pH to 4.0～5.0, filtration, fill, rolls lid, sterilizes 8 minutes through 121 ℃, promptly gets Zedoary turmeric oil glucose injection.
Embodiment 4: the preparation of Zedoary turmeric oil glucose injection
Get water for injection 100ml, adding glucose 50g, add disodium edetate 0.15g, stir and make dissolving, add active carbon 0.1g, boiled 15 minutes, filter, get solution 1; Get Oleum Curcumae 0.4g, add vitamin E 0.08g, stir evenly, add tween 80 2.0g, stir evenly; Get water for injection 100ml, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2; Solution 1 and solution 2 is mixed, add to the full amount of water for injection, the citric acid solution with 10% is regulated pH to 4.0～5.0, filtration, fill, rolls lid, sterilizes 8 minutes through 121 ℃, promptly gets Zedoary turmeric oil glucose injection.
Claims (9)
1. Zedoary turmeric oil glucose injection is characterized in that this injection is prepared by following method:
Step 1: get water for injection 80-200 parts by volume, adding glucose 40-100 weight portion, add calcium disodium edetate 0.1～0.2 weight portion, stir and make dissolving, add active carbon 0.04～0.4 weight portion, boiled 5～30 minutes, filter, get solution 1;
Step 2: get Oleum Curcumae 0.3～0.5 weight portion, add vitamin E 0.01-0.5 weight portion, stir evenly, add tween 80 1.5-3.0 weight portion, stir evenly;
Step 3: get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2;
Step 4: solution 1 and solution 2 is mixed, add injection water to 1000 parts by volume, lid, is rolled at filtration, fill in citric acid solution adjusting pH to 4.0～5.0 with 1～20%, sterilize Zedoary turmeric oil glucose injection.
2. injection as claimed in claim 1 is characterized in that step 3 replaced by following method: get proper amount of water for injection, slowly join in the mixed liquor of Oleum Curcumae and tween 80, stir evenly, solution 2.
3. injection as claimed in claim 1 is characterized in that the sterilizing methods of step 4 is: sterilized 30 minutes in 8 minutes or 115 ℃ through 121 ℃ of sterilizations.
4. as the arbitrary described injection of claim 1-3, it is characterized in that calcium disodium edetate substitutes with disodium edetate in this injection.
5. as the arbitrary described injection of claim 1-3, it is characterized in that tween 80 substitutes with poloxamer in this injection.
6. the preparation method of a Zedoary turmeric oil glucose injection is characterized in that this method comprises the steps:
Step 1: get water for injection 80-200 parts by volume, adding glucose 40-100 weight portion, add calcium disodium edetate 0.1～0.2 weight portion, stir and make dissolving, add active carbon 0.04～0.4 weight portion, boiled 5～30 minutes, filter, get solution 1;
Step 2: get Oleum Curcumae 0.3～0.5 weight portion, add vitamin E 0.01-0.5 weight portion, stir evenly, add tween 80 1.5-3.0 weight portion, stir evenly;
Step 3: get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2;
Step 4: solution 1 and solution 2 is mixed, add injection water to 1000 parts by volume, lid, is rolled at filtration, fill in citric acid solution adjusting pH to 4.0～5.0 with 1～20%, sterilize Zedoary turmeric oil glucose injection.
7. preparation method as claimed in claim 6 is characterized in that step 3 replaced by following method: get proper amount of water for injection, slowly join in the mixed liquor of Oleum Curcumae and tween 80, stir evenly, solution 2.
8. preparation method as claimed in claim 6 is characterized in that sterilizing methods is: sterilized 30 minutes in 8 minutes or 115 ℃ through 121 ℃ of sterilizations.
9. preparation method as claimed in claim 6 is characterized in that this method comprises the steps:
Step 1: get water for injection 100 parts by volume, adding glucose 50 weight portions, add calcium disodium edetate 0.15 weight portion, stir and make dissolving, add active carbon 0.1 weight portion, boiled 15 minutes, filter, get solution 1;
Step 2: get Oleum Curcumae 0.4 weight portion, add vitamin E 0.08 weight portion, stir evenly, add tween 80 2.0 weight portions, stir evenly;
Step 3: get proper amount of water for injection, the mixed liquor of Oleum Curcumae and tween 80 slowly added, stir evenly, solution 2;
Step 4: solution 1 and solution 2 are mixed, add injection water to 1000 parts by volume, lid, is rolled at filtration, fill in citric acid solution adjusting pH to 4.0～5.0 with 10%, sterilized 30 minutes in 8 minutes or 115 ℃ through 121 ℃ of sterilizations, promptly get Zedoary turmeric oil glucose injection.
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| CN103239684A (en) * | 2013-05-23 | 2013-08-14 | 张蕊 | Zedoary oil injection and preparation method thereof |
| CN105213952B (en) * | 2014-06-18 | 2019-11-08 | 张蕊 | A kind of Oleum Curcumae injection and preparation method thereof |
| CN105477531A (en) * | 2014-09-18 | 2016-04-13 | 张蕊 | Large-volume zedoary turmeric oil injection and preparation method thereof |
| CN107693488B (en) * | 2017-11-02 | 2020-01-03 | 重庆理工大学 | Fat-soluble medicine submicron capsule glucose injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1546068A (en) * | 2003-07-22 | 2004-11-17 | 丽珠集团利民制药厂 | Modified technique for making zedoary turmeric oil and glucose injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1546068A (en) * | 2003-07-22 | 2004-11-17 | 丽珠集团利民制药厂 | Modified technique for making zedoary turmeric oil and glucose injection |
Non-Patent Citations (1)
| Title |
|---|
| 孟秋风 等.聚山梨酯-80对莪术油葡萄糖注射液质量影响的研究.《中药研究与信息》.2005,第7卷(第12期),21,28. * |
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Assignee: Liaoning Minkang Pharmaceutical Co.,Ltd. Assignor: Sichuan Kelun Pharmaceutical Co., Ltd. Contract record no.: 2012510000046 Denomination of invention: Zedoary turmeric oil glucose injection and preparation method thereof Granted publication date: 20110907 License type: Exclusive License Open date: 20090429 Record date: 20120523 |