CN1704113A - Chinese traditional medicinal preparation containing red sange root and safflower for treating cardiovascular and cerebrovascular diseases and preparing process thereof - Google Patents
Chinese traditional medicinal preparation containing red sange root and safflower for treating cardiovascular and cerebrovascular diseases and preparing process thereof Download PDFInfo
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- CN1704113A CN1704113A CN 200510009265 CN200510009265A CN1704113A CN 1704113 A CN1704113 A CN 1704113A CN 200510009265 CN200510009265 CN 200510009265 CN 200510009265 A CN200510009265 A CN 200510009265A CN 1704113 A CN1704113 A CN 1704113A
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a Chinese traditional medicinal preparation containing red sange root and safflower for treating cardiovascular and cerebrovascular diseases and a preparing process thereof, the preparation is prepared as an injection liquid, a freeze-dried powder preparation or a general powder injection preparation, etc.; compared with a current technic, by experiment observation, the medicine prepared by the invention has effects of activate blood circulation and stasis removing, tongmai shuluo, increasing coronary artery vessel blood flux, experiment sesults show that the medicine can be used for treating diseases of chest blocking, apoplexy, coronary heart disease, miocardial infarction and blood stasis type cor pulmonale and the like due to blocked blood stasis.
Description
Technical field: the present invention relates to Chinese medicine preparation containing red sange root and safflower for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belong to the field of medical technology.
Background technology: along with the development of human civilization, the raising of people's living standard, cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris have become human second largest killer.Exploitation heart disease class medicine has become instant challenge of pharmacy industry.Same veriety Main Ingredients and Appearance in the market mostly is Radix Salviae Miltiorrhizae, and the general color and luster of its finished product is darker, and transportation and storage are inconvenient, and oxidation stain easily takes place, and pH value also can change thereupon, and feasible effect duration and the storage life of containing the injection products of Radix Salviae Miltiorrhizae is restricted.CN 1272500A discloses Flos Carthami total flavochromes and has had antithrombotic formation, and anticoagulant resists myocardial ischemia, and can treat or prevent cardiovascular and cerebrovascular disease; CN 1247855A discloses the preparation method and the purposes of salvianolate, can be used for preparing cardiovascular and cerebrovascular medicine.But do not see the Chinese medicine preparation of the treatment cardiovascular and cerebrovascular vessel of forming by the Radix Salviae Miltiorrhizae and Flos Carthami as yet.The applicant had once applied for to Patent Office of the People's Republic of China that name was called: " a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof ", number of patent application are 02153312.1 patent of invention, and the applicant finds that the water extract combination of the water extract combination of Radix Salviae Miltiorrhizae ethanol extract and Flos Carthami or Radix Salviae Miltiorrhizae ethanol extract and Radix Salviae Miltiorrhizae and Flos Carthami is had synergy to the treatment cardiovascular and cerebrovascular vessel; But it is long find to adopt the effective ingredient Carthamus yellow stability of the main effective ingredient salvianolic acid of Radix Salviae Miltiorrhizae and Flos Carthami to stablize relatively poor, traditional technology extraction time in research process in high temperature and aqueous solution, is unfavorable for the quality of product; And Radix Salviae Miltiorrhizae is rich in tannin, the acid ingredient of its effective ingredient original pair tea phenol aldehyde and some band phenolic hydroxyl groups is similar to the chemical constituent of tannin again, physicochemical property is approaching, so the effective ingredient that desire to remove tannin in the ejection preparation production technology, keeps Radix Salviae Miltiorrhizae is very difficult, tannin not only can cause the injection clarity poor, the more important thing is that tannin becomes insoluble tannalbin to cause the local absorption difficulty with protein bound in the body tissue, brings great side effect.
Summary of the invention: the objective of the invention is to: a kind of Chinese medicine preparation containing red sange root and safflower of cardiovascular and cerebrovascular disease and other preparation method for the treatment of is provided, this medicine that utilizes the inventor to provide, can more effectively treat cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, the prescription of this preparation is simple simultaneously, effect is obvious, the quality of production is beneficial to control, its dosage form is many, be convenient to the doctor and the patient selects for use, has satisfied the instructions for use of different crowd, varying environment; The invention provides their preparation method in addition, solved the question and answer that the effective ingredient bioavailability is relatively poor, side effect is big.The present invention constitutes like this: calculate with composition by weight, it is injection, freeze-dried powder preparation or the common powder injection formulation of being made by the extract of Radix Salviae Miltiorrhizae 1-6 part, Flos Carthami 1-3 part or corresponding weight.
