CN1712056A - Medicinal composition, preparation and quality control thereof - Google Patents
Medicinal composition, preparation and quality control thereof Download PDFInfo
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Abstract
A Chinese medicine for treating coronary heart disease, angena pectoris, myocardiac infarction, hyperlepemia, hyperglycemia, etc is prepared from 8 Chinese-medicinal materials including astragalus root, pilose asiabell root, red sage root, haw, etc. Its preparing process and quality control method are also disclosed.
Description
Invention field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof and method of quality control, particularly a kind of pharmaceutical composition that is used for the treatment of coronary heart disease, angina pectoris, myocardial infarction and preparation method thereof and method of quality control.
Background technology
Coronary atherosclerotic heart disease (coronary heart disease) is the serious disease of harm humans health even life always, the generation of coronary heart disease, cause a considerable amount of patients disability in various degree, both caused difficulty in life to the patient, sensual misery brings a series of problems and heavy losses for again country, society.Motherland's medical science thinks that though the generation of coronary heart disease is real for mark, real is deficiency in origin, blood circulation promoting and blood stasis dispelling can be controlled its mark on the method for making, but more answers QI invigorating to consolidate to mend its void, and the present invention is just holding up this according to this theoretical having admittedly of founding, benefiting QI for activating blood circulation, the effective Chinese patent medicine of row arteries and veins analgesic.Succeeding in developing of it overcome the simple blood circulation promoting and blood stasis dispelling of part medicine and consumed the habit-forming harmful trend of gas, avoided the part medicine to adopt famous and precious animals and plants in short supply again, costs an arm and a leg the deficiency that should not promote.
Summary of the invention
One object of the present invention is to disclose a kind of pharmaceutical composition; Another object of the present invention is to disclose a kind of pharmaceutical composition that is used for the treatment of coronary heart disease, angina pectoris, myocardial infarction; The 3rd purpose of the present invention is to disclose a kind of preparation of drug combination method; The object of the invention also is to disclose a kind of method of quality control of pharmaceutical composition.
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Radix Astragali 100-150 weight portion Radix Codonopsis 80-120 weight portion
Radix Salviae Miltiorrhizae 60-100 weight portion Radix Puerariae 60-100 weight portion
Fructus Crataegi 60-100 weight portion Radix Angelicae Sinensis 40-70 weight portion
Rhizoma Corydalis (processing) 40-70 weight portion Radix Ginseng 20-30 weight portion
Radix Glycyrrhizae (processing) 20-30 weight portion
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Astragali 140 weight portion Radix Codonopsis 90 weight portions
Radix Salviae Miltiorrhizae 90 weight portion Radix Puerariaes 70 weight portions
Fructus Crataegi 70 weight portion Radix Angelicae Sinensis 45 weight portions
Rhizoma Corydalis (processing) 45 weight portion Radix Ginsengs 22 weight portions
Radix Glycyrrhizae 28 weight portions
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Astragali 110 weight portion Radix Codonopsis 110 weight portions
Radix Salviae Miltiorrhizae 70 weight portion Radix Puerariaes 90 weight portions
Fructus Crataegi 90 weight portion Radix Angelicae Sinensis 65 weight portions
Rhizoma Corydalis 65 weight portion Radix Ginsengs 28 weight portions
Radix Glycyrrhizae (processing) 22 weight portions.
It is (by weight) that the crude drug of pharmaceutical composition of the present invention is formed optimum ratio:
The Radix Astragali 120 weight portion Radix Codonopsis 100 weight portions
Radix Salviae Miltiorrhizae 80 weight portion Radix Puerariaes 80 weight portions
Fructus Crataegi 80 weight portion Radix Angelicae Sinensis 60 weight portions
Radix Ginseng 25 weight portion Radix Glycyrrhizaes (processing) 25 weight portions
Rhizoma Corydalis (processing) 60 weight portions
The pharmaceutical composition of the invention described above nine flavor raw materials can also add following raw material medicaments (by weight):
Herba Epimedii 60-100 weight portion Radix Rehmanniae 40-70 weight portion
Rhizoma Coptidis 40-70 weight portion Ganoderma 40-70 weight portion
The pharmaceutical composition of the invention described above nine flavor raw materials can also add following raw material medicaments (by weight) optimum ratio and be (by weight):
Herba Epimedii 80 weight portion Radix Rehmanniae 60 weight portions
Rhizoma Coptidis 60 weight portion Ganodermas 60 weight portions
More than nine the flavor or 13 the flavor medicines can make clinical acceptable forms according to conventional method, as tablet, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, injection etc.
This preparation of drug combination method:
More than nine the flavor, Radix Ginseng, Rhizoma Corydalis, half amount of the Fructus Crataegi and the Radix Astragali is ground into fine powder, the five tastes such as all the other Radix Codonopsis decoct with water 2-3 time with the residue Radix Astragali, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12 (90-95 ℃), puts coldly, and the amount of doubling ethanol makes precipitation, get supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90-95 ℃), mix with above-mentioned medicated powder, make clinical acceptable forms, comprise tablet, granule, capsule, oral liquid, the drop pill syrup, slow releasing preparation, controlled release preparation, microsphere, injection etc.
The present invention's 13 flavor crude drug preparation of drug combination methods:
More than 13 the flavor medicines, Radix Ginseng, Rhizoma Coptidis, Rhizoma Corydalis, half amount of the Fructus Crataegi and the Radix Astragali is ground into fine powder, all the other eight flavors decoct with water 2-3 time with the residue Radix Astragali, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12 (90～95 ℃), put coldly, the amount of doubling ethanol makes precipitation, gets supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90～95 ℃), and mix with above-mentioned medicated powder, make the tablet of clinical acceptance, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, injection.
The method of quality control of this composite preparation contains one or more in the following discrimination method:
A, get this product, remove coating, porphyrize takes by weighing 2g, adds methanol 25ml, and reflux 1-3 hour, put coldly, filter, filtrate evaporate to dryness, residue add methanol 1ml dissolving, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 10-15: 5-8: 2-4: 2-4: the benzene-ethyl acetate of 1-2 ratio-methanol-isopropyl alcohol-liquor ammoniae fortis is developing solvent, put in the chromatography cylinder with the ammonia saturated with vapor, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle.
