CN1279935C - Prpearation method of xueshuan xinmoining Chinese medicine for curing cerebrovascular diseases - Google Patents
Prpearation method of xueshuan xinmoining Chinese medicine for curing cerebrovascular diseases Download PDFInfo
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- CN1279935C CN1279935C CNB031413730A CN03141373A CN1279935C CN 1279935 C CN1279935 C CN 1279935C CN B031413730 A CNB031413730 A CN B031413730A CN 03141373 A CN03141373 A CN 03141373A CN 1279935 C CN1279935 C CN 1279935C
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Abstract
The present invention provides a new method for preparing xueshuan xinmoining, which has the advantages of fine preparation, little dosage, stable drug effect and controllable quality. The present invention comprises: musk, borneol, bezoars, ginsenoside and venenum bufonis are pulverized into fine powder; red sage roots and hairy holly roots are treated by ethanol reflux extraction, and the extract is concentrated into thick paste; volatile oil is extracted from chuanxiong rhizomes; the ethanol extract dregs and hirudo are merged and decocted with water, the decoction dregs and dregs of the chuanxiong rhizomes are mixed and decocted with water, the decoction liquid is concentrated into thick paste, and the thick paste and the ethanol extracted thick paste are mixed and pulverized into fine powder; rutin is extracted from flos sophorae with saturated aqueous solution of calcium carbonate, and the rutin is pulverized into fine powder; all the fine powders are uniformly mixed, granulated, dried and sprayed with the volatile oil of the chuanxiong rhizomes to obtain the active components of the xueshuan xinmaining, and the active components are manufactured into preparations.
Description
Technical field:
The present invention relates to a kind of preparation method of Chinese medicine, the new preparation method of particularly a kind of XUESHUANXINMAINING.
Background technology:
Cardiovascular and cerebrovascular disease is common ailment of middle-aged and old, frequently-occurring disease, is one of human underlying cause of death.Motherland's medical science thinks that apoplexy, the thoracic obstruction all are diseases of clinical common serious harm population health, and the reason of its generation is many-sided.The generation of apoplexy, main cause are patient's QI and blood deficiency usually, reach the heart, liver, kidney three dirty imbalance of YIN and YANG, be worried angry or the diet of drinking, or the chamber fatigue, or inducement such as exopathogen invasion and attack, so that QI-blood circulation is obstructed, and the muscle arteries and veins of skin loses in moistening foster, or YIN-deficiency in the lower part, liver-yang is opened cruelly, and positive wind-transformation is moving, bleeding resulting from adverse flow of QI, hold expectorant under the arm and hold fire under the arm, the horizontal channel tunnel of scurrying is hoodwinked key clearly, thereby the critical card marquis that formation excess in the upper and deficiency in the lower, negative and positive do not maintain mutually.The generation of the thoracic obstruction mainly is owing to worn with age, overstrain internal injury, makes the heart, kidney, insufficiency of the spleen damage, and intemperance of taking food, feelings will internal injury, it is attacked by the cold and evil form pathological changes such as stagnation of phlegm, the stagnation of QI, blood stasis, cold coagulation in addition, causes the resistance of the heart arteries and veins stasis of blood and chest pain.Apoplexy, the total pathogenesis of the thoracic obstruction are deficiency in origin and excess in superficiality, at this is deficiency of the liver and kindey, QI and blood declines few, be designated as fire and wind stirring up each other, phlegm-damp is stopped up Sheng, and the strongly fragrant resistance of QI and blood has the difference of the cold double heat of holding concurrently simultaneously again, and many during acute onset is urgency to mark real, wherein the blood stasis turbid numbness of the expectorant resistance venation of holding concurrently is its basic pathogenesis, the heat-transformation tendency of often holding concurrently.
