CN103041198B - Traditional Chinese medicine preparation for treating essential hypotension and preparation method of traditional Chinese medicine preparation - Google Patents
Traditional Chinese medicine preparation for treating essential hypotension and preparation method of traditional Chinese medicine preparation Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine preparation for treating essential hypotension and a preparation method of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared by taking 120 parts of red ginseng, 360 parts of immature bitter orange, 180 parts of Chinese ephedra, 300 parts of ramulus cinnamomi, 300 parts of prepared rehmannia root, 300 parts of radix ophiopogonis, 400 parts of Chinese starjasmine stem, 540 parts of hairyvein agrimony, 12 parts of donkey-hide gelatin, and 32 parts of rhizoma gastrodiae as raw materials, extracting and purifying and adopting pharmaceutically acceptable auxiliary materials. The traditional Chinese medicine preparation comprises granules, tablets, hard capsules, pills, and the like. A clinical pharmacodynamics experiment verifies that the traditional Chinese medicine preparation has a more significant curative effect in essential hypotension treatment.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation method for the treatment of essential hypotension, belong to field of medicine preparing technology.
Background technology
Hypotension is a kind of commonly encountered diseases, frequently-occurring disease extensively occurring all over the world.According to incompletely statistics, hypotension sickness rate is 4% left and right, and can reach 10% in elderly population.Patient suffers from hypotension for a long time, can cause body function greatly to decline, and also may cause cerebral infarction and myocardial infarction, and hypotension crowd's mortality rate, also higher than normal population, has brought serious problem to patient, family and society, can not be ignored.Treatment to this type of disease at present, this area is not effective especially Therapeutic Method also.Patient's long-term taking western drug is treated, and is difficult to make blood pressure to remain normal after can producing toxic and side effects and drug withdrawal.And traditional Chinese medicine has certain advantage to the treatment of this type of disease.
Essential hypotension generally refers to systolic arterial pressure lower than 90mmHg, even diastolic pressure lower than 60mmHg be feature and with having a dizzy spell, the symptom such as malaise, cardiopalmus, insomnia and dreamful sleep, forgetful, perspiration, hands and feet coolness faintness.It belongs to the category of the traditional Chinese medical science " dizzy ", " cardiopalmus ", " asthenia ".Be more common in thin and weak 20～50 years old women of body constitution and old people, often there is Inheritance history.Essential hypotension is by due to deficiency of both QI and YIN, venation silt resistance.The gas deficiency of YIN is this, and venation is become silted up resistance for mark, healthy energy virtual loss, and it is foster that god becomes homeless, and is short of physical strength, therefore see spiritlessness and weakness; Deficiency of YIN-blood, lack of preservation of spirit, is shown in cardiopalmus; Deficiency of YIN-blood, brain is become homeless foster, the deficiency of vital energy can not be agitated in QI and blood and be reached in addition, YANG-orifices failing to be nourished, blockage of the vessel, thus see forgetful, have a dizzy spell; Yin and fluid deficiency, is shown in xerostomia; Light red tongue HongShaoJin(SIC), thready pulse without strength is all the card of deficiency of both QI and YIN.Control suitable supplementing QI and nourishing YIN, the method for warming the meridian and promoting blood circulation.Accordingly, designer spy of the present invention chooses that some drug effects are concentrated and is the raw material of Chinese medicine medicine composition of absorption of human body, medicine in side is made up of Radix Ginseng Rubra, Fructus Aurantii Immaturus, Herba Ephedrae, Ramulus Cinnamomi, Radix Rehmanniae Preparata, Radix Ophiopogonis, Caulis Trachelospermi, Herba Agrimoniae, Colla Corii Asini, Rhizoma Gastrodiae Ten Herbs, there is thus effect of supplementing QI and nourishing YIN, warming the meridian and promoting blood circulation, and aspect treatment essential hypotension disease, there is very effective clinical effectiveness.
Between this, for this Chinese medicine composition, we have successively applied for following 3 patents of invention, its publication number is respectively CN1471928A, CN1733027A and CN1733257A, open day is respectively 2006.01.04, 2006.02.15 and 2006.02.15, above patent of invention file is different amounts of components from prescription, preparation technology, and the aspect such as method of quality control and dosage form discloses, protection, but in actual application, we find that the effect of the Chinese patent medicine of being made up of above-mentioned preparation method is desirable not enough, and the application's patent is to grope by lot of experiments, further optimize process of preparing, and find best preparation parameter, pharmacological evaluation effect is more remarkable, to improve preparation stability and bioavailability as object, and creationary a kind of Chinese medicine preparation for the treatment of essential hypotension of succeeding in developing.
