CN1939389A - Chinese-medicinal preparation and its making method - Google Patents

Chinese-medicinal preparation and its making method Download PDF

Info

Publication number
CN1939389A
CN1939389A CN 200510107810 CN200510107810A CN1939389A CN 1939389 A CN1939389 A CN 1939389A CN 200510107810 CN200510107810 CN 200510107810 CN 200510107810 A CN200510107810 A CN 200510107810A CN 1939389 A CN1939389 A CN 1939389A
Authority
CN
China
Prior art keywords
extract
radix astragali
preparation
ethanol
water
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 200510107810
Other languages
Chinese (zh)
Inventor
于文风
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Qiyuanyide Medicines Institute Beijing
Original Assignee
Qiyuanyide Medicines Institute Beijing
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Qiyuanyide Medicines Institute Beijing filed Critical Qiyuanyide Medicines Institute Beijing
Priority to CN 200510107810 priority Critical patent/CN1939389A/en
Publication of CN1939389A publication Critical patent/CN1939389A/en
Pending legal-status Critical Current

Links

Landscapes

  • Medicines Containing Plant Substances (AREA)

Abstract

A Chinese medicine in the form of injection or the orally taken forms for treating ischemic cerebral apoplexy, apoplexy sequelae senile dementia, coronary heart disease, angina pectoris, viral myocarditis, etc is prepared from astragalus root, notoginseng and shortscape fleabane herb. Its preparing process is also disclosed.