Say accurately: described Chinese medicine preparation containing red sange root and safflower calculates with composition by weight, and it is injection, freeze-dried powder preparation or the common powder injection formulation of being made by the extract of 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami or corresponding weight.This Chinese medicine preparation containing red sange root and safflower can also be capsule, soft capsule, microcapsule, granule, pill, micropill, concentrated pill, drop pill, slow releasing preparation, controlled release preparation, quick releasing formulation, targeting preparation, oral liquid, syrup, powder or mixture.
The preparation method of this Chinese medicine preparation containing red sange root and safflower is: get Radix Salviae Miltiorrhizae 1-6 part, Flos Carthami 1-3 part, pulverize, decoct with water 1～3 time again, add 3～12 times of water gagings at every turn, each 0.5～2 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, with 50～90% ethanol elutions, collect eluent, reclaim ethanol, concentrate, refabrication becomes different preparations.Pulverizing of the present invention is a micronizing, is about to the Radix Salviae Miltiorrhizae and Flos Carthami and carries out micronizing 15-30min with micronizing equipment.
Concrete preparation method is: get Radix Salviae Miltiorrhizae 1-6 part, Flos Carthami 1-3 part, micronizing decocts with water 1～3 time again, add 3～12 times of water gagings at every turn, each 0.5～2 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, with 50～90% ethanol elutions, collect eluent, reclaim ethanol, concentrate, refabrication becomes different preparations.
Say accurately: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami, feed intake, micronizing under-10 ℃ of low temperature with coarse powder, the pulverizing time is 20min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is used 10%NaOH adjust pH 5.5 ~ 7.5, boil, standing over night, fine straining, filtrate adds the injection water; 667g mannitol is mixed with 20% solution,, filters with the filtrate mixing, packing, lyophilization promptly gets lyophilized injectable powder.
The present invention is all right: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 20min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is boiled with 10%Na0H adjust pH 5.5 ~ 7.5, standing over night, fine straining, filtrate add injection water, spray drying, packing promptly gets injectable powder.
The present invention also can: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 20min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is boiled with 10%NaOH adjust pH 5.5 ~ 7.5, standing over night, fine straining, filtrate add injection water, packing, sterilization promptly gets injection.
The present invention proportionally gets Radix Salviae Miltiorrhizae, Flos Carthami, pulverizes, and decocts with water 0.5 hour again, adds 3 times of water gagings at every turn, filters, filtrate concentrates, and crosses polyamide column, and 50% ethanol elution is collected eluent, reclaims ethanol, concentrate, drying, extrude-spheronization prepares micropill, promptly gets pellet.
Proportionally get Radix Salviae Miltiorrhizae, Flos Carthami, pulverize, decoct with water again 3 times, add 12 times of water gagings at every turn, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 90% ethanol elution is collected eluent, reclaims ethanol, concentrate, splash into the ratio that adopts PEG6000 and PEG4000 and be in 5: 2 the mixed-matrix, the water dropper model adopts No. 1 water dropper, coolant temperature is 20～22 ℃, promptly gets drop pill.
Compared with prior art: the medicine of the present invention's preparation has blood circulation promoting and blood stasis dispelling, TONGMAI SHULUO, the effect of coronary blood flow increasing through laboratory observation.Experimental result shows the thoracic obstruction, the apoplexy that can be used for due to the blood stasis impatency, treatment of diseases such as coronary heart disease, myocardial infarction and blood stasis type pulmonary heart disease; Among the present invention, the applicant adopts superfine communication technique, thereby the effective ingredient salvianolic acid, the Carthamus yellow that make poor stability also can extract fully at short notice, reduced loss of active ingredients, and discover that by experiment best micronizing technology is under the low temperature (10 ℃), feed intake with coarse powder, pulverize 20min; Equipment used in this application is commercially available BFM-6 Baily super micron mill.Because the less stable of effective ingredient is if not strict control process conditions can cause the finished product curative effect not rise counter falling.In addition owing to Radix Salviae Miltiorrhizae, Flos Carthami contain impurity such as a large amount of tannins, protein, not only can influence stability of formulation, and can bring certain trouble to the use of medicine, common process adopts Amberlyst process to come effective ingredient is made with extra care and separated more, but the applicant adopts the polyamide column method, because the applicant finds: effective ingredient mostly is water soluble ingredient in the DANHONG prescription of the present invention, polyamide column is to the separation of water soluble ingredient, forming hydrogen bond force, and the ability that forms hydrogen bond to remove the effect of tannin more by force obvious; And macroporous resin column is to rely on macroporous resin and the Van der Waals force that is adsorbed between the molecule is separated, and removes the weak effect of tannin, and organic residual problem, and there is hidden danger in safety.Find under study for action, should removing the tannin that has side effects in the extract refining technology, to keep effective ingredient again very difficult, study by experiment, grope, the polyamide column that the applicant adopts is to the good separation of this product effective ingredient, and the effect of particularly removing tannin when 60% ethanol preferably and the loss of active ingredients rate is low.