B, get this product, remove coating, porphyrize, take by weighing 3g, add ethanol 50ml, reflux 1-3 hour, put coldly, filter the filtrate evaporate to dryness, residue adds water 10ml, strong ammonia solution 4ml, mixing, with ether extraction 3 times, each 15ml merges ether solution, evaporate to dryness, residue add ethanol 1.5ml makes dissolving, as need testing solution.Other gets the tetrahydropalmatine reference substance, add ethanol and make the solution that every 1ml contains 1mg, product solution according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B) test, is drawn each 10 μ 1 of above-mentioned two kinds of solution in contrast, put respectively on the silica gel g thin-layer plate of same usefulness 1% seizing and turning over of hydrogen sodium solution preparation, toluene-dehydrated alcohol with the 7-9:1-3 ratio is developing solvent, launches, and takes out, dry, put in the iodine vapor smoked.In the test sample chromatograph, with contrast chromatograph corresponding position on, show the speckle of same color.
This pharmaceutical composition has strengthening the body resistance, benefiting QI for activating blood circulation, the effect of row arteries and veins analgesic; Be used for coronary heart disease with qi deficiency and blood stasis, angina pectoris, myocardial infarction and merge disease opinions such as hyperlipidemia, hyperglycemia that above-mentioned disease person is arranged; The preparation stabilization that the present invention realizes, quality controllable.
Pharmacodynamics to this pharmaceutical composition tablet (heart nourishing sheet) partly carries out preliminary study, and the result shows: (1.5g/kg 3g/kg) has remarkable antagonism to experimental dog acute myocardial ischemia to heart nourishing; (1.5g/L 3g/L) has the effect of remarkable increase isolated rat heart coronary flow to heart nourishing; Heart nourishing (1g/kg, but 2g/kg) continuous gastric infusion 10d significant prolongation mice hypoxia endurance time; (1.5g/kg, 3g/kg) successive administration 30d have obvious antagonism to rat fat disorder due to the high lipid food to heart nourishing; (1.5g/kg 3g/kg) has the trend of reduction to heart nourishing to the blood glucose value of alloxan hyperglycemic rat; (1g/kg, 2g/kg) gastric infusion 7d can obviously increase foreign bodies removal rate in the mice serum to heart nourishing, increase the mice phagocytic function, and have the effect that improves mouse immune power.Following experimental example is used to further specify the present invention:
Experimental example 1: heart nourishing is to the influence of experimental dog acute myocardial ischemia:
Choose 20 of healthy adult dogs, body weight 12-18kg, the male and female dual-purpose is divided into four groups: normal saline blank group (NS) 5ml/kg, positive control drug propranolol group 1mg/kg, heart nourishing low dose group 1.5g/kg, high dose group 3g/kg.Except that the propranolol intravenously administrable, all the other are made into suitable concn with distilled water before experiment, gastric infusion.
With pentobarbital sodium 30mg/kg intravenous anesthesia dog, tracheal intubation connects respirator, opens breast, cuts off pericardium during experiment, exposes heart, separates M-LAD, and threading is in order to ligation.Seam is put the fixed epicardial lead of multiple spot, connects polygraph, sweeps the note epicardial electrogram.Behind the ligation arteria coronaria 15min, write down every index as medicine before control value, test medicine and normal saline through irritating stomach then, and behind medicine 30,60,120 and 180min record epicardial electrogram, compute degree of myocardial ischemia (∑-ST) and myocardial ischemia scope (N-ST).
Take off heart and claim its weight, and, below the heart ligature, be parallel to coronary sulcus and evenly the crosscut of ventricle part become 5, be put in 20min in nitro tetrazole orchid (N-BT) dye liquor, with drop point method (24 points/cm at-4 ℃～-6 ℃ freezing about 1h
2) two infarcts of surveying (being the non-dyeing of N-BT district) of every cardiac muscle of measurement and non-infarct (being that N-BT dyeing is distinguished) area, every myocardium weighing and calculate every myocardial area, the ventricle gross area and the infarct gross area, calculate percentage that the infarct area accounts for the ventricle area when the infarct area account for the percentage ratio of heart area, the results are shown in Table 1, table 2, table 3.
Table 1: heart nourishing is to experimental dog acute myocardial ischemia degree
(influence (the visceral pericardium heart figure mapping) X ± SD of ∑-ST)
| Group | A number of animals .n | Dosage/kg | Before the administration | After the administration (min) | |||
| ??30 | ??60 | ??120 | ??180 | ||||
| NS propranolol heart nourishing heart nourishing | ??5 ?? ??5 ??5 ??5 | ??5ml ?? ??1mg ??1.5g ??3g | 204.10 ± 101.57 rates of change (%) 217.60 ± 174.78 rates of change (%) 244.20 ± 106.51 rates of change (%) 221.50 ± 45.66 rates of change (%) | ??210.10±106.41 ??2.94±16.24 ??133.00±104.33 ※????-33.82±28.89 ??210.40±105.51 ??-13.82±19.40 ??200.10±114.41 ??-9.68±20.64 | ??218.80±98.42 ??7.23±9.82 ??128.60±134.21 ※※????-38.88±23.92 ??197.20±80.54 ※????-19.25±20.45 ??160.50±121.52 ※※????-27.53±20.22 | ??224.60±121.22 ??10.09±14.45 ??104.40±128.53 ※※????-52.02±30.10 ??178.80±78.86 ※※????-26.76±16.40 ??132.20±139.53 ※※????-40.32±23.15 | ??217.70±89.46 ??6.69±20.22 ??88.68±79.44 ??-59.28±16.16 ※※????145.20±71.34 ??-40.53±17.71 ※※????110.00±85.43 ??-50.32±18.15 ※※ |
Compare ※ P＜0.05 ※ ※ P＜0.01 ※ ※ ※ P＜0.001 with matched group
All have by visible two dosage groups of heart nourishing of table 1 and positive controls and significantly to alleviate the degree of myocardial ischemia (effect of ∑-ST).