Description

A kind of compound Chinese medicinal preparation and preparation method thereof
Technical field
The present invention relates to a kind of compound Chinese medicinal preparation that is used for the treatment of cardiovascular and cerebrovascular disease, the preparation method of said preparation is provided simultaneously, belong to technical field of Chinese medicine.
Technical background
Cardiovascular and cerebrovascular disease is worldwide commonly encountered diseases of a class and frequently-occurring disease, refractory with sickness rate height, relapse rate height, disability rate height, mortality rate height and complication many " four is high by more than the one " disease that heals, and need to take medicine for a long time or all the life, quality of life is had a strong impact on, simultaneously along with growth in the living standard, ill crowd is huge day by day, in, young patient's number constantly increases especially, this severe situation makes development and such medicine of exploitation seem very urgent.Although it is a lot of to treat the Chinese medicine and western medicine of cardiovascular and cerebrovascular disease at present, Western medicine has side effect more; Though Chinese medicine relies on its advantage aspect safety, more and more obtain affirming of the personage of speciality circles, become the new focus of cardiovascular and cerebrovascular vessel area research in recent years, but up to now, the Chinese patent medicine of really rapid-action, determined curative effect, treatment cardiovascular and cerebrovascular disease that composition is distinct is also rarely found.For this reason, be necessary to develop a kind of Chinese medicine preparation of safe, effective, quality controllable treatment cardiovascular and cerebrovascular disease, to satisfy doctors and patients' demand.The Radix Astragali is a conventional Chinese medicine, and head is stated from Shennong's Herbal, classifies as top gradely, has the effect of " tonifying Qi and lifting yang, beneficial consolidating superficial resistance are defended, inducing diuresis to remove edema, holder skin ulcer granulation promoting ", enjoys the good reputation of " length of tonic ".Its chemical constituent is mainly monosaccharide, polysaccharide, Saponin, flavone, aminoacid and trace element etc., and wherein polyoses content is more.Pharmacological effect studies show that the Radix Astragali has the cardio-pulmonary function of improvement, strengthens cardiac contractile force, blood vessel dilating; microcirculation improvement suppresses platelet aggregation, reduces the blood stickiness; bring high blood pressure down blood sugar lowering, blood fat reducing; antioxidation; the protection vascular endothelial cell, suppress microangiopathies, improve the symptom of diabetes and renal complication thereof, effectively reduce the content of plasma fibrinogen, strengthen body immunity; improve human body anti allergic reaction ability, suppress effects such as virus breeding.The Radix Astragali injection of listing, Radix Astragali essenc oral liquid etc. are subjected to doctors and patients' favor very much at present, and are as the most frequently used lengthening one's life and one of qi-invigorating herb, with other Chinese medicine and western medicine prescription, of many uses.Herba Erigerontis is sweet in flavor and warm in property, has expelling cold and relieving exterior syndrome, blood circulation promoting and blood stasis dispelling, the pain relieving removing food stagnancy, the effect of expelling wind and removing dampness, the pharmacological effect test shows that having antithrombotic forms, the erigeron breviscapus effective component total flavones helps preventing and treating the thrombotic disease of following platelet aggregation to increase, wherein lamp-dish flower acetic has the cerebral blood flow increasing amount, reduce cerebral vascular resistance, improve the permeability of blood brain barrier and the platelet aggregation effect that antagonism is caused by adenosine diphosphate (ADP), clinical trial shows treatment coronary heart disease, curative effect to treat angina pectoris is definite, obvious adjusting cardiac function is arranged, improve cardiac hemodynamic, coronary blood flow increasing reduces the effect of myocardial oxygen consumption.Radix Notoginseng has the reduction myocardial oxygen consumption, improves myocardial ischemia, arrhythmia, and protection ischemic myocardial cell injury suppresses thrombosis, and functions such as blood fat reducing, blood sugar lowering are widely used in the treatment of cardiovascular and cerebrovascular disease.So the present invention adopts Herba Erigerontis, the Radix Notoginseng of blood circulation promoting and blood stasis dispelling, be equipped with Radix Astragali prescription with QI invigorating effect, study the preparation method and the curative effect in the treatment cardiovascular and cerebrovascular disease of the preparation of three's prescription.
Summary of the invention
The objective of the invention is to disclose a kind of compound Chinese medicinal preparation for the treatment of cardiovascular and cerebrovascular disease, adopt Herba Erigerontis, Radix Notoginseng, the Radix Astragali or its extract formula, at prior art, Herba Erigerontis, the Radix Astragali, Radix Notoginseng has been obtained great curative effect aspect cardiovascular and cerebrovascular diseases, obtain affirming of people in the industry, but so far, there is not the preparation listing of three's prescription, select in order to be more conducive to the patient, bring into play the cooperative compensating effect of three flavor conventional Chinese medicines simultaneously, improve the quality of life of cardio-cerebral vascular disease patient, alleviate the pressure that the patient causes society, this composing prescription preparation of the upright topic exploitation of the applicant.Another object of the present invention is to disclose the preparation method of the compound preparation of this treatment cardiovascular and cerebrovascular disease, comprise multiple injection type and peroral dosage form, effectively avoid the single inconvenience that brings of dosage form of present doctors and patients' medication, satisfied the selection of clinician and extensive patients to a greater degree.
Preparation of the present invention is to constitute like this: calculate according to composition by weight, it is made for 1～100 part by 10～500 parts of Herba Erigerontiss, 1～100 part of the Radix Astragali and Radix Notoginseng; Or add suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
Specifically, calculate according to composition by weight, it is made for 5～50 parts with Radix Notoginseng by 1～50 part of 20～200 parts of Herba Erigerontis, the Radix Astragali, or is added suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
Exactly, calculate according to composition by weight, it is made for 10～50 parts with Radix Notoginseng by 5～50 parts of 20～100 parts of Herba Erigerontiss, the Radix Astragali, or is added suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
Preparation of the present invention is injection and oral formulations; Injection comprises: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method; Oral formulations comprises: all acceptable dosage forms on tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, soft extract, extractum, gel, membrane and other pharmaceuticss.Preferred preparation is the injection that is directly used in drug administration by injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and aseptic block, drop pill, capsule, soft capsule, oral cavity disintegration tablet, tablet, capsule, dispersible tablet and the granule that makes with freeze-drying or spray drying method.
Contain saponin component, polysaccharide composition and flavones ingredient in the compound Chinese medicinal preparation of described treatment cardiovascular and cerebrovascular disease, calculate according to percentage by weight, wherein the content of saponin component is not less than 1% of the total solid after the deduction adjuvant amount and water quantities in the preparation; The content of flavones ingredient is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities, the content of polysaccharide composition is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities, and all the content sums that can survey composition of the saponin component in the injection, polysaccharide composition and flavones ingredient and other account for that the total solid after the deduction adjuvant amount and water quantities is not less than 25% in the preparation.
The preparation method of the compound Chinese medicinal preparation of described treatment cardiovascular and cerebrovascular disease is: get Herba Erigerontis, Radix Notoginseng, the Radix Astragali, add water or ethanol extraction respectively, the extracting solution concentrate drying gets the medical material crude extract, one or more that further adopt that alcohol deposition method, water returns molten method, organic solvent extractionprocess, flocculent precipitation, column chromatography unite use carry out suitably refining, get the medical material extract, three medical material crude extracts or extract are merged, add adjuvant and be prepared into different preparations with diverse ways.
Specifically, the preparation method of described preparation is: get Herba Erigerontis, pseudo-ginseng, add ethanol extraction respectively, extracting solution concentrates, and refining through organic solvent extraction or macroporous adsorbent resin, concentrate drying gets Herba Erigerontis extract, Radix Notoginseng extract; Get the Radix Astragali, decoct with water, filter, filtrate is crossed macroporous adsorptive resins, elder generation's water and low-concentration ethanol eluting, sample effluent and eluent in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds the ethanol precipitate with ethanol, filter, collecting precipitation gets Radix Astragali extract I; The reuse high concentration ethanol is crossed macroporous adsorptive resins and is carried out desorbing, collects stripping liquid, and decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, and Radix Astragali extract I and Radix Astragali extract II are merged, the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are mixed back adding adjuvant make different preparations.
