CN1346648A - Diemailing injection and its preparing process - Google Patents
Diemailing injection and its preparing process Download PDFInfo
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- CN1346648A CN1346648A CN 01114136 CN01114136A CN1346648A CN 1346648 A CN1346648 A CN 1346648A CN 01114136 CN01114136 CN 01114136 CN 01114136 A CN01114136 A CN 01114136A CN 1346648 A CN1346648 A CN 1346648A
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- zhusheye
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Abstract
An injection "Diemailing" is prepared from Ixeris sonchifolia as main raw material through decocting several times, merging decoctions, concentrating, adding CaO, centrifugal separation, precipitation, adding alcohol, suspending, centrifugal separation, adding H2SO4 for neutralizing, voltatilizing alcohol, adding water for injection, high-pressure sterilizing, freezing, membrane separation, ultrafiltering, diluting, loading in container, sealing and sterilizing. The content of general flavone is 0.36-0.55 mg/ml.
Description
The present invention relates to a kind ofly make the medicine and the method for injection, i.e. DIEMAILING ZHUSHEYE and preparation method thereof with medicinal plants.
DIEMAILING ZHUSHEYE is that primary raw material extracts refining forming with feverfew Herba Ixeritis Sonchifoliae dry aerial parts.Flavonoid content is higher in the Herba Ixeritis Sonchifoliae chemical constituent, so the DIEMAILING ZHUSHEYE effective ingredient is flavone compound C
27H
30O
16, molecular weight 610, ribosidoadenine C
10H
13N
5O
4, molecular weight 267.The two biological activity is very strong, easily microbiological contamination, and traditional handicraft is extracted and is not guaranteed drug quality.In traditional medicinal plants injection extracting process, filtrate often adopts the active carbon boiling method to filter, its shortcoming be active carbon in absorption antibacterial and impurity, also adsorbed effective medicinal ingredient.
The present invention seeks to provide a kind of DIEMAILING ZHUSHEYE of abundant exploitation Herba Ixeritis Sonchifoliae medicinal function, provide a kind of effective ingredient of guaranteeing simultaneously, the DIEMAILING ZHUSHEYE preparation method of improving the quality of products at above-mentioned deficiency.
The object of the present invention is achieved like this: DIEMAILING ZHUSHEYE is an effective ingredient with the Herba Ixeritis Sonchifoliae aqueous extract, and every milliliter of injection contains total flavones 0.36mg/ml-0.55mg/ml.
The preparation method of DIEMAILING ZHUSHEYE is to be primary raw material with the medicinal plants Herba Ixeritis Sonchifoliae, Herba Ixeritis Sonchifoliae is decocted with water → collecting decoction → concentrate → adds CaO, centrifugal, precipitate → add ethanol, suspension, centrifugal → as to add H
2SO
4Neutralization, wave alcohol → add injection dilute with water → autoclaving → freezing → membrane separation technique ultrafiltration → dilution → potting → sterilization → promptly.Described autoclaving temperature is 115 ℃-120 ℃, time 15min.50,000 molecular weight Hollow Fiber Ultrafiltrations are once used in described membrane separation technique ultrafiltration, add injection water dilution after, with 10,000 molecular weight Hollow Fiber Ultrafiltrations.
DIEMAILING ZHUSHEYE has obvious therapeutic effect to cerebral thrombosis, coronary heart disease, angina pectoris, optic atrophy and fundus oculi disease.Have no side effect.
Advantage of the present invention is: 1, developed the Herba Ixeritis Sonchifoliae medicinal plants, for treatment cerebral thrombosis, coronary heart disease, angina pectoris, optic atrophy and fundus oculi disease etc. provide a kind of new drug.2, its effective ingredient adenosine of DIEMAILING ZHUSHEYE and flavone compound biological activity are very strong, and autoclaving is adopted in easily microbiological contamination in the technology, can remove pyrogen effectively, and the effective ingredient that is not destroyed.3, adopt the doughnut membrane separation technique to filter in the technology, macromolecule impurity and antibacterial have been removed, kept content of effective effectively and clarity is qualified, overcome the Chinese medicine injection and adopted activated carbon adsorption antibacterial and impurity, the shortcoming of adsorbing effective ingredient again simultaneously.
Below in conjunction with embodiment the present invention is described in further detail:
DIEMAILING ZHUSHEYE: the Herba Ixeritis Sonchifoliae concentrated solution adds injection and is diluted with water to the sterile water solution that every 1ml contains total flavones 0.55mg.