XUESHUANXINMAINING is to have a refreshment of having one's ideas straightened out by what Rhizoma Chuanxiong, the Flos Sophorae Immaturus, Radix Salviae Miltiorrhizae, Hirudo, Radix Ilicis Pubescentis, Calculus Bovis, Moschus, stem and leaf of Radix Ginseng saponin, Borneolum Syntheticum, Venenum Bufonis were made; the effect of blood circulation promoting and blood stasis dispelling; be applicable to cerebral thrombosis, coronary atherosclerotic heart disease, the treatment of diseases such as angina pectoris.Bibliographical information, the XUESHUANXINMAINING capsule has the brain of improvement, core ischemia effect, the cerebral blood flow increasing amount, (P<0.01=takes counter point at random with the XUESHUANXINMAINING capsule, treatment cerebral thrombosis 158 examples for blood fat reducing, blood viscosity, packed cell volume and platelet aggregation rate, control with obvious effective rate more be 62.1%, total effective rate is 96.3%, adds troxerutin (117 example) with the matched group low molecular dextran and compares that there were significant differences (P<0.01=has no side effect.But this product prior preparation method more complicated, the preparation dose is big, unsettled shortcoming under the room temperature.Former technology is as follows:
1, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Ilicis Pubescentis etc. are with 60% ethanol extraction 2 times, and extracting liquid filtering reclaims ethanol, and decompression shortens paste into.Drying is pulverized standby;
2, Hirudo is refluxed 3 times with 70% ethanol extraction, and decompression recycling ethanol also is concentrated into the thick paste shape.Cold drying is pulverized standby;
3, Flos Sophorae Immaturus is transferred between the pH value 4 ~ 5 with acid with the limewater extraction rutin.Cooling, precipitation, sucking filtration, drying, pulverizing are standby;
4, Venenum Bufonis grinds impalpable powder with ball mushroom machine, and it is standby to cross 160 mesh sieves;
5, Moschus, Borneolum Syntheticum, Calculus Bovis, Venenum Bufonis and group's medicated powder cover grind evenly packing.
Above-mentionedly should go out medicated powder 1000g ± 3%.Specification is 1 * 0.5g (capsule)
Summary of the invention:
The object of the present invention is to provide that a kind of preparation exquisiteness, dose are little, the new preparation method of efficacy stability and quality controllable XUESHUANXINMAINING, to overcome the deficiencies in the prior art.
Preparation method of the present invention is as follows:
1, Moschus, Borneolum Syntheticum, Calculus Bovis, stem and leaf of Radix Ginseng saponin, Venenum Bufonis are ground into fine powder,
2, Radix Salviae Miltiorrhizae, Radix Ilicis Pubescentis are used the alcohol reflux secondary, and merging filtrate reclaims ethanol, is condensed into thick paste, and medicinal residues are standby,
3, Rhizoma Chuanxiong extracts volatile oil, collects volatile oil, and distillation rear solution device is in addition collected, and medicinal residues are standby,
4, Hirudo and alcohol extraction medicinal residues merge decocting, filter, and filtrate is placed, and medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, and decocting filters, and filtrate and above-mentioned each decocting liquid merge, and are condensed into thick paste, and mix with alcohol extraction cream, and drying is ground into fine powder,
5, Flos Sophorae is used unsaturated carbonate calcium extraction with aqueous solution rutin, and powder becomes fine powder, with above-mentioned each fine powder mixing, makes granule, drying, and spray adds Rhizoma Chuanxiong volatile oil, makes the XUESHUANXINMAINING active component,
6, this active component can directly be made preparation, also can add medicine and can accept to such an extent that carrier is made preparation.
Preferred manufacturing procedure is as follows:
1, Moschus, Borneolum Syntheticum, Calculus Bovis, stem and leaf of Radix Ginseng saponin, Venenum Bufonis are ground into fine powder,
2, Radix Salviae Miltiorrhizae, Radix Ilicis Pubescentis be with 70~90% alcohol reflux secondaries, and each 2~3 hours, make a living 4~8 times of dose of alcohol adding amount filtered, and merging filtrate reclaims ethanol, is concentrated into the thick paste of relative density 1.23~1.36 (60 ℃ of surveys), and medicinal residues are standby,
3, Rhizoma Chuanxiong adds 3~6 times of water gagings extraction volatile oil, collects volatile oil, and distillation rear solution device is in addition collected, and medicinal residues are standby,
4, Hirudo and alcohol extraction medicinal residues merge and add 6~10 times of water gagings, decoct 1.5~3 hours, filter, filtrate is placed, and medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, add 6~10 times of water gagings, decocted 1.5~3 hours, filter, filtrate and above-mentioned each decocting liquid merge, when being concentrated into relative density 1.23~1.36 (60 ℃ of surveys) thick paste, mix with alcohol extraction cream, in 50~80 ℃ of dryings, be ground into fine powder
5, Flos Sophorae is used unsaturated carbonate calcium extraction with aqueous solution rutin, and powder becomes fine powder, with above-mentioned each fine powder mixing, makes granule, drying, and spray adds Rhizoma Chuanxiong volatile oil, and mixing makes the XUESHUANXINMAINING active component,
6, this active component can directly be made preparation, also can add medicine and can accept to such an extent that carrier is made preparation.
Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose family and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.The present invention is peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum, most preferably tablet, capsule.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-8 grain/or sheet.
