A kind of Chinese medicine composition for the treatment of angina pectoris and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of angina pectoris, the present invention also relates to the preparation method of this Chinese medicine composition.
Background technology
Coronary atherosclerotic heart disease is meant that coronary arterial wall forms speckle, causes the lumen of vessels stenosis or occlusion to cause myocardial ischemia, anoxia, is classified as the ischemic heart desease category with coronary spasm.
TONGXINLUO JIAONANG is that professor Wu Yiling develops and three class Chinese patent medicines of the treatment diseases of cardiovascular and cerebrovascular systems of patent (ZL01131203.3).Professor Wu Yiling initiates utilization traditional Chinese medical science network ens morbi, inquire into cause of coronary heart disease mechanism, and five kinds of insect medicines such as Scorpio, Scolopendra, eupolyphaga, Hirudo and Periostracum Cicadae are applied in the treatment of angina pectoris, have unique curative effect for diseases such as coronary heart disease, angina pectoris, cerebral thrombosiss.The TONGXINLUO JIAONANG prescription is made up of Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga, Periostracum Cicadae, Radix Ginseng, Olibanum, Radix Paeoniae Rubra, Lignum Dalbergiae Odoriferae, Lignum Santali Albi, Borneolum Syntheticum and Semen Ziziphi Spinosae, its uniqueness is five kinds of promoting blood circulation to remove obstruction in the collateral of pooled applications and searches wind spasmolytic insect medicine Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and Periostracum Cicadae, embody better curative effect in the treatment to coronary heart disease, angina pectoris especially ariant angina.But since insect medicine exploitation with use in have many difficult points, not exclusively clear and definite as most active component, it is still immature to extract process for purification, lacks reference substance, so they all adopt traditional direct comminuting method to make medicated powder to be used as medicine in production technology.But traditional disintegrating process exists: 1) can not destroy cellularity, the release and the stripping that influence effective ingredient in the medical material need be passed cell membrane; 2) crushing process is because mechanical heat energy influence, and temperature can reach more than 80 ℃, and the stability of the protein-based effective ingredient of insect medicine is caused negative effect; 3) the pulverizing complexity difference of insects medical material different parts is mixed uneven phenomenon because of granule difference causes, influences problems such as product quality homogeneity.These problems also directly have influence on the stability and the absorption by human body of medicine active ingredient, thereby make pharmaceutical effectiveness descend.For this reason, the inventor studies by a large amount of experiments, and the disintegrating process employing micronization technology of these insect medicines is improved, and obtains ultramicro medicine powder, has improved curative effect greatly, thereby has finished the present invention.
Goal of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition (being also referred to as the supermicro Tongxinluo Chinese medicine composition in this manual) for the treatment of angina pectoris.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
Summary of the invention
Supermicro Tongxinluo Chinese medicine composition of the present invention is the further improvement to the ZL01131203.3 patent, so this patent is quoted in full in the present invention, also no longer describes the measure feature of using of said composition component herein, referring to the ZL01131203.3 patent.Claims and the disclosed content of description according to the ZL01131203.3 patent, this patent relates to a kind of treatment treating coronary heart disease and angina pectoris compositions, and the raw material that wherein prepares its active ingredient comprises: Radix Ginseng 3-10 gram, Hirudo 3-11 gram, Eupolyphaga Seu Steleophaga 5-10 gram, Olibanum (processed) 1-5 gram, Radix Paeoniae Rubra 3-9 gram, Lignum Dalbergiae Odoriferae 1-5 gram, Lignum Santali Albi 1-5 gram, Scorpio 3-9 gram, Periostracum Cicadae 3-12 gram, Scolopendra 1-3 gram, Borneolum Syntheticum 1-7 gram, Semen Ziziphi Spinosae (parched) 3-10 gram.This patent also relates to a kind of treatment treating coronary heart disease and angina pectoris compositions, and the raw material that wherein prepares its active ingredient comprises: Radix Ginseng 6 grams, Hirudo 10 grams, Eupolyphaga Seu Steleophaga 7 grams, Olibanum (processed) 2 grams, Radix Paeoniae Rubra 5 grams, Lignum Dalbergiae Odoriferae 2 grams, Lignum Santali Albi 2 grams, Scorpio 7 grams, Periostracum Cicadae 7 grams, Scolopendra 1 gram, Borneolum Syntheticum 5 grams, Semen Ziziphi Spinosae (parched) 5 grams.This patent also relates to a kind of treatment treating coronary heart disease and angina pectoris