Summary of the invention
The object of the invention: have problems for state of the art, by excavating the abundant Chinese medicine resource of motherland, a kind of preparation method of Chinese medicine preparation for the treatment of essential hypotension disease is provided, the method is simple and feasible, steady quality, finally makes curative effect and treat more significantly the natural Chinese medicine preparation of essential hypotension disease.
Technical solution of the present invention is realized by following step:
A. prescription composition: 120 parts of Radix Ginseng Rubra, 360 parts of Fructus Aurantii Immaturuss, 180 parts, Herba Ephedrae, 300 parts of Ramulus Cinnamomi, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Ophiopogonis, 400 parts of Caulis Trachelospermis, 540 parts of Herba Agrimoniaes, 12 parts, Colla Corii Asini, 32 parts, Rhizoma Gastrodiae;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 6～10 times of sour waters that amount, pH value are 3.0～5.0, heating extraction 1～3 time, and each 1～3 h, filters, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 60%～90% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 8～12 times of water gagings soak, adopt vapor distillation 0.5～3 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 3～7 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 60%～80% 1～3 time, each 1～3 h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 6～12 times of amounts, decocts and extracts 1～3 time, each 1～2h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 50%～70% containing alcohol amount, cold preservation leaves standstill 12～48 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
Technical solution of the present invention is specifically realized by following steps:
A. prescription composition: 120 parts of Radix Ginseng Rubra, 360 parts of Fructus Aurantii Immaturuss, 180 parts, Herba Ephedrae, 300 parts of Ramulus Cinnamomi, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Ophiopogonis, 400 parts of Caulis Trachelospermis, 540 parts of Herba Agrimoniaes, 12 parts, Colla Corii Asini, 32 parts, Rhizoma Gastrodiae;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 8 times of sour waters that amount, pH value are 4.0, heating extraction 2 times, and each 2 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 75% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 10 times of water gagings soak, adopt vapor distillation 1.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, and each 2 h, filter, and merging filtrate also reclaims ethanol, concentrated, dry after and be ground into dried cream powder, the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 10 times of amounts, decocts and extracts 2 times, each 1.5h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 24 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
The oral formulations of finally making in technique scheme is granule, tablet, hard capsule or drop pill, and wherein the concrete preparation method of each oral formulations is (7) to operate as follows:
Tablet: by gained total mixture, mix with appropriate amount of starch, dextrin, granulate, be pressed into tablet.
Granule: by gained total mixture, dextrin, sucrose with appropriate, mix, granulates, dry, granulation agent.
Hard capsule: by gained total mixture, add suitable adjuvant, granulate, encapsulated, make hard capsule.
Drop pill: by gained total mixture, the substrate hot melt with suitable, stirs, and carries out dripping, makes drop pill.
Chinese medicine preparation of the present invention cures mainly deficiency of both QI and YIN, dizzy due to venation is smooth.Radix Ginseng Rubra strongly invigorating primordial QI in side, promoting the production of body fluid to quench thirst, agitates in QI and blood and reaches; Radix Ophiopogonis YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire, two medicines share benefiting qi and nourishing yin to effect a permanent cure, and are monarch drug altogether.The Radix Rehmanniae Preparata yin nourishing of enriching blood, life essence-filling, marrow-benefitting; Colla Corii Asini nourishing blood YIN nourishing, lung moistening, two medicine mutual reinforcements between, for nourishing YIN and benefiting blood, help YIN nourishing and the production of body fluid promoting Radix Ophiopogonis altogether; Ramulus Cinnamomi warming the meridian and promoting blood circulation, with the Radix Ginseng Rubra supplementing qi and invigorating vasculum that matches, above three medicines are ministerial drug altogether.The Fructus Aurantii Immaturus the chest stuffiness relieving of regulating the flow of vital energy, matches and can make QI and blood unobstructed with Ramulus Cinnamomi; Help less Herba Ephedrae, ventilation meridian, coordinates with Ramulus Cinnamomi, can loosing the interspaces of skin and muscles, draw yang-energy going from the interior to the exterior, the current whole body; Caulis Trachelospermi the meridian dredging is to coordinate Ramulus Cinnamomi promoting blood circulation; Herba Agrimoniae tonify deficiency is helped the weak, and coordinates Radix Ginseng Rubra with Zhi Tuoli impairment caused by overstrain; Rhizoma Gastrodiae is flat, and to put out liver-wind dizzy to control, and above five kinds of Chinese medicine coordinates the monarch and his subjects to declare venting QI-blood, and dredge the meridian passage, relieves dizziness, high fever, infantile convulsions, epilepsy, etc. surely dizzy, is adjuvant drug altogether.All medicines share the merit of playing altogether supplementing QI and nourishing YIN, warming the meridian and promoting blood circulation.