Table 2: heart nourishing is to the influence of experimental dog myocardial ischemia scope (N-ST)
(epicardial electrogram mapping) X ± SD
| Group | A number of animals .n | Dosage/kg | Before the administration | After the administration (min) | |||
| ??30 | ??60 | ??120 | ??180 | ||||
| NS propranolol heart nourishing heart nourishing | ??5 ??5 ? ??5 ??5 | ??5ml ??5mg ?? ??1.5g ??3g | 28.60 ± 2.29 rates of change (%) 28.70 ± 1.86 rates of change (%) 29.30 ± 0.98 rates of change (%) 29.30 ± 0.55 rates of change (%) | ??28.70±1.92 ??0.35±3.14 ??22.10±5.84 ※????-23.00±14.13 ??28.10±2.32 ??-4.10±11.60 ??28.80±6.22 ??-3.36±4.55 | ??29.20±2.31 ??2.09±4.41 ??20.30±4.10 ※※????-29.27±12.14 ??27.82±1.83 ??-5.12±10.44 ??28.10±2.77 ※※????-5.70±2.64 | ??29.30±2.19 ??2.45±3.02 ??18.00±3.22 ※※????-37.28±22.05 ??27.70±2.05 ??-5.46±8.32 ??26.30±1.15 ※※????-11.74±5.22 | ??29.60±2.05 ??1.40±5.01 ??15.80±2.11 ??-44.95±11.06 ※※????26.60±2.77 ??-9.22±7.32 ※????24.30±1.24 ??--18.46±8.24 ※※ |
Compare with matched group: ※ P＜0.05 ※ ※ P＜0.01
By table 2 as seen, two dosage groups of heart nourishing and propranolol all have the effect that alleviates myocardial ischemia scope (N-ST) in various degree.
Table 3: heart nourishing is to influence (the form quantitative tissue the is learned mensuration-N-BT dyeing) X ± SD of experimental dog myocardial ischemia scope
| Group | Number of animals is only: n | Dosage/kg | Infarct/heart (0/0) | Infarct/ventricle (0/0) |
| NS propranolol heart nourishing heart nourishing | ??5 ??5 ??5 ??5 | ??5ml ??1mg ??1.5g ??3g | ??8.98±3.12 ??3.36±1.49※※ ????4.14±2.66※ ????3.84±1.74※ | ??12.38±3.52 ??4.87±2.44※※ ????5.90±3.48※ ????5.50±2.02※※ |
Compare with matched group: ※ P＜0.05 ※ ※ P＜0.01
Table 3 shows that two dosage groups of heart nourishing and propranolol group have the work that obviously dwindles myocardial infarct size to have.
Experimental example 2: heart nourishing is to the influence of isolated rat heart function.
Select 30 of Wistar rat, body weight 180 ± 20g, the male and female dual-purpose is divided into three groups at random, normal saline blank group (NS); Heart nourishing (extract) low dose group [1.5g (sheet)/L]; Heart nourishing (extract) high dose group [3g (sheet)/L].With Langendonff rat heart perfusion device, after foundation improvement Ning Shi method is fixed on perfusion device with heart, carry out physiology K-H liquid perfusion 15min recorded heart rate (HR), heart shrinkage amplitude (AC), coronary flow (CBF) as data contrast before the administration.Change to after the administration of pastille perfusate record 5,10,15,20, every index of 30min, the results are shown in Table 4.
Table 4: heart nourishing is to the influence of isolated rat heart coronary flow
| Group | Number of animals is only: n | Liquor strength g/L | Change through percentage rate (%) X ± SD after the administration | ||||
| ??5 | ??10 | ??15 | ??20 | ??30 | |||
| NS heart nourishing heart nourishing | ??10 ??10 ??10 | ??- ??1.5 ??3 | ??-2.40±13.21 ??7.64±13.21 ??17.00±13.16 | ??-2.55±13.75 ??32.60±27.23※ ????42.05±33.24※ | ??-2.33±11.04 ??25.30±25.22 ??31.08±21.22 | ??-2.44±13.21 ??22.18±21.55 ??27.44±25.31 | ??-2.38±14.39 ??18.04±18.24 ??20.04±13.66 |
Compare ※ P＜0.01 with matched group
The result shows that heart nourishing can obviously increase normal isolated rat heart coronary flow, and dose-effect relationship is preferably arranged, and effect in 10 minutes can reach peak value after the administration.The experimental observation heart nourishing has the effect of certain decreased heart rate (HR).
Experimental example 3: heart nourishing is to the influence of mice normal pressure hypoxia endurance time
Choose 60 of healthy Kunming mouses, body weight 20 ± 2g male and female half and half are divided into four groups at random, gavage heart nourishing 1g/kg, heart nourishing 2g/kg, propranolol 40mg/kg every day respectively, and normal saline (NS), and the administration capacity is 0.3ml, continue 10d.Begin test behind the last administration 1h.Get the 250ml port grinding bottle and put into sodica calx 10g, bottle stopper is coated with vaseline, respectively mice is put into bottle then, and 1 every bottle, animal will be covered tightly after advancing bottle at once, and the opening entry time is until respiratory arrest.This section period is considered as " hypoxia endurance time ", the results are shown in Table 5.
Table 5: heart nourishing is to the influence of mice normal pressure hypoxia endurance time
| Group | A number of animals .n | Dosage g/kg | Hypoxia endurance time S (X ± SD) |
| NS propranolol heart nourishing heart nourishing | ??15 ??15 ??15 ??15 | ??- ??0.04 ??1 ??2 | ??40.66±18.31 ??74.85±22.45 ※※????58.92±19.34 ※????68.71±20.22 ※※ |
Compare ※ P＜0.05 ※ ※ P＜0.01 with matched group
Find out that thus two dosage groups of heart nourishing and propranolol group all have the effect that prolongs the mice hypoxia endurance time.
Experimental example 4: heart nourishing is to the influence of experimental hyperlipidemia rat fat level
Select 32 of Wistar rats, body weight 180 ± 20g, male and female half and half, be divided into four groups at random, normal saline matched group (NS), clofibrate group 35mg/kg, heart nourishing low dose group 1.5g/kg, high dose group 3g/kg get blood with the shallow numb tail vein of ether during experiment, use FeCl behind the separation of serum
3Serum total cholesterol (TC) is surveyed in colour developing, and polyethylene glycol precipitation is measured serum high-density LP cholesterol (HDL-C) and calculated the TC/HDL-C value.
Each organizes gastric infusion simultaneously, raises with the continuous 30d of high lipid food (normal diet 92.5%, cholesterol 2%, Fel Sus domestica salt 0.5% and Adeps Sus domestica 5%), measures each index simultaneously, the results are shown in Table 6.