DIEMAILING ZHUSHEYE preparation method: get Herba Ixeritis Sonchifoliae and decoct with water twice, adding for the first time 12-15 times of water gaging decocted 1 hour, adding for the second time 8-10 times of water gaging decocted 0.5 hour, the merging decoction liquor is concentrated into every 1ml and is equivalent to crude drug in whole 0.5g, puts to be chilled to below 40 ℃, under agitation add 10% calcium oxide breast to pH10, placed 12 hours, centrifugal, precipitate is weighed, be suspended in 5.0-5.5 times of 95% ethanol, add 50% sulfuric acid solution to pH3-4, fully stir, centrifugal, clear and bright liquid adds 40% sodium hydroxide solution to pH7.8-8.0, cardboard filter, filtrate recycling ethanol is also waved most ethanol, adds injection and is diluted with water to every 1ml and is equivalent to crude drug in whole 4g.115 ℃ of-120 ℃ of autoclaving 15min, put coldly, place down in-5 ℃ again and reach more than 24 hours thawing naturally, 50,000 molecular weight Hollow Fiber Ultrafiltrations, transfer pH7.6-7.8, add injection and be diluted with water to every 1ml and contain flavone 0.55mg, with 10,000 molecular weight Hollow Fiber Ultrafiltrations, microporous filter membrane filters, embedding is 105 ℃ of sterilizations 45 minutes, promptly.
DIEMAILING ZHUSHEYE is based on injection.Also can be made into injectable powder, tablet, the time spent adds the injection dilute with water.
The first clinical hospital adopts that DIEMAILING ZHUSHEYE is clinical to have obtained better curative effect to 156 routine cerebral thrombus patients' treatments through the Norman Bethune Medical University, produce effects 46 examples wherein, and 98 examples that take a turn for the better, invalid 12 examples, effective percentage is 92.3%.Conclusion: DIEMAILING ZHUSHEYE has the brain microcirculation of improvement, reduce cerebral vascular resistance, the effect that blood flow increasing, reduction body oxygen metabolism, oxygen consumption reduce, and have the reduction platelet aggregation, and suppress thrombosis, reduce the blood plasma granularity, thereby alleviate or block developing of cerebral hypoxia ischemia and cerebral edema, improve the blood oxygen supply of cerebral tissue, promote the recovery of diseased region function of nervous system, clinical symptoms is taken a turn for the better.It also has effects such as reducing blood viscosity in addition.
Through Guangdong Zhongshan Medical Univ., ophthalmology center, middle mountain adopts that DIEMAILING ZHUSHEYE is clinical cures 6 examples to 44 routine retinopathy patient treatments, produce effects 17 examples, and effective 13 examples, invalid 8 examples, total effective rate is 81.8%.Conclusion: ophthalmic diseasess such as DIEMAILING ZHUSHEYE treatment optic nerve disease, retinal hemorrhage and uveitis, evident in efficacy, safe and reliable.
Adopt DIEMAILING ZHUSHEYE clinical through Attached Hospital, Changchun Chinese Medicinal College to 124 routine coronary heart disease, patient with angina pectoris treatment, produce effects 89 examples, effective 31 examples, invalid 4 examples, total effective rate is 96.77%.Conclusion: DIEMAILING ZHUSHEYE has obvious coronary artery dilator, increases blood flow coronarius, improves the effect that the myocardial blood of ischemic region is supplied with, thus allevating angina pectoris symptom well.Practice is proof also: the spirit of dish arteries and veins has the reduction blood viscosity, and anticoagulant and thrombolytic prevents platelet aggregation, improves hemorheological property and microcirculation, and protecting myocardial cell improves left auxocardia function, suppresses the appearance of heart failure, can prolong survival time of patients, and improves
The first clinical hospital adopts that DIEMAILING ZHUSHEYE is clinical to have obtained better curative effect to 156 routine cerebral thrombus patients' treatments through the Norman Bethune Medical University, produce effects 46 examples wherein, and 98 examples that take a turn for the better, invalid 12 examples, effective percentage is 923%.Conclusion: DIEMAILING ZHUSHEYE has the brain microcirculation of improvement, reduce cerebral vascular resistance, the effect that blood flow increasing, reduction body oxygen metabolism, oxygen consumption reduce, and have the reduction platelet aggregation, and suppress thrombosis, reduce the blood plasma granularity, thereby alleviate or block developing of cerebral hypoxia ischemia and cerebral edema, improve the blood oxygen supply of cerebral tissue, promote the recovery of diseased region function of nervous system, clinical symptoms is taken a turn for the better.It also has effects such as reducing blood viscosity in addition.