The present invention is in the middle of practical study process, and than 3 patents of invention of earlier application, its main creation point is the extraction purification aspect of medical material, has brought thus significant technological progress, and its main beneficial effect is as follows.
Chinese medicine preparation of the present invention is made up of 10 taste Chinese medicines such as Herba Agrimoniae, Caulis Trachelospermi, Ramulus Cinnamomi, Fructus Aurantii Immaturus, Herba Ephedraes; application number is that the dosage form of 200510043065.5 protections is common oral preparation; its technique is beaten powder with Rhizoma Gastrodiae and Colla Corii Asini and is used as medicine; in side, other medical materials adopt the water extraction mode of combining to prepare; but, in actual use, find that its drug effect is not also desirable especially; may be active component enrichment not enough, cause drug bioavailability lower.Therefore Radix Ophiopogonis in preparation technology of the present invention general side, Herba Agrimoniae, Caulis Trachelospermi medical material, modern study shows, its main active has: Radix Ophiopogonis total saponins, Radix Ophiopogonis total polysaccharides, agrimony total flavone, Herba Agrimoniae total polyphenols, Caulis Trachelospermi total flavones etc., these materials all have excellent dissolution effect in the ethanol of middle concentration, therefore adopt ethanol extraction, Chinese medicine active component can be extracted; In Herba Ephedrae, contain ephedrine effective ingredient, its dissolving in sour water is larger, therefore adopt acid extraction; In Radix Ginseng Rubra medical material, effective ingredient is ginsenoside, in order to improve its extract yield, adopts ethanol to carry out percolation; In side, in Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, contain volatile oil, adopt vapor distillation to extract, in order to prevent that volatile oil from losing in preparation production process, adopt beta-cyclodextrin inclusion compound to become drug powder, increase its stability; For to greatest extent by complete extracts active ingredients in medical material, therefore will be after ethanol extraction and after vapor distillation medicinal residues and Radix Rehmanniae Preparata medical material decoct extraction with hydration, after extracting solution is concentrated, and adopt water extract-alcohol precipitation method, to remove chlorophyll, the impurity components such as starch, the content of raising active substance component; Rhizoma Gastrodiae and Colla Corii Asini consumption in side is less, and its physicochemical property is applicable to beating powder and being used as medicine, therefore employing superfine grinding method is ground into fine powder.The superfine communication technique abundant complete reservation active component of energy and medicated powder granularity are more even, have larger specific surface area, can improve drug bioavailability, and according to above-mentioned preparation technology, the Chinese medicine extract obtaining has very significantly therapeutic effect.
In a word, the technical scheme of extraction purification of the present invention, molding is that we are in actual research process, by unremitting groping and accidental discovery, and the clinical practice demand of the said preparation of comprehensively having investigated, reasonably plan as a whole, comparison and the process route that draws, thereby ensured science, the high efficiency of the Chinese medicine preparation of finally making.
Below that the medicine that technical solution of the present invention is obtained carries out pharmacodynamic study test, because core innovative point of the present invention is the extraction and purification process aspect of medical material, and with we previous disclosed publication number CN1471948A, CN1733207A, after the patent document contrast of CN1733257A, we are taking the technical scheme of publication number CN1733257A as correlation technique, therefore we in pharmacodynamic experiment taking the two technology contents as contrast, in conjunction with the research level of modern pharmacology, and test by equity, illustrate fully the pharmacodynamics curative effect of Drug therapy essential hypotension disease of the present invention.In order to simplify experimental implementation, save research expenditure, follow the experiment principle of parallel control, get rid of the Different therapeutical effect that each medicine group is brought because of Dosage Form Factors itself, thereby the creativeness of the outstanding technical solution of the present invention of science more, the middle product group CN1733257A of the technical scheme that we approach the most taking one of them studies as representative, but this can derive for those skilled in the art completely thus, understand the beneficial effect of other parameter point technical scheme in the application, therefore the technology of the present invention content and drug effect result are never limited to this scope.
1 test material and result processing method:
The preparation of 1.1 trial drugs:
A. the preparation of trial drug of the present invention:
A. prescription composition: Radix Ginseng Rubra 120g, Fructus Aurantii Immaturus 360g, Herba Ephedrae 180g, Ramulus Cinnamomi 300g, Radix Rehmanniae Preparata 300g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, Herba Agrimoniae 540g, Colla Corii Asini 12g, Rhizoma Gastrodiae 32g;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini 12g, Rhizoma Gastrodiae 32g, is ground into coarse powder, then superfine powder to be broken into fine powder for subsequent use;
(2) get Herba Ephedrae 180g, using with medical material weight ratio is 8 times of sour waters that amount, pH value are 4.0, heating extraction 2 times, and each 2 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) by Radix Ginseng Rubra 120g, be ground into coarse powder, ethanol infiltrates, and the ethanol that is 75% with concentration carries out percolation extraction, and collection percolate also reclaims ethanol, concentrate drying to be ground into dried cream powder for subsequent use, and medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus 360g, Ramulus Cinnamomi 300g, adding with medical material weight ratio is after 10 times of water gagings soak, adopt vapor distillation 1.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae 540g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, each 2h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata 300g again, adding with medical material weight ratio is the water of 10 times of amounts, decocts and extracts 2 times, each 1.5h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 24h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, add before use normal saline and be configured to the medicinal liquid of 0.1g/ml, obtain product group in the middle of the present invention.