Table 6: heart nourishing is to the influence of experimental hyperlipidemia rat fat level
| Group | Number of animals only | Dosage/kg | Blood fat (mg/ml) X ± SD | |||
| ??TC | ??HDL-C | ??TC/HDL-C | ||||
| NS clofibrate heart nourishing heart nourishing | Behind the medicine prodrug behind the medicine prodrug behind the medicine prodrug behind the medicine prodrug | ??8 ? ??8 ??8 ??8 | ??- ??35mg ? ??1.5g ??3g | ??78.02±20.11 ??225.18±35.45 ▲▲????77.44±15.98 ??142.75±26.23 ※※▲▲????79.34±26.28 ▲▲????188.04±21.50 ※▲▲????77.49±27.40 ??153.67±21.09 ※※▲▲ | ??47.31±12.15 ??34.22±4.59 ▲????48.09±9.26 ??36.68±3.03 ▲▲????47.35±8.96 ??33.09±3.15 ▲▲????49.36±8.13 ??34.06±7.22 ▲▲ | ??1.65±1.08 ??6.58±1.38 ▲▲????1.61±1.36 ??3.89±0.68 ※※▲▲????1.68±0.89 ??5.68±0.97 ※※▲▲????1.57±0.76 ??4.51±0.35 ※※▲▲ |
Compare with the blank group: ※ P＜0.05 ※ ※ P＜0.01
With compare before the medicine: ▲ P＜0.05 ▲ ▲ P＜0.01
Contrast shows before and after the medication, and the fed with high rat can make hyperlipemia form, and obviously as seen heart nourishing and clofibrate have antagonism to the food hyperlipidemia.
Experimental example 5: heart nourishing is to the influence of alloxan hyperglycemic rat blood glucose value:
Choose 24 of Wistar male rats, body weight 180 ± 20g, feed with normal diet in laboratory observation after one week, the tail vein is got blood, survey blood glucose value (BG) with the ortho-aminotoluene micromethod, animal is divided into three groups at random, normal saline matched group 4ml/kg, heart nourishing low dose group 1.5g/kg, heart nourishing high dose group 3g/kg, continuous irrigation stomach 5d measures the BG meansigma methods respectively, and subcutaneous injection alloxan 90mg/kg, annotate 2hr at skin, 24hr, 2d, 3d, 4d, measure the BG value behind the 5d respectively, each preceding animal fasting 8～9hr of blood glucose that surveys, administration and feeding are continued in general blood sampling back, and experimental result sees Table 7.
Table 7: heart nourishing is to the influence of experimental rat hyperglycemia
| An animal .n | Dosage/kg | BG normal value X | BG X behind the 5d | BG X behind the skin notes alloxan 90mg/kg | ||||||
| ??2h | ??24g | ??2d | ??3d | ??4d | ??5d | |||||
| ??NS | ??8 | ??4ml | ??70.90 | ??70.77 | ??87.94 | ??165.26 | ??246.33 | ??228.77 | ??191.53 | ??210.09 |
| The heart nourishing heart nourishing | ??8 ??8 | ??1.5g ??3g | ??61.04 ??60.84 | ??57.89 ??56.30 | ??63.10 ??72.23 | ??103.36 ??108.87 | ??210.74 ??120.12 | ??178.70 ??149.86 | ??163.28 ??134.12 | ??153.36※ ????139.14※ |
※P＞0.05
As seen from table, two dosage groups of heart nourishing 1.5g/kg and 3g/kg, after skin is annotated alloxan, blood glucose value all raises, but compares with matched group, and blood glucose value rising amplitude is less, learn by statistics and handle nonsignificance, show that heart nourishing only has the trend of blood sugar lowering, and high dose group compares with low dose group, BG raises less.
Experimental example 6: heart nourishing is to the influence of mice phagocytic function:
Choose 30 of body weight 20 ± 2g Kunming mouses, the male and female dual-purpose is divided into five groups at random, 10 every group: normal saline blank group, heart nourishing low dose group 1g/kg, heart nourishing high dose group 2g/kg, each treated animal gastric infusion 7d, 2 behind the tail vein injection india ink, each eye socket is got blood 0.2 μ 1 during 10min, insert in the 4ml distilled water lysed erythrocyte and use 7520 type spectrophotometers (600nm) and measure optical density, serum carbon granules clearance rate in the unit of account time the results are shown in Table 8.
Table 8: heart nourishing is to the influence of mice phagocytic function
| Group | An animal .n | Dosage g/kg | Clearance rate (X ± SD) |
| NS heart nourishing heart nourishing | ??10 ??10 ??10 | ??- ??1 ??2 | ??0.0244±0.0078 ??0.0352±0.0080※ ????0.0368±0.0094※ |
Compare with matched group: ※ P＜0.01
The result shows that heart nourishing can obviously increase foreign bodies removal rate in the mice serum, has the effect that improves animal body immunity.
Experimental example 7: the 312 routine clinical observations of heart nourishing treatment coronary heart disease are summed up
Treat coronary heart disease 312 examples with heart nourishing, and contrast with " FUFANG DANSHEN PIAN " 95 examples, the clinical observation situation is summarized as follows.
One, the object of observation
All have a coronary heart disease symptom, and electrocardiogram turns out to be the coronary disease patient, all belongs to the object of observation, wherein inpatient's 248 examples, outpatient's 64 examples, man's 185 examples, women 127 examples, minimal ages 42 years old, maximum 83 years old age, 59.7 years old mean age (matched group age physical data is suitable with the heart nourishing group), angina pectoris labour type 203 examples wherein, non-labour's type 109 examples.Merge hyperlipidemia person, high person's 164 examples of triglyceride wherein, high person's 187 examples of cholesterol; Hyperglycemia person's 66 examples; Hypertension person 134 examples.
Two, observational technique
312 examples are observed patients and are taken the heart nourishing treatment, each 4-6 sheet, and 3 times on the, matched group " FUFANG DANSHEN PIAN " is oral, and each 3,3 times on the one.Take medicine be the course of treatment around, at the viewing duration Chinese and western drugs of other treatment coronary heart disease of stopping using,, can add with containing of nitroglycerin if not person very of angina pectoris is arranged.
Observe case and have an electro-cardiogram without exception, weekly 1 time or 2 weeks 1 time; Chemical examination blood fat, blood glucose, three big routines, each once selects front and back respectively once, optionally blood test rheology before and after treating; Measuring blood pressure once weekly.
Three, observed result
" coronary heart disease, curative effect to treat angina pectoris standard " evaluation that efficacy evaluation passes through by in JIUYUE, 1979 Shanghai meeting.
1, angina pectoris symptom curative effect: treatment is organized among the 312 routine patients, exertional angina pectoris 203 examples, 4 examples of wherein fully recovering, produce effects 92 examples are improved 103 examples, no change 4 examples, increase the weight of 0 example, total effective rate 98.03%, noneffort angina 109 examples, 3 examples of wherein fully recovering, produce effects 84 examples, improve 21 examples, no change or increase the weight of each 0 example, total effective rate 100%.Add up to amphitypy angina pectoris total effective rate 98.72%, see Table 9.