Through Guangdong Zhongshan Medical Univ., ophthalmology center, middle mountain adopts that DIEMAILING ZHUSHEYE is clinical cures 6 examples to 44 routine retinopathy patient treatments, produce effects 17 examples, and effective 13 examples, invalid 8 examples, total effective rate is 81.8%.Conclusion: ophthalmic diseasess such as DIEMAILING ZHUSHEYE treatment optic nerve disease, retinal hemorrhage and uveitis, evident in efficacy, safe and reliable.
Adopt DIEMAILING ZHUSHEYE clinical through Attached Hospital, Changchun Chinese Medicinal College to 124 routine coronary heart disease, patient with angina pectoris treatment, produce effects 89 examples, effective 31 examples, invalid 4 examples, total effective rate is 96.77%.Conclusion: DIEMAILING ZHUSHEYE has obvious coronary artery dilator, increases blood flow coronarius, improves the effect that the myocardial blood of ischemic region is supplied with, thus allevating angina pectoris symptom well.Practice is proof also: the spirit of dish arteries and veins has the reduction blood viscosity, and anticoagulant and thrombolytic prevents platelet aggregation; improve hemorheological property and microcirculation, protecting myocardial cell improves left auxocardia function; suppress the appearance of heart failure, can prolong survival time of patients, and improve patient's life quality.Clinical observation also finds, this medicine can not only allevating angina pectoris, to the cerebral thrombosis effect that also has clear improvement, also can be used for treating the peripheral blood vessel pathological changes.And not occurring anaphylaxis in the application process, hepatic and renal function is not had obvious damage, is to treat coronary heart disease, anginal active drug clinically.
Through Royal Bank Venture Capital Co., Ltd the DIEMAILING ZHUSHEYE acute toxicity test is shown: with concentrated 50 times DIEMAILING ZHUSHEYE, by mice maximum injection volume, lumbar injection and intravenous injection respectively, none death.Show that DIEMAILING ZHUSHEYE toxicity is low, clinical medicine dose is safe and reliable.
Claims (6)
1, a kind of DIEMAILING ZHUSHEYE is characterized in that with the Herba Ixeritis Sonchifoliae aqueous extract be effective ingredient, and every milliliter of injection contains total flavones 0.36mg/ml-0.55mg/ml.
2, the preparation method of the described DIEMAILING ZHUSHEYE of a kind of production claim 1, it is characterized in that with the medicinal plants Herba Ixeritis Sonchifoliae be primary raw material, Herba Ixeritis Sonchifoliae is decocted with water → collecting decoction → concentrate → adds CaO, centrifugal, precipitate → add ethanol, suspension, centrifugal → as to add H
2SO
4Neutralization, wave alcohol → add injection dilute with water → autoclaving → freezing → membrane separation technique ultrafiltration → dilution → potting → sterilization → promptly.
3,, it is characterized in that described autoclaving temperature is 115 ℃-120 ℃, time 15min according to the preparation method of the described DIEMAILING ZHUSHEYE of claim 2.
4, according to the preparation method of claim 2 or 3 described DIEMAILING ZHUSHEYE, it is characterized in that described membrane separation technique ultrafiltration once uses 50,000 molecular weight Hollow Fiber Ultrafiltrations, add the injection water dilution after, reuse 10,000 molecular weight Hollow Fiber Ultrafiltrations.
5, preparation method according to the arbitrary described DIEMAILING ZHUSHEYE of claim 2 to 4, it is characterized in that selection process decocts with water twice for getting Herba Ixeritis Sonchifoliae, adding for the first time 12-15 times of water gaging decocted 1 hour, adding for the second time 8-10 times of water gaging decocted 0.5 hour, merge decoction liquor, be concentrated into every 1ml and be equivalent to crude drug in whole 0.5g, put and be chilled to below 40 ℃, under agitation add 10% calcium oxide breast to pH10, placed 12 hours, centrifugal, precipitate is weighed, and is suspended in 5.0-5.5 times of 95% ethanol, adds 50% sulfuric acid solution to pH3-4, fully stir, centrifugal, clear and bright liquid adds 40% sodium hydroxide solution to pH7.8-8.0, cardboard filter, filtrate recycling ethanol is also waved most ethanol, add injection and be diluted with water to every 1ml and be equivalent to crude drug in whole 4g, 115 ℃ of-120 ℃ of autoclaving 15min are put cold, place down in-5 ℃ again and reach more than 24 hours, naturally melt, 50,000 molecular weight Hollow Fiber Ultrafiltrations are transferred pH7.6-7.8, adding injection is diluted with water to every 1ml and contains flavone 0.55mg, with 10,000 molecular weight Hollow Fiber Ultrafiltrations, microporous filter membrane filters, embedding, 105 ℃ of sterilizations 45 minutes, promptly.