B. the preparation of product group in the middle of CN1733257A:
Colla Corii Asini 12g, Rhizoma Gastrodiae 32g, be ground into fine powder, Radix Ginseng Rubra 120g, Fructus Aurantii Immaturus 360g, Herba Ephedrae 180g, Ramulus Cinnamomi 300g, Radix Rehmanniae Preparata 300g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, Herba Agrimoniae 540 g, above eight tastes, mixing and water adding decocts three times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into approximately 1.10～1.15(60 ° of heat survey of relative density) time, let cool, add equal-volume ethanol, staticly settle, leaching supernatant, reclaiming ethanol concentrating under reduced pressure, to become relative density be 1.12～1.15 clear paste, after spraying is dry, obtain powder and add Rhizoma Gastrodiae fine powder, donkey-hide gelatin fine powder, for subsequent use after mix homogeneously, before use, the medicinal liquid that adding distil water is mixed with in the middle of the invention described above, product group concentration is identical, obtains the middle product group of CN1733257A.
1.2 experimental animals: Wistar rat, male and female dual-purpose.Provided by The Fourth Military Medical University's Experimental Animal Center.
1.3 test methods: observe each medicine group to the kinemic impact of rat.
1.4 statistical procedures: experimental result with
represent, adopt t inspection, measure the significance of group difference.
2 test methods and result:
2.1 on the kinemic impact of rat:
Get 30 of rats, male and female half and half, body weight 200 ± 20g; Fasting 24h, is divided into 3 groups at random, 10 every group.Respectively taking normal saline as matched group, product group in the middle of product group and CN1733257A in the middle of the present invention, with oral administration continuous 5 days, dosage is 2.8g crude drug amount/ml, first use urethane (10ml/Kg) intraperitoneal injection of anesthesia, make intubate with trachea, practice artificial respiration.Lumbar injection chlorination succinum alkali (1mg/Kg), to eliminate autonomous respiration, is adjusted respirator and is made respiratory depth and respiratory frequency and autonomous respiration close.By AI-600G impedance plethysmogram plug-in unit, trace impedance cardiogram by level Four method (doing electrode with filamentary silver, subcutaneous the passing from corresponding back), calculate every pulse blood discharge amount, numeration heart rate (HR), calculates cardiac output (CO).For fear of the cardiac output difference due to body weight difference, when calculating, be all converted into per kilogram of body weight cardiac output [CO:L/ (minKg)], after last administration, 2h records cardiac output, and result of the test is in table 1.
Table 1 on the kinemic impact of rat (
)
Note: with the comparison of normal saline group,
* *p<0.001,
*p<0.01; With product group comparison in the middle of CN1733257A,
△ △p<0.01.
Experimental data from table 1: compare with normal saline matched group, in the middle of the present invention, in the middle of product group medicine, CN1733257A, product group all can obviously increase rat cardiac output, and has reached significant statistical significance; With product group comparison in the middle of CN1733257A, in the middle of the present invention, product group medicine increases obviously rat cardiac output, also there is outstanding diversity effect, result of study prompting: in the middle of of the present invention, product group medicine can increase rat cardiac output, and it is had to obvious therapeutical effect.
2.2 experimental studies of boosting:
Get 30 of rats, male and female half and half, body weight 200 ± 20g; Fasting 24h, is respectively normal saline matched group, the middle product group of the present invention and the middle product group of CN1733257A, 10 every group.First use urethane (10ml/Kg) intraperitoneal injection of anesthesia, back of the body position is fixed in laboratory table, do tracheorrhaphy from, tracheal intubation, separates a side common carotid artery, inserts ductus arteriosus, connects the pressure transducer in two road physiographs with stop,threeway.One side femoral artery inserts a PE50 polyethylene tube for blood-letting.Opposite side femoral arteriography be used for injecting 0.5mg/100g heparin in case blood clotting and for blood transfusion.Abdominal operation, finds out duodenum, and insertion polyethylene tube is in intestinal tube and fix it, for administrable.Trace after Normal Cervical arteriotony (11.8 ± 1.07kpa) curve, the slow blood-letting of femoral artery, make Blood pressure of carotid artery continually and steadily at 6.67kpa, 30min rear intestinal is to product group in the middle of product group in the middle of the present invention and CN1733257A, dosage is 2.8g crude drug amount/ml, control group administered physiological saline, observes blood pressure, and record the results are shown in following table 2.