Table 9: curative effect to treat angina pectoris is judged
In matched group 95 examples, exertional angina pectoris 36 examples, 1 example of wherein fully recovering, produce effects 7 examples are improved 24 examples, and no change 3 examples increase the weight of 1 example, total effective rate 88.89%; Noneffort angina 59 examples, 0 example of wherein fully recovering, produce effects 17 examples are improved 35 examples, and no change 5 examples increase the weight of 2 examples, and total effective rate 88.14% adds up to amphitypy angina pectoris total effective rate 88.42%.
2, ECG curative effect: among the 312 routine patients, labour's type 203 examples, 1 example of fully recovering, produce effects 76 examples are improved 59 examples, and no change 67 examples increase the weight of 0 example, total effective rate 66.99%; In non-labour's type 109 examples, 0 example of fully recovering, produce effects 44 examples are improved 30 examples, do not have 35 examples of change, increase the weight of 0 example, and total effective rate 67.89% adds up to amphitypy total effective rate 67.31%. to see Table 10.
Table 10: ECG curative effect critical table
In matched group 95 examples, labour's type 36 examples, 0 example of wherein fully recovering, produce effects 11 examples are improved 11 examples, and no change 14 examples increase the weight of 0 example, total effective rate 61.11%; Non-labour's type 59 examples, 1 example of wherein fully recovering, produce effects 15 examples are improved 18 examples, and no change 23 examples increase the weight of 2 examples, and total effective rate 57.63% adds up to amphitypy total effective rate 58.95%.
3, to the influence of blood glucose: to the high case of 216 routine blood glucose, average 7.03mmol/l before the treatment, treatment back average 5.68mmol/l.Average down grand 1.35mmol/l.
4, to the influence of blood fat: to the high case of 169 routine triglyceride, average 2.21mmol/l before the treatment, treatment back average 1.47mmol/l, 0.74mmol/l on average descends; To the high case of 231 routine cholesterol, average 7.50mmol/l before the treatment, treatment back average 5.97mmol/l, 1.53mmol/l on average descends.
5, to the influence of blood pressure: to the case of 175 examples with hypertension, contrast slightly descends before and after taking medicine.
Four, model case
[example one] in * *, woman, 60 years old, certain retired worker of factory.
The patient is admitted to hospital May 12 nineteen ninety because of chest pain 3 days, time angina pectoris attacks surplus having 10 every day, each outbreak pain continues more than 10 minutes, companion's cardiopalmus, more so examine and be the severe noneffort angina night uncomfortable in chest, not obvious through the western medicine curative effect, take heart nourishing treatment, each 4, every day 3 times May 14 nineteen ninety.The dark tongue of tongue is white, deep-thready pulse.
BP14/10KPa, the obvious coronary insufficiency of electrocardiogram, blood glucose 4.8mmol/l, blood fat: triglyceride 0.97mmol/l, cholesterol 4.5mmol/l, through treatment all around, angina, cardiopalmus, disappearance uncomfortable in chest, it is roughly normal that electrocardiogram recovers, blood fat; Triglyceride 0.98mmol/l, cholesterol 4.6mmol/l, blood glucose 4.6mmol/l, therapeutic outcome produce effects.
[example two] Guo * *, woman, 58 years old, workman.
The patient is because of coronary heart disease, and diabetes were in hospital May 21 nineteen ninety.Its angina pectoris is slight non-labour's type, had palpitation during rest, and night is uncomfortable in chest obviously, the dark white and thin fur of tongue, deep-thready pulse.
BP26/13KPa, electrocardio illustrates obvious ischemia, blood fat: triglyceride 2.8mmol/l, cholesterol 8.6mmol/l, blood glucose 9.8mmol/l. is through treating angina pectoris, cardiopalmus, disappearance uncomfortable in chest all around with heart nourishing (5 day 3 times), BP22/13KPa, electrocardiogram obviously improves, triglyceride 2.1mmol/l, cholesterol 5.8mmol/l blood glucose 6.8mmol/l therapeutic outcome produce effects.
[example three] Lee * *, man, 75 years old, cadre.
Because of surplus the pain of precordial fullness repeatedly 10 year, increase the weight of over nearly one month and be admitted to hospital, took 4 of heart nourishing May 16, every day 3 times, the back symptom is clearly better all around, and electrocardiogram is transferred to roughly normal by obvious ischemia.Therapeutic outcome electrocardiogram produce effects, angina pectoris symptom improves.
Five, conclusion
1, " heart nourishing " to treatment angina pectoris determined curative effect, total effective rate is 98.72%, is 67.31% to the Electrocardiographic total effective rate that improves, all than matched group effect obviously (P＜0.01)
2, this medicine has certain blood sugar lowering, effect for reducing blood fat.
3, do not find side effect such as dizziness, feeling of fullness in the head, headache, nausea,vomiting,diarrhea in the medication process, three big routines and liver, renal function chemical examination no abnormality seen illustrate liver, kidney are had no side effect.
Embodiment 1:
Radix Astragali 140g Radix Codonopsis 90g Radix Salviae Miltiorrhizae 90g Radix Puerariae 70g
Fructus Crataegi 70g Radix Angelicae Sinensis 45g Rhizoma Corydalis (processing) 45g Radix Ginseng 22g
Radix Glycyrrhizae 28g
The five tastes such as half amount of Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali is ground into fine powder, all the other Radix Codonopsis decoct with water three times with the residue Radix Astragali, 2 hours for the first time, 1.5 hours for the second time, 3 hours for the third time collecting decoctions filtered, filtrate is concentrated into relative density 1.06-1.12 (90-95 ℃), put coldly, the amount of doubling ethanol makes precipitation, gets supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90-95 ℃), and mix with above-mentioned medicated powder, make granule.
Embodiment 2:
Radix Astragali 110g Radix Codonopsis 110g Radix Salviae Miltiorrhizae 70g Radix Puerariae 90g
Fructus Crataegi 90g Radix Angelicae Sinensis 65g Rhizoma Corydalis 65g Radix Ginseng 28g
Radix Glycyrrhizae (processing) 22g
The five tastes such as half amount of Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali is ground into fine powder, all the other Radix Codonopsis decoct with water twice, each 1.5 hours with the residue Radix Astragali, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12 (90-95 ℃), puts cold, the amount of doubling ethanol makes precipitation, get supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90-95 ℃), mix with above-mentioned medicated powder, make 500 of capsules.Oral, a 2-3 sheet; Every day 3 times.
