CN1814166A - Pulse-promoting powder injecta and preparing method - Google Patents
Pulse-promoting powder injecta and preparing method Download PDFInfo
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Abstract
The invention relates to a pulse-activating powder for injection and the preparing method thereof. The invention purifies extracts from traditional Chinese drugs by ultrafiltration and alcoholic sedimentation, largely improving the stability.
Description
Technical field
The present invention relates to injection pulse-promoting powder pin and preparation method thereof, specifically, the present invention relates to a kind of is the herbal mixture injection powder injection formulation and preparation method thereof of main component with Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis.
Background technology
SHENGMAI ZHUSHEYE is a kind of intravenous fluid of making through form improvement according to China's tradition ancient prescription SHENGMAI SAN.Its function with cure mainly to supplementing QI and nourishing YIN, multiple arteries and veins take off admittedly, be used for cardiopalmus that QIYINLIANGXU, deficient pulse desire to take off, breathe hard, extreme cold of the limbs, sweating, arteries and veins reach myocardial infarction, cardiogenic shock, septic shock etc. wild.
SHENGMAI ZHUSHEYE is made up of Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis three flavor Chinese medicines, and wherein Radix Ginseng Rubra is the processed product of Radix Ginseng, and effective ingredient is the ginsenoside, has heart tonifying, adjust blood pressure, improvement circulation, promotes effects such as substance metabolism and protein synthesis; The effective ingredient of Radix Ophiopogonis is an ophiopogonin, has the myocardial contraction of improvement and heart pump function, protection cardiac muscle, arrhythmia, anoxia enduring, blood sugar lowering and effect such as antibiotic; The effective ingredient of Fructus Schisandrae Chinensis is a schizandrin, has the enhancing liver detoxification function, promotes the effects such as biosynthesis of hepatic protein and glycogen.The effect of SHENGMAI ZHUSHEYE by these three kinds of drug interactions, coordinate mutually and embody jointly.
Confirm that after deliberation the pharmacological action of SHENGMAI ZHUSHEYE mainly contains:
1) strengthens myocardial contraction, improve cardiac output, improve left heart function, have tangible cardiotonic.
2) dilating coronary blood vessel, coronary blood flow increasing reduces myocardial oxygen consumption, improves myocardial ischemia.
3) eliminate free radical, antagonism hypoxic-ischemic and bacterial endotoxin are to the heart and brain cells injury.
4) microcirculation improvement, blood viscosity lowering reduces platelet aggregation, suppresses thrombosis.
5) antiinflammatory, raise immunity.
Therefore, its clinical indication mainly comprises following disease:
1) various types of shocks comprise hemorrhagic shock, cardiogenic shock, septic shock, traumatic shock, anaphylactic shock;
2) heart disease comprises congestive heart failure, coronary heart disease, angina pectoris, myocardial infarction, pulmonary heart disease, viral myocarditis, arrhythmia, microcirculation disturbance disease;
3) cerebrovascular disease comprises cerebral thrombosis, cerebral embolism, cerebral hemorrhage etc.; With
The auxiliary treatment of 4) radiotherapy, chemotherapy patients and tumor patient.
It is clinically during life-time service, menses routine urinalysis, hepatic and renal function, Electrocardioscopy, goes out coagulation time test etc. and does not find toxic reaction.
The SHENGMAI ZHUSHEYE liquid drugs injection of producing exists the quality problem of unstable at present; this be because Chinese medicine generally just through extraction, simple refining back dosing sealed cans sterilization and getting; contain a large amount of impurity such as tannin, pigment, antibacterial thermal source etc. in the Chinese herbal medicine extract; can occur color and luster when standing time is of a specified duration and deepen, produce problems such as precipitation, content reduction; and exist than big-difference between the quality of each batch, influenced the curative effect and the large-scale production of injection.
A kind of living arteries and veins chewable tablet and pulse-promoting powder pin and preparation method thereof are disclosed in Chinese patent application CN03158220.6, wherein the preparation method of pulse-promoting powder pin comprise with Radix Ginseng Rubra, Radix Ophiopogonis and Fructus Schisandrae Chinensis through mix to pulverize, directly concentrate with solvent extraction, after filtering, drying and make product.Though the stability of this product increases than SHENGMAI ZHUSHEYE, owing to wherein still contain more impurity, pigment etc., the quality of product is still very unstable.In addition, owing to contain more impurity such as small molecular sugar in the extracting solution, make to concentrate, exsiccant process is very consuming time, effort, and the product that obtains is all not really desirable at aspects such as color and luster, outward appearances.