compositions, and the raw material that wherein prepares its active ingredient comprises: Radix Ginseng 10 grams, Hirudo 8 grams, Eupolyphaga Seu Steleophaga 7 grams, Olibanum (processed) 2 grams, Radix Paeoniae Rubra 5 grams, Lignum Dalbergiae Odoriferae 2 grams, Lignum Santali Albi 2 grams, Scorpio 9 grams, Periostracum Cicadae 7 grams, Scolopendra 1 gram, Borneolum Syntheticum 5 grams, Semen Ziziphi Spinosae (parched) 5 grams.This patent also relates to a kind of treatment treating coronary heart disease and angina pectoris compositions, and the raw material that wherein prepares its active ingredient comprises: Radix Ginseng 6 grams, Hirudo 11 grams, Eupolyphaga Seu Steleophaga 7 grams, Olibanum (processed) 2 grams, Radix Paeoniae Rubra 5 grams, Lignum Dalbergiae Odoriferae 2 grams, Lignum Santali Albi 2 grams, Scorpio 3 grams, Periostracum Cicadae 7 grams, Scolopendra 1 gram, Borneolum Syntheticum 5 grams, Semen Ziziphi Spinosae (parched) 5 grams.This patent also relates to a kind of treatment treating coronary heart disease and angina pectoris compositions, and the raw material that wherein prepares its active ingredient comprises: 5 parts of Radix Ginsengs, 3 parts of the Radixs Astragali, 10 parts of Hirudos, 7 parts of Eupolyphaga Seu Steleophagas, 2 parts of Olibanum (processed)s, 5 parts of Radix Paeoniae Rubra, 2 parts of Lignum Dalbergiae Odoriferaes, 2 parts in Lignum Santali Albi, 7 parts of Scorpios, 3 parts of Periostracum Cicadaes, 1 part of Scolopendra, 5 parts of Borneolum Syntheticums, 5 parts of Semen Ziziphi Spinosae (parched)s.
Supermicro Tongxinluo Chinese medicine composition of the present invention is by Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and Periostracum Cicadae five tastes insect medicine and the Olibanum (processed) medicated powder of mean diameter less than 100 μ m, Borneolum Syntheticum medicated powder, and Lignum Dalbergiae Odoriferae and Lignum Santali Albi are extracted the volatile oil of the medical material of volatile oil; Medicinal residues reuse water extraction with Lignum Dalbergiae Odoriferae and Lignum Santali Albi; Radix Paeoniae Rubra and Semen Ziziphi Spinosae decoct with water with the medical material of water extraction, after the water extract filters, and extractum to be condensed into; After Radix Ginseng is carried earlier with ethanol, the reuse water extraction, alcohol extract is condensed into alcohol-extracted extract after reclaiming ethanol; The water extract filter with all water extract mixings after be condensed into the water extracted immersing paste and form.
Supermicro Tongxinluo preparation of compositions method of the present invention:
1.1 pulverizing medicinal materials technology:
Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are concocted afterwards Olibanum and prepared burden by recipe quantity through cleaning, wash to handle the back and clean, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, and messenger drug powder fineness mean diameter is less than 100 μ m, and medical material to be pulverized is prepared burden after the cleaning, drying sterilization;
Concentrate and do behaviour's technology 1.2 extract:
Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae decoct with water, after the water extract filters, extractum to be condensed into; Radix Ginseng with the alcohol extraction of the medical material of ethanol extraction elder generation after, the reuse water extraction, alcohol extract is condensed into alcohol-extracted extract after reclaiming ethanol, the water extract filter with all water extract mixings after be condensed into the water extracted immersing paste; The extractum of making, a kind of method are that extractum is passed to granulator under directly, and by the direct spray granulation of granulator, another kind of method is that extractum directly is spray dried to spray powder, granulates again with behind the superfine powder mixing;
1.3 preparation process:
Pelletization is divided into two kinds of method of granulating according to the semi-finished product difference after extracting, and a kind of is that the superfine powder flour is added in the Fluidbedgranulatingdrier with spray drying powder, sprays solvent again and makes granule; Another kind method is earlier to add the superfine powder flour at Fluidbedgranulatingdrier, will extract extractum again and spray into granulation, with the granule made through granulate, add the Borneolum Syntheticum fine powder, spray into the volatile oil that extracts by Lignum Dalbergiae Odoriferae and Lignum Santali Albi, by the capsule filler filling, make capsule behind the mixing.
The preparation method of five kinds of insect medicine micronizing of the present invention can adopt any means of existing ultramicrotechnique, preferably use micronizing equipment sealing better, ultramicro medicine powder yield height, pulverize the very little micronizing unit of loss insect medicine is pulverized, surpass more than 95% less than 100 μ m fine powders through fineness test micronizing medicine fineness.