Embodiment 3:
Radix Astragali 120g Radix Codonopsis 100g Radix Salviae Miltiorrhizae 80g Radix Puerariae 80g
Fructus Crataegi 80g Radix Angelicae Sinensis 60g Radix Ginseng 25g Radix Glycyrrhizae (processing) 25g
Rhizoma Corydalis (processing) 60g
Half amount of Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali is ground into fine powder, the five tastes such as all the other Radix Codonopsis decoct with water twice with the residue Radix Astragali, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12 (90-95 ℃), puts cold, the amount of doubling ethanol makes precipitation, get supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90-95 ℃), mix with above-mentioned medicated powder, make granule, drying is pressed into 1000 (small pieces), sugar coating or film-coat, or be pressed into 500 (sheets), the bag film-coat, promptly.
Embodiment 4:
Radix Astragali 140g Radix Codonopsis 90g Radix Salviae Miltiorrhizae 90g Radix Puerariae 70g
Fructus Crataegi 70g Radix Angelicae Sinensis 45g Rhizoma Corydalis (processing) 45g Radix Ginseng 22g
Radix Glycyrrhizae 28g
Make 500 according to conventional method, the bag film-coat.Oral, a 2-3 sheet; Every day 3 times.
Embodiment 5:
Radix Astragali 110g Radix Codonopsis 110g Radix Salviae Miltiorrhizae 70g Radix Puerariae 90g
Fructus Crataegi 90g Radix Angelicae Sinensis 65g Rhizoma Corydalis 65g Radix Ginseng 28g
Radix Glycyrrhizae (processing) 22g
Make 1000 according to conventional method.Oral, a 4-6 sheet; Every day 3 times.
Embodiment 6:
Radix Astragali 120g Radix Codonopsis 100g Radix Salviae Miltiorrhizae 80g Radix Puerariae 80g
Fructus Crataegi 80g Radix Angelicae Sinensis 60g Radix Ginseng 25g Radix Glycyrrhizae (processing) 25g
Rhizoma Corydalis (processing) 60g
Make granule according to conventional method, oral.
Embodiment 7:
Radix Astragali 120g Radix Codonopsis 100g Radix Salviae Miltiorrhizae 80g Radix Puerariae 80g
Herba Epimedii 80g Fructus Crataegi 80g Radix Rehmanniae 60g Radix Angelicae Sinensis 60g
Rhizoma Coptidis 60g Ganoderma 60g Radix Ginseng 25g Radix Glycyrrhizae (processing) 25g
Rhizoma Corydalis (processing) 60g
Make 1000 according to conventional method.Oral, a 4-6 sheet; Every day 3 times.
Embodiment 8:
Radix Astragali 120g Radix Codonopsis 100g Radix Salviae Miltiorrhizae 80g Radix Puerariae 80g
Herba Epimedii 80g Fructus Crataegi 80g Radix Rehmanniae 60g Radix Angelicae Sinensis 60g
Rhizoma Coptidis 60g Ganoderma 60g Radix Ginseng 25g Radix Glycyrrhizae (processing) 25g
Rhizoma Corydalis (processing) 60g
Make 500 according to conventional method, the bag film-coat.Oral, a 2-3 sheet; Every day 3 times.
Embodiment 9:
Get this product, remove coating, porphyrize takes by weighing 2g, adds methanol 25ml, and reflux 1.5 hours is put coldly, filters, and filtrate evaporate to dryness, residue add methanol 1ml dissolving, as need testing solution.Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-methanol-isopropyl alcohol-liquor ammoniae fortis (12: 6: 3: 3: 1) is developing solvent, put in the chromatography cylinder with the ammonia saturated with vapor, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle.
Embodiment 10:
Get this product, remove coating, porphyrize, take by weighing 3g, add ethanol 50ml, reflux 1.5 hours, put coldly, filter the filtrate evaporate to dryness, residue adds water 10ml, strong ammonia solution 4ml, mixing, with ether extraction 3 times, each 15ml merges ether solution, evaporate to dryness, residue add ethanol 1.5ml makes dissolving, as need testing solution.Other gets the tetrahydropalmatine reference substance, add ethanol and make the solution that every 1ml contains lmg, product solution according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B) test, is drawn each 10 μ l of above-mentioned two kinds of solution in contrast, put respectively on the silica gel g thin-layer plate of same usefulness 1% sodium hydroxide solution preparation, with toluene-dehydrated alcohol (8: 1) is developing solvent, launches, and takes out, dry, put in the iodine vapor smoked.In the test sample chromatograph, with contrast chromatograph corresponding position on, show the speckle of same color.
Embodiment 11:
A, get this product, remove coating, porphyrize takes by weighing 2g, adds methanol 25ml, and reflux 1.5 hours is put coldly, filters, and filtrate evaporate to dryness, residue add methanol 1ml dissolving, as need testing solution.Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-methanol-isopropyl alcohol-liquor ammoniae fortis (12: 6: 3: 3: 1) is developing solvent, put in the chromatography cylinder with the ammonia saturated with vapor, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle.
B, get this product, remove coating, porphyrize, take by weighing 3g, add ethanol 50ml, reflux 1.5 hours, put coldly, filter the filtrate evaporate to dryness, residue adds water 10ml, strong ammonia solution 4ml, mixing, with ether extraction 3 times, each 15ml merges ether solution, evaporate to dryness, residue add ethanol 1.5ml makes dissolving, as need testing solution.Other gets the tetrahydropalmatine reference substance, add ethanol and make the solution that every 1ml contains 1mg, product solution according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia nineteen ninety-five version B) test, is drawn each 10 μ l of above-mentioned two kinds of solution in contrast, put respectively in same usefulness 1% hydrogen and seize and turn on the silica gel g thin-layer plate of sodium hydroxide solution preparation, with toluene-dehydrated alcohol (8: 1) is developing solvent, launches, and takes out, dry, put in the iodine vapor smoked.In the test sample chromatograph, with contrast chromatograph corresponding position on, show the speckle of same color.