Therefore, the method that still needs the more stable pulse-promoting powder injecta of a kind of preparation quality with low cost.
Summary of the invention
The object of the present invention is to provide a kind of method for preparing injection pulse-promoting powder pin, this method can solve a difficult problem that exists in the present preparation SHENGMAI ZHUSHEYE, and a kind of medicine of more safe and effective, good stability is provided for the patient.
Adopted hyperfiltration technique that medicinal liquid is carried out ultrafiltration at first, in the method for the invention.This process can be removed impurity and the particulate matter in a large amount of Chinese herbal medicine, thereby has improved stability of formulation and clarity greatly.Hyperfiltration technique is that the microcellular structure by the film surface carries out Selective Separation to material.When liquid mixture is flowed through the film surface under certain pressure, the micromolecule solute sees through film (being called ultrafiltrate), macromolecular substances then is trapped, and makes that macromole concentration improves (being called concentrated solution) gradually in the stock solution, thereby realizes the separation of large and small molecule, the purpose that concentrates, purifies.The ultrafilter membrane material substance of using among the present invention is preferably Kynoar, and molecular cut off is 6000-10000.By adopting ultrafiltration step, the purpose that has realized removing impurity such as thermal source, macromolecular polysaccharide, tannin, protein fully improves the stability of product greatly.
In addition, also adopted the repeatedly method of precipitate with ethanol in the method for the invention, to remove invalid components such as water colo(u)r, micromolecule saccharide.These materials are easily suction in freeze-drying process, is difficult to drying, influences the lyophilizing quality, makes freeze-drying prods produce the atrophy variable color.Method of the present invention has been removed most of this type of material by precipitate with ethanol repeatedly, and the lyophilizing effect is improved, and has improved the lyophilizing quality, has reduced the lyophilizing cost, has improved product stability greatly simultaneously, reduces the incidence rate of clinical use side effect.
Therefore, the invention provides a kind of method for preparing injection pulse-promoting powder pin, this method comprises the steps:
1, extracts and make with extra care
Radix Ginseng Rubra takes by weighing the Radix Ginseng Rubra of removing LU and thinly slices, and adds alcohol reflux, collects extracting solution, filters, and filtrate is concentrated into the thick paste shape, adds water for injection to an amount of, stirs evenly, and cold preservation 48 hours filters, and is standby.
Radix Schisandrae Bicoloris takes by weighing Radix Schisandrae Bicoloris, decocts with water collecting decoction three times, filter, filtrate is concentrated into the thick paste shape, adds ethanol and carries out precipitate with ethanol three times, filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, adds water for injection to an amount of, stir evenly, cold preservation 48 hours filters, and the filtrate cryopreservation is used for dosing.
Take by weighing selected Radix Ophiopogonis Radix Ophiopogonis, behind water rinse, adding distil water decocts 3 times, collect 3 times decoction liquor, be concentrated into syrupy shape, add ethanol and carry out precipitate with ethanol three times, filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, add water for injection to an amount of, stir evenly, cold preservation 48 hours filters, make clear and bright aqueous solution Radix Ophiopogonis, use for dosing.
2, ultrafiltration and dosing:
With Fructus Schisandrae Chinensis water liquid and Radix Ophiopogonis water liquid to transfer to pH value with 20% sodium hydroxide solution respectively be 7, filter filtrate and red ginseng extract merging, add the dissolving of recipe quantity mannitol, mix homogeneously filters, the filtrate sucking filtration is to clear and bright, and in the infusion bottle of packing into, flowing steam was handled 40 minutes, after treating the medicinal liquid cooling, cold preservation 48 hours is filtered, filtrate adds 0.05% active carbon and boiled 15 minutes, sucking filtration continues with the microporous filter membrane ultrafiltration to clarification, standardize solution.
3, canned, lyophilizing.
Method of the present invention has solved the ubiquitous problems of Chinese medicine such as clarity, particulate matter by adopting hyperfiltration technique, after making freeze-dried powder, has solved the stability problem of SHENGMAI ZHUSHEYE.All obtained improving greatly by the indexs such as stability of the prepared powder pin of this preparation technology product at color and luster, clarity, active ingredient.