Superfine communication technique is meant and utilizes medium to make material be subjected to high-speed impact and friction in the mill letter, reaches μ m level granularity micronization technology.The present invention preferably pulverizes with the micronizing unit, this micronizing unit is made up of four groups of stainless steel tank bodies, utilize vacuum selecting crude drugs with winnower facility to realize serialization production, utilize medium under the dither of agitator, producing multiple mechanical forces such as shearing, bump and grinding realizes material grinding, advantage is that the medicated powder mean diameter handled through miniaturization is less than 100 μ m, specific energy consumption is much smaller than jet mill commonly used, and can finish powder surface modification coating operation, reduce the oxidational losses of granule surface activity material; The crushing process closed operation, loss rate is low.The slave unit performance, this unit is the desirable system of processing that present Chinese crude drug is realized the pulverizing of miniaturization, this system has realized the control of electromechanical integration in whole process, GMP compatible, and has refrigerating plant with regulating and controlling temperature, the loss of effective components that causes because of being heated is avoided in assurance, the slave unit performance, this unit is that present Chinese crude drug is realized the desirable system of processing that miniaturization is pulverized.
Five kinds of insect medicines by the advantage that adopts superfine communication technique are in this preparation:
1) make the fineness ratio of medicated powder more even, mean diameter is under 100 μ m, its degree of refinement does not still relate to intervention and the operation on atom or the molecular structure aspect, tangible molecule structure change does not take place, do not influence the change that attribute, pharmacodynamic profile and the function of Chinese medicine cure mainly, guaranteed the stability of Chinese medicine.
2) the composition loss of having avoided causing because of being heated makes membranolysis, accelerates the dissolution of effective ingredient, has improved the quality of the pharmaceutical preparations, and then has improved clinical efficacy.
Existing experimental results show that: TONGXINLUO JIAONANG has improved bioavailability owing to adopt the micronizing improved process, has significantly increased curative effect.This experiment further compares the superfine powder of the different-grain diameter curative effect with regard to above-mentioned effect, adopt epicardial electrogram mapping myocardial ischemia scope and degree, quantitative tissue is learned (N-BT staining) and is measured myocardial infarct size, has observed the influence of TONGXINLUO JIAONANG to experimental dog acute myocardial ischemia.Experimental result confirms that the Tongxinluo superfine powder tries each particle diameter and all has the obvious effect that improves dog acute myocardial ischemia and myocardial infarction, alleviates the degree of myocardial ischemia (∑-ST), reduce myocardial ischemia scope (N-ST) by epicardial electrogram mapping; Obviously reduce by the shown infarct of N-BT dyeing.All there is not evident difference between each group of Tongxinluo.
By micronizing technology the Tongxinluo old technology is transformed at present; have and experimental results show that the new technology main pharmacodynamics of Isodose obviously is better than old technology, the myocardial ischemia that different-grain diameter Tongxinluo superfine powder causes pituitrin all has significant protection and improvement effect.
By micronizing technology the Tongxinluo old technology is transformed at present, had and experimental results show that the new technology main pharmacodynamics of Isodose obviously is better than old technology, the Tongxinluo superfine powder of different-grain diameter all can obviously suppress rabbit experiment thrombosis.
Specific embodiment
Embodiment 1: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter is less than 1 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology:
With reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae decoct with water, after the water extract filters, and extractum to be condensed into; After the alcohol extraction of Radix Ginseng elder generation, the reuse water extraction, alcohol extract is condensed into alcohol-extracted extract after reclaiming ethanol; The water extract filter with all water extract mixings after be condensed into the water extracted immersing paste; The extractum of making, a kind of method are that extractum is passed to the granulation post under directly, and by the direct spray granulation in granulation post, another kind of method is that extractum directly is spray dried to spray powder, granulates again with behind the superfine powder mixing;
C) preparation process:
Pelletization is according to the semi-finished product difference after extracting, be divided into two kinds of method of granulating, a kind of is that the superfine powder flour is added in the granulation drying machine that boils with spray drying powder, spray solvent again and make granule: another kind of method is to add the superfine powder flour at the granulation drying machine that boils earlier, will extract extractum again and spray into granulation.The granule of making is checked behind the granulate mixing, and qualified back is by the capsule filler filling.
Embodiment 2: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 1-5 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 3: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 5-10 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 4: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 10-20 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 5: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 20-30 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 6: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 30-40 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 7: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 40-50 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 8: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 50-60 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching:
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 9: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 60-70 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 10: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 70-80 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching:
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 11: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 80-90 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1;
Embodiment 12: capsular preparation
A) pulverizing medicinal materials technology:
Five kinds of worm medicines are concocted afterwards Olibanum and are prepared burden by recipe quantity through cleaning, wash to handle the back and clean, and are pulverized by pulverizer, and the medicated powder fineness reaches more than 80 orders.Medicated powder behind the coarse powder carries out micronizing through super micron mill, and medicated powder fineness mean diameter reaches 90-100 μ m, and medical material to be pulverized is through cleaning for after doing sterilization batching;
B) extract concentrated and dried behaviour's technology: see embodiment 1;
C) preparation process: see embodiment 1.