In order to confirm that further the medicine that the present invention produces has reliable curative effect, the applicant tests:
Experimental example 1: pharmacological research
(1) to the influence of rat brain vascular permeability
Get 70 of healthy male Wistar rats, be divided into 5 groups by different level at random, 10 every group: 1. sham operated rats by body weight; 2. normal saline matched group; 3. troxerutin matched group (0.04g/kg); 4. DANHONG SHUIZHEN common process preparation (7.2g crude drug/kg); 5. the liquid drugs injection of prepared of the present invention (7.2g crude drug/kg); 2.-5. the organize each rat intraperitoneal injection of saline 7.2ml/kg, troxerutin 7.2ml/kg, the DANHONG SHUIZHEN of 1g/ml common process preparation, the liquid drugs injection 7.2ml/kg of prepared of the present invention respectively, every day 1 time, for three days on end.Behind the last administration 1hr, organize each Mus lumbar injection pentobarbital sodium solution anesthesia, face upward the position and be fixed on the operating-table to each.The cervical region median incision separates bilateral carotid.Intravenous injection 0.5% azovan blue solution 10ml/kg, behind the 5min, 2.-5. 1. organize each not ligation of Mus, organizes each Mus ligation bilateral common carotid arteries.Put to death behind the 3hr, broken end is opened cranium and is got brain, and analytical balance is weighed.Each brain is soaked in the 5ml Methanamide incubation 72hr in 45 ℃ of calorstats.Get incubation liquid, measure trap at the 620nm place, calculate azovan blue content (μ g/g brain is heavy) in each brain, the results are shown in Table 1 according to standard curve with 722 type spectrophotometers
Table 1 DANHONG FENZHEN is to the influence of rat brain vascular permeability
| Group | Number of animals | Dosage (g/kg) | Azovan blue content (μ g/g) |
| The conventional DANHONG SHUIZHEN of sham operated rats normal saline group troxerutin group DANHONG SHUIZHEN of the present invention | ??10 ??10 ??10 ??10 ? ??10 ? | ? ? ????0.04 ????7.2 ? ????7.2 ? | ? ? ????2.99±0.82 ????4.55±1.14 ? ????3.09±0.86 ? |
(2) to the influence of cerebral tissue blood flow after the pituitrin effect
Getting Wistar is 50 of rats, body weight 180-200g, and male and female half and half are divided into 5 groups at random.The intraperitoneal anesthesia of pentobarbital sodium solution, lie on the back on operating-table, fixing, open cranium, the BE-ND needle electrode of anticipating is inserted about 2mm in the cerebral tissue with 30 ° of oblique angles, fixing, near in addition dish-shaped Ag-Aga reference electrode being placed, two electrodes are connected on the RBF-II electrolytic tissue blood flow amount meter through electrode output casket, stablize 20min after, control group administered physiological saline 5ml/kg, experimental group (are equivalent to 5g crude drug/kg) for respectively preparation 5ml/kg.Ear vein injects pituitrin 0.1u/kg respectively, and the method for using behind the 10min is measured the cerebral tissue flow, the results are shown in Table 2.