In addition, method of the present invention improves the freeze-drying process of solution by after repeatedly precipitate with ethanol is removed invalid components such as water colo(u)r, small molecular sugar, and the freeze dried time is shortened, and has saved the time, has reduced energy consumption, and the lyophilizing cost is minimized.Simultaneously, the quality of freeze-drying prods also improves greatly, and the stability of product increases, and the obvious difference of quality diminishes between different batches, thereby has improved the safety of clinical use, has reduced the incidence rate of side effect.
The invention still further relates to the injection pulse-promoting powder pin by method for preparing, its stability obviously is better than existing clinical practice dosage form, long shelf-life, and when depositing, be difficult for taking place to decompose and oxidation reaction, the safety of clinical use is improved greatly.In addition, it also is being better than present clinical practice dosage form aspect transportation, the preservation.
Injection pulse-promoting powder pin of the present invention can face with preceding usefulness for example water for injection dissolve again and obtain injection.Injection pulse-promoting powder pin of the present invention can dissolve rapidly in water for injection, forms light yellow clear and bright liquid.
Preferred every of injection pulse-promoting powder pin of the present invention contains and is equivalent to primary dose: Radix Ginseng Rubra (removing LU) 1g, Radix Ophiopogonis 3.12g, Radix Schisandrae Bicoloris 1.56g.
In addition, injection pulse-promoting powder pin of the present invention preferably also contains excipient, preferred mannitol.
By following indefiniteness embodiment the preparation method of injection pulse-promoting powder pin of the present invention is illustrated.
Embodiment
Contain the preparation of the injection pulse-promoting powder pin that is equivalent to primary dose Radix Ginseng Rubra 100g (removing LU), Radix Ophiopogonis 312g, Radix Schisandrae Bicoloris 156g in embodiment 1, per 100 the powder pins
1, the Radix Ginseng Rubra that takes by weighing the 100g removing LU is thinly sliced, and adds the alcohol reflux of 50-95%, extracts 3-7 time, and each consumption of ethanol is that the time that 600-1000ml extracts is 1-3 hour.Merge the extracting solution of collecting, filter, filtrate is concentrated into the thick paste shape, adds water for injection to 400ml, stirs evenly, and cold preservation 48 hours filters, and is standby.
2, take by weighing selected Radix Ophiopogonis of 312g, behind water rinse, adding distil water 6-10 doubly measures and decocts 3 times, collect 3 times decoction liquor, be concentrated into proportion 1.10-1.12 (70 ℃-80 ℃), add 80-95% ethanol and carry out precipitate with ethanol, repeat 1-3 time, alcohol precipitation concentration is respectively 60-85%, and each alcohol sinks to 10 ℃ of following cold preservations and placed 12-48 hour.Filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, adds water for injection to 300ml, stirs evenly, and cold preservation 48 hours filters, and makes clear and bright aqueous solution Radix Ophiopogonis, uses for dosing.
3, take by weighing the 156g Radix Schisandrae Bicoloris, add water 6-10 and doubly measure decoction three times, collecting decoction, filter, filtrate is concentrated into proportion 1.10-1.12 (70 ℃-80 ℃), adds 80-95% ethanol and carries out precipitate with ethanol, repeats 1-3 time, alcohol precipitation concentration is other 60-85% respectively, and each alcohol sinks to 10 ℃ of following cold preservations and placed 12-48 hour.Filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, adds water for injection to 300ml, stirs evenly, and cold preservation 48 hours filters, and the filtrate cryopreservation is used for dosing.
4, with Fructus Schisandrae Chinensis water liquid and Radix Ophiopogonis water liquid to transfer to pH value with 20% sodium hydroxide solution respectively be 7, filter, filtrate merges with red ginseng extract, adds mannitol and dissolves, its consumption is every 100-500mg, mix homogeneously.
5, filter, the filtrate sucking filtration is to clear and bright, and in the infusion bottle of packing into, flowing steam was handled 40 minutes, treat the medicinal liquid cooling after, cold preservation 48 hours is filtered, filtrate adds 0.05% active carbon and boiled sucking filtration 15 minutes.
