Summary of the invention
The purpose of this invention is to provide a kind of unique curative effect that has, untoward reaction is little, can take for a long time, the treatment coronary heart disease that tool has no side effect and anginal medicine and preparation method thereof.
Solution of the present invention is based on motherland's medical science to coronary heart disease and angina pectoris and pathogenetic understanding of complication and Therapeutic Principle, with reference to the modern pharmacological research achievement, by traditional Chinese medical science prescription theory, skims the cream off milk.Make its performance blood circulation promoting and blood stasis dispelling, the effect of removing obstruction in the collateral to relieve pain.
Medicine of the present invention is made by following component: (consumption is a weight portion)
Radix Puerariae total flavones 4~60 Fructus Crataegi extracts 1~30 Herb Gynostemmae Pentaphylli total glycosides 0.4~10
Soybean oil 5~100 Cera Flavas 0.1~3 hydrogenated palm oil 0.4~10
Soybean phospholipid 0.2~5 methyl-silicone oil 0.01~0.5 gelatin 8~150
Glycerol 3~80 distilled water 8~150 ethylparabens 0.01~0.8
The optimum weight of medicine of the present invention (part) proportioning is:
Radix Puerariae total flavones 20 Fructus Crataegi extracts 6 Herb Gynostemmae Pentaphylli total glycosides 2 soybean oils 25.4
Cera Flava 0.6 hydrogenated palm oil 2 soybean phospholipids 1 methyl-silicone oil 0.05
Gelatin 40 glycerol 16 distilled water 40 ethylparabens 0.08
Above-mentioned each component is made medicine production method of the present invention is:
1, the preparation of glue: at first gelatin is dissolved, it suck to be expanded, in glycerol, remaining distilled water, putting of ethylparaben glue jar with an amount of distilled water, be heated to 70~80 ℃, mix homogeneously adds expansible gelatin, stir, making it fusion becomes uniform gelatin, opens the vacuum system of glue pot, removes the bubble in the gelatin solution, the limit heating edge boils off the moisture in the gelatin solution, up to viscosity is 28000~32000 millipoises, puts into steady glue bucket and is incubated, standby.
2, with adding quantitative Cera Flava, hydrogenated palm oil in the soybean oil, be heated to 70~80 ℃, make the dissolving fully in soybean oil of above-mentioned two kinds of materials, be cooled to 30~35 ℃, add soybean phospholipid, fully stir, make it even.
3, the Herb Gynostemmae Pentaphylli total glycosides, Fructus Crataegi extract, the Radix Puerariae total flavones medicated powder that added 60 mesh sieves more one by one fully stir, and make its mix homogeneously, cross colloid mill 2 times, add methyl-silicone oil, leave standstill, and evacuation treats that bubble is removed substantially in the medicinal liquid, and is standby.
4, with changing good glue pelleting, every dress 580mg suppresses, and the about 0.85~0.95mm of rubber thickness uses the pressing pill.
Advantage of the present invention is:
1, dosage form advantage:
1.1 soft capsule dosage form is compared with pill with Chinese medicinal tablet, has that disintegrate is fast, bioavailability is high, toxic and side effects is low, and can cover advantages such as bad smell, zest;
1.2 compare characteristics such as useful again prescription just, cost is low with injection;
1.3, be to be used for old people's frequently-occurring disease such as angina pectoris, and soft capsule external form slyness is flexible, swallows after the saliva moistening conveniently, helps old people's medication for this medicine;
1.4 the medicine in the soft capsule dosage form is sealed containing within rubber fully, more help the storage of active, the easy oxidation of character, reductive medicine, especially containing volatile ingredient and determined curative effect for some but material base is indeterminate or the active Chinese patent medicine of character, is the optimum selection dosage form.
2, prescription advantage:
Raising day by day along with modernization of Chinese medicine degree, on the basis of herbal pharmacology and fitochemical studies, pharmaceutically active ingredient or effective site are proved to be definite curative effect and obtain purification in increasing, the present invention arises at the historic moment in this evolution, its scientific and technical content height is modern herbal species.
Fructus Crataegi extract has effects such as blood pressure lowering, coronary artery dilating, heart tonifying, arrhythmia and myocardial ischemia in the prescription; Radix Puerariae total flavones has effects such as the effect of expansion coronary vasodilator, the myocardium coefficient of oxygen utilization of reduction and myocardial oxygen consumption, blood pressure lowering, decreased heart rate, arrhythmia; The Herb Gynostemmae Pentaphylli total glycosides has effects such as blood pressure lowering, blood fat reducing.More than three flavors share common tool coronary artery dilating, blood pressure lowering, effect for reducing blood fat.
For showing the therapeutic effect of medicine of the present invention to angina pectoris, the present invention is through the clinical observation of 98 routine systems, wherein male 61 examples, woman's 37 examples, 39~73 years old age, 60 years old mean age, course of disease June~27 years, wherein light, in, heavier, severe case load is respectively 33 examples, 30 examples, 21 examples, 14 examples, all cases all meet the stagnation of heart-blood standard.
Instructions of taking: oral, one time 2,3 times on the one, treatment time is January, clinical experiment result such as table 1, table 2, table 3.
The fractionated relation of table 1 curative effect and the state of an illness
| Degree | The example number | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate (%) |
| The slight more heavy degree of moderate | 33 30 21 14 | 23 17 6 3 | 9 8 7 5 | 1 4 5 6 | 0 1 3 / | 97.0 83.3 61.9 57.1 |
By table 1 as seen, light, the moderate angina pectoris curative effect of Drug therapy of the present invention obviously is better than weight degree, severe patient.