6,, it is characterized in that also can be made into injectable powder, tablet, capsule according to the described DIEMAILING ZHUSHEYE of claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011141360A CN1190205C (en) | 2001-06-24 | 2001-06-24 | Diemailing injection and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011141360A CN1190205C (en) | 2001-06-24 | 2001-06-24 | Diemailing injection and its preparing process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1346648A true CN1346648A (en) | 2002-05-01 |
| CN1190205C CN1190205C (en) | 2005-02-23 |
Family
ID=4660810
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011141360A Ceased CN1190205C (en) | 2001-06-24 | 2001-06-24 | Diemailing injection and its preparing process |
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| Country | Link |
|---|---|
| CN (1) | CN1190205C (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1502595A4 (en) * | 2002-04-23 | 2005-09-28 | Wang Maoxiang | An injection made from ixeris sonchifolia for treatment of cardio-cerebral vascular disease and fundus diseases and method of producing thereof |
| CN100387243C (en) * | 2005-10-11 | 2008-05-14 | 沈阳双鼎制药有限公司 | Quality control method of ixeris sonchifolia injection |
| CN100462081C (en) * | 2004-02-09 | 2009-02-18 | 徐绥绪 | Novel medical uses of perennial sowthistle and preparing method for intermediate thereof |
| CN1864706B (en) * | 2005-05-17 | 2010-05-12 | 广东世信药业有限公司 | Injection liquid of Ixeris sonchifolia (Bge.) Hance and preparation method thereof |
| CN108420842A (en) * | 2018-04-28 | 2018-08-21 | 通化师范学院 | A kind of sowthistle-leaf ixeris seedling preparation of antigout effect |
| CN111110714A (en) * | 2020-01-20 | 2020-05-08 | 沈阳双鼎制药有限公司 | Chinese medicinal preparation for treating angina pectoris and atherosclerosis diseases and preparation method thereof |
-
2001
- 2001-06-24 CN CNB011141360A patent/CN1190205C/en not_active Ceased
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1502595A4 (en) * | 2002-04-23 | 2005-09-28 | Wang Maoxiang | An injection made from ixeris sonchifolia for treatment of cardio-cerebral vascular disease and fundus diseases and method of producing thereof |
| KR100897656B1 (en) * | 2002-04-23 | 2009-05-14 | 왕 마오셩 | An Injection made from lxeris Sonchifolia Hance for Treatment of Cardio-Cerebral Vascular Diseases and Fundus Diseases and Method of Producing Thereof |
| CN100462081C (en) * | 2004-02-09 | 2009-02-18 | 徐绥绪 | Novel medical uses of perennial sowthistle and preparing method for intermediate thereof |
| CN1864706B (en) * | 2005-05-17 | 2010-05-12 | 广东世信药业有限公司 | Injection liquid of Ixeris sonchifolia (Bge.) Hance and preparation method thereof |
| CN100387243C (en) * | 2005-10-11 | 2008-05-14 | 沈阳双鼎制药有限公司 | Quality control method of ixeris sonchifolia injection |
| CN108420842A (en) * | 2018-04-28 | 2018-08-21 | 通化师范学院 | A kind of sowthistle-leaf ixeris seedling preparation of antigout effect |
| CN111110714A (en) * | 2020-01-20 | 2020-05-08 | 沈阳双鼎制药有限公司 | Chinese medicinal preparation for treating angina pectoris and atherosclerosis diseases and preparation method thereof |
| CN111110714B (en) * | 2020-01-20 | 2021-11-02 | 沈阳双鼎制药有限公司 | Chinese medicinal preparation for treating angina pectoris and atherosclerosis diseases and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1190205C (en) | 2005-02-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Tonghua Huaxia Pharmaceutical Co., Ltd. Assignor: Hua Yuqiang Contract fulfillment period: 2009.12.16 to 2021.6.23 contract change Contract record no.: 2009220000083 Denomination of invention: Injection liquid of Ixeris sonchifolia (Bge.) Hance and preparation method thereof Granted publication date: 20050223 License type: Exclusive license Record date: 20091224 |
|
| LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2009.12.16 TO 2021.6.23; CHANGE OF CONTRACT Name of requester: TONGHUA HUAXIA PHARMACEUTICAL CO., LTD Effective date: 20091224 |
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| C35 | Partial or whole invalidation of patent or utility model | ||
| IW01 | Full invalidation of patent right |
Decision date of declaring invalidation: 20091216 Decision number of declaring invalidation: 14239 Granted publication date: 20050223 |