CN102085222B - Method for preparing Shuxuening injection - Google Patents
Method for preparing Shuxuening injection Download PDFInfo
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- CN102085222B CN102085222B CN200910217956.6A CN200910217956A CN102085222B CN 102085222 B CN102085222 B CN 102085222B CN 200910217956 A CN200910217956 A CN 200910217956A CN 102085222 B CN102085222 B CN 102085222B
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Abstract
The invention belongs to the field of medicinal preparations and particularly discloses a method for preparing a Shuxuening injection having the effects of expanding blood vessels and improving microcirculation. The preparation method comprises the following steps of: grinding ginkgo leaves and performing the technical treatments of the ginkgo leaves, such as ethanol soakage, condensation filtration, ethanol refrigeration, resin adsorption and ethanol elution, to obtain extracting solution of ginkgo. The method can guarantee that inactive substances such as proteins and tannins are completely eliminated, the degradation of active substances is avoided, related substances in the preparation are reduced, and the finished product of the preparation has the advantages of high stability, small irritability, high solubility and stable curative effect. Clinical tests prove that the Shuxuening injection can be used for intravenous drip to treat diseases such as ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina, cerebral embolism, cerebrovascular spasm and the like.
Description
Technical field
This medicine belongs to medicine preparation preparation method technical field, is specifically related to a kind of SHUXUENING ZHUSHEYE preparation method, more specifically relates to a kind of injection with small volume take Semen Ginkgo extrac as main component.
Background technology
SHUXUENING ZHUSHEYE is that Folium Ginkgo is through extracting the sterile water solution of making.Folium Ginkgo is the dried leaves of Ginkgoaceae plant Ginkgo biloba, and it is traditional blood-activating and stasis-removing material, has good treatment cough and asthma due to lung deficiency, coronary heart disease, angina pectoris, the pharmacological action of hyperlipidemia.In Folium Ginkgo extract, contain the effective ingredient such as total flavones, total lactone, the main active that total flavones is Folium Ginkgo extract.Total flavones mainly exists with glycoside form in Folium Ginkgo extract, is mainly Quercetin, kaempferide and isorhamnetin.The expansible blood vessel of Semen Ginkgo extrac; anti-PAF short of money, anticoagulant, reduces hyperlipidemia; increase ischemia internal organs blood flow; improve microcirculation and blood flow rate, remove free radical, suppress Cell membrane lipids generation peroxidization; prevent that radical pair body from causing the infringement such as thrombosis, arteriosclerosis; neuroprotective cell, improves memory function, has blood circulation promoting and blood stasis dispelling, regulates the flow of vital energy, effect of pain relieving, TONGMAI SHULUO.Be mainly used in ischemic cardio cerebrovascular diseases, coronary heart disease, angina pectoris, blood embolization, the treatment of the diseases such as cerebral vasospasm.
At present, the SHUXUENING ZHUSHEYE on domestic market has many enterprises to produce, and its product exists poor solubility, the technical barriers such as unstable product quality.Its main cause is Folium Ginkgo extract, and in preparation process, partial impurities is as the not removal completely of the invalid components such as protein, tannin, and dissolubility is bad, and the breakthrough of SHUXUENING ZHUSHEYE technique of the present invention has fundamentally solved the problems referred to above.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of SHUXUENING ZHUSHEYE.
Preparation method of the present invention comprises the steps: the preparation of ginkgo extract: Folium Ginkgo is pulverized, with soak with ethanol, thickening filtration, ethanol cold preservation, resin absorption, ethanol elution, obtains filtrate and is ginkgo extract, and backlash nitrogen is canned, sterilizing, lamp inspection, packing, obtains SHUXUENING ZHUSHEYE finished product.
Preparation method detailed process of the present invention is as follows:
The preparation of ginkgo extract: Folium Ginkgo is pulverized, add the ethanol of 10～50 times of amounts 60～95%, 40～80 ℃ are soaked 1～6 hour, be concentrated to 1/5～1/10 of extracting liquid volume, filter, add the ethanol of 2～4 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 1～4% concentrated amount to filter, collect filtrate and be concentrated to 5～20 times of column volumes, regulate pH value 2～6.5, through macroporous resin adsorption, after use 60～90% alcoholic solution desorbings, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
More preferred preparation method comprises the steps:
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 20 times of amounts 75%, 70 ℃ are soaked 3 hours, be concentrated to 1/8 of extracting liquid volume, filter, add the ethanol of 3 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 2% concentrated amount to filter, collect filtrate and be concentrated to 10 times of column volumes, regulate pH value 5, through macroporous resin adsorption, after use 70% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
In appeal preparation method, adopting the molecular weight that dams is 30,000 ultrafilter membrane ultrafiltration, is the control step of invalid components in institute's preparating liquid, and ultrafilter membrane used is commercially available prod.Qi Sheng manufacturer should be the production unit of industry approval.
In above-mentioned preparation method, the filter membrane aperture that terminal aseptic filtration is used is 0.22 μ m.For making constant product quality, filter membrane should be provided by fixing manufacturer as far as possible.
In above-mentioned preparation method, cosolvent is Poloxamer 188, and its volume is 1～4% of concentrated liquid measure.
In above-mentioned preparation method, macroporous resin is AB-8.
In above-mentioned preparation method, the pH value of filtrate is 2～6.5.