Table 2 DANHONG FENZHEN to the effect of rat pituitary pituitrin after the influence of cerebral tissue blood flow
| Group | Number of animals | Dosage | Blood flow (ml/min/10g) |
| The physiological saline control group is the DANHONG SHUIZHEN DANHONG SHUIZHEN of the present invention DANHONG FENZHEN of the present invention of the DANHONG SHUIZHEN employing macroreticular resin preparation of ultramicro grinding preparation not | ??10 ??10 ? ? ? ??10 ??10 | ??5.0ml/kg ??5.0g/kg ? ? ? ??2.5g/kg ??5.0g/kg | ????55.4±9.6 ????68.3±11.4 ? ????69.1±10.5 ? ????77.9±11.2 ????76.5±10.7 |
(3) to the protective effect of experimental brain tissue of rat ischemia
Get 60 of healthy male Wistar rats, be divided into 4 groups at random, every group 10,2-6 organizes dosage 7.2g crude drug/kg, the heavy dose of 14.4g crude drug/kg of DANHONG FENZHEN in each rat difference intraperitoneal injection of saline 7.2ml/kg, the low dose of 3.6g crude drug/kg of DANHONG FENZHEN, the DANHONG FENZHEN, every day 1 time, for three days on end.Behind the last administration 1hr, organize each Mus anesthesia to each, the cervical region median incision is after the 1st group of each Mus separates bilateral carotid 3hr, after 2-6 organizes each Mus separation and ligation bilateral carotid 3hr, put to death, broken end is opened cranium and is got brain, and analytical balance claims that wet brain is heavy, roasting to constant weight in 110 ℃ of baking boxs then, analytical balance is weighed.The result shows that behind healthy rat ligation bilateral common carotid arteries, obvious edema appears in cerebral tissue, shows as that wet brain representation work raises (P＜0.01), cerebral index increases, brain water content significantly increases (P＜0.01); Large, medium and small each dosage of DANHONG ZHUSHEYE and powder pin all can resist the cerebral tissue edema phenomenon that causes because of cerebral ischemia; wherein heavy dose can make wet brain representation work decline (P＜0.05); dosage big or middle can make brain water content significantly descend (P＜0.05), shows that DANHONG FENZHEN has protective effect to rat cerebral ischemia.
(4) to the thrombotic influence of rats in vitro
Getting Wistar is 40 of rats, male and female half and half, and body weight 200-250g is divided into 4 groups at random, the tail vein injection administration, blank group is given normal saline 8mi/kg/d; Matched group is to the DANHONG SHUIZHEN 8ml/mg/d of common process preparation; Experimental group is given DANHONG FENZHEN 4,8ml/kg/d respectively, totally 4 days, 30min after the last administration adopts fasting blood 1.8ml from ventral aorta, injects at once in the silicon rubber loop, be installed on the extracorporeal thrombosis forming device, with 17rpm running 15min, remove the weight in wet base that claims thrombosis behind the unnecessary blood, put 30min in 75 ℃ of drying baker again, claim its dry weight, the results are shown in Table 3.
The influence that table 3 DANHONG FENZHEN forms the rat external thrombus
| Group | Number of animals | Dosage ml/kg | Wet weight of thrombus (mg) | Suppression ratio P (%) | Thrombosis dry weight (mg) | Suppression ratio P (%) |
| Blank group matched group is low dose of heavy dose of | ?10 ?10 ?10 ? ?10 ? ? | ?8 ?4 ? ?8 ? ? | ?126.744±19.21 ?99.17±14.43 ?105.63±12.09 ? ?87.09±14.18 ? ? | ??21.75????＜ ??0.01 ??16.66????＜ ??0.01 ? ??31.28????＜ ??0.01 | ?48.46±12.74 ?29.09±7.36 ?34.33±3.89 ? ?25.93±4.09 ? ? | ?39.97????＜ ?0.01 ?29.16????＜ ?0.01 ? ?46.49????＜ ?0.01 |
Conclusion: the vermilion injection of the present invention's preparation has and significantly has blood vessel dilating, increases effects such as cerebral tissue blood flow, the outer thrombosis of antibody.
Experimental example 2: the research of preparation process
(1) research of medical material pre-treating technology
Superfine communication technique can make most cell wall breakinges, intracellular effective ingredient directly is exposed in the solvent, thereby makes the stripping of effective ingredient and onset more rapidly, fully.The main effective ingredient salvianolic acid of Radix Salviae Miltiorrhizae and the effective ingredient Carthamus yellow instability of Flos Carthami.So the applicant intends adopting superfine communication technique that Radix Salviae Miltiorrhizae and flos carthami in the DANHONG prescription are handled, thereby shortens extraction time.