The relation that table 2 curative effect and electrocardiogram change
| Total routine number | Produce effects | Effectively | Invalid | Increase the weight of | Total effective rate (%) |
| 98 | 41 | 36 | 18 | 3 | 78.6 |
By table 2 as seen, Drug therapy 98 routine angina pectoris patients of the present invention, wherein 41 routine patient's electrocardiograms roughly recover normally, and 36 routine S-T, T ripple have clear improvement, and it is 78.6% that electrocardiogram improves total effective rate.
Table 3 curative effect with take the variation relation of active remedy time
| | 0-3 minute | 3-5 minute | More than 5 minutes | Increase the weight of |
| (example) treatment back (example) before the treatment | 21 42 | 36 25 | 41 27 | / 4 |
By table 3 as seen, treat among the preceding 98 routine patients, 21 routine patients take pain relief in the active remedy 3 minutes, pain relief in the 36 routine patients 3~5 minutes, and 41 routine patients were alleviated more than 5 minutes; Pain relief in the pain relief in treatment back 42 examples 3 minutes, 25 examples 3~5 minutes, 27 routine patient pain relieves more than 5 minutes have 4 routine patient's state of an illness to increase the weight of, and taking active remedy pain can not alleviate.The state of an illness was obviously alleviated after treatment was described.
Any toxicity and side effect are not found in the clinical use of 98 routine patients, and liver, kidney merit do not have change before and after the treatment.
In sum, medicine of the present invention has blood circulation promoting and blood stasis dispelling, the effect of removing obstruction in the collateral to relieve pain, have coronary artery dilator, increase the coronary vasodilator flow, improve myocardial ischemia-anoxemia, reduce the effect of myocardial oxygen consumption and blood viscosity, the treatment angina pectoris is evident in efficacy, particularly light, moderate is better than weight degree and severe, and it is 78.6% that electrocardiogram is improved total effective rate, is worth clinical expansion to use.
Specific embodiment
The preparation method of Radix Puerariae total flavones, Fructus Crataegi extract, Herb Gynostemmae Pentaphylli total glycosides is;
1, Radix Puerariae total flavones
This product is the ethanol extraction (total flavones) that wild root Pueraria Iobata (Willd) Ohwi. of leguminous plant extracts, and contains puerarin (C
21H
20O
9) must not be less than 15.0%.
[method for making] gets the Herba Gelsemii Elegantis coarse powder, according to the percolation under fluid extract and extractum (an appendix I of the Chinese Pharmacopoeia nineteen ninety-five version O) item, is solvent with ethanol, floods percolation after 2 days, collects effluent, and decompression recycling ethanol also is condensed into thick paste, the drying of dusting, promptly.
2, Fructus Crataegi extract
This product is 70% ethanol extraction of rosaceous plant Fructus Pyri Pashiae Crataegus pinnatifida Bge var.major N.E.Br. Fructus Crataegi Crataegus pinnatifida Bgede.In 60 ℃ of dryings 6 hours, contain rutin (C
27H
30O
16) must not be less than 2.0%.
[method for making] gets Fructus Crataegi, is ground into coarse powder, adds 6 times of amounts of 70% ethanol, twice of heating and refluxing extraction, each 2 hours, merge extracted twice liquid, filter decompression recycling ethanol, being concentrated into relative density is the extractum of 1.32~1.35 (60 ℃ of heat are surveyed), the drying of dusting, promptly.
3, Herb Gynostemmae Pentaphylli total glycosides is pressed the Ministry of Public Health standard, and standard No. is WS3-Z-006-93 (Z) preparation.
Take by weighing raw material by following proportioning: (unit: gram)
Radix Puerariae total flavones 20 Fructus Crataegi extracts 6 Herb Gynostemmae Pentaphylli total glycosides 2 soybean oils 25.4
Cera Flava 0.6 hydrogenated palm oil 2 soybean phospholipids 1 methyl-silicone oil 0.05
Gelatin 40 glycerol 16 distilled water 40 ethylparabens 0.08
Above-mentioned each component is made medicine production method of the present invention is:
1, the preparation of glue: at first gelatin is dissolved, it is sucked expand with an amount of distilled water.In glycerol, remaining distilled water, putting of ethylparaben glue jar, be heated to 70~80 ℃, mix homogeneously adds expansible gelatin, stir, making it fusion becomes uniform gelatin, opens the vacuum system of glue pot, removes the bubble in the gelatin solution, the limit heating edge boils off the moisture in the gelatin solution, up to viscosity is 28000~32000 millipoises, puts into steady glue bucket and is incubated, standby.
2, with adding quantitative Cera Flava, hydrogenated palm oil in the soybean oil, be heated to 70~80 ℃, make the dissolving fully in soybean oil of above-mentioned two kinds of materials.Be cooled to 30~35 ℃, add soybean phospholipid, fully stir, make it even.
3, the Herb Gynostemmae Pentaphylli total glycosides, Fructus Crataegi extract, the Radix Puerariae total flavones medicated powder that added 60 mesh sieves more one by one fully stir, and make its mix homogeneously.Cross colloid mill 2 times.Add methyl-silicone oil, leave standstill, evacuation treats that bubble is removed substantially in the medicinal liquid, and is standby.
4, with changing good glue pelleting, every dress 580mg suppresses, and the about 0.85~0.95mm of rubber thickness uses the pressing pill.
5, typing is dry: will make soft capsule and place the tumble-dryers inner drying, 20 ℃ ± 2 ℃ of temperature, 95% ethanol flush away soft capsule surface, dry back oil, again soft capsule is placed on hang between dry (20 ℃~25 ℃), and to measure the soft capsule shell moisture be 6%~12%.
6, select: dried soft capsule is checked under the light platform, the failure is rejected.
7, check, packing, promptly.