Embodiment 12:
Radix Astragali 120g Radix Codonopsis 100g Radix Salviae Miltiorrhizae 80g Radix Puerariae 80g
Herba Epimedii 80g Fructus Crataegi 80g Radix Rehmanniae 60g Radix Angelicae Sinensis 60g
Rhizoma Coptidis 60g Ganoderma 60g Radix Ginseng 25g Radix Glycyrrhizae (processing) 25g
Rhizoma Corydalis (processing) 60g
Get Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali, decoct with water 3 times, each 1 hour, merge decocting liquid, filter, concentrating under reduced pressure adds ethanol precipitation, leaves standstill, supernatant decompression recycling ethanol, drying are ground into the above fine powder of 60 orders, promptly get Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and Radix Astragali extract.All the other nine flavors are ground into coarse powder, use 70% alcohol reflux, reclaim ethanol after each one hour, are dissolved in water, and use the macroporous resin exquisiteness, use 70% ethanol elution.Collect effluent to colourless, concentrate, dry, be ground into the above fine powder of 60 orders, again with Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and Radix Astragali extract mix homogeneously, add the injection water and dissolve, add the i.e. 0.1% needle-use activated carbon mixed solution heated and boiled of injection water, filter, add an amount of sodium chloride for injection and make it dissolving, add water for injection again to certain volume, filtration, fill, sterilization promptly get injection.
Claims (18)
1, a kind of pharmaceutical composition is characterized in that this pharmaceutical composition made by following raw medicaments in portion by weight:
Radix Astragali 100-150 weight portion Radix Codonopsis 80-120 weight portion
Radix Salviae Miltiorrhizae 60-100 weight portion Radix Puerariae 60-100 weight portion
Fructus Crataegi 60-100 weight portion Radix Angelicae Sinensis 40-70 weight portion
Rhizoma Corydalis 40-70 weight portion Radix Ginseng 20-30 weight portion
Radix Glycyrrhizae 20-30 weight portion.
2, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw medicaments in portion by weight:
The Radix Astragali 140 weight portion Radix Codonopsis 90 weight portion Radix Salviae Miltiorrhizaes 90 weight portions
Radix Puerariae 70 weight portion Fructus Crataegis 70 weight portion Radix Angelicae Sinensis 45 weight portions
Process Rhizoma Corydalis 45 weight portion Radix Ginsengs 22 weight portion Radix Glycyrrhizaes 28 weight portions.
3, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw medicaments in portion by weight:
The Radix Astragali 110 weight portion Radix Codonopsis 110 weight portion Radix Salviae Miltiorrhizaes 70 weight portions
Radix Puerariae 90 weight portion Fructus Crataegis 90 weight portion Radix Angelicae Sinensis 65 weight portions
Rhizoma Corydalis 65 weight portion Radix Ginsengs 28 weight portion Radix Glycyrrhizae Preparatas 22 weight portions.
4, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw medicaments in portion by weight:
The Radix Astragali 120 weight portion Radix Codonopsis 100 weight portion Radix Salviae Miltiorrhizaes 80 weight portions
Radix Puerariae 80 weight portion Fructus Crataegis 80 weight portion Radix Angelicae Sinensis 60 weight portions
Radix Ginseng 25 weight portion Radix Glycyrrhizae Preparatas 25 weight portions are processed Rhizoma Corydalis 60 weight portions.
5, pharmaceutical composition as claimed in claim 1 is characterized in that also adding in this pharmaceutical composition following raw medicaments in portion by weight:
Herba Epimedii 60-100 weight portion Radix Rehmanniae 40-70 weight portion
Rhizoma Coptidis 40-70 weight portion Ganoderma 40-70 weight portion.
6, pharmaceutical composition as claimed in claim 5 is characterized in that also adding in this pharmaceutical composition following raw medicaments in portion by weight:
Herba Epimedii 80 weight portion Radix Rehmanniae 60 weight portions
Rhizoma Coptidis 60 weight portion Ganodermas 60 weight portions.
7, as claim 1,2,3 or 4 described preparation of drug combination methods, it is characterized in that this method is:
More than nine the flavor medicines, half amount of Radix Ginseng, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali is ground into fine powder, all the other five tastes decoct with water 2-3 time with the residue Radix Astragali, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12, put coldly, the amount of doubling ethanol makes precipitation, gets supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32, and mix with above-mentioned medicated powder, make tablet, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, the injection of clinical acceptance.
8, preparation of drug combination method as claimed in claim 7 is characterized in that this method is:
More than nine the flavor medicines, Radix Ginseng, Rhizoma Corydalis, half amount of the Fructus Crataegi and the Radix Astragali is ground into fine powder, the five tastes such as all the other Radix Codonopsis decoct with water three times with the residue Radix Astragali, 2 hours for the first time, 1.5 hours for the second time, 3 hours for the third time collecting decoctions, filter, filtrate is concentrated into relative density 1.06-1.12, puts cold, the amount of doubling ethanol makes precipitation, get supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32, mix with above-mentioned medicated powder, make the tablet of clinical acceptance, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, injection.
9, as claim 5 or 6 described preparation of drug combination methods, it is characterized in that this method is:
More than 13 the flavor medicines, half amount of Radix Ginseng, Rhizoma Coptidis, Rhizoma Corydalis, Fructus Crataegi and the Radix Astragali is ground into fine powder, all the other eight flavors decoct with water 2-3 time with the residue Radix Astragali, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12, put coldly, the amount of doubling ethanol makes precipitation, gets supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32, and mix with above-mentioned medicated powder, make tablet, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, the injection of clinical acceptance.
10, preparation of drug combination method as claimed in claim 9 is characterized in that this method is:
More than 13 the flavor medicines, Radix Ginseng, Rhizoma Coptidis, Rhizoma Corydalis, half amount of the Fructus Crataegi and the Radix Astragali is ground into fine powder, eight flavors such as all the other Radix Codonopsis decoct with water twice with the residue Radix Astragali, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into relative density 1.06-1.12, puts cold, the amount of doubling ethanol makes precipitation, get supernatant, reclaim ethanol, and be concentrated into the clear paste of relative density 1.26-1.32 (90-95 ℃), mix with above-mentioned medicated powder, make the tablet of clinical acceptance, granule, capsule, oral liquid, drop pill, syrup, slow releasing preparation, controlled release preparation, microsphere, injection.