Find that in trial test pulverizing time, pulverizing temperature and feed fineness are the key factors of the last grinding particle size of influence.So the applicant studies micronizing technology respectively at above three factors.
1. administration fineness is to the influence of grinding particle size
Radix Salviae Miltiorrhizae, the coarse pulverization of Flos Carthami difference 1 time are taken out a part of material with 80 mesh sieve branches, can not screened material be＜80 order coarse powder, and another part is without screening, as coarse powder.The result: two flavor medicinal material coarse powder than its＜the feed intake order number of gained medicated powder of 80 order coarse powder is high.
The administration fineness is to the influence of grinding particle size (Radix Salviae Miltiorrhizae)
Administration fineness granularity cumulative distribution (%)
＜100 orders 100～200 orders 200～300 orders＞300 orders
＜80 order coarse powder 29.62 35.14 27.52 7.72
Radix Salviae Miltiorrhizae coarse powder 8.54 32.42 42.93 16.11
The administration fineness is to the influence of grinding particle size (Flos Carthami)
Administration fineness granularity cumulative distribution (%)
＜100 orders 100～200 orders 200～300 orders＞300 orders
＜80 order coarse powder 31.51 34.62 29.38 4.49
Flos Carthami coarse powder 9.48 31.75 43.56 15.21
2. pulverize the influence of time to grinding particle size
Get Radix Salviae Miltiorrhizae coarse powder and Flos Carthami coarse powder, at room temperature pulverize respectively with pulverizing mill, every 10min sampling, granularity is measured in screening, and it is broken that sample drops into pulverizing mill relaying continued powder again, repetitive operation 3 times.The result: two kinds of medical material situations are similar, and then granularity is too big to pulverize 10min, pulverize 20min after granularity satisfied, prolong the pulverizing time more then to fail to make and pulverize the order number and improve.
The pulverizing time is to the influence of grinding particle size (Radix Salviae Miltiorrhizae)
Pulverize time granularity cumulative distribution (%)
Min＜100 orders, 100～200 orders, 200～300 orders＞300 orders
10?????????29.61?????35.27?????????28.04?????????7.08
20?????????22.74?????32.35?????????29.17?????????15.74
30?????????22.39?????31.83?????????29.86?????????15.92
The pulverizing time is to the influence of grinding particle size (Flos Carthami)
Pulverize time granularity cumulative distribution (%)
Min＜100 orders, 100～200 orders, 200～300 orders＞300 orders
10??????????31.49????34.63?????????29.15???????4.73
20??????????25.26????31.72?????????32.57???????10.45
30??????????24.97????31.48?????????32.92???????10.63
3. pulverize the influence of temperature to grinding particle size
Get Radix Salviae Miltiorrhizae coarse powder and Flos Carthami coarse powder, pulverize 20min at room temperature (25 ℃) and low temperature (10 ℃) respectively, repetitive operation 3 times, the result: two kinds of medical materials at low temperature (10 ℃) down than under room temperature (25 ℃), pulverizing to such an extent that the order number average of medicated powder increases.
Pulverize the influence of temperature to grinding particle size (Radix Salviae Miltiorrhizae)
Pulverize temperature granularity cumulative distribution (%)
℃＜100 orders, 100～200 orders, 200～300 orders＞300 orders
Room temperature (25 ℃) 29.34 35.32 27.85 7.49
Low temperature (10 ℃) 14.52 27.18 40.86 17.44
Pulverize the influence of temperature to grinding particle size (Flos Carthami)
Pulverize temperature granularity cumulative distribution (%)
℃＜100 orders, 100～200 orders, 200～300 orders＞300 orders
Room temperature (25 ℃) 31.67 34.54 29.21 4.58
Low temperature (10 ℃) 15.86 28.71 38.42 17.01
The result shows that best micronizing technology is under the low temperature (10 ℃), feeds intake with coarse powder, pulverizes 20min.