The effect of table 2 to hypotention in rats state (
)
Note: with the comparison of normal saline group,
* *p<0.001,
*p<0.01; With product group comparison in the middle of CN1733257A,
△ △p<0.01.
Experimental data from table 2: after experimental group administration 25 min, find that rat blood pressure starts to rise gradually, to 55 min peakings, after 70 min, blood pressure starts to decline, and matched group blood pressure is without significant change.Experimental result prompting, in the middle of the present invention, the product group rat carotid artery systolic pressure that can raise in the middle of product group and CN1733257A, with the comparison of normal saline group, and has reached statistical meaning.
2.3 mice swimming tests
Get 30 of white mice, male and female half and half, body weight, at 18～22 g, is divided into 3 groups at random, is respectively normal saline matched group, the middle product group of the present invention and the middle product group of CN1733257A.Press the dosage of 2.8g crude drug amount/ml, fill with the middle product group of medicine of the present invention and the middle product group of CN1733257A medicine, once a day, gastric infusion 7d continuously, after last administration, after 30 min, by mouse tail bundle 2g weight, put into the calorstat of 13 ± 1 DEG C of water temperatures, with stopwatch record time to mice submerged in white mice input water, be the swimming time of mice.Result of the test sees the following form 3.
The impact of table 3 on mice swimming time (
)
Note: with the comparison of normal saline group,
* *p<0.001; With product group comparison in the middle of CN1733257A,
△ △p<0.01.
Experimental data from table 3: in the middle of medicine of the present invention, in the middle of product group and CN1733257A, product group, to mice swimming time, is compared with matched group result, has significant difference; With product group comparison in the middle of CN1733257A, in the middle of the present invention, product group obviously extended the rats'swimming time, also there is good diversity effect, results suggest: in the middle of medicine group of the present invention, product group has increasing action to mice swimming time, show that it can improve the oxygen tolerance of laboratory animal, Enhancement test animal stress body constitution, and be better than product group in the middle of CN1733257A.
In sum, in the middle of medicine of the present invention, in the middle of product group and CN1733257A, product group all has the experimental rat of increasing cardiac output, rising rat carotid artery systolic pressure and improves the effects such as mouse cardiac muscle oxygen tolerance, these effects are pharmacological basis for the treatment of essential hypotension disease, wherein curative effect the best of medicine of the present invention, as can be seen here, medicine of the present invention has outstanding beneficial effect compared with approaching most correlation technique.
Detailed description of the invention
Be below the specific embodiment of content of the present invention, want the technical scheme of technical solution problem for setting forth present specification, contribute to those skilled in the art to understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiment.
Embodiment 1
(1) by Colla Corii Asini 12g, Rhizoma Gastrodiae 12g, adopts superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae 180g, using with medical material weight ratio is 8 times of sour waters that amount, pH value are 4.0, heating extraction 2 times, and each 2 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) Radix Ginseng Rubra 120g is ground into coarse powder, the ethanol that is 75% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus 360g, Ramulus Cinnamomi 300g, adding with medical material weight ratio is after 10 times of water gagings soak, adopt vapor distillation 1.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae 54g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, each 2h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata 300g again, adding with medical material weight ratio is the water of 10 times of amounts, decocts and extracts 2 times, each 1.5h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 24 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, by gained total mixture, dextrin, sucrose with appropriate, mix, and granulates, dry, make 1000g granule.
Embodiment 2
(1) by Colla Corii Asini 12g, Rhizoma Gastrodiae 12g, adopts superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae 180g, using with medical material weight ratio is 6 times of sour waters that amount, pH value are 5.0, heating extraction 1 time, and each 3 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) Radix Ginseng Rubra 120g is ground into coarse powder, the ethanol that is 90% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus 360g, Ramulus Cinnamomi 300g, adding with medical material weight ratio is after 8 times of water gagings soak, adopt vapor distillation 2 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 6 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae 540g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, each 1h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata 300g again, adding with medical material weight ratio is the water of 12 times of amounts, decocts and extracts 3 times, each 1h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 48 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, by gained total mixture, mix with appropriate amount of starch, dextrin, granulate, be pressed into 1000g tablet.