Intramuscular injection when SHUXUENING ZHUSHEYE clinical practice of the present invention, the 8～10ml that is grown up a time, 1～2 time on the one.Intravenous drip, every day 15～20ml, with using after 5% glucose injection dilution 250ml or 500ml.
In the present invention, Folium Ginkgo is through immersion, thickening filtration, cold preservation; the technical finesse such as resin absorption, eluting; and there is a nitrogen filled protection; guarantee that invalid components is completely removed, avoided the degraded of effective ingredient, reduced the related substance in preparation; make the better stability of preparation of making; zest is little, and dissolubility is good, stable curative effect.
The specific embodiment
Embodiment 1
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 10 times of amounts 95%, 40 ℃ are soaked 6 hours, be concentrated to 1/5 of extracting liquid volume, filter, add the ethanol of 2 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 2% concentrated amount to filter, collect filtrate and be concentrated to 5 times of column volumes, regulate pH value 3, through macroporous resin adsorption, after use 60% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
Embodiment 2
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 30 times of amounts 80%, 50 ℃ are soaked 5 hours, be concentrated to 1/6 of extracting liquid volume, filter, add the ethanol of 2 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 3% concentrated amount to filter, collect filtrate and be concentrated to 15 times of column volumes, regulate pH value 4, through macroporous resin adsorption, after use 65% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
Embodiment 3
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 40 times of amounts 70%, 60 ℃ are soaked 2 hours, be concentrated to 1/7 of extracting liquid volume, filter, add the ethanol of 3 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 3% concentrated amount to filter, collect filtrate and be concentrated to 17 times of column volumes, regulate pH value 6, through macroporous resin adsorption, after use 80% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
Embodiment 4
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 50 times of amounts 60%, 80 ℃ are soaked 1 hour, be concentrated to 1/10 of extracting liquid volume, filter, add the ethanol of 4 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 4% concentrated amount to filter, collect filtrate and be concentrated to 20 times of column volumes, regulate pH value 6.5, through macroporous resin adsorption, after use 90% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
Embodiment 5
The preparation of ginkgo extract: Folium Ginkgo is pulverized, added the ethanol of 20 times of amounts 75%, 70 ℃ are soaked 3 hours, be concentrated to 1/8 of extracting liquid volume, filter, add the ethanol of 3 times of concentrated liquid measures 95%, cold preservation is spent the night, add again the cosolvent of 2% concentrated amount to filter, collect filtrate and be concentrated to 10 times of column volumes, regulate pH value 5, through macroporous resin adsorption, after use 70% alcoholic solution desorbing, with damming the ultrafilter membrane ultrafiltration of molecular weight 30,000, obtain ginkgo extract.
Claims (1)
1. the preparation method of a SHUXUENING ZHUSHEYE, it is characterized in that comprising the steps: the preparation of ginkgo extract: Folium Ginkgo is pulverized, add the ethanol of 50 times of amounts 60%, 80 ℃ are soaked 1 hour, be concentrated to 1/10 of extracting liquid volume, filter, the ethanol that adds 4 times of concentrated liquid measures 95%, cold preservation is spent the night, then adds the cosolvent of 4% concentrated amount to filter, collect filtrate and be concentrated to 20 times of column volumes, regulate pH value 6.5, through macroporous resin adsorption, rear use 90% alcoholic solution desorbing, with the ultrafilter membrane ultrafiltration of the molecular weight 30,000 that dams, obtain ginkgo extract.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910217956.6A CN102085222B (en) | 2009-12-07 | 2009-12-07 | Method for preparing Shuxuening injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910217956.6A CN102085222B (en) | 2009-12-07 | 2009-12-07 | Method for preparing Shuxuening injection |
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| CN102085222A CN102085222A (en) | 2011-06-08 |
| CN102085222B true CN102085222B (en) | 2014-07-09 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1772012A (en) * | 2005-11-14 | 2006-05-17 | 张正生 | Freeze dried ginkgo leaf powder for injection and its prepn |
| CN1939357A (en) * | 2005-09-27 | 2007-04-04 | 巴里莫尔制药（通化）有限公司 | Preparation of Ginkgo Damo injection |
| CN101091730A (en) * | 2006-06-23 | 2007-12-26 | 海南医学院 | Technique for preparing gingkgo extractive with low content of ginkgolic acid |
| CN101411728A (en) * | 2007-10-18 | 2009-04-22 | 郭鸿旭 | Shuxuening injection formulation and preparation method thereof |
-
2009
- 2009-12-07 CN CN200910217956.6A patent/CN102085222B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939357A (en) * | 2005-09-27 | 2007-04-04 | 巴里莫尔制药（通化）有限公司 | Preparation of Ginkgo Damo injection |
| CN1772012A (en) * | 2005-11-14 | 2006-05-17 | 张正生 | Freeze dried ginkgo leaf powder for injection and its prepn |
| CN101091730A (en) * | 2006-06-23 | 2007-12-26 | 海南医学院 | Technique for preparing gingkgo extractive with low content of ginkgolic acid |
| CN101411728A (en) * | 2007-10-18 | 2009-04-22 | 郭鸿旭 | Shuxuening injection formulation and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 吴梅林等.大孔吸附树脂纯化银杏活性化合物的工艺研究.《中南药学》.2005,第03卷(第02期),第76页1.3节. |
| 大孔吸附树脂纯化银杏活性化合物的工艺研究;吴梅林等;《中南药学》;20050420;第03卷(第02期);第76页1.3节 * |
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