6, with extremely clarification (molecular cut off is 6000-10000) of 0.45 μ m polyvinylidene fluoride microporous filtering film ultrafiltration, be settled to 300-400ml, divide then to install in 100 bottles.
7, lyophilization: pre-freeze: quick freezing ,-45 ℃ pre-freeze 3-4 hour.Distillation: evacuation, be warming up to-33 ℃, heat up (about 5 hours) insulation; To sample substantially dry (freezing repeatedly); Dry again: slowly be warming up to 30 ℃, be incubated 3-5 hour, lyophilizing finishes (low eutectic point is-31 ℃).Freeze-drying time is about 48 hours.
Injection pulse-promoting powder pin by method for preparing is light yellow to unformed powder of light yellowish brown or porous solid thing; Mildly bitter flavor, have draw moist.After every of this product added the 10ml water dissolution, it is light yellow that color shows, and color and luster, clarity obviously are better than existing SHENGMAI ZHUSHEYE liquid drugs injection.
Stability study
The main quality index of injection pulse-promoting powder pin of the present invention is: every contains the ginsenoside Rg1 and must not be less than 0.8mg, contains the ginsenoside Re and must not be less than 0.4mg, contains schisandrin and must not be less than 0.2mg, contains total saponins and must not be less than 10mg.
In order to test the stability of injection pulse-promoting powder pin of the present invention, the injection pulse-promoting powder pin that will make by the described method of the foregoing description is in accelerated test condition (40 ℃ of temperature, RH75% ± 5%) deposits under, placing the 1st, 2 and detect by every index of this product quality standard draft 3 months the time respectively to sample, promptly, ginsenoside Rg1's content in the working sample, ginsenoside Re's content, schisandrin content and contain total saponin content.Test result is as follows:
| Detect index | 0 month | January | February | March |
| Character | Light yellow porous solid shape thing | Light yellow porous solid shape thing | Light yellow porous solid shape thing | Light yellow porous solid shape thing |
| The solution clarity | Light yellow clear and bright solution | Light yellow clear and bright solution | Light yellow clear and bright solution | Light yellow clear and bright solution |
| Ginsenoside Rg1's content mg/ props up | 2.87 | 2.94 | 2.90 | 2.89 |
| Ginsenoside Re's content mg/ props up | 1.02 | 0.94 | 0.96 | 0.98 |
| Schisandrin content mg/ props up | 0.495 | 0.488 | 0.490 | 0.488 |
| Total saponins | 11.27 | 11.30 | 11.24 | 11.27 |
From the listed result of last table as can be seen, injection pulse-promoting powder needle set of the present invention has good stable, and it is after placing 3 months under the accelerated test condition, and every quality index does not have significant change.
Claims (7)
1, a kind of method for preparing injection pulse-promoting powder pin, this method comprises the steps:
1), extracts and make with extra care
Radix Ginseng Rubra takes by weighing the Radix Ginseng Rubra of removing LU and thinly slices, and adds alcohol reflux, collects extracting solution, filters, and filtrate is concentrated into the thick paste shape, adds water for injection to an amount of, stirs evenly, and cold preservation 48 hours filters, and is standby;
Radix Schisandrae Bicoloris takes by weighing Radix Schisandrae Bicoloris, decocts with water collecting decoction three times, filter, filtrate is concentrated into the thick paste shape, adds ethanol and carries out precipitate with ethanol three times, filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, adds water for injection to an amount of, stir evenly, cold preservation 48 hours filters, and the filtrate cryopreservation is used for dosing;
Take by weighing selected Radix Ophiopogonis Radix Ophiopogonis, behind water rinse, adding distil water decocts 3 times, collect 3 times decoction liquor, be concentrated into syrupy shape, add ethanol and carry out precipitate with ethanol three times, filter, merging filtrate reclaims ethanol and is concentrated into the thick paste shape, add water for injection to an amount of, stir evenly, cold preservation 48 hours filters, make clear and bright aqueous solution Radix Ophiopogonis, use for dosing;
2), ultrafiltration and dosing:
With Fructus Schisandrae Chinensis water liquid and Radix Ophiopogonis water liquid to transfer to pH value with 20% sodium hydroxide solution respectively be 7, filter filtrate and red ginseng extract merging, add the dissolving of recipe quantity mannitol, mix homogeneously filters, the filtrate sucking filtration is to clear and bright, and in the infusion bottle of packing into, flowing steam was handled 40 minutes, after treating the medicinal liquid cooling, cold preservation 48 hours is filtered, filtrate adds 0.05% active carbon and boiled 15 minutes, sucking filtration continues with the microporous filter membrane ultrafiltration to clarification, standardize solution;
3), canned, lyophilizing.