The method that the present invention adopts alcohol extraction and water to carry respectively according to the different physicochemical properties of each flavour of a drug, and Rhizoma Chuanxiong extracted volatile oil, improved the rate that of medical material effective ingredient, extracted and drying all adopts low temperature, prevented the destruction of the effective ingredient of withstand high temperatures not, and technology easy operating, no special installation and chemical reagent, production safety, process conditions are basicly stable, do not have " three wastes " and handle problems, be suitable for industrialized great production.
Description of drawings:
Fig. 1 is a process chart of the present invention.
Following data declaration beneficial effect of the present invention by experiment:
Experimental example 1:
XUESHUANXINMAINING character is investigated
According to above-mentioned technological operation, prepare three batches of XUESHUANXINMAININGs, and to alcohol extracting cream yield, the volatilization oil mass, water extraction cream yield, Pulverize flour extraction, assay is tested, and the results are shown in Table 1.
Table 1, XUESHUANXINMAINING pilot scale data
Lot number | Dosage (g) | The alcohol extracting amount of getting dry extract (g) | Alcohol raises cream yield (%) | Volatile oil must be measured (ml) | The poach amount of getting dry extract (g) | Poach the rate of extract (%) | The five tastes such as Moschus are pulverized powder outlet quantity (g) | Pulverize flour extraction (%) | Tanshinone IIA content (μ g/g) |
990410 | 16675 | 975 | 13.00 | 16.20 | 2170 | 15.78 | 394 | 92.71 | 175.4 |
990418 | 16675 | 990 | 13.20 | 16.50 | 2000 | 14.55 | 397 | 93.41 | 174.4 |
990422 | 16675 | 1000 | 13.33 | 16.40 | 1980 | 14.40 | 398 | 93.65 | 172.8 |
XUESHUANXINMAINING extract character is as follows: 1. proterties: be brown particle, gas delicate fragrance, mildly bitter flavor. 2. have the red sage root, The characteristic differentiation of Ligusticum wallichii, sophora flower, borneol, cow-bezoar, ginsenoside. 3. every 1g extract contains tanshinone IIA and is no less than 162.5 μ g.
Experimental example 2: XUESHUANXINMAINING treatment apoplexy test report summary
Treatment group: the tablet of the embodiment of the invention 1 method preparation, oral, every day three times, each 2 (0.4g) are all around One course for the treatment of, observe a course for the treatment of.
Control group: the capsule of former explained hereafter, oral, every day three times, each 4 (0.5g) are a course for the treatment of all around, see Examine a course for the treatment of.
Result: adopt random packet and former formulation contrast method treatment apoplexy, observe through clinical 100 examples, 60 routine check experiment knots Fruit shows that Xueshuan xinmaining Tablet is 51% to the aobvious more rate of apoplexy wind phlegm Yu Xue Bi resistance train of thought card, and total effective rate is 91%, contrast The aobvious more rate of group is 46.66%, and total effective rate is 89%, two group of relatively there was no significant difference, and this medicine can obviously improve the apoplexy wind phlegm stasis of blood Blood-arthralgia resistance train of thought syndrome, have a dizzy spell in improvement, aspect the tongue fur with the control group significant difference, significant is arranged, and has Improve the effect of hemorheology state, descend to some extent with rear blood pressure, may certain regulating action be arranged to blood pressure in normal range (NR). Cranial Computed Tomography confirms that focus improves and the control group there was no significant difference, to acute stage and convalescence the curative effect there was no significant difference. Treatment Routine blood tests, routine urinalysis before and after the group 100 example treatments, just routine, liver function, kidney merit do not have unusual change before the treatment, show the phase course for the treatment of Between liver, kidney, hematological system and digestive system are had no adverse reaction, other bad reactions are not found in clinical observation yet, and this product is described Clinical use is safe and effective.
Experimental example 3: XUESHUANXINMAINING treatment obstruction of qi in the chest test report summary
Treatment group: the tablet of the embodiment of the invention 1 method preparation, oral, every day three times, each 2 (0.4g) are all around One course for the treatment of, observe a course for the treatment of.
Control group; The capsule of former explained hereafter, oral, every day three times, each 4 (0.5g) are a course for the treatment of all around, see Examine a course for the treatment of.