4. micronizing technology is to the influence of effective ingredient salvianolic acid, Carthamus yellow dissolution
Salvianolic acid is the effective ingredient in the Radix Salviae Miltiorrhizae, has antithrombotic, improves blood circulation, effects such as antioxidation.Carthamus yellow is the aqueous soluble active constituent in the Flos Carthami, and it has and restores menstrual flow and invigorates blood circulation, the microcirculation of stasis-dispelling and pain-killing, improvement local organization, enhances metabolism, treats pharmacological actions such as subcutaneous congested swelling.So the applicant is an object of study with salvianolic acid and Flos Carthami flavochrome, measures its content in following four kinds of extracting solution respectively.
Respectively Radix Salviae Miltiorrhizae coarse powder and Flos Carthami coarse powder (No. 1 extracting solution), Radix Salviae Miltiorrhizae coarse powder and Flos Carthami micropowder (No. 2 extracting solution), Radix Salviae Miltiorrhizae micropowder and Flos Carthami coarse powder (No. 3 extracting solution), Radix Salviae Miltiorrhizae micropowder and Flos Carthami micropowder (No. 4 extracting solution) are pressed the prescription mixed, extract by preparation technology in the standard, compare the content of salvianolic acid and Flos Carthami flavochrome in four kinds of extracting solution.
Micronizing technology is to the influence of effective ingredient salvianolic acid, Carthamus yellow dissolution (%)
Extracting solution Carthamus yellow salvianolic acid
No. 1 64.58 53.24
No. 2 82.49 51.65
No. 3 65.72 79.26
No. 4 81.73 79.58
The result shows, with the Radix Salviae Miltiorrhizae micropowder serve as extract in the extracting solution of object salvianolic acid content will be apparently higher than serving as to extract object with the Radix Salviae Miltiorrhizae coarse powder; With the Flos Carthami micropowder serve as extract in the extracting solution of object carthamus tinctorius yellow color content will be apparently higher than serving as to extract object with the Flos Carthami coarse powder.
(2) research of refining effective ingredients technology
1. the selection of eluent
Because Radix Salviae Miltiorrhizae, Flos Carthami contain impurity such as a large amount of tannins, protein, not only can influence stability of formulation, and can bring certain trouble to the use of medicine.Common process adopts Amberlyst process to come effective ingredient is made with extra care and separated more.But the applicant adopts the polyamide column method, because effective ingredient mostly is water soluble ingredient in the DANHONG prescription, and polyamide column is to the separation of water soluble ingredient, forming hydrogen bond force, and the ability that forms hydrogen bond to remove the effect of tannin more by force obvious; And macroporous resin column is to rely on macroporous resin and the Van der Waals force that is adsorbed between the molecule is separated, and removes the weak effect of tannin and organic residual problem.Find that in trial test the selection of eluent is the key factor that influences effective component yield.So this research has been carried out following test at the selection of eluent.
The investigation that removes the tannin effect is by tannin inspection technique under the version Chinese Pharmacopoeia appendix injection item in 2000.Get injection 1ml, add the normal saline 5ml that contains 1% Ovum Gallus domesticus album of new preparation, place 10min, muddiness or precipitation must not occur.Or get injection 1ml, and add 1 of spirit of vinegar, add 4～5 of gelatin sodium chloride solutions (aqueous solution of gelatin 1%, sodium chloride 10% faces with newly joining) again, muddiness and precipitation must not appear.
With Different concentrations of alcohol liquid eluting, investigate the loss rate of salvianolic acid in the eluent and remove the tannin effect.The result shows the ethanol elution with 60%, and salvianolic acid yield height, to remove the tannin effect best, so the ethanol of selection 60% is eluent.
The eluting concentration screening
10% ethanol, 30% ethanol, 50% ethanol, 60% ethanol, 90% ethanol
Salvianolic acid yield % 18.9 23.5 28.7 40.6 38.2
It is muddy slightly to remove the clarification of tannin effect bulk precipitation bulk precipitation and turbidity
2. the comparison of polyamide column and macroporous resin column elute effect
With effective ingredient in polyamide column, the macroporous resin column method separation and Extraction DANHONG prescription, investigate the yield of salvianolic acid and remove the tannin effect respectively.Result: this good product effect of polyamide column method preparation.