The preparation method of described preparation is: get the Herba Erigerontis medical material, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water heating for dissolving that adds 1～5 times of medical material volume is filtered, and filtrate is with 0.3～1.0ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 4～12 times of amount 40～85% alcohol reflux 1～5 time, each 0.5～3.5h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 1～4 times of water dissolution, filters, and filtrate is with 0.2～1.0ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 6～15 times of water gagings decocts 1～5 time, each 0.5～3.5 hour, merge extractive liquid,, filter, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 2～8 times of resinite hydrops and 1～5 times of resin volume 5～20% ethanol elution, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 1～3 time, filter collecting precipitation, the dry Radix Astragali extract I that gets, 3～8 times of resin volume 40～80% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; The said extracted thing is merged, add adjuvant and make different preparations.
Described Injectable sterile block is preparation like this: get the Herba Erigerontis medical material, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water heating for dissolving that adds 3 times of medical material volumes is filtered, and filtrate is with the 0.5ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, be ground into coarse powder, with 70% alcohol reflux 2 times, add 6 times of amounts for the first time, refluxed 2 hours, add 5 times of amounts for the second time, refluxed 1.5 hours, merge extractive liquid, filters, and the concentrated gained extractum of filtrate adds 2 times of water dissolutioies, filtration, and filtrate is with the 0.6ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 8 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 6 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 10 times of water gagings decocts 3 times, each 1 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins, earlier with 6 times of resinite hydrops and 3 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed ZTC-1 type macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged, and vacuum drying gets Radix Astragali extract; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are merged, add an amount of water for injection dissolving, by volume add 2.0% needle-use activated carbon, boil, keep little 20min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 6.0～7.5 boils, spend the night coarse filtration, fine straining 4 ℃ of cold preservations; Injection mannitol is added the injection water be mixed with 120mg/ml solution, with above-mentioned medicinal liquid mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; And in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, be warming up to 30 ℃, keep 2h, promptly.
This preparation technology has kept the polysaccharide composition in the Milkvetch Root targetedly.
The adjuvant that is adopted in the preparation comprises mannitol, galactose, glycine, glucose, sodium chloride, dextran, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, poloxamer, dextrin, starch, low substituted carboxymethyl sodium cellulosate, hydroxypropyl starch, sodium carboxymethyl cellulose, the crospolyvinylpyrrolidone microcrystalline Cellulose, the Radix Glycyrrhizae charcoal, active carbon, stevioside, vegetable oil, soybean oil, sorbitol, Pulvis Talci, Cera Flava, modified starch, magnesium stearate, dimethicone, in the liquid paraffin one or more.
The Herba Erigerontis extract that the present invention relates to, Radix Notoginseng extract and Radix Astragali extract can also be commercially available or adopt other preparation methoies to prepare; Herba Erigerontis extract can also be a flavones ingredient content greater than the effective site of 80% Herba Erigerontis total flavones, Radix Notoginseng extract can also be a saponin component content greater than the effective site of 70% Radix Notoginseng total arasaponins, and Radix Astragali extract can also be saponins, polysaccharide component content sum greater than 80% effective site.
Described preparation is mainly used in diseases such as treatment ischemia apoplexy, apoplexy sequela, senile dementia, angina pectoris, cardiac insufficiency, viral myocarditis.
In the prior art, western medicine remains many disputes to the diagnostic criteria of cardiovascular and cerebrovascular vessel, the mechanism that arteriosclerosis takes place is not understood fully as yet fully, the theory of relatively generally acknowledging has " theory is replied in damage ", " lipid is invaded the profit theory ", " thrombosis theory ", " natural death of cerebral cells theory " or the like at present, but many inexplicable phenomenons are all arranged separately.Therefore, clinical treatment still stays in anti symptom treatment, as transferring fat, bring high blood pressure down, blood vessel dilating, blood sugar control, thrombolytic, improving Nutrition and Metabolism, microcirculation improvement etc.The traditional Chinese medical science has certain advantage than doctor trained in Western medicine aspect the treatment cardiovascular and cerebrovascular disease, can on " many target spots " of human body, play a role simultaneously, play comprehensive therapeutical effect by multipath, too many levels, help the recovery of human body body function, especially adjusting internal milieu, improving clinical symptoms, curative effect preferably all arranged aspect improving the quality of living, as dizziness, headache, the limb fiber crops, weak, indigestion and loss of appetite that can make the patient, even symptom such as stuttering puckery, the hemiplegia of speech is clearly better, and can also prevent or alleviate as diseases such as hepatorenal syndrome, sexually transmitted disease (STD) changes on every side simultaneously.The present invention adopts drug for invigorating blood circulation and eliminating stasis Herba Erigerontis and Radix Notoginseng to have the blood supply of cardiac muscle of improvement, participate in self effect such as adjustings grade of ischemic myocardial cells, whole therapeutic process through cardiovascular and cerebrovascular disease, blood stasis is many by the deficiency of vital energy, the deficiency of vital energy be because of, blood stasis be the fruit, Gu Zuo with the Radix Astragali in order to QI invigorating, to get the effect of blood circulation depending on qi flow; Qi as the commander of blood, the capable then blood of gas is capable, and then the blood vessel of mediation obstruction, and current blood vessels promote that blood is capable.Modern pharmacodynamic study shows, prescription of the present invention can be removed the poly-state of the dense agglutinated of blood, improve the cardiovascular and cerebrovascular vessel microcirculation, increase the brain cell oxygen saturation, improve abnormal hemodynamics, effects such as while enhancing human body immunity indicate that this composing prescription preparation has good curative effect as coronary heart disease, angina pectoris, ischemic cerebrovascular aspect aspect the treatment cardiovascular and cerebrovascular disease.
The applicant has carried out a series of experiments, to prove the effective effect of medicine provided by the invention.
Experimental example 1: medicament composing prescription efficiency assay research
The present invention has carried out affirmation and the side's of tearing open research of prescription effectiveness on the basis of prescription study on the efficiency, with commercially available Radix Astragali injection group, XUESAITONG ZHUSHEYE group, the Herba Erigerontis injection group has been carried out the comparison of the test of pesticide effectiveness, the results are shown in Table 1.
The affirmation of table 1 prescription effectiveness and the side's of tearing open research conclusion
Pilot project The XUESAITONG group The Herba Erigerontis group Radix Astragali group Of the present invention group
Medicine method Myocardial Ischemia model test is improved the mouse microcirculation test and is improved blood stasis model rat blood rheology test platelet aggregation-against and test the inspection of anti-mouse tail thrombotest rabbit fibrin solubility test mouse normal pressure resistant anoxia effect doctor model of qi-asthenia Immune Function In Animals Effect obvious effect general action obvious effect obvious effect obvious effect general action general action is general Effect obvious effect obvious effect obvious effect obvious effect obvious effect obvious effect general action is general Effect obvious effect obvious effect obvious effect general action general action general action obvious effect is obvious Effect humidification humidification humidification humidification humidification humidification humidification strengthens
As shown in Table 1, behind the three herbal medicine compatibilities,, improve cardiac hemodynamic improving myocardial ischemia, microcirculation improvement and hemorheological property, there is the obvious synergistic synergistic function enhance immunity aspect, all will get well than independent medication.
Experimental example 2: Radix Astragali technology examination
(1) extraction conditions is investigated
1. extract the investigation of solvent
Take by weighing Radix Astragali 100g, totally 5 parts, add 10 times of water gagings, 30%, 50%, 70%, 85% ethanol extraction respectively 3 times, each 1 hour, filter, concentrate, drying is measured Astragaloside content and polyoses content, the results are shown in Table 2.
Table 2 extracts the influence of solvent to extraction effect
The experiment number Solvent Medical material weight (g) Cream heavy (g) Astragaloside content (%) Polysaccharide extract rate (%)
1 2 3 4 5 Water 30% 50% 70% 85% 100.07 100.01 100.03 100.04 100.05 44.62 40.58 34.45 28.59 27.01 0.16 0.18 0.21 0.25 0.27 80.25 74.32 58.36 50.05 42.18
Annotate: Astragaloside content is 0.08% in the medical material, and astragalus polysaccharides content is 3.56%.
As can be seen from Table 2, astragaloside, astragalus polysaccharides all have certain dissolubility in ethanol, water, but the content of astragaloside in high concentration ethanol is higher, the content of astragalus polysaccharides in water and low-concentration ethanol is higher, overall merit astragaloside and astragalus polysaccharides content, in conjunction with economic factor, select water again for extracting solvent.
2. the optimization of extraction conditions
Extracting under the definite situation of solvent, the principal element that influences extraction effect has: the consumption of solvent, extraction time and extraction time, therefore these major influence factors are investigated.Take by weighing 9 parts of Radixs Astragali, every part of 100g decocts respectively by table 3 scheme condition, filters, and filtrate merges, concentrate, and drying,, as investigating index, the results are shown in Table 3 with dried cream yield, Astragaloside content, polyoses content.
Table 3 Radix Astragali extraction factor water-glass
The factor sequence number A extraction time (hour) B extraction time (inferior) C solvent load (doubly) Error term Polysaccharide extract rate (%)