Embodiment 3
(1) by Colla Corii Asini 12g, Rhizoma Gastrodiae 12g, adopts superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae 180g, using with medical material weight ratio is 10 times of sour waters that amount, pH value are 4.0, heating extraction 3 times, and each 1h, filters, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) Radix Ginseng Rubra 120g is ground into coarse powder, the ethanol that is 80% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus 360g, Ramulus Cinnamomi 300g, adding with medical material weight ratio is after 9 times of water gagings soak, adopt vapor distillation 0.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 7 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae 540g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 80% 1 time, each 3 h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata 300g again, adding with medical material weight ratio is the water of 9 times of amounts, decocts and extracts 1 time, each 2h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 50% containing alcohol amount, cold preservation leaves standstill 36h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, by gained total mixture, add suitable adjuvant, granulate, encapsulated, make 1000g hard capsule.
Embodiment 4
(1) by Colla Corii Asini 12g, Rhizoma Gastrodiae 12g, adopts superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae 180g, using with medical material weight ratio is 9 times of sour waters that amount, pH value are 3.0, heating extraction 2 times, and each 1h, filters, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) Radix Ginseng Rubra 120g is ground into coarse powder, the ethanol that is 60% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus 360g, Ramulus Cinnamomi 300g, adding with medical material weight ratio is after 12 times of water gagings soak, adopt vapor distillation 3 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 3 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae 540g, Radix Ophiopogonis 300g, Caulis Trachelospermi 400g, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 60% 3 times, each 1 h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata 300g again, adding with medical material weight ratio is the water of 6 times of amounts, decocts and extracts 2 times, each 1h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 70% containing alcohol amount, cold preservation leaves standstill 12h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, by gained total mixture, with suitable substrate hot melt, stir, and carry out dripping, make 1000g drop pill.
In order further to verify the curative effect of finished product preparation of the present invention, the finished particle agent of preparing in above-mentioned specific embodiment 1-4, tablet, hard capsule and drop pill medicine have been carried out corresponding clinical trial by we, existing that report the test is as follows.
Clinical observation and curative effect
(1) object of study: choose tested case 299 examples of in January, 2009～2011 year August in step-length hospital, age was at 30～65 years old, adopt parallel control, random method for designing, be divided at random 6 groups, wherein 1 group of 51 example of embodiment, wherein male's 23 examples, women's 28 examples, year mean age (51.3 ± 1.2); 2 group of 46 example of embodiment, wherein male's 21 examples, women's 25 examples, year mean age (47.5 ± 1.6); 3 group of 54 example of embodiment, wherein male's 26 examples, women's 28 examples, year mean age (47.4 ± 1.1); 4 group of 49 example of embodiment, wherein male's 26 examples, women's 23 examples, year mean age (45.7 ± 1.1); Matched group (CN1733257A capsule) 51 examples, wherein male's 23 examples, women's 28 examples, year mean age (49.5 ± 1.6); Matched group (SHENGMAI YIN) 52 examples, wherein male's 28 examples, women's 24 examples, average (46.8 ± 1.2) year.
(2) case selection:
Include in and diagnostic criteria 1. continuous measurement 3d brachial arterial pressure lower than 90/60mmHg (12/8kPa); 2. dizzy, the headache of clinical appearance, shortness of breath and palpitation, lassitude, how with symptoms such as soreness of the waist and knees, spontaneous perspiration, aversion to cold and cold limbs, inappetence, abdominal distention after meals; 3. check without organ diseases such as liver, spleen, lung, kidneys, meet above-mentioned 3 conditions, can be diagnosed as essential hypotension.
(3) Therapeutic Method:
Observation group and CN1733257A capsule adopt, and every day 1 time, are used in conjunction 4 weeks.Matched group, every day 1 time, 2 groups of courses for the treatment of are identical, and patient regularly follows up a case by regular visits at special outpatient clinic weekly, observes the symptoms, blood pressure, heart rate and hemodynamic variation.Every example all, in the time that treatment starts and finish, is carried out Doppler echocardiography inspection, measures the hematodinamics indexs such as heart output (CO), cardiac index (CL), ejection fraction (EF).
(4) criterion of therapeutical effect:
Efficacy assessment standard: 1. effective: clinical symptom disappearance, blood pressure > 100/70mmHg; 2. effective: clinical symptom relief or disappearance, blood pressure > 90/60mmHg; 3. invalid: clinical symptoms is without improvement, blood pressure < 90/60mmHg.
(5) results and analysis:
The comparison of the each experimental group curative effect of table 4
1 group, 2 groups, 3 groups, 4 groups of the embodiment of the present invention and CN1733257A Capsules group total effective rate are respectively 88.2%, 87.0%, 83.3%, 85.7%, 74.5%, and matched group (SHENGMAI YIN) is 71.2%, above clinical efficacy results suggest: medicine prepared by technical solution of the present invention is aspect treatment essential hypotension, have curing protrusion effect, curative effect is all better than matched group and CN1733257A Capsules group.