11,, it is characterized in that comprising in this method in the following discrimination method one or more as the method for quality control of claim 1,2,3,4,5 or 6 described pharmaceutical compositions:
A, get pharmaceutical composition content of the present invention, porphyrize takes by weighing 2g, adds methanol 25ml, and reflux 1-3 hour, put coldly, filter, filtrate evaporate to dryness, residue add methanol 1ml dissolving, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 10-15: 5-8: 2-4: 2-4: the benzene-ethyl acetate of 1-2 ratio-methanol-isopropyl alcohol-liquor ammoniae fortis is developing solvent, put in the chromatography cylinder with the ammonia saturated with vapor, launch, take out, dry, put under the ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle;
B, get pharmaceutical composition content of the present invention, porphyrize takes by weighing 3g, add ethanol 50ml, reflux 1-3 hour, put cold, filter, filtrate evaporate to dryness, residue add water 10ml, strong ammonia solution 4ml, mixing is used ether extraction 3 times, each 15ml merges ether solution, evaporate to dryness, residue adds ethanol 1.5ml makes dissolving, as need testing solution; Other gets the tetrahydropalmatine reference substance, add ethanol and make the solution that every 1ml contains 1mg, product solution according to the thin layer chromatography test, is drawn each 10 μ l of above-mentioned two kinds of solution in contrast, put respectively on the silica gel g thin-layer plate of same usefulness 1% sodium hydroxide solution preparation, with 7-9: the toluene-dehydrated alcohol of 1-3 ratio is developing solvent, launches, and takes out, dry, put in the iodine vapor smoked; In the test sample chromatograph, with contrast chromatograph corresponding position on, show the speckle of same color.
12, method of quality control as claimed in claim 8 is characterized in that comprising in this method in the following discrimination method one or more:
A, get this present invention pharmaceutical composition content, remove coating, porphyrize takes by weighing 2g, adds methanol 25ml, and reflux 1.5 hours is put coldly, filters, and filtrate evaporate to dryness, residue add methanol 1ml dissolving, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 12: 6: 3: the benzene-ethyl acetate of 3: 1 ratios-methanol-isopropyl alcohol-liquor ammoniae fortis was developing solvent, put in the chromatography cylinder with the ammonia saturated with vapor, launch, take out, dry, put under the ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow fluorescence speckle;
B, get invention pharmaceutical composition content, remove coating, porphyrize, take by weighing 3g, add ethanol 50ml, reflux 1.5 hours, put coldly, filter the filtrate evaporate to dryness, residue adds water 10ml, strong ammonia solution 4ml, mixing, with ether extraction 3 times, each 15ml merges ether solution, evaporate to dryness, residue add ethanol 1.5ml makes dissolving, as need testing solution; Other gets the tetrahydropalmatine reference substance, add ethanol and make the solution that every 1ml contains 1mg, product solution according to the thin layer chromatography test, is drawn each 10 μ l of above-mentioned two kinds of solution in contrast, put respectively on the silica gel g thin-layer plate of same usefulness 1% sodium hydroxide solution preparation, toluene-dehydrated alcohol with 8: 1 ratios is developing solvent, launches, and takes out, dry, put in the iodine vapor smoked; In the test sample chromatograph, with contrast chromatograph corresponding position on, show the speckle of same color.
13, as claim 1,2,3,4, the application of 5 or 6 described pharmaceutical compositions in the medicine of preparation treatment coronary heart disease, angina pectoris, myocardial infarction or merging hyperlipidemia, hyperglycemia.
14, as claim 1,2,3,4,5 or 6 described pharmaceutical compositions have the effect of antagonism myocardial ischemia in preparation, increase the effect of heart coronary flow, prolong the hypoxia endurance time effect, the effect of antagonism blood fat disorder, blood sugar lowering effect or improve application in the medicine of immunity.
15, application as claimed in claim 13, it is characterized in that treating coronary heart disease, angina pectoris, myocardial infarction or merge hyperlipidemia, hyperglycemia is meant the effect of antagonism blood fat disorder, blood sugar lowering effect.
16, the application of pharmaceutical composition as claimed in claim 13 in the medicine of preparation treatment coronary heart disease, angina pectoris or myocardial infarction is characterized in that treating coronary heart disease, angina pectoris or myocardial infarction and is meant increase heart coronary flow, decreased heart rate or prolongs hypoxia endurance time.
17, pharmaceutical composition as claimed in claim 14 has application in the medicine of antagonism myocardial ischemia effect in preparation, it is characterized in that the antagonism myocardial ischemia is meant to alleviate the core ischemia degree, dwindle the myocardial ischemia scope or dwindle myocardial infarct size.
18, pharmaceutical composition as claimed in claim 14 has application in the medicine that improves immunity in preparation, it is characterized in that improving immunity and is meant the foreign bodies removal rate in the mice serum that increases.
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| CN101953935A (en) * | 2009-07-13 | 2011-01-26 | 青岛国风药业股份有限公司 | Qi-nourishing and blood-activating medicinal composition and preparation method, detection method and application thereof |
| CN101085071B (en) * | 2006-06-08 | 2012-02-22 | 天津天士力制药股份有限公司 | Traditional Chinese medicinal composition containing red sage root and haw and its preparation |
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2005
- 2005-06-28 CN CN 200510079757 patent/CN1285358C/en active Active
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| CN101085071B (en) * | 2006-06-08 | 2012-02-22 | 天津天士力制药股份有限公司 | Traditional Chinese medicinal composition containing red sage root and haw and its preparation |
| CN101953935A (en) * | 2009-07-13 | 2011-01-26 | 青岛国风药业股份有限公司 | Qi-nourishing and blood-activating medicinal composition and preparation method, detection method and application thereof |
| CN101953935B (en) * | 2009-07-13 | 2012-07-04 | 青岛国风药业股份有限公司 | Qi-nourishing and blood-activating medicinal composition and preparation method, detection method and application thereof |
| CN101953915B (en) * | 2009-07-13 | 2012-10-31 | 青岛国风药业股份有限公司 | Content measuring method and discriminating method for pharmaceutical composition preparation |
| CN103432538A (en) * | 2013-07-12 | 2013-12-11 | 吴长运 | Chinese herbal preparation for treating hyperlipidemia and preparation method thereof |
| CN103432538B (en) * | 2013-07-12 | 2015-11-11 | 吴长运 | A kind of Chinese medicine preparation being used for the treatment of hyperlipemia and preparation method thereof |
| CN105079397A (en) * | 2015-10-10 | 2015-11-25 | 临沂草之美医药科技有限公司 | Application of traditional Chinese medicine composition to preparation of drugs for treating myocardial infarction |
| CN114609303A (en) * | 2022-04-18 | 2022-06-10 | 上海医药集团青岛国风药业股份有限公司 | Method for extracting and detecting chemical components in aizoon stonecrop herb tablets by using biosurfactant and application of method |
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