123456789 averages, 1 average, 2 averages, 3 extreme differences 1 1 1 1.5 1.5 1.5 2 2 2 82.707 87.347 86.943 4.640 1 2 3 1 2 3 1 2 3 79.397 85.640 91.960 12.563 8 10 12 10 12 8 12 8 10 84.817 85.847 86.333 1.516 1 2 3 3 1 2 2 3 1 85.617 85.033 86.347 1.314 75.54 82.23 90.35 81.94 87.94 92.16 80.71 86.75 93.37
As shown in Table 3, each factor to the order of index influence size is: B＞A＞C, and promptly extraction time has the greatest impact to extraction effect, secondly is extraction time, and the consumption influence of solvent is less; ANOVA showed significant, the impact effect of extraction time and solvent load is not obvious, and extraction time has tangible influence to the extraction ratio of polysaccharide; The result of comprehensive intuitive analysis and variance analysis, consideration simultaneously saves time, energy-conservation, economical, determines that optimised process is combined as A 1B 3C 1, promptly 10 times of water gagings decoct 3 times, each 1h.
Experimental example 3 process for refining are investigated
The comparison of process for purification: the butanol extraction liquid method: precision is measured Radix Astragali extract, extracts 4 times with water saturated n-butyl alcohol jolting, and each 15ml merges n-butyl alcohol liquid, reclaims solvent, drying; Water liquid adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, makes that to contain the alcohol amount be 80% for the second time, merges twice precipitation, dry back and the dry thing merging of above-mentioned n-butyl alcohol.The macroporous resin column chromatography method: precision is measured Radix Astragali extract, add 4 times of water dissolutioies, filter, filtrate is added on the AB-8 type resin column of having handled well, earlier with 6 times of resinite hydrops and 3 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed AB-8 type macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged, and vacuum drying gets Radix Astragali extract; The results are shown in Table 4.
The comparison of table 4 process for purification
Process for purification Astragaloside content (%) Polyoses content (%)
Extraction macroporous adsorbent resin method 2.19 5.78 57.58 62.78
As shown in Table 4, extraction and macroreticular resin absorbing method can both play certain purification, and the two compares, and the Astragaloside content and the polyoses content of macroreticular resin absorbing method are higher, so preferred version is for adopting macroporous adsorbent resin as purified method.
Because its absorption affinity of resin and the specific surface area of different model are all inequality, so separating effect difference to some extent, the inventor screens the situation of the resin absorption saponin component of different model, the results are shown in Table 5.
The selection of table 5 resin model
The resin model Carrying capacity (g medical material/100g resin)
ZTC-1 D-101 D-605 AB-8 60.68 50.36 50.25 72.39
As shown in Table 5, different resins can adsorb and separation and purification saponin and polysaccharide composition, and comparatively speaking, the carrying capacity of AB-8 type resin is bigger, so we determine with AB-8 type resin to be optimal case.
Experimental example 3: injection technical study
1, injection with small volume or concentrated solution for injection molding research
(1) the activated carbon dosage usage is investigated:
Injection has the pyrogen material owing to solvent, raw material, container etc. in process of production, and the safety of injection is reduced, and therefore needs to remove the pyrogen material in the process of preparation injection.The method of depyrogenation mainly contains high temperature method, acid-base method, ultrafiltration and absorption method at present, active carbon adsorption not only can heat of adsorption originality composition, the effect that also has filter of helping and decolouring, when removing pyrogen, can improve the appearance character of preparation, therefore we select the active carbon adsorption depyrogenation for use, and its consumption is investigated.The results are shown in following table 6.
Table 6 activated carbon dosage investigation table
Activated carbon dosage (%) Cream heavy (g) The rate of transform (%) Outward appearance
0.2 1.0 1.5 13.48 13.12 12.86 58.17 57.92 55.46 Reddish brown red
From the medicinal liquid outward appearance, select activated carbon dosage be 1% and 1.5% proper; But judge that from the rate of transform 0.2% consumption and 1% consumption are slightly better, the three all can satisfy the related request of injection, but takes all factors into consideration above factor, so that be the best with the activated carbon decolorizing of medicine liquid volume 1%.
Table 7 bleaching time investigation table
Time (min) Cream heavy (g) The rate of transform (%) Outward appearance
10 30 60 13.56 13.47 13.10 58.30 58.02 57.41 Reddish brown red pale red
As can be seen from Table 7, along with the color of the prolongation medicinal liquid of bleaching time is thin out, but above-mentioned factor is taken all factors into consideration in the also corresponding minimizing of the rate of transform of effective ingredient, selects for use and boils 30 minutes for best.
(2) pH value of solution is investigated
For adapting to the Human Physiology needs, also to consider the character of each constituents in the medicinal liquid simultaneously, when dosing, need suitably adjust the pH value of medicinal liquid.Select scutellarin content as evaluation index.
Test method and result: after feeding intake and handle by recipe quantity,, filter with the concentrated solution mix homogeneously by above-mentioned condition, add water to 1000ml, adjust pH is when the different pH value that reaches shown in the following table, boil the back standing over night, observe the variation of appearance character under different pH condition.Experimental result sees Table 8:
The investigation of table 8 dosing pH value (is to investigate index with the solution appearance)
Sequence number 1 2 3 4 5 6 7 8 9
Dosing pH boils pH 4.5 4.0 5.0 4.5 5.5 5.1 6.0 5.8 6.5 6.3 7.0 6.6 7.5 7.3 8.0 7.8 8.5 8.0
Outward appearance Precipitation appears No significant change Color burn
The result shows, medicinal liquid boils the back pH value and occurs precipitating at the sample 5.5 below, and pH value is obviously deepened in the color sample more than 8.5, and pH value is that 6.0～8.0 medicinal liquid is relatively stable, and outward appearance does not have significant change.Below its scutellarin content is measured.The results are shown in Table 9.
The investigation of table 9 dosing pH value (is to investigate index with the scutellarin)
Sequence number Dosing pH Content during dosing (%) Boil back pH Boil back content (%)
1 2 3 4 5 6.0 6.5 7.0 7.5 8.0 4.15 4.15 4.15 4.15 4.15 5.6 6.1 6.6 7.2 7.7 4.04 4.09 3.98 4.00 3.92
As seen from table, medicinal liquid is being adjusted the pH value front and back, the not too big variation of index components scutellarin content.The appearance character of comprehensive above-mentioned medicinal liquid and the changes of contents of astragaloside, the pH value of medicinal liquid is transferred between 6.0～8.0 when determining dosing.
2, the freeze-dry process of Injectable sterile block is investigated
(1) screening of caffolding agent kind
The screening of table 10 caffolding agent kind
The caffolding agent kind Caffolding agent: medicinal liquid (V: V) Solubility The finished product outward appearance
Glucose galactose mannitol glycine dextran mannitol, the propylene glycol glycine, the Polyethylene Glycol dextran, sorbitol, the blank medicinal liquid of tween 1∶1 1∶1 1∶1 1∶1 1∶1 1∶1 1∶1 1∶1 3ml Well generally carefully generally well carefully Molding, the part molding of subsiding, part is subsided moulding moulded, frangible moulding moulded molding, frangible molding atrophy
As shown in Table 10, in the adjuvant that is screened, under the identical situation of other conditions, all adjuvants all can be made into freeze-dried powder, but solubility angle integrated survey from yield rate, molding situation and sample, mannitol and mixed accessories mannitol, propylene glycol effect are better than other adjuvants, but consider to reduce supplementary product consumption as far as possible, select to use mannitol as the lyophilizing caffolding agent separately.。
(2) caffolding agent consumption screening
The mannitol solution (100mg/ml, 150mg/ml and 200mg/ml) of variable concentrations is mixed in varing proportions with medicinal liquid, filter, every cillin bottle loading amount is 3ml, lyophilization.Lyophilisation condition :-45 ℃, behind the pre-freeze 8h, the beginning evacuation, and be warming up to-40 ℃, keep 10h; Be warming up to-30 ℃, keep 10h; Be warming up to-20 ℃, keep 10h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 15 ℃, keep 3h; Be warming up to 25 ℃, keep 3h.Result such as table 11.
The screening of table 11 mannitol consumption
Numbering Mannitol concentration (mg/ml) Mannitol: medicinal liquid (v: v) Color and luster Profile Solubility Clarity
1 2 3 100 150 200 1∶1 1∶1 1∶1 Yellowish-brown Huang is yellowish Part is subsided intact Well carefully Up to specification up to specification
As shown in Table 11, when the ratio of caffolding agent consumption and medicinal liquid is 1: 1, the sample character is that the sample of 150mg/ml and 200mg/ml is relatively good with the mannitol concentration, the sample of 100mg/ml has part to subside, but major part still is molding, but take all factors into consideration the consumption and the clinical dose of adjuvant, the optimum selection mannitol concentration is 150mg/ml, and the volume ratio of mannitol solution and medicinal liquid is 1: 1.
(3) lyophilization conditional filtering
An ideal lyophilisation condition not only can be saved a large amount of energy, can also shorten man-hour simultaneously, so we are optimized screening to existing lyophilisation condition.The actual conditions screening sees Table 12.
Table 12 lyophilization conditional filtering
Temperature (℃) Condition I Condition II Old terms Cold-trap
35 (vacuumizing)-35 (vacuumizing)-30 (vacuumizing)-25 (vacuumizing)-20 (vacuumizing)-15 (vacuumizing)-10 (vacuumizing) ,-45 (pre-freeze)-40 (pre-freeze), 0 (vacuumizing) 10 (vacuumizing), 20 (vacuumizing) 30 (vacuumizing) 8 - 8 - 8 - 8 - 5 5 2 2 2 - 8 - 8 - 8 - 8 - 5 4 4 2 8 - 10 - 10 - 10 - 5 5 3 3 2 Keep-70 ℃
Experimental result shows: finished product appearance character that condition I, II and III make and the equal conformance with standard of moisture.But comparatively speaking, condition II yield rate is low slightly, and condition III power consumption is bigger, considers the practical situation of production, short condition I of finally selected overall time spent, i.e. and lyophilization condition is: pre-freeze temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 2h, be warming up to 30 ℃, keep 2h, get product.
Concrete embodiment