Result: adopt random packet and former formulation contrast method treatment obstruction of qi in the chest heart blood silt 100 examples, with former formulation thrombus heart arteries and veins Yiganning capsule contrasts 60 examples, and XUESHUANXINMAINING tablet group produce effects 50 examples account for 50% as a result, and effective 44 examples account for 44%, and invalid 6 Example accounts for 6%, total effective rate 94%, and control group produce effects 23 examples account for 38.33%, and effective 31 examples account for 51.67%, and invalid 6 Example accounts for 10%, total effective rate 90%, and observation group's curative effect is good than control group, but statistical procedures is meaningless, and this product is to the traditional Chinese medical science Syndrome integration, tongue, arteries and veins, blood change etc. all have good therapeutic action, this product technology advanced person, and consumption is little, takes, the side of carrying Just, cheap, the patient is easy to accept.
The specific embodiment:
The present invention is described further by the following examples.
Embodiment 1: the preparation of tablet
Rhizoma Chuanxiong 500g Radix Salviae Miltiorrhizae 500g Flos Sophorae 250g Radix Ilicis Pubescentis 250g Hirudo 125g
Moschus 1.25g Borneolum Syntheticum 2.50g Calculus Bovis 12.5g stem and leaf of Radix Ginseng saponin 25g Venenum Bufonis 1.25g
With Moschus; Borneolum Syntheticum; Calculus Bovis; stem and leaf of Radix Ginseng saponin; Venenum Bufonis is ground into fine powder; Radix Salviae Miltiorrhizae; Radix Ilicis Pubescentis is with 70 alcohol reflux secondaries; each 2 hours; make a living 4 times of dose of alcohol adding amount; filter, merging filtrate reclaims ethanol; be concentrated into the thick paste of relative density 1.23~1.36 (60 ℃ of surveys); medicinal residues are standby, and Rhizoma Chuanxiong adds 3 times of water gagings and extracts volatile oil, collects volatile oil; distillation rear solution device is in addition collected; medicinal residues are standby, and Hirudo and alcohol extraction medicinal residues merge and add 6 times of water gagings, decoct 1.5 hours; filter; filtrate is placed, and medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, add 6 times of water gagings; decocted 1.5 hours; filter, filtrate and above-mentioned each decocting liquid merge, when being concentrated into relative density 1.23~1.36 (60 ℃ of surveys) thick paste; mix with alcohol extraction cream; in 60 ℃ of vacuum dryings, be ground into fine powder, Flos Sophorae is used unsaturated carbonate calcium extraction with aqueous solution rutin; powder becomes fine powder; with above-mentioned each fine powder mixing, make granule, drying; add an amount of Pulvis Talci; magnesium stearate; carboxymethylstach sodium; and the spray add Rhizoma Chuanxiong volatile oil, mixing is pressed into 1000; the bag film-coat, yield 98%.
Embodiment 2: the preparation of tablet
Rhizoma Chuanxiong 500g Radix Salviae Miltiorrhizae 500g Flos Sophorae 250g Radix Ilicis Pubescentis 250g Hirudo 125g
Moschus 1.25g Borneolum Syntheticum 2.50g Calculus Bovis 12.5g stem and leaf of Radix Ginseng saponin 25g Venenum Bufonis 1.25g
With Moschus; Borneolum Syntheticum; Calculus Bovis; stem and leaf of Radix Ginseng saponin; Venenum Bufonis is ground into fine powder; Radix Salviae Miltiorrhizae; Radix Ilicis Pubescentis is with 90% alcohol reflux secondary; each 3 hours; make a living 8 times of dose of alcohol adding amount; filter, merging filtrate reclaims ethanol; be concentrated into the thick paste of relative density 1.23~1.36 (60 ℃ of surveys); medicinal residues are standby, and Rhizoma Chuanxiong adds 6 times of water gagings and extracts volatile oil, collects volatile oil; distillation rear solution device is in addition collected; medicinal residues are standby, and Hirudo and alcohol extraction medicinal residues merge and add 10 times of water gagings, decoct 3 hours; filter; filtrate is placed, and medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, add 10 times of water gagings; decocted 3 hours; filter, filtrate and above-mentioned each decocting liquid merge, when being concentrated into relative density 1.23~1.36 (60 ℃ of surveys) thick paste; mix with alcohol extraction cream; spray drying is ground into fine powder, and Flos Sophorae is used unsaturated carbonate calcium extraction with aqueous solution rutin; powder becomes fine powder; with above-mentioned each fine powder mixing, make granule, low-temperature vacuum drying; add an amount of Pulvis Talci; magnesium stearate; carboxymethylstach sodium; and the spray add Rhizoma Chuanxiong volatile oil, mixing is pressed into 1000; the bag film-coat, yield 98%.