Salvianolic acid yield (%)
1 group of 2 groups of 3 cell mean of method
Macroporous resin column method 64.5 62.7 64.1 63.8
Polyamide column method 75.6 71.8 73.5 73.6
Remove the tannin effect
Method is removed the tannin effect
Macroporous resin column method muddiness
The clarification of polyamide column method
Concrete embodiment:
Embodiment 1: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, and-10 ℃ of low temperature adopt BFM-6 Baily super micron mill to pulverize down, the pulverizing time is 20min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is used 10%NaOH adjust pH 5.5～7.5, boil, standing over night, fine straining, filtrate adds the injection water; 667g mannitol is mixed with 20% solution,, filters with the filtrate mixing, packing, lyophilization promptly gets lyophilized injectable powder, intravenous drip, one time 4 bottles, 1 time on the one.
Embodiment 2: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 15min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is boiled with 10%NaOH adjust pH 5.5～7.5, standing over night, fine straining, filtrate add injection water, spray drying, packing promptly gets injectable powder.
Embodiment 3: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 30min, decocts with water 2 times again, adds 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is boiled with 10%NaOH adjust pH 5.5～7.5, standing over night, fine straining, filtrate add injection water, packing, sterilization promptly gets injection.
Embodiment 4: get 1 part of Radix Salviae Miltiorrhizae, 1 part on Flos Carthami, pulverize, decoct with water 0.5 hour again, add 3 times of water gagings at every turn, filter, filtrate concentrates, and crosses polyamide column, and 50% ethanol elution is collected eluent, reclaims ethanol, concentrate, drying, extrude-spheronization prepares micropill, promptly gets pellet
Embodiment 5: get 6 parts of Radix Salviae Miltiorrhizaes, 3 parts on Flos Carthami, pulverize, decoct with water 3 times again, add 12 times of water gagings at every turn, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 90% ethanol elution is collected eluent, reclaims ethanol, concentrate, splash into the ratio that adopts PEG6000 and PEG4000 and be in 5: 2 the mixed-matrix, the water dropper model adopts No. 1 water dropper, coolant temperature is 20～22 ℃, promptly gets drop pill.
Claims (10)
1. Chinese medicine preparation containing red sange root and safflower for the treatment of cardiovascular and cerebrovascular disease is characterized in that: calculate with composition by weight, it is injection, freeze-dried powder preparation or the common powder injection formulation of being made by the extract of Radix Salviae Miltiorrhizae 1-6 part, Flos Carthami 1-3 part or corresponding weight.
2, according to the Chinese medicine preparation containing red sange root and safflower of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: calculate with composition by weight, it is injection, freeze-dried powder preparation or the common powder injection formulation of being made by the extract of 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami or corresponding weight.
3, according to the Chinese medicine preparation containing red sange root and safflower of claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: described preparation can also be capsule, soft capsule, microcapsule, granule, pill, micropill, concentrated pill, drop pill, slow releasing preparation, controlled release preparation, quick releasing formulation, targeting preparation, oral liquid, syrup, powder or mixture.
4, as the preparation method of the Chinese medicine preparation containing red sange root and safflower of any described treatment cardiovascular and cerebrovascular disease among the claim 1-3, it is characterized in that: get Radix Salviae Miltiorrhizae 1-6 part, Flos Carthami 1-3 part, pulverize, decoct with water again 1～3 time, add 3～12 times of water gagings at every turn, each 0.5～2 hour, merge decoction liquor, filter, filtrate concentrates, cross polyamide column, with 50～90% ethanol elutions, collect eluent, reclaim ethanol, concentrate, refabrication becomes different preparations.
5, according to the preparation method of the Chinese medicine preparation containing red sange root and safflower of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that: described pulverizing is a micronizing, is about to the Radix Salviae Miltiorrhizae and Flos Carthami and carries out micronizing 15-30min with micronizing equipment.
6, preparation method according to the Chinese medicine preparation containing red sange root and safflower of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases is characterized in that: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 20min, decocts with water 2 times again, add 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution is collected eluent, reclaims ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is boiled standing over night with 10%NaOH adjust pH 5.5～7.5, fine straining, filtrate add the injection water; 667g mannitol is mixed with 20% solution,, filters with the filtrate mixing, packing, lyophilization promptly gets lyophilized injectable powder.
7, preparation method according to the Chinese medicine preparation containing red sange root and safflower of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases is characterized in that: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 20min, decocts with water 2 times again, add 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is used 10%NaOH adjust pH 5.5～7.5, boil standing over night, fine straining, filtrate adds the injection water, spray drying, packing promptly gets injectable powder.