(part is a unit of weight, as ton, kilogram, gram)
1 part of 1 portion of Radix Notoginseng of 10 parts of Radixs Astragali of embodiment 1 Herba Erigerontis
Get the Herba Erigerontis medical material, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 3 times of medical material volumes, filter, filtrate is with the 0.5ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, be ground into coarse powder, with 70% alcohol reflux 2 times, add 6 times of amounts for the first time, refluxed 2 hours, add 5 times of amounts for the second time, refluxed 1.5 hours, merge extractive liquid, filters, and the concentrated gained extractum of filtrate adds 2 times of water dissolutioies, filtration, and filtrate is with the 0.6ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 8 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 6 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 10 times of water gagings decocts 3 times, each 1 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins, earlier with 6 times of resinite hydrops and 3 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed AB-8 type macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged, and vacuum drying gets Radix Astragali extract; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are merged, add an amount of water for injection dissolving, by volume add 1.0% needle-use activated carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 6.0～8.0 boils, spend the night coarse filtration, fine straining 4 ℃ of cold preservations; Injection mannitol is added the injection water be mixed with 150mg/ml solution, with above-mentioned medicinal liquid mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; And in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, be warming up to 30 ℃, keep 2h, promptly get the aseptic block of lyophilizing.After testing, all the content sums that can survey composition of the saponin component in the preparation, polysaccharide composition and flavones ingredient and other account for 79% of the total solid after the deduction adjuvant amount and water quantities in the preparation.
100 parts of 100 portions of Radix Notoginseng of 500 parts of Radixs Astragali of embodiment 2 Herba Erigerontiss
Get the Herba Erigerontis medical material, add 12 times of volume 70% alcohol reflux 3 times, each 1.5 hours, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 3 times of medical material volumes, filter, filtrate is with the 0.8ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 5 times of resinite hydrops and 3 times of resin volume 12% alcohol flushing impurity successively, use 50% alcohol desorption of 4 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 8 times of amount 75% alcohol reflux 3 times, each 2.0h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 2 times of water dissolutioies, filters, and filtrate is with the 0.6ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 4 times of resinite hydrops and 3 times of resin volume 12% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 10 times of water gagings decocts 3 times, each 1 hour, merge extractive liquid, filtered, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 5 times of resinite hydrops and 3 times of resin volume 15% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 3 times, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are merged, add injection and blunge and make it dissolving, boil, between adjust pH to 6.0～8.0, add 0.5% activated needle-use activated carbon, boil absorption, carbon removal, fine straining, filtrate adds the injection water to ormal weight, spend the night 4 ℃ of cold preservations, coarse filtration, fine straining divide to install in the ampoule bottle sterilization, packing promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.
5 parts of 1 portion of Radix Notoginseng of 20 parts of Radixs Astragali of embodiment 3 Herba Erigerontiss
Get the Herba Erigerontis medical material, add 12 times of volume 60% alcohol reflux 3 times, each 1.5 hours, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 3 times of medical material volumes, filter, filtrate is with the 0.8ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 3 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 3 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 10 times of amount 65% alcohol reflux 3 times, each 2.0h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 2 times of water dissolutioies, filters, and filtrate is with the 0.8ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 4 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 4 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 2.0 hours, merge extractive liquid,, filter, filtrate is crossed AB-8 type macroporous adsorptive resins, earlier with 5 times of resinite hydrops and 3 times of resin volume 15% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds the ethanol precipitate with ethanol 2 times, makes for the first time to contain the alcohol amount and reach 65%, make for the second time and contain the alcohol amount and reach 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract, Radix Astragali extract are merged, add the dissolving of injection water, add the glucose of ormal weight, boil, regulating pH value is 6.0～8.0, adds 1.5% activated needle-use activated carbon, boil absorption, carbon removal, fine straining is spent the night in 4 ℃ of placements, filtrate adds the injection water to ormal weight, packing, sterilization promptly gets the glucose intravenous infusion agent.
10 parts of 5 portions of Radix Notoginseng of 20 parts of Radixs Astragali of embodiment 4 Herba Erigerontiss
Get the Herba Erigerontis medical material, add 2 times of volume 60% alcohol reflux 4 times, each 0.5 hour, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 3 times of medical material volumes, filter, filtrate is with the 0.6ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 6 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 55% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 8 times of amount 75% alcohol reflux 2 times, each 1.5h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 2 times of water dissolutioies, filters, and filtrate is with the 0.5ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 8 times of resinite hydrops and 2 times of resin volume 10% alcohol flushing impurity successively, use 70% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 2.0 hours, merge extractive liquid, filtered, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 4 times of resinite hydrops and 3 times of resin volume 15% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 2 times, filter collecting precipitation, the dry Radix Astragali extract I that gets, 6 times of resin volume 70% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract, Radix Astragali extract are merged, add and inject the dissolving of blunging, filter, filtrate is boiled the needle-use activated carbon of back by quality percent by volume adding 0.5%, keep little and boiled 30 minutes, cold slightly filtration, filtrate adjust pH 6.0～7.5, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining add an amount of 0.9% sodium chloride solution through boiling, be diluted to ormal weight with water for injection, promptly get the sodium chloride infusion solution.
50 parts of 50 portions of Radix Notoginseng of 200 parts of Radixs Astragali of embodiment 5 Herba Erigerontiss
Get the Herba Erigerontis medical material, add 8 times of volume 75% alcohol reflux 3 times, each 1.5 hours, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 4 times of medical material volumes, filter, filtrate is with the 0.8ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 5 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 45% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 8 times of amount 65% alcohol reflux 3 times, each 2.5h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 3 times of water dissolutioies, filters, and filtrate is with the 0.8ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 6 times of resinite hydrops and 3 times of resin volume 12% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 2.5 hours, merge extractive liquid, filters, and filtrate is crossed AB-8 type macroporous adsorptive resins, earlier with 6 times of resinite hydrops and 4 times of resin volume 12% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds the ethanol precipitate with ethanol 3 times, make for the first time and contain the alcohol amount and reach 50%, make for the second time to contain the alcohol amount and reach 65%, make for the third time to contain the alcohol amount and reach 85%, filter, collecting precipitation, the dry Radix Astragali extract I that gets, 4 times of resin volume 50% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, get Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged, the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are merged, add an amount of water for injection dissolving, by volume add 1.2% needle-use activated carbon, boil, keep little 20min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH 6.0～7.5 boils, and spends the night 4 ℃ of cold preservations, coarse filtration, fine straining, divide to install in the enamel tray temperature-40 ℃, pre-freeze time 10h;-35 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 4h; Be warming up to 0 ℃, keep 4h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 2h, be warming up to 25 ℃, keep 2h, under aseptic condition, divide to install in the cillin bottle, promptly get the freeze dry sterile powder end.After testing, all the content sums that can survey composition of the saponin component in the preparation, polysaccharide composition and flavones ingredient and other account for 53% of the total solid after the deduction adjuvant amount and water quantities in the preparation.
80 parts of 100 portions of Radix Notoginseng of 10 parts of Radixs Astragali of embodiment 6 Herba Erigerontiss