Claims (8)
1, a kind of preparation method of XUESHUANXINMAINING is characterized in that, the process following steps:
A. Moschus, Borneolum Syntheticum, Calculus Bovis, stem and leaf of Radix Ginseng saponin, Venenum Bufonis are ground into fine powder,
B. Radix Salviae Miltiorrhizae, Radix Ilicis Pubescentis are used the alcohol reflux secondary, and merging filtrate reclaims ethanol, is condensed into thick paste, and medicinal residues are standby,
C. Rhizoma Chuanxiong extracts volatile oil, collects volatile oil, and distillation rear solution device is in addition collected, and medicinal residues are standby,
D. Hirudo and above-mentioned alcohol extraction medicinal residues merge decocting, filter, and filtrate is placed, and medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, and decocting filters, and filtrate and above-mentioned each decocting liquid merge, and are condensed into thick paste, and mix with alcohol extraction cream, and drying is ground into fine powder,
E. Flos Sophorae is used unsaturated carbonate calcium extraction with aqueous solution rutin, and powder becomes fine powder, with above-mentioned each fine powder mixing, makes granule, drying, and spray adds Rhizoma Chuanxiong volatile oil, and mixing makes the XUESHUANXINMAINING active component,
F. active component and medicine acceptable carrier are mixed and made into preparation.
2, the preparation method of claim 1 is characterized in that,
Ethanol content among the step b is 70~90%, the reflux, extract, secondary, and each 2~3 hours, make a living 4~8 times of dose of alcohol adding amount, Rhizoma Chuanxiong adds 3~6 times of water gagings and extracts volatile oil among the step c,
Hirudo and alcohol extraction medicinal residues merge and add 6~10 times of water gagings in the steps d, decoct 1.5~3 hours, filter, filtrate is placed, medicinal residues mix with above-mentioned Rhizoma Chuanxiong medicinal residues, add 6~10 times of water gagings, decoct 1.5~3 hours, filter, filtrate and above-mentioned each decocting liquid merge, and relative density is 1.23~1.36 thick paste when being concentrated into 60 ℃ of surveys, mixes with alcohol extraction cream, in 50~80 ℃ of dryings, be ground into fine powder.
3, claim 1 or 2 described preparation methoies is characterized in that, used concentration of ethanol is 70%~90% among the step b, and pure extracting method is a reflux, extract,, and alcohol extract low temperature reclaims ethanol, and relative density is 1.23~1.36 thick paste when being concentrated into 60 ℃ of surveys.
4, claim 1 or 2 described preparation methoies is characterized in that, Rhizoma Chuanxiong adds the volatile oil that 3~6 times of water gagings extract among the step c, and e sprays in the medicated powder in step.
5, claim 1 or 2 described preparation methoies is characterized in that, the water extract cryoconcentration in the steps d becomes thick paste, and relative density is 1.23~1.36 during 60 ℃ of surveys.
6, claim 1 or 2 described preparation methoies is characterized in that, drying wherein is low-temperature vacuum drying or spray drying.
7, the preparation method of claim 1 is characterized in that, makes tablet, capsule, oral liquid, buccal tablet, granule, electuary, pill, powder, suspensoid, powder, solution, drop or drop pill.
8, the preparation method of claim 1 is characterized in that, makes tablet, capsule or granule.
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Cited By (1)
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US9168720B2 (en) | 2009-02-27 | 2015-10-27 | Exxonmobil Chemical Patents Inc. | Biaxially elastic nonwoven laminates having inelastic zones |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN1305481C (en) * | 2004-02-11 | 2007-03-21 | 冯学君 | Preparation of moschus for refreshment |
CN101161272B (en) * | 2006-10-11 | 2011-09-21 | 吉林华康药业股份有限公司 | A Chinese medicine for treating apoplexy and its preparing method |
CN101342238B (en) * | 2008-08-27 | 2012-02-08 | 吉林华康药业股份有限公司 | Medicinal composition for treating cardiovascular and cerebrovascular diseases |
CN102507844B (en) * | 2011-11-13 | 2013-10-16 | 吉林华康药业股份有限公司 | Testing method for Xueshuan xinmaining tablet |
CN102507843B (en) * | 2011-11-13 | 2014-01-08 | 吉林华康药业股份有限公司 | Method for testing effective contents of Xueshuan xinmaining tablet |
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Publication number | Priority date | Publication date | Assignee | Title |
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US9168720B2 (en) | 2009-02-27 | 2015-10-27 | Exxonmobil Chemical Patents Inc. | Biaxially elastic nonwoven laminates having inelastic zones |
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