Hemodynamics variation before and after the each experimental group treatment of table 5 (
)
Note: self compare with treatment front and back,
*p < 0.01,
*p < 0.05; Matched group (SHENGMAI YIN) compares,
△p<0.05.
Before 1 group, 2 groups, 3 groups, 4 groups heart output of the embodiment of the present invention (CO), cardiac index (CL), ejection fraction (EF) value and medication, compare, there is obvious increase and have the difference of highly significant, wherein curative effect the best of 1 group of embodiment, and matched group (SHENGMAI YIN) relatively, ejection fraction (EF) value obviously increases, and has significant difference.And take after CN1733257A capsule and matched group (SHENGMAI YIN) medicine, before heart output value (CO), cardiac index value (CL) and medication, relatively, there is increase and have statistical meaning.Its result demonstration, medicine prepared by technical solution of the present invention can obviously improve the dynamic (dynamical) effect of essential hypotension blood samples of patients.
Hematodinamics before and after the each experimental group treatment of table 6 (
)
Note: self compare with treatment front and back,
*p < 0.01,
*p < 0.05; Matched group (SHENGMAI YIN) compares,
△p<0.05.
Take 1 group of the embodiment of the present invention, the medicine of 2 groups, 3 groups, 4 groups, observing systolic pressure compares with before medication with diastolic blood pressure values, there is obvious increase and have significant difference, after matched group (SHENGMAI YIN) and CN1733257A capsule administration, experimental result is found, systolic pressure and diastolic pressure raise to some extent and have statistical significance, from experimental result, 1 group, 2 groups of the embodiment of the present invention, 3 groups are all effective to the increase of heart rate, wherein curative effect the best of 1 group of embodiment, and relatively, heart rate obviously increases matched group (SHENGMAI YIN), and has significant difference.Take 4 groups of embodiment, the medicine of CN1733257A Capsules group and matched group (SHENGMAI YIN), compares before and after treatment, heart rate all increases to some extent, but change all not significantly, this experimental result, points out of the present invention group of medicine to have good therapeutical effect to essential hypotension patient.
Above clinical efficacy results suggest: medicine prepared by technical solution of the present invention, aspect treatment essential hypotension, all has obvious therapeutic action, and curative effect is better than matched group and CN1733257A Capsules group.Results suggest: Chinese medicine preparation of the present invention has the advantages such as preparation technology is efficiently feasible, drug effect is clear and definite, stable curative effect is reliable, its beneficial effect, no matter from the extraction and purification process of medicine, or on the forming technique of finished product preparation, all effectively ensured the excellent results of preparation of the present invention, the clinical practice for this Chinese medicine preparation is brought huge potentiality and development space by this.
Claims (10)
1. treat a Chinese medicine preparation for essential hypotension, it is characterized in that it is to be prepared from by following technique:
A. prescription composition: 120 parts of Radix Ginseng Rubra, 360 parts of Fructus Aurantii Immaturuss, 180 parts, Herba Ephedrae, 300 parts of Ramulus Cinnamomi, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Ophiopogonis, 400 parts of Caulis Trachelospermis, 540 parts of Herba Agrimoniaes, 12 parts, Colla Corii Asini, 32 parts, Rhizoma Gastrodiae;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 6～10 times of sour waters that amount, pH value are 3.0～5.0, heating extraction 1～3 time, and each 1～3 h, filters, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 60%～90% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 8～12 times of water gagings soak, adopt vapor distillation 0.5～3 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 3～7 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 60%～80% 1～3 time, each 1～3 h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 6～12 times of amounts, decocts and extracts 1～3 time, each 1～2h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 50%～70% containing alcohol amount, cold preservation leaves standstill 12h～48 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
2. the Chinese medicine preparation for the treatment of essential hypotension as claimed in claim 1, is characterized in that it is to be prepared from by following technique:
A. prescription composition: 120 parts of Radix Ginseng Rubra, 360 parts of Fructus Aurantii Immaturuss, 180 parts, Herba Ephedrae, 300 parts of Ramulus Cinnamomi, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Ophiopogonis, 400 parts of Caulis Trachelospermis, 540 parts of Herba Agrimoniaes, 12 parts, Colla Corii Asini, 32 parts, Rhizoma Gastrodiae;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 8 times of sour waters that amount, pH value are 4.0, heating extraction 2 times, and each 2 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 75% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 10 times of water gagings soak, adopt vapor distillation 1.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, and each 2 h, filter, and merging filtrate also reclaims ethanol, concentrated, dry after and be ground into dried cream powder, the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 10 times of amounts, decocts and extracts 2 times, each 1.5h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 24 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
3. the Chinese medicine preparation for the treatment of essential hypotension as claimed in claim 1 or 2, is characterized in that this Chinese medicine preparation is granule, tablet, hard capsule or drop pill.