Get the Herba Erigerontis medical material, add 12 times of volume 60% alcohol reflux 3 times, each 1.5 hours, measuring relative density when merge extractive liquid,, decompression recycling ethanol to 60 ℃ is 1.05～1.15, adds the water heating for dissolving of 3 times of medical material volumes, filter, filtrate is with the 0.7ml/g medical material.The speed of min is crossed AB-8 type macroporous adsorbent resin, use 6 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 40% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 8 times of amount 75% alcohol reflux 3 times, each 3.0h, merge extractive liquid, filters, and filtrate concentrates gained extractum and adds 3 times of water dissolutioies, filters, and filtrate is with the 0.6ml/g medical material.The speed of min is crossed ZTC-1 type macroporous adsorbent resin, use 6 times of resinite hydrops and 2 times of resin volume 10% alcohol flushing impurity successively, use 55% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 1.5 hours, merge extractive liquid,, filter, filtrate is crossed AB-8 type macroporous adsorptive resins, earlier with 4 times of resinite hydrops and 3 times of resin volume 15% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds the ethanol precipitate with ethanol 2 times, makes for the first time to contain the alcohol amount and reach 50%, make for the second time and contain the alcohol amount and reach 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Astragali extract, Radix Notoginseng extract are merged, add an amount of water for injection stirring and dissolving, add the needle-use activated carbon of 1.0% (W/V), boil, keep little 40min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 6.0～7.5 boils, spend the night 5 ℃ of cold preservations, coarse filtration, fine straining are 150 ℃ in inlet temperature, leaving air temp is 70 ℃, air velocity is that spray drying gets powder under the condition of 18ms-1, and packing promptly gets the spray drying sterilized powder.After testing, the flavones ingredient in the preparation, saponin component, polysaccharide component content sum are 26% of adjuvant amount in the deduction preparation and the total solid after the water quantities.
10 parts of 10 parts of Radix Notoginseng extracts of 10 parts of Radix Astragali extracts of embodiment 7 Herba Erigerontis extracts
Get Herba Erigerontis extract, Radix Astragali extract and Radix Notoginseng extract and merge, add the mixture of 2 times of amount PEG400 and PEG6000 (2: 1), mix homogeneously, heat 80～90 ℃ of fusions, stirring, be transferred to the drop pill machine, is coolant with the dimethicone, drip system, drip apart from being 3～6cm, dripping speed is 25～35/min, collects drop pill, remove the dimethicone on surface, promptly get drop pill.After testing, flavones ingredient content in the preparation is 1.5% of adjuvant amount in the deduction preparation and the total solid after the water quantities, saponin component content is 1.3% of adjuvant amount in the deduction preparation and the total solid after the water quantities, and the polysaccharide component content is 27% of adjuvant amount in the deduction preparation and the total solid after the water quantities.
1 part of 1 portion of Radix Notoginseng of 500 parts of Radixs Astragali of embodiment 8 Herba Erigerontiss
Get Herba Erigerontis, add 10 times of water gagings and decoct 3 times, each 1.5 hours, merge extractive liquid,, relative density is 1.05～1.15 thick paste when being concentrated into 80 ℃, adds ethanol and makes that to contain the alcohol amount be 50%, and cold preservation is spent the night, and filters, filtrate recycling ethanol, drying under reduced pressure gets Herba Erigerontis extract; Get Radix Notoginseng, be ground into coarse powder, add 10 times of volume 60% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 3 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin, with 4 times of resinite hydrops and 3 times of resin volume 15% alcohol flushing impurity, use 60% alcohol desorption of 4 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 1.5 hours, merge extractive liquid, filtered, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 6 times of resinite hydrops and 2 times of resin volume 12% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 2 times, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract H, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Above-mentioned three kinds of extracts are mixed evenly, be ground into fine powder, add starch, magnesium stearate is an amount of, mixing is used 65% alcohol granulation, and drying is encapsulated, promptly gets capsule.
100 parts of 1 portion of Radix Notoginseng of embodiment 10 parts of Radix Astragali extracts of 9 Herba Erigerontiss (containing polysaccharide)
Get Herba Erigerontis, add 80 ℃ of warm macerating of 10 times of volume water and extract 3 times, each 1 hour, merge extractive liquid,, relative density is 1.05～1.15 thick paste when being concentrated into 80 ℃, adding 20% sulfuric acid solution adjustment pH value is 2～3, stirs, and adds the equal-volume ethyl acetate extraction 4 times, isolate ethyl acetate layer, reclaim solvent, concentrate, drying under reduced pressure gets Herba Erigerontis extract; Get Radix Notoginseng, be ground into coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 85% ethanol, flood after 48 hours, carry out percolation with the speed of per minute 12ml, collect percolate, percolate filters through activated carbon decolorizing, reclaim ethanol and be concentrated to the thick paste shape, behind the aqueous precipitation, ether defatting, degreaser is crossed pretreatment good resin column absorption and eluting, collect eluent, reclaim solvent, be concentrated into the thick paste shape, drying gets Radix Notoginseng extract; With Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract (containing polysaccharide) mix homogeneously, the soybean oil of 1 times of medicated powder weight of adding and 2% Cera Flava are an amount of, the dropping preparation method pill, and compacting promptly getting soft capsule.After testing, the polysaccharide component content in the preparation is 54% of adjuvant amount in the deduction preparation and the total solid after the water quantities.
1 part of 100 parts of Radix Notoginseng extract of 10 parts of Radixs Astragali of embodiment 10 Herba Erigerontis extracts
Get the Radix Astragali, adding 12 times of water gagings decocts 3 times, each 2.5 hours, merge extractive liquid, filtered, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 5 times of resinite hydrops and 2 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 2 times, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Radix Astragali extract, Herba Erigerontis extract and Radix Astragali extract are ground into fine powder, add low substituted carboxymethyl sodium cellulosate and hydroxypropyl starch (3: 2) in right amount, add an amount of lemon yellow again, tabletting promptly gets oral cavity disintegration tablet.After testing, the flavones ingredient content in the preparation is 12% of adjuvant amount in the deduction preparation and the total solid after the water quantities, and saponin component content is 23% of adjuvant amount in the deduction preparation and the total solid after the water quantities.
2 parts of 20 parts of Radix Notoginseng extracts of 20 parts of Radixs Astragali of embodiment 11 Herba Erigerontiss
Get the Radix Astragali, be ground into the coarse powder of 10 mesh sieves, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, filter, measuring relative density when filtrate is concentrated into 60 ℃ is 1.05～1.15, adds the water dissolution of 2 times of medical material bulking values, filters, filtrate is crossed the AB-8 macroporous adsorptive resins, with 5 times of resinite hydrops and 3 times of resin volume 15% alcohol flushing resin posts, use 50% alcohol desorption then, collect 50% ethanolysis imbibition, reclaim ethanol and get thick paste, promptly get Radix Astragali extract; Get Herba Erigerontis, add 8 times of volume decoctings and boil each 1.5 hours 3 times, merge extractive liquid,, relative density is 1.05～1.15 thick paste when being concentrated into 80 ℃, adds 20% sodium carbonate liquor stirring and dissolving, filter, filtrate adds 20% sulfuric acid solution, and regulating pH value is 2～3, stir, cold preservation 24 hours is filtered, the precipitation water wash to pH value be 5～6, drying under reduced pressure promptly gets Herba Erigerontis extract; With Herba Erigerontis extract, Radix Astragali extract and Radix Notoginseng extract mix homogeneously, to pulverize, adding starch is an amount of, and mixing is granulated, drying, tabletting, coating promptly gets tablet.
50 parts of 1 portion of Radix Notoginseng of 500 parts of Radixs Astragali of embodiment 12 Herba Erigerontis extracts
Get the Radix Astragali, adding 10 times of water gagings decocts 3 times, each 1 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins, earlier with 6 times of resinite hydrops and 3 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed AB-8 type macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; Get Radix Notoginseng, be ground into coarse powder, the decocting that adds 10 times of amounts, 5 times of amounts boils twice and (decocts 60min for the first time, decoct 30min for the second time, keep little boiling), after the cooling, centrifugalize, merge supernatant, be concentrated into 1 times of amount volume, add 10%, 30%, 50%, 70% Different concentrations of alcohol, stir, leave standstill, treat that precipitation fully after, centrifugal, get supernatant, concentrate, the dry Radix Notoginseng extract that gets; With Radix Astragali extract, Radix Notoginseng extract and Herba Erigerontis extract mix homogeneously, add an amount of mixing of sodium carboxymethyl cellulose and crospolyvinylpyrrolidone (1: 2), add stevioside granulation, granulate, tabletting promptly gets dispersible tablet.
2 parts of 5 parts of Radix Notoginseng extracts of embodiment 10 parts of Radix Astragali extracts of 13 Herba Erigerontis extracts (containing polysaccharide)
Get Herba Erigerontis extract, Radix Astragali extract and Radix Notoginseng extract add appropriate amount of starch and dextrin, the spheronization pill, and the bag active carbon promptly gets pellet.
2 parts of 1 part of Radix Notoginseng extracts of embodiment 1 part of Radix Astragali extract of 14 Herba Erigerontis extracts (containing polysaccharide)
Get Herba Erigerontis extract, Radix Astragali extract (containing polysaccharide) and Radix Notoginseng extract and mix, add suitable adjuvant system soft material, drying is ground into fine powder, adds stevioside and starch is an amount of, mixing, and granulation, drying promptly gets granule.
1 part of 2 parts of Radix Notoginseng total arasaponins of 2 parts of Radix Astragali effective sites of embodiment 15 Herba Erigerontis total flavones (containing saponin and polysaccharide)
Herba Erigerontis total flavones, Radix Astragali effective site and Radix Notoginseng total arasaponins are merged, add an amount of water for injection dissolving, by volume add 1.0% needle-use activated carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 6.0～8.0 boils, spend the night coarse filtration, fine straining 4 ℃ of cold preservations; Injection mannitol is added the injection water be mixed with 150mg/ml solution, with above-mentioned medicinal liquid mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; And in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, be warming up to 30 ℃, keep 2h, promptly get the aseptic block of lyophilizing.After testing, the content of saponin component accounts in the preparation 45% of total solid after deduction adjuvant amount and the water quantities in the preparation; Flavones ingredient content accounts in the preparation 28% of total solid after deduction adjuvant amount and the water quantities.