2, the described method of claim 1, wherein the used microporous filter membrane of ultrafiltration is a polyvinylidene fluoride microporous filtering film.
3, the described method of claim 2, the molecular cut off of polyvinylidene fluoride microporous filtering film wherein is 6000-10000.
4, the described method of claim 1, wherein used concentration of ethanol is 80-95% in the precipitate with ethanol step of Radix Schisandrae Bicoloris and Radix Ophiopogonis.
5, the injection pulse-promoting powder pin for preparing according to the described method of above-mentioned any claim.
6, injection pulse-promoting powder pin according to claim 5, wherein, every contains the Radix Ginseng Rubra 1g that is equivalent to primary dose, Radix Ophiopogonis 3.12g, Radix Schisandrae Bicoloris 1.56g.
7, according to claim 5 or 6 described injection pulse-promoting powder pins, wherein also contain mannitol.
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526466A (en) * | 2012-02-15 | 2012-07-04 | 江苏苏中药业集团股份有限公司 | Novel method for uniformizing feeding of medicinal materials of Shengmai injection |
| CN101745004B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Method for extracting radix ophiopogonis, ginseng and schisandra chinensis as well as preparation thereof |
| CN101745003B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Extraction method of ophiopogon root, ginseng and shiandra and preparation thereof |
| CN101745000B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
| CN101745006B (en) * | 2008-12-05 | 2013-03-13 | 天津天士力之骄药业有限公司 | Extraction method of ophiopogon root, ginseng and shiandra and preparation thereof |
| CN101744986B (en) * | 2008-12-05 | 2013-06-05 | 天津天士力之骄药业有限公司 | Extraction method for ginseng, ophiopogon root and schisandra chinensis and preparation thereof |
| CN101744997B (en) * | 2008-12-05 | 2013-06-05 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
| CN101744995B (en) * | 2008-12-05 | 2013-06-26 | 天津天士力之骄药业有限公司 | Method for extracting ginseng, dwarf lilyturf tuber and schisandra chinensis and preparation thereof |
| CN101744990B (en) * | 2008-12-05 | 2013-06-26 | 天津天士力之骄药业有限公司 | Method for individually extracting ginseng, radix ophiopogonis and schisandra chinensis and preparation thereof |
| CN101744998B (en) * | 2008-12-05 | 2013-07-10 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
-
2005
- 2005-12-02 CN CN 200510127414 patent/CN1814166A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101745004B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Method for extracting radix ophiopogonis, ginseng and schisandra chinensis as well as preparation thereof |
| CN101745003B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Extraction method of ophiopogon root, ginseng and shiandra and preparation thereof |
| CN101745000B (en) * | 2008-12-05 | 2012-09-19 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
| CN101745006B (en) * | 2008-12-05 | 2013-03-13 | 天津天士力之骄药业有限公司 | Extraction method of ophiopogon root, ginseng and shiandra and preparation thereof |
| CN101744986B (en) * | 2008-12-05 | 2013-06-05 | 天津天士力之骄药业有限公司 | Extraction method for ginseng, ophiopogon root and schisandra chinensis and preparation thereof |
| CN101744997B (en) * | 2008-12-05 | 2013-06-05 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
| CN101744995B (en) * | 2008-12-05 | 2013-06-26 | 天津天士力之骄药业有限公司 | Method for extracting ginseng, dwarf lilyturf tuber and schisandra chinensis and preparation thereof |
| CN101744990B (en) * | 2008-12-05 | 2013-06-26 | 天津天士力之骄药业有限公司 | Method for individually extracting ginseng, radix ophiopogonis and schisandra chinensis and preparation thereof |
| CN101744998B (en) * | 2008-12-05 | 2013-07-10 | 天津天士力之骄药业有限公司 | Extraction method of ginseng, ophiopogon root and shiandra and preparation thereof |
| CN102526466A (en) * | 2012-02-15 | 2012-07-04 | 江苏苏中药业集团股份有限公司 | Novel method for uniformizing feeding of medicinal materials of Shengmai injection |
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