8, preparation method according to the Chinese medicine preparation containing red sange root and safflower of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases is characterized in that: get 3 parts of Radix Salviae Miltiorrhizaes, 1 part on Flos Carthami feeds intake with coarse powder, micronizing under-10 ℃ of low temperature, the pulverizing time is 20min, decocts with water 2 times again, add 10 times of water gagings at every turn, each 0.5 hour, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 60% ethanol elution, collect eluent, reclaim ethanol, concentrate, add the injection dilute with water, add active carbon after boiling and be equivalent to 0.1% of crude drug amount, keep little and boiled 30 minutes, filter, filtrate is used 10%NaOH adjust pH 5.5～7.5, boil standing over night, fine straining, filtrate adds the injection water, packing, sterilization promptly gets injection.
9, according to the preparation method of the Chinese medicine preparation containing red sange root and safflower of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: proportionally get Radix Salviae Miltiorrhizae, Flos Carthami, pulverize, decoct with water 0.5 hour again, add 3 times of water gagings at every turn, filter, filtrate concentrates, and crosses polyamide column, 50% ethanol elution, collect eluent, reclaim ethanol, concentrate drying, extrude-spheronization prepares micropill, promptly gets pellet.
10, according to the preparation method of the Chinese medicine preparation containing red sange root and safflower of claim 4 or 5 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: proportionally get Radix Salviae Miltiorrhizae, Flos Carthami, pulverize, decoct with water again 3 times, add 12 times of water gagings at every turn, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and crosses polyamide column, 90% ethanol elution, collect eluent, reclaim ethanol, concentrate, splash into the ratio that adopts PEG6000 and PEG4000 and be in 5: 2 the mixed-matrix, the water dropper model adopts No. 1 water dropper, and coolant temperature is 20～22 ℃, promptly gets drop pill.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100425231C (en) * | 2006-09-04 | 2008-10-15 | 郭爱华 | Oral formulation of danshensu and safflower yellow and preparation process thereof |
| CN104324138A (en) * | 2014-10-30 | 2015-02-04 | 宿州学院 | Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular disease and preparation method of traditional Chinese medicine composition |
| CN105250376A (en) * | 2015-11-30 | 2016-01-20 | 南京中医药大学 | Composition having gastric mucosa protecting effect and application thereof |
| CN105920096A (en) * | 2016-06-12 | 2016-09-07 | 南京中医药大学 | Composition with salviae miltiorrhiza and safflower as well as preparation method and application thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1232273C (en) * | 2002-11-27 | 2005-12-21 | 咸阳步长医药科技发展有限公司 | Medicine compositions for treating cardiovascular cranialvascular disease, and its prepn. method |
| CN1520859A (en) * | 2003-01-28 | 2004-08-18 | 黄衍民 | Cerebrovascular and cardiovascular disease treating injection containing red-rooted salvia and safflower |
-
2005
- 2005-02-02 CN CNB2005100092659A patent/CN100431562C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100425231C (en) * | 2006-09-04 | 2008-10-15 | 郭爱华 | Oral formulation of danshensu and safflower yellow and preparation process thereof |
| CN104324138A (en) * | 2014-10-30 | 2015-02-04 | 宿州学院 | Traditional Chinese medicine composition for treating cardiovascular and cerebrovascular disease and preparation method of traditional Chinese medicine composition |
| CN105250376A (en) * | 2015-11-30 | 2016-01-20 | 南京中医药大学 | Composition having gastric mucosa protecting effect and application thereof |
| CN105920096A (en) * | 2016-06-12 | 2016-09-07 | 南京中医药大学 | Composition with salviae miltiorrhiza and safflower as well as preparation method and application thereof |
| CN105920096B (en) * | 2016-06-12 | 2020-05-08 | 南京中医药大学 | Composition of red sage root and safflower, preparation method and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100431562C (en) | 2008-11-12 |
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Assignee: Qiyuanyide Medicines Inst., Beijing Assignor: Yu Wenyong Contract fulfillment period: 2008.11.20 to 2014.11.20 contract change Contract record no.: 2008990001315 Denomination of invention: Chinese traditional medicinal preparation containing red sange root and safflower for treating cardiovascular and cerebrovascular diseases and preparing process thereof Granted publication date: 20081112 License type: Exclusive license Record date: 2008.12.2 |
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