Claims (15)

1, a kind of compound Chinese medicinal preparation for the treatment of cardiovascular and cerebrovascular disease is characterized in that: calculate according to composition by weight, it is made for 1～100 part by 10～500 parts of Herba Erigerontiss, 1～100 part of the Radix Astragali and Radix Notoginseng; Or add suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
2, according to the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: calculate according to composition by weight, it is made for 5～50 parts with Radix Notoginseng by 1～50 part of 20～200 parts of Herba Erigerontis, the Radix Astragali, or is added suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
3, according to the compound Chinese medicinal preparation of claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to composition by weight, it is made for 10～50 parts with Radix Notoginseng by 5～50 parts of 20～100 parts of Herba Erigerontiss, the Radix Astragali, or is added suitable adjuvant and be made through extracting the extract that obtains after refining by corresponding weight portion medical material.
4, according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease of claim 1-3, it is characterized in that: preparation of the present invention is injection and oral formulations; Injection comprises: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method; Oral formulations comprises: all acceptable dosage forms on tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, soft extract, extractum, gel, membrane and other pharmaceuticss.
5, according to the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that: preparation of the present invention is the injection that is directly used in drug administration by injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and aseptic block, drop pill, capsule, soft capsule, oral cavity disintegration tablet, tablet, capsule, dispersible tablet and the granule that makes with freeze-drying or spray drying method.
6, according to the compound Chinese medicinal preparation of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: contain saponin component, polysaccharide composition and flavones ingredient in the preparation, calculate according to percentage by weight, wherein the content of saponin component is not less than 1% of the total solid after the deduction adjuvant amount and water quantities in the preparation; The content of flavones ingredient is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities, the content of polysaccharide composition is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities, and all the content sums that can survey composition of the saponin component in the injection, polysaccharide composition, flavones ingredient and other account for that the total solid after the deduction adjuvant amount and water quantities is not less than 25% in the preparation.
7, according to the compound Chinese medicinal preparation of claim 1,2 or 3 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: Herba Erigerontis extract is a flavones ingredient content greater than the effective site of 80% Herba Erigerontis total flavones, Radix Notoginseng extract is a saponin component content greater than the effective site of 70% Radix Notoginseng total arasaponins, and Radix Astragali extract is saponins, polysaccharide component content sum greater than 80% effective site.
8, according to the preparation method of the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease of claim 1～7, it is characterized in that: get Herba Erigerontis, Radix Notoginseng, the Radix Astragali, add water or ethanol extraction respectively, the extracting solution concentrate drying gets the medical material crude extract, one or more that further adopt that alcohol deposition method, water returns molten method, organic solvent extractionprocess, flocculent precipitation, column chromatography unite use carry out suitably refining, get the medical material extract, three medical material crude extracts or extract are merged, add adjuvant and be prepared into different preparations with diverse ways.
9, according to the preparation method of the compound Chinese medicinal preparation of the described treatment cardiovascular and cerebrovascular disease of claim 8, it is characterized in that: get Herba Erigerontis, pseudo-ginseng, add ethanol extraction respectively, extracting solution concentrates, refining through organic solvent extraction or macroporous adsorbent resin, concentrate drying gets Herba Erigerontis extract, Radix Notoginseng extract; Get the Radix Astragali, decoct with water, filter, filtrate is crossed macroporous adsorptive resins, elder generation's water and low-concentration ethanol eluting, sample effluent and eluent in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds the ethanol precipitate with ethanol, filter, collecting precipitation gets Radix Astragali extract I; The reuse high concentration ethanol is crossed macroporous adsorptive resins and is carried out desorbing, collects stripping liquid, and decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, and Radix Astragali extract I and Radix Astragali extract II are merged, the dry Radix Astragali extract that gets; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are mixed back adding adjuvant make different preparations.
10, preparation method according to the compound Chinese medicinal preparation of claim 8 or 9 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get the Herba Erigerontis medical material, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water heating for dissolving that adds 1～5 times of medical material volume, filter, filtrate is crossed AB-8 type macroporous adsorbent resin with the speed of 0.3～1.0ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, add 4～12 times of amount 40～85% alcohol reflux 1～5 time, each 0.5～3.5h, merge extractive liquid,, filter, filtrate concentrates gained extractum and adds 1～4 times of water dissolution, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.2～1.0ml/g medical material .min, use 1～10 times of resinite hydrops and 1～6 times of resin volume 5～15% alcohol flushing impurity successively, use 30～70% alcohol desorptions of 1～7 times of resin volume then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 6～15 times of water gagings decocts 1～5 time, each 0.5～3.5 hour, merge extractive liquid,, filter, filtrate is crossed AB-8 type macroporous adsorptive resins, first with 2～8 times of resinite hydrops and 1～5 times of resin volume 5～20% ethanol elution, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, add the ethanol precipitate with ethanol 1～3 time, filter collecting precipitation, the dry Radix Astragali extract I that gets, 3～8 times of resin volume 40～80% ethanol of reuse are crossed macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged the dry Radix Astragali extract that gets; The said extracted thing is merged, add adjuvant and make different preparations.
11, preparation method according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease of claim 8～10, it is characterized in that: the Injectable sterile block is preparation like this: get the Herba Erigerontis medical material, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water heating for dissolving that adds 3 times of medical material volumes, filter, filtrate is crossed AB-8 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 5 times of resinite hydrops and 4 times of resin volume 10% alcohol flushing impurity successively, use 50% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract; Get Radix Notoginseng, be ground into coarse powder, with 70% alcohol reflux 2 times, add for the first time 6 times of amounts, refluxed 2 hours, and added 5 times of amounts for the second time, refluxed 1.5 hours, merge extractive liquid,, filter, filtrate concentrates gained extractum and adds 2 times of water dissolutioies, filters, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.6ml/g medical material .min, use 8 times of resinite hydrops and 3 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 6 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, Radix Notoginseng extract; Get the Radix Astragali, adding 10 times of water gagings decocts 3 times, each 1 hour, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins, earlier with 6 times of resinite hydrops and 3 times of resin volume 10% ethanol elutions, sample effluent and water lotion in the collection, being evaporated to 60 ℃ of relative densities is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 80%, filter collecting precipitation, the dry Radix Astragali extract I that gets, 5 times of resin volume 60% ethanol of reuse are crossed AB-8 type macroporous adsorptive resins and are carried out desorbing, collect stripping liquid, decompression recycling ethanol to 60 ℃ relative density is 1.05～1.15, gets Radix Astragali extract II, Radix Astragali extract I and Radix Astragali extract II are merged, and vacuum drying gets Radix Astragali extract; Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract are merged, add an amount of water for injection dissolving, by volume add 1.0% needle-use activated carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 6.0～8.0 boils, spend the night coarse filtration, fine straining 4 ℃ of cold preservations; Injection mannitol is added the injection water be mixed with 150mg/ml solution, with above-mentioned medicinal liquid mixing, coarse filtration, fine straining, packing, temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; And in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, be warming up to 30 ℃, keep 2h, promptly.
12, according to the preparation method of the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 8～11, it is characterized in that: this preparation technology has kept the polysaccharide composition in the Milkvetch Root targetedly.
13, according to claim 1～3, the preparation method of the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in 8～10, it is characterized in that: the adjuvant that is adopted in the preparation comprises mannitol, galactose, glycine, glucose, sodium chloride, dextran, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, poloxamer, dextrin, starch, low substituted carboxymethyl sodium cellulosate, hydroxypropyl starch, sodium carboxymethyl cellulose, the crospolyvinylpyrrolidone microcrystalline Cellulose, the Radix Glycyrrhizae charcoal, active carbon, stevioside, vegetable oil, soybean oil, sorbitol, Pulvis Talci, Cera Flava, modified starch, magnesium stearate, dimethicone, in the liquid paraffin one or more.
14, according to the compound Chinese medicinal preparation of any described treatment cardiovascular and cerebrovascular disease in claim 1～3 and 7～11, it is characterized in that: Herba Erigerontis extract, Radix Notoginseng extract and Radix Astragali extract can also be commercially available or adopt other preparation methoies to prepare.
15, as the application of the described Chinese medicine composition of claim 1～3 in disease medicaments such as preparation treatment ischemia apoplexy, apoplexy sequela, senile dementia, angina pectoris, cardiac insufficiency, viral myocarditis.
CN 200510107810 2005-09-30 2005-09-30 Chinese-medicinal preparation and its making method Pending CN1939389A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200510107810 CN1939389A (en) 2005-09-30 2005-09-30 Chinese-medicinal preparation and its making method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200510107810 CN1939389A (en) 2005-09-30 2005-09-30 Chinese-medicinal preparation and its making method