4. the preparation method of the Chinese medicine preparation for the treatment of essential hypotension as claimed in claim 1, is characterized in that:
A. prescription composition: 120 parts of Radix Ginseng Rubra, 360 parts of Fructus Aurantii Immaturuss, 180 parts, Herba Ephedrae, 300 parts of Ramulus Cinnamomi, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Ophiopogonis, 400 parts of Caulis Trachelospermis, 540 parts of Herba Agrimoniaes, 12 parts, Colla Corii Asini, 32 parts, Rhizoma Gastrodiae;
B. preparation method: by above-mentioned 10 taste Chinese crude drugs, operation in the steps below:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 6～10 times of sour waters that amount, pH value are 3.0～5.0, heating extraction 1～3 time, and each 1～3 h, filters, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 60%～90% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 8～12 times of water gagings soak, adopt vapor distillation 0.5～3 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 3～7 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 60%～80% 1～3 time, each 1～3 h, filter, merging filtrate also reclaims ethanol, concentrates, is dried rear and be ground into dried cream powder, and the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 6～12 times of amounts, decocts and extracts 1～3 time, each 1～2h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 50%～70% containing alcohol amount, cold preservation leaves standstill 12h～48 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
5. the preparation method of the Chinese medicine preparation for the treatment of essential hypotension as claimed in claim 4, is characterized in that:
(1) by Colla Corii Asini and Rhizoma Gastrodiae, adopt superfine powder to be broken into after fine powder for subsequent use;
(2) get Herba Ephedrae, using with medical material weight ratio is 8 times of sour waters that amount, pH value are 4.0, heating extraction 2 times, and each 2 h, filter, and medicinal residues are continued to employ, and merging filtrate also concentrates, is dried and crushed into dried cream powder, for subsequent use;
(3) red ginseng powder is broken into coarse powder, the ethanol that is 75% by concentration carries out percolation extraction, and collect percolate and also reclaim ethanol, concentrate drying to be ground into dried cream powder for subsequent use, medicinal residues are continued to employ;
(4) get again Fructus Aurantii Immaturus, Ramulus Cinnamomi medical material, adding with medical material weight ratio is after 10 times of water gagings soak, adopt vapor distillation 1.5 h, it is for subsequent use after the beta-cyclodextrin inclusion compound of 5 times of amounts collecting volatile oil and using with volatile oil weight ratio, and the aqueous solution after distillation and medicinal residues are continued to employ respectively after filtering;
(5) get Herba Agrimoniae, Radix Ophiopogonis, Caulis Trachelospermi medical material, using with medical material weight ratio is 8 times of amounts, concentration alcohol reflux that is 70% 2 times, and each 2 h, filter, and merging filtrate also reclaims ethanol, concentrated, dry after and be ground into dried cream powder, the medicinal residues after filtration are for subsequent use;
By (2), (3), (4) and the medicinal residues of continuing to employ (5) merge with Radix Rehmanniae Preparata medical material again, adding with medical material weight ratio is the water of 10 times of amounts, decocts and extracts 2 times, each 1.5h, filter, merging filtrate again with (4) in the aqueous solution continued to employ merge, it is 1.15～1.20 clear paste that concentrating under reduced pressure becomes relative density, adds ethanol to make to reach 60% containing alcohol amount, cold preservation leaves standstill 24 h, filter, decompression filtrate recycling ethanol concentrate drying, be ground into dried cream powder, for subsequent use;
By above-mentioned (1) in Colla Corii Asini, Rhizoma Gastrodiae fine powder for subsequent use, (2), (3), (6) in dried cream powder for subsequent use, with the above-mentioned volatile oil clathrate compound making in (4), after fully mixing, obtain mixed extract, then add adjuvant conventional on pharmaceutics to make various different oral formulations.
6. the preparation method of the Chinese medicine preparation of the treatment essential hypotension as described in claim 4 or 5, is characterized in that: by the mixed extract of gained, granulates, and dry, granulation agent.
7. the preparation method of the Chinese medicine preparation of the treatment essential hypotension as described in claim 4 or 5, is characterized in that: by the mixed extract of gained, granulate, in flakes, coating is made tablet in compacting.
8. the preparation method of the Chinese medicine preparation of the treatment essential hypotension as described in claim 4 or 5, is characterized in that: by the mixed extract of gained, granulates, and encapsulated, make hard capsule.
9. the preparation method of the Chinese medicine preparation of the treatment essential hypotension as described in claim 4 or 5, is characterized in that: by the mixed extract of gained, with drug matrices mixed melting, carry out dripping, cooling, be dried, make drop pill.
10. the application of Chinese medicine preparation as claimed in claim 1 in preparation treatment essential hypotension medicine.
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