Publications (1)

Publication Number Publication Date
CN1939389A true CN1939389A (en) 2007-04-04

Family

ID=37958091

Family Applications (1)

Application Number Title Priority Date Filing Date
CN 200510107810 Pending CN1939389A (en) 2005-09-30 2005-09-30 Chinese-medicinal preparation and its making method

Country Status (1)

Country Link
CN (1) CN1939389A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104435080A (en) * 2014-11-10 2015-03-25 成都果睿医药科技有限公司 Ginseng-containing pharmaceutical composition for treating cardiovascular and cerebrovascular diseases

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104435080A (en) * 2014-11-10 2015-03-25 成都果睿医药科技有限公司 Ginseng-containing pharmaceutical composition for treating cardiovascular and cerebrovascular diseases

Similar Documents

Publication Publication Date Title
CN101036705A (en) Buyang huanwu gantong medicine for preventing and curing cardiovascular or cerebrovascular disease and the agent and the method for preparing the same
CN1788758A (en) Use of traditional Chinese medicine garden burnet and its extract in preparing drug for raising red cell and blood hemoglobin
CN1939390A (en) Medicinal composition and its making method
CN1853688A (en) Chinese medicinal preparation for treating heart cerebrovascular disease and ischemic apoplexia and making method thereof
CN1939389A (en) Chinese-medicinal preparation and its making method
CN1254252C (en) Medicine for treating ischemic angiocardiopathy and cerebrovascular disease and its preparation method
CN1272026C (en) Medicinal composition for treating cardiocerebral vasculr disease and its preparing method
CN1935183A (en) Chinese medicine compound preparation and its preparing method
CN1899385A (en) Process for preparing Chinese medicine compound injection for treating chronic renal failure and use
CN1557403A (en) Medicine for treating angiocardiopathy and cerebrovascular disease and its preparing method
CN1634241A (en) Compound formulation of notoginseng for treating cardiovascular and cerebrovascular diseases and its preparing process
CN1634246A (en) Compound formulation of breviscapine and asarum herb for treating cardiovascular and cerebrovascular diseases and its preparing process
CN104825784A (en) Traditional Chinese medicine composition with anti-gastric cancer activity and preparation method and application of traditional Chinese medicine composition
CN1939373A (en) Chinese-medicine injection preparation and its making method
CN1931248A (en) Medicine composition and its prepn process
CN1919301A (en) Traditional medicine Injectio and its preparing method
CN1915273A (en) Medicinal composition, preparation method and quality control method
CN1915250A (en) Medicinal composition, preparation method and quality control method
CN1915316A (en) Medicinal composition, preparation method and quality control method
CN1919305A (en) Traditional medicine Injectio and its preparing method
CN1602919A (en) Chinese medicinal preparation for treating cardiovascular and cerebrovascular diseases and its preparing process
CN1919306A (en) Traditional medicine Injectio and its preparing method
CN1919302A (en) Traditional medicine Injectio and its preparing method
CN1911368A (en) Injection contg. traditional Chinese medicine, and its prepn. method
CN1915317A (en) Medicinal composition, preparation method and quality control method

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication