WO2008106821A1

WO2008106821A1 - A chinese medicine composition and the extract of worms thereof and their preparation

Info

Publication number: WO2008106821A1
Application number: PCT/CN2007/000707
Authority: WO
Inventors: Yiling Wu
Original assignee: Hebei Yiling Medicine Research Institute Co., Ltd.
Priority date: 2007-03-05
Filing date: 2007-03-05
Publication date: 2008-09-12
Also published as: KR20100005064A; CN101657208A; HK1137661A1; KR101082007B1; RU2009132927A; RU2427381C2; CN101657208B

Abstract

A method for preparation of a Chinese medicine composition, wherein the composition is made from Semen Ziziphi SpinosaeA method for preparation of an extract of worms, wherein the extract is made from Scorpio, Scolopendra, Eupolyphaga Seu Steleophaga, Periostracum Cicadae and Hirudo.The Chinese medicine composition and the extract obtained by said methods.

Description

Traditional Chinese medicine composition, insect extract containing same and preparation method thereof

The present invention relates to a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases, an extract thereof, and a preparation method thereof. Background technique

Coronary atherosclerotic heart disease refers to the formation of plaques in the coronary artery wall, resulting in stenosis or obstruction of the vascular lumen, causing myocardial ischemia and hypoxia. It is classified as ischemic heart disease with coronary artery spasm.

Professor Wu Yiwei pioneered the theory of traditional Chinese medicine collateral disease, explored the pathogenesis of coronary heart disease, and applied five kinds of insecticides such as scorpion, entertainment, earthen, 7J and scorpion to the treatment of coronary heart disease and angina pectoris. Developed Tongxinluo capsule, which has unique curative effect on diseases such as coronary heart disease, angina pectoris and cerebral thrombosis. Tongxinluojiao has obtained the Chinese patent (ZL01131203. 3), which consists of scorpion, leeches, cockroaches, earthworms, cockroaches, ginseng, frankincense, red peony, scent, sandalwood, borneol and jujube kernel. Its unique feature is the concentrated application of the five kinds of sputum, leeches, cockroaches, earthworms and cockroaches. Tongxinluo capsule has a good effect in the treatment of coronary heart disease, angina pectoris, especially variant angina pectoris.

Because of the many difficulties in the development and application of insecticides, for example, most active ingredients are not completely clear, the extraction and purification methods are not mature, and there is no reference substance. Therefore, the traditional direct pulverization method is generally used in the existing production processes. The insect medicine is made into a medicine powder. However, the conventional pulverization process has the following problems: 1) The cell structure of the worm drug cannot be destroyed. Therefore, the active ingredient in the medicinal material is difficult to fully release and dissolve through the cell membrane; 2) the temperature of the material during the pulverization process due to the influence of mechanical heat energy Up to 80 °C, which has a negative impact on the stability of the active ingredients of the protein of the insecticide; 3) The degree of difficulty in crushing different parts of the insect medicine is different, the mixing is uneven due to the difference of the particles, and the quality of the product is affected. Uniformity. These problems directly affect the stability of the drug's medicinal ingredients and the absorption of the body, so that the efficacy of the drug cannot be fully utilized.

CN1593623A (Application No.: 200410049615. X) discloses a Tongxinluo Orally Disintegrating Tablet and a preparation method thereof, wherein the orally disintegrating tablet is composed of water extract of scorpion, leeches, mites, earthworms, cockroaches 15― 70 parts by weight, ginseng, erythraea ethanol extract 1-12 parts by weight, borneol inclusion complex 10 - 100 parts by weight and medicinal excipients. The preparation method is characterized in that: the macroporous resin adsorption technology is adopted for the removal of impurities of the botanical material, and the five kinds of insect medicines are extracted by ultrasonic vibration and concentrated by a rotary doctor blade method.

Ultrasonic extraction is applied to five kinds of insect medicines. Since the extraction temperature is room temperature, some active ingredients that require high temperature extraction are impossible to obtain by ultrasonic extraction alone. Therefore, an unsuitable preparation method not only affects the exertion of the drug effect, but also causes waste of precious insect medicines.

In the existing traditional Chinese medicine preparation process, most of the insect medicinal materials are directly pulverized, decoction (95 - 100 ° C), 60% ethanol warming (60. 0, brine warming (60 ° C), etc. In the method, low-temperature extraction can not completely extract the active ingredients, and decoction (95 - 100 Ό) will destroy some active ingredients.

So far, more desirable methods for extracting insecticides have not been disclosed in the prior art, especially the technique of extracting insecticides that combines low temperature extraction and high temperature extraction. Summary of the invention

After long-term research and experiments, we found that: the effective ingredients obtained by low-temperature extraction of insects such as scorpion, leeches, snails, earthworms, cockroaches, etc. are very limited, far from being full and complete; After low-temperature dynamic reflux extraction (that is, using a vacuum system to bring it to a negative pressure state, the boiling point can be lowered, and the solvent can be boiled at a lower temperature, thereby avoiding the disadvantage that the active ingredient in the medicinal material is damaged due to excessive temperature. , can quickly extract the heat-sensitive components in the medicine, compete for low cost and environmental pollution, shorten the production cycle), and then extract the high temperature of the drug residue, the effect of the obtained extract is lower than pure low-temperature extraction or direct The comminution is greatly improved, and the amount of administration can be reduced, and the irritation to the stomach can be reduced.

Accordingly, it is an object of the present invention to provide a traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases, an insect extract containing the same, and a method for preparing the same, based on the prior art.

The preparation method of the traditional Chinese medicine composition for treating cardiovascular and cerebrovascular diseases provided by the invention comprises: weighing the whole cockroach, leeches, cockroaches, earthworms, cockroaches, ginseng, frankincense, red peony, fragrant, sandalwood according to the prescription amount Extracting the above-mentioned bulk drug, extracting the extract, and preparing the extract; wherein the extraction of the whole cockroach, leeches, cockroaches, earthworms, cockroaches includes the following Steps: (1) pulverize the insect drug into a coarse powder; (2) add 8-12 times the amount of water to the coarse powder, raise the temperature to 25 - 65 ° C, extract 1 - 3 times, each time 1-5 hours , separating the extract and the dregs; (3) adding 8-12 times of water to the dregs, heating to 70-100 ° C, extracting 1 - 3 times, each time 1-3 hours, separating the extract and the medicine (4) Combine the extract obtained in the above step, and obtain the insect extract by concentration and drying.

The invention also provides a traditional Chinese medicine composition product prepared according to the above preparation method, wherein the dosage form used in the product is selected from the group consisting of: a tablet, an orally disintegrating tablet, a dispersible tablet, an effervescent tablet, a capsule, a pill, a granule Any one of a dose, an oral solution, a pellet, a microcyanide, and a spray.

In addition, the present invention also provides an insect medicine extraction method, wherein the insect medicine is composed of whole cockroaches, leeches, cockroaches, earthworms, cockroaches, and includes the following extraction steps: (1) worm medicine Crushed into coarse powder; (2) Add 8 - 12 times of water to the coarse powder, raise the temperature to 25 - 65 °C, extract 1 - 3 times, each time for 1 - 5 hours, separate the extract and dregs; 3) Add 8-12 times of water to the dregs, raise the temperature to 70-100 ° C, extract 1 - 3 times, each time 1-3 hours, separate the extract and dregs; (4) Combine the above steps The obtained extract was concentrated and dried to obtain an insect extract.

Accordingly, the present invention also provides an insect drug extract prepared according to the above extraction method, wherein the color of the insect drug extract is brownish yellow to blackish yellow, and the gas is salty and salty. The contents of the present invention will be described in detail below.

The traditional Chinese medicine composition of the present invention comprises: ginseng 3- 10 g, leech 3- 11 g, soil aphid 5-10 g, frankincense 1 to 5 g, red oak 3-9 g, 'decocting 1 to 5 g, 1 to 5 grams of sandalwood, 3 - 9 grams of whole glutinous rice, 3 - 12 grams of medlar, 1 - 3 grams of medlar, 1 - 7 grams of water, and 3 - 10 grams of jujube. For more details, please refer to the description in ZL01131203.3.

In the step of extracting the insect medicine according to the present invention, the five herbs of the leeches, the cockroaches, the cockroaches, the earthworms, and the cockroaches may be extracted separately or together. The extraction steps of the insect medicine are described in detail as follows:

Step (1): The above-mentioned insect medicine is pulverized into a coarse powder of 18-40 mesh, preferably a coarse powder of 24 mesh. Step (2): adding 8 - 12 times the amount of water to the coarse powder, preferably 10 times the amount of water; heating to 25 - 65 ° C; extracting 1 - 3 times, preferably 2 times; each time 1 - 5 hours, Preferably 3 hours; From the extract and dregs. In the specific preparation process, the step may be carried out by low temperature water extraction, low temperature dynamic extraction or ultrasonic extraction. When low temperature water extraction is employed, the extraction temperature is preferably about 50 °C. When the low temperature dynamic extraction is used, the extraction process is performed under reduced pressure. For example, the degree of vacuum may be 0.05 to 0.1 MPa, and the mixture is simultaneously stirred to boil the water under low temperature conditions, thereby allowing extraction. The process goes faster and more completely. When ultrasonic extraction is used, the output power and oscillation frequency of the ultrasonic extraction device should be appropriately controlled. The output power of the ultrasonic extraction device is feasible in the range of 200-10000 W, preferably 250-8000 W, more preferably 1000-6000 W or 2000- 6000W, the oscillation frequency of the ultrasonic extraction equipment is feasible range of 20-80KHz, preferably 20-60KHz, more preferably 30-50KHZ; 200-2000 20-80KHz can be used under laboratory conditions; 2000 can be used in industrial production process - 10000 W, 20 - 80 KHz, wherein, preferably, 3000-8000 W, 30-60 KHz, and the temperature of the extract is controlled within a desired range. The extraction temperature of the ultrasonic extraction is preferably 30 - 5 (TC, more preferably about 40 °C.

Step (3): adding 8 - 12 times the amount of water to the dregs obtained in the step (2), preferably 10 times the amount of water; heating to 70 - 100 ° C, preferably 95 ° C; extracting 1 - 3 times, preferably 2 times; each time 1

- 3 hours, preferably 2 hours each time; separating the extract and the dregs.

Step (4): Combine the extract obtained in the above step, and obtain the insect extract by concentration and drying. The concentration process described in this step is preferably carried out at 50 to 60 ° C to concentrate the extract into a density of 1. 05 - 1. 10g / cffi ³ ; the drying process is preferably 50 - 60 The resulting clear paste was dried under reduced pressure at °C. In the method for preparing a traditional Chinese medicine composition provided by the present invention, the extraction of the ginseng may be, but is not limited to, any one of the following methods:

1. Take ginseng herbs and extract them with 4 - 12 times 40-95% ethanol for 1-3 times, each time 1

- 2 hours, the extracts are combined, filtered, and ethanol is recovered from the extract, and the residue obtained by recovering the ethanol is concentrated or dried or spray-dried to obtain a ginseng extract.

1. Take ginseng herbs, 4 - 12 times 40-95% ethanol reflux for 1-3 times, each time 1-2 hours, combine the extracts, filter, recover ethanol from the extract to no alcohol, add 6 - dissolve the solution with 8 times the amount of medicinal material. Pass the solution through the treated macroporous adsorption resin column, first wash it with 3 - 8 column volumes of water until colorless, discard the water wash solution, and then use 40 - 95 % ethanol. Elution, yield The eluate is recovered from ethanol, concentrated, dried under reduced pressure or spray dried to obtain a ginseng extract.

3, take ginseng herbs, 4-12 times the amount of ⁴ 0-95% ethanol reflux extraction 1-3 times, each time 1-2 hours, combined extract, filtered, ethanol recovery from the extract to no alcohol, add 6- 8 times the amount of medicinal material to dissolve it, pass the solution through the treated macroporous adsorption resin column, first wash it with 3-8 column volumes of water until colorless, discard the water washing solution, and then use 40 - 95% ethanol. After elution, the obtained eluate is passed through an alumina column and then eluted with 40-80% ethanol. The obtained eluate is recovered into ethanol, concentrated, dried or spray-dried to obtain a ginseng extract.

4, take ginseng herbs, 4- 12 times the amount of water reflux extraction 1-3 times, each time 1-3 hours, combined with aqueous extracts, filtered, and concentrated to 2 - 4 times the amount of herbs, heat (40 - 80 ° C) Add ethanol to the obtained concentrate to achieve an ethanol concentration of 40 - 90%, let stand for more than 12 hours, take the supernatant, recover the ethanol to an alcohol-free taste, add 6-8 times the amount of water to dissolve , through the macroporous adsorption resin column, first wash with water until colorless, discard the water wash, and then elute with 3-8 times column volume 40 - 95% ethanol, the eluate is passed through the alumina column, and then used 3- 6 column volumes of 40 - 80% ethanol were eluted, and the obtained eluate was recovered from ethanol, concentrated under reduced pressure or spray dried to obtain a ginseng extract. In the method for preparing a traditional Chinese medicine composition provided by the present invention, the extraction of the red peony may be, but is not limited to, any one of the following methods:

1. Take the red peony root, extract it 1-4 times with 4-12 times 40-90% ethanol, 1-3 hours each time, combine the extract, filter, recover the ethanol from the extract, recover the ethanol. The residue is concentrated or spray dried to obtain a red peony extract.

2, red peony take medicine, with 40-90% ethanol under reflux for ^4-12 times the amount of extracted I- ³ times, 1-2 hours each time, the combined extracts were filtered, recovering ethanol from the extract to no alcohol odor Add 6-8 times the amount of medicinal material to dissolve it. Pass the solution through the ruthenium-treated macroporous adsorption resin column, first wash it with 3-8 column volumes of water until colorless, discard the water wash solution, and then use 3- 8 The column volume is eluted with 30-90% ethanol, and the obtained eluate is recovered from ethanol, concentrated and dried or spray-dried to obtain an extract of red peony.

3. Take the red peony medicinal herbs and reflux the extracts with 4- 12 times of 40-90% ethanol for 3 times, each time for 1-2 hours, combine the extracts, filter, and recover the ethanol from the extract to the non-alcoholic taste. , 力口6 -8 times the amount of medicinal material to dissolve it, pass the solution through the treated macroporous adsorption resin column, first wash it with 3- 8 column volume water until colorless, discard the water eluent, then use 3 - 8 times The column volume is eluted with 30-90% ethanol, and the obtained alcohol eluate is passed through an alumina column and rinsed with 30-80% ethanol. The obtained washing liquid is recovered into ethanol, and then concentrated under reduced pressure or spray-dried to obtain a red peony extract.

4. Take the red peony medicinal material and extract it 1-3 times with 4- 12 times water, 1-2 hours each time, combine the aqueous extract, and concentrate it to 2 - 4 times the amount of medicinal material, 趁 heat ( 40 - 80 ° C) Add ethanol to the obtained concentrated solution to achieve an ethanol concentration of 60 - 85 %, let stand for more than 12 hours, take the supernatant, recover the ethanol to an alcohol-free taste, add 6-8 times the amount of water to dissolve , through the processed macroporous adsorption resin column, first washed with 3- 8 column volumes of water until colorless, discard the water eluent, and then elute with 3- 8 column volume 30 - 90% ethanol, The obtained eluate is further passed through an alumina column and eluted with 3-6 column volumes of 30-80% ethanol. The obtained eluate is recovered from ethanol, concentrated under reduced pressure or spray-dried to obtain an extract of red peony.

5. Take the red peony medicinal material and extract it 1-3 times with 4- 12 times of 30-90% ethanol reflux, 1-2 hours each time, combine the alcohol extract, filter, recover the ethanol to the non-alcohol flavor, add 6- 8 times the amount of medicinal material to dissolve it, let stand for more than 12 hours, take the supernatant, pass it through the processed macroporous adsorption resin column, first wash with 3-8 times column volume water until colorless, discard the water wash After deliquoring, it is further washed with 38 column volumes of 30-90% ethanol, and the obtained eluate is passed through an alumina column and then eluted with 40-80% ethanol. The obtained washing liquid is recovered from ethanol, and then concentrated under reduced pressure or sprayed. Dry, and obtain red peony extract. In the preparation method of the traditional Chinese medicine composition provided by the present invention, the extraction of the jujube kernel may be, but is not limited to, any one of the following methods:

1. Take the jujube seed medicine, extract it 1-3 times with 4-12 times of 40-90% ethanol, 1-3 hours each time, combine the extract, filter, recover the ethanol from the extract, reduce the water The extract of Suanzaoren is obtained by pressure concentration drying or spray drying.

2. Take the jujube seed medicine, extract it 1-3 times with 4- 12 times of 40-90% ethanol, 1-3 hours each time, combine the extracts, filter, and recover the ethanol from the extract to the non-alcoholic taste. Add 6-8 times of the medicinal material to dissolve the water. Pass the aqueous solution through the treated macroporous adsorption resin column, first wash it with 3- 8 column volume water until it is colorless, discard the water washing solution, and then use 3-8 Double column volume After elution with 30 - 90% ethanol, the obtained eluate is recovered from ethanol, concentrated and dried or spray-dried to obtain a jujube extract.

3. Take the jujube seed medicine, extract it 1-3 times with 4 - 12 times of 40-95% ethanol reflux, each time for 1-3 hours, combine the extract, recover the ethanol to the non-alcohol flavor, add 6 - 8 times the medicinal material Dissolve in water, let stand for more than 12 hours, take the supernatant, pass it through the processed macroporous adsorption resin column, first wash it with 3- 8 column volume water until colorless, discard the water wash, and then use 3- 8 column volume 30 - 90% ethanol rinse, the resulting eluate passes through the alumina column, then 40 - 80

After elution with % ethanol, the obtained eluate is recovered from ethanol, concentrated under reduced pressure or spray-dried to obtain an extract of jujube kernel.

4. Take the jujube seed medicine, extract it 1-3 times with 4 - 12 times water, 1-3 hours each time, combine the water extract, and concentrate it to 2 - 4 times the amount of the medicine, heat (40 - 8(TC) Add ethanol to the obtained concentrate to make the ethanol concentration reach 60 - 85 %, let stand for more than 12 hours, take the supernatant, recover the ethanol to the non-alcoholic taste, add 6 - 8 times the amount of the medicine to dissolve it. , through the processed macroporous adsorption resin column, first washed with 3-8 column volumes of water until colorless, discard the water washing solution, and then elute with 3- 8 times column volume 30 - 90% ethanol, the resulting washing The solution is dehydrated and then passed through an alumina column and eluted with 3-6 column volumes of 30-80% ethanol. The obtained eluate is recovered from ethanol, and then concentrated under reduced pressure or spray-dried to obtain an extract of Suanzaoren. In the method for preparing a traditional Chinese medicine composition, the extraction of the reduced fragrance may be, but is not limited to, any one of the following methods:

1. Take the fragrant herbs, distill with 4 - 15 times the amount of water, extract the volatile oil for more than 4 hours, collect the volatile oil, and obtain the extract of the scent.

2, taking the fragrant herbs, using supercritical C0 ₂ extraction, adding 10 - 50% of the amount of 70 - 100% ethanol as an entrainer, collecting the extract, drying, to obtain the extract.

3. Take the fragrant herbs, extract the volatile oil with 4 - 15 times the amount of petroleum ether for more than 4 hours, recover the petroleum ether, collect the volatile oil, and obtain the extract. In the preparation method of the traditional Chinese medicine composition provided by the present invention, the extraction of the sandalwood may be, but is not limited to, any one of the following methods: 1. Take the sandalwood medicinal herbs, distill with 4 - 15 times the amount of water, extract the volatile oil for more than 4 hours, collect the volatile oil, and obtain the sandalwood extract.

2, take sandalwood herbs, using supercritical C0 ₂ extraction, add 10 - 50% of the amount of 70 - 100% ethanol as an entrainer, collect the extract, dry, to make sandalwood extract.

3. Take the sandalwood medicinal herbs and extract the volatile oil by refluxing with 4 - 15 times of petroleum ether for more than 4 hours, recover petroleum ether, collect volatile oil, and obtain sandalwood extract. In the preparation method of the traditional Chinese medicine composition provided by the present invention, the extraction of the malt-like scent may be, but is not limited to, any one of the following methods:

1. Take the frankincense medicinal material, distill it with 4 - 15 times the amount of water, extract the volatile oil for more than 4 hours, collect the volatile oil, and prepare the frankincense extract.

2. Take the frankincense herbs, extract the volatile oil by steaming with 4 - 15 times the amount of water for more than 4 hours, collect the volatile oil; the remaining dregs, freeze-dry, the obtained volatile oil and dried matter are the extract of frankincense.

3. Take the frankincense medicinal material, extract it with supercritical C0 ₂ , add 10 - 50% of the amount of 70-100% ethanol as the entrainer, collect the extract, and dry to obtain the frankincense extract.

4. Take the frankincense medicinal material, extract it with 4 - 15 times the amount of petroleum ether for more than 4 hours, recover the petroleum ether under reduced pressure, collect the extract, and prepare the frankincense extract.

5, take the frankincense herbs, steam with 4 - 15 times the amount of water, extract the volatile oil for more than 4 hours, collect the volatile oil; the remaining dregs with 4 - 15 times the amount of ethanol extracted 1 - 3 times, each 1 - 2 hours The alcohol solution is combined and concentrated, dried under reduced pressure or freeze-dried, and the obtained volatile oil and dried product are the extract of the frankincense. In the preparation method of the traditional Chinese medicine composition provided by the present invention, the inclusion compound of the borneol can be prepared by the following method: taking the borneol medicine according to the prescription amount, pulverizing to 60 mesh for use; taking another 1-3 times the amount of borneol Polyethylene glycol-6000, heated and melted at 60-80 ° C, and then added borneol fine powder, stirred rapidly, chilled after low temperature cooling and pulverized into a fine powder, for example, 60 mesh, to prepare a borneol clathrate. In the preparation method of the traditional Chinese medicine composition provided by the present invention, the insecticide-like medicine, the rest The seven traditional Chinese medicines are preferably extracted or prepared according to the following steps:

- Take the ginseng medicinal materials according to the prescription, pulverize into coarse powder, and extract twice with 10 times 70% ethanol, 2 hours each time, the extraction temperature is 95 °C, combine the extracts, recover the ethanol to the non-alcoholic taste, add water Up to 10 times the amount of medicinal material, let stand for 12 hours, filter, filtrate through the processed AB-8 macroporous adsorption resin column, first rinse the resin column with 4 times column volume of water to colorless, discard the water wash solution, and then use Rinse the resin column with 5 column volumes of 70% ethanol, concentrate the solution, and spray dry to obtain ginseng extract;

- Take the red peony medicinal material according to the prescription, pulverize it into a coarse powder, and extract it twice with 10 times of 50% ethanol, and extract for 2 hours each time. The extraction temperature is 95. C, combine the extract, recover the ethanol to a non-alcoholic taste, add water to 8 times the amount of the medicine, let stand for 12 hours, filter, and pass the filtrate through the treated AB-8 macroporous adsorption resin column, first use 5 times column volume of water Rinse the resin column until it is colorless, discard the water washing solution, rinse the resin column with 5 column volumes of 70% ethanol, concentrate the solution, and spray dry to obtain the red peony extract;

- Take the jujube seed medicine according to the prescription, pulverize it into coarse powder, and then extract it twice with 10 times 80% ethanol, the extraction time is 2 hours, the extraction temperature is 95 °C, the extract is combined, and the ethanol is recovered to no alcohol. Flavor, add water to 8 times the amount of herbs, let stand for 12 hours, filter, filtrate through the processed AB-8 macroporous adsorption resin column, first rinse the resin column with 4 column volumes of water to colorless, discard the water wash Then, the resin column is washed with 5 column volumes of 80% ethanol, and the washing liquid is concentrated and spray-dried to obtain a jujube kernel extract;

- Take the medicinal herbs according to the prescription, and distill the water for 8 hours in 8 times to collect the volatile oil;

- Take the sandalwood medicinal herbs according to the prescription, and distill the water for 8 hours in 8 times to collect the volatile oil;

- Take the boswellic medicinal materials according to the prescription amount, and distill the water for 8 hours in 8 times, collect the volatile oil, and extract the slag with 6 times of ethanol for 2 times, each time for 1 hour, combine the alcohol extracts, and concentrate and dry under reduced pressure;

- Take the borneol according to the prescription, grind it, add 2 times the amount of molten matrix PEG6000, stir rapidly, cool at 4 °C, for example, it can be cooled and pulverized at 0 °C - ²⁰ °C. In the above extraction process of the drug substance, the macroporous adsorption resin column is selected from the group consisting of: D101, NKA-9, DA201, DM130, WLD-3, HPD-400, HPD-450, HPD- Any one of 500, AB-8; the alumina column may be an acid alumina column, Neutral alumina column or basic alumina column.

In the extraction process of the above raw material drug, the ginseng extract contains not less than ginseng total saponin

10 - 60%; the total extract of red peony root contains not less than 15 - 70%; and the extract of jujube kernel contains not less than 10 - 60% of total saponin.

In the extraction method of the present invention, the scent, sandalwood and savory may be separately extracted, or two or three of them may be extracted together.

The traditional Chinese medicine composition product provided by the invention is prepared according to the above method, and the dosage form used in the product may be a tablet, an orally disintegrating tablet, a dispersible tablet, an effervescent tablet, a capsule, a pill, a granule, Any of a dosage form such as an oral solution, a pellet, an elixir, or a spray. Excipients used in this product are selected from the group consisting of: disintegrants, fillers, lubricants, binders, adsorbents, dispersants, surfactants, suspensions, preservatives, colorants, antioxidants, suspending agents, One or a mixture of one or more of a wetting agent, a solubilizer, a propellant, and a coating agent.

In the insect drug extract provided by the present invention, the insect medicine is composed of whole mites, leeches, mites, earthworms, and earthworms. The five-flavored drugs can be extracted separately or together. The extraction step of the insect drug has been described in detail in the foregoing, and therefore will not be repeated here.

Compared with the prior art, since the invention adopts a combination of low-temperature extraction and high-temperature extraction to fully extract the insect medicine, the obtained extract has a greatly improved pharmacological effect than the simple low-temperature extraction, and thus can be greatly improved. Significantly reduce the amount of insecticides. The traditional Chinese medicine composition product provided by the invention has the characteristics of advanced technology, more effective curative effect and small dosage. It can be seen from the pharmacodynamic comparison experiment that the traditional Chinese medicine composition product provided by the invention has more ideal effects against myocardial ischemia and anti-platelet aggregation, treatment of coronary heart disease, angina pectoris, and heart and blood stasis. detailed description

The method and product thereof provided by the present invention are further illustrated by the following examples, but the invention is not limited thereby. Example 1

This example illustrates: an insect drug extract prepared according to the method provided by the present invention and A capsule of a pharmaceutical composition.

Leeches were taken by prescription medicine 2075g, Eupolyphaga herbs 1375 g, 275 g of herbs centipede, scorpion 1375 g herbs, herbs cicada 1375 _g, pulverized to 24 mesh coarse powder, to 10 times the amount of injection water, warmed to 60 ° C, the dynamic The extract and the dregs were separated by extracting for 3 hours. Eight times the amount of water was again injected into the obtained dregs, and the temperature was raised to 60 ° C, and the mixture was dynamically extracted for 2 hours to separate the extract and the dregs. 10 times of water was injected into the obtained dregs, the temperature was raised to 95 ° C, and the extraction was carried out for 2 hours, and the extract and the dregs were separated. Eight times the amount of water was again injected into the obtained dregs, the temperature was raised to 95 ° C, and the extraction was carried out for 1 hour, and the extract and the dregs were separated. The four aqueous extracts obtained were combined and concentrated to a density of 1.20 g/cm ³ at 55 ° C by a spherical vacuum concentration device (Model QN-500, produced by Wenzhou Lihong Light Industry Machinery Co., Ltd.). The clear paste (measured at 40 °C) was dried in a vacuum drying oven (model DGT2006, manufactured by Chongqing Hengda Instrument Factory), and the obtained clear paste was dried at 60 ° C to obtain 1180 g of the insect extract.

According to the prescription, the ginseng medicinal material was taken for 1,100, and the ginseng medicinal materials were extracted three times with 10 times, 8 times and 6 times of 70% ethanol. The extraction time was 1 hour, 2 hours and 1 hour respectively. 95 ° C; Combine the extract, recover the ethanol to a non-alcoholic taste, add water to 10 times the amount of the drug (ml / g), let stand for 12 hours, filter, the filtrate passed through the processed AB-8 macroporous adsorption resin column ( Produced by Wuxi Xuelang Pharmaceutical Chemical Equipment Factory), the ratio of ginseng medicinal materials to resin is 1: 2 (g/ral), and the diameter ratio of the resin column is 1:9. Rinse the resin column with 4 column volumes of water until colorless, discard the water wash solution, then rinse the resin column with 5 column volumes of 70% ethanol, concentrate the solution, and spray dry to obtain ginseng column purified product 40.5 _g. .

According to the prescription, 950g of Radix Paeoniae Alba was taken and pulverized into coarse powder. It was extracted three times with 10 times, 8 times and 6 times of 50% ethanol. The extraction time was 2 hours, 1 hour and 1 hour respectively. The temperature was 95 ° C, the extracts were combined, and ethanol was recovered. The obtained liquid was concentrated to a density of 1.18 g/cra ³ (55 ° C), and spray-dried to obtain 250 g of erythritol extract.

According to the prescription, 925g of jujube seed medicine was pulverized, and it was smashed by 8 times, 8 times and 6 times of 80°/. The ethanol was refluxed for 3 times, the extraction time was 2 hours, 1 hour and 1 hour, respectively, the extraction temperature was 95 ° C, the extracts were combined, the ethanol was recovered to an alcohol-free taste, and the obtained liquid was concentrated to a density of 1.18 g/cm ³ (50 The clear paste of °C was spray-dried to obtain 130g of the alcohol extract of jujube.

Take 475g and 450g of fragrant and sandalwood medicinal materials according to the prescription amount, steam distillation extraction After oiling for 6 hours, 11 ml of scented and sandalwood volatile oil was obtained, and the aqueous extract was concentrated to a density of 1.18 g/cm ³ (measured at 50 ° C). The spray was dried to obtain a fragrance and sandal perfume. Extract 18g.

According to the prescription, 450g of Frankincense medicinal material was taken and pulverized into 80 mesh fine powder.

Take 275g of borneol according to the prescription, grind finely, add 280g of molten matrix PEG6000 (polyethylene glycol-6000, provided by Tianjin Guangfu Fine Chemical Research Institute), add the volatile oil prepared in the above step, stir evenly, tilt The mixture was cooled in a freezer and pulverized through a 60 mesh sieve to obtain 556 g of borneol and volatile oil clathrate.

Combine the above-mentioned insects, ginseng, red peony, jujube kernel, scent, sandalwood extract, granulate with 70% ethanol, then add the inclusion compound of emulsified milk powder, borneol and volatile oil, mix, fill the rubber嚢 20,000 granules, that is, the traditional Chinese medicine composition product S 1 prepared by the method of the present invention is obtained. Example 2

This example illustrates: an insecticide extract prepared according to the method of the present invention and a tablet of the same.

According to the prescription amount, 2075g of medicinal herbs, 1375g of scorpion medicinal materials, 275g of medicinal herbs, 1375g of medicinal herbs, 1375g of medicinal herbs, and pulverized into 24th coarse powder, and 10 times, 8 times and 8 times of water were added. Ultrasonic extraction three times (250W, 40KHZ, 35 °C), extraction time is 1 hour, 2 hours and 1 hour, respectively, combined with water extract, into the dregs, 10 times and 8 times the amount of water, at 95 ° The heat extraction was carried out twice under C, and the extraction time was 2 hours and 1 hour, respectively, and the five aqueous extracts were combined. Using the same concentration and drying equipment and conditions as in Example 1, the aqueous extract was first concentrated to a density of 1.18 g/cm ³ (4 (TC)), and then dried under reduced pressure at a low temperature to obtain leeches, The total water extract of the soil mites, cockroaches, cockroaches and cockroaches was 1175 g.

According to the prescription, the ginseng medicinal material was ll OOg, and the ginseng medicinal materials were extracted three times with 10 times, 8 times and 6 times of 70% ethanol. The extraction time was 2 hours, 2 hours and 1 hour respectively. The extract was combined at 95 ° C, and the ethanol was recovered to an alcohol-free taste. The resulting liquid was concentrated to a clear density of 1.0 g/cm ³ (50 Å), and spray-dried to obtain 220 g of the ethanol extract of ginseng.

According to the prescription, 950g of Radix Paeoniae Alba was pulverized into coarse powder, which was used in 10 times and 8 times. 6 times the amount of water was refluxed and extracted 3 times, the extraction time was 2 hours, 2 hours and 1 hour respectively, the extraction temperature was 99, the extracts were combined, concentrated to 1900 ml, ethanol was added to make the alcohol concentration 70%, and allowed to stand for 12 hours. The supernatant was taken, ethanol was returned to an alcohol-free taste, and the resulting liquid was concentrated to a clear paste having a density of 1.10 g/cm ³ (50 Å), and spray-dried to obtain 230 g of red peony extract.

According to the prescription, 925g of jujube seed was taken and pulverized. It was extracted three times with 10 times, 8 times and 6 times of water. The extraction time was 2 hours, 1 hour and 1 hour respectively, and the extraction temperature was 99 °C. , combined extracts. Concentrate it to 2 times the amount of medicinal material (ml/g), add ethanol to the obtained concentrated solution at a temperature of 60 ° C to make the ethanol concentration reach 80%, let stand for 12 hours, and take the supernatant to recover ethanol to no The mellow taste was further concentrated to a clearing paste having a density of 1.10 g/cm ³ (measured at 50 ° C), and spray-dried to obtain 105 g of the ethanol extract of Suanzaoren.

475g and 450g of fragrant and sandalwood medicinal materials were taken according to the prescription amount, and the volatile oil was extracted by steaming and steaming for 6 hours to obtain llml of fragrant and sandalwood volatile oil. The aqueous extract was concentrated to a clearing paste having a density of 1.10 g/cm ³ (measured at 50 ° C), and spray-dried to obtain a scented and scented scented extract of 18 g.

According to the prescription, 450g of the fragrant herbs were taken and pulverized into fine powder.

Take 275g of water, and grind it.

The above-mentioned insect medicine, ginseng, red peony, jujube kernel, scented, sandalwood extract is pulverized into a fine powder of 80 mesh, uniformly mixed with the fine powder of the emulsified milk, granulated with 70% ethanol, dried, sprayed The borneol and volatile oil dissolved in an appropriate amount of ethanol were sealed for 20,000 sheets by sealing for half an hour to obtain a traditional Chinese medicine composition product prepared by the method of the present invention. Example 3

This example illustrates: an insecticide extract prepared according to the method of the present invention and a soft gelatin agent of a traditional Chinese medicine composition.

According to the prescription amount, 2075g of leeches, 1375g of scorpion medicinal materials, 275g of medicinal materials, 1375g of medicinal herbs, 1375g of medicinal herbs, and pulverized into 24th coarse powder, and 10 times, 8 times and 8 times of water were added. Ultrasonic extraction three times (1500W, 40KHZ, 40 °C), the extraction time is 3 hours, 2 hours and 2 hours respectively, combined with the aqueous extract, inject 10 times and 8 times the amount of water into the dregs, at 98 ° The heat extraction was carried out twice under C, and the extraction time was 2 hours and 1 hour, respectively, and the five aqueous extracts were combined. Use the same concentration and dryness as in Example 1. Drying equipment and conditions, first concentrate the aqueous extract into a clear paste (40 ° C) with a density of 1.10 g / cm ³ , and then dry at a low temperature (55 ° C) under reduced pressure to obtain leeches, soil mites, mites, and cockroaches. , the total water extract of sputum is 1170g.

According to the prescription, 1100g of ginseng medicinal materials were taken. The ginseng medicinal materials were extracted three times with 10 times, 8 times and 6 times of 70% ethanol. The extraction time was 2 hours, 2 hours and 1 hour respectively. The extraction temperature was 95 ° C, combined extract, ethanol recovery to alcohol-free, add water to 10 times the amount of herbs, allowed to stand for 12 hours, filtered, the filtrate passed through the processed AB-8 macroporous adsorption resin column (by Wuxi Xuelang Pharmaceutical) The chemical equipment factory produces), the ratio of ginseng medicinal materials to resin is 1: 2 (g/ral), and the diameter ratio of the resin column is 1:9. Rinse the resin column with 4 column volumes of water until it is colorless, discard the water wash solution, then rinse the resin column with 5 column volumes of 70% ethanol. The eluate is concentrated and spray dried to obtain a ginseng column. 40.5 g.

According to the prescription, 950g of Radix Paeoniae Alba was pulverized into a coarse powder, which was extracted three times with 10 times, 8 times and 6 times of 50% ethanol. The extraction time was 2 hours, 1.5 hours and 1 hour respectively. The temperature is 95 ° C, the extract is combined, the ethanol is recovered to an alcohol-free taste, water is added to 10 times the amount of the drug (ml/g), allowed to stand for 12 hours, filtered, and the filtrate is passed through the processed AB-8 macroporous adsorption resin column. (produced by Wuxi Xuelang Pharmaceutical Chemical Equipment Factory), the ratio of the amount of red peony to resin is 1: 2.2 (g/ml), and the diameter ratio of the resin column is 1:8. Rinse the resin column with 4 column volumes of water until it is colorless, discard the water wash solution, then rinse the resin column with 6 column volumes of 70% ethanol. The eluate is concentrated and spray dried to obtain the red peony column. 92.5g.

According to the prescription, 925g of jujube seed was taken and pulverized into coarse powder. It was extracted three times with 8 times, 8 times and 6 times of 80% ethanol. The extraction time was 2 hours, 2 hours and 1 hour respectively. The temperature was 95 ° C, the extracts were combined, the ethanol was recovered to an alcohol-free taste, water was added to 10 times the amount of the drug (ml/g), allowed to stand for 12 hours, filtered, and the filtrate was passed through a treated D-101 macroporous adsorption resin column ( Produced by Wuxi Xuelang Pharmaceutical Chemical Equipment Factory), the ratio of the amount of jujube seed and resin is 1: 2 (g/ml), and the diameter ratio of the resin column is 1:8. Rinse the resin column with 4 column volumes of water until it is colorless, discard the water wash solution, and then rinse the resin column with 6 column volumes of 80% ethanol. The eluate is concentrated and spray dried to obtain the refined jujube kernel. 32g.

According to the prescription, 475g of fragrant incense, 450g of sandalwood, 450g of frankincense, and steam distillation to extract volatile oil for 6 hours, to obtain fragrant, sandalwood and frankincense volatile oil 21⁄2il. Take 275g of borneol according to the prescription and grind it.

The above extract, the volatile oil, and the borneol fine powder are mixed and hooked; the vegetable oil of the weight of the obtained extract is added in an amount of 1.9 times, and the mixture is ground with a colloid to prepare 20,000 capsules of soft capsules, 2 to 4 capsules each time, 曰The moon is 3 times. Example 4

This example illustrates: an insecticide extract prepared according to the method of the present invention and a pill of a traditional Chinese medicine composition.

According to the prescription amount, 2075g of medicinal herbs, 1375g of scorpion medicinal materials, 275g of medicinal herbs, 1375g of medicinal herbs, and 1375g of medicinal herbs were pulverized one by one, and each medicinal herb was separately extracted. The extraction steps were as follows: Each herbicide was firstly subjected to two low-temperature dynamic extractions; 10 times and 8 times of water were added respectively, and the extraction temperature was 6 (TC, and the extraction time was 3 hours and 2 hours, respectively, and the extract and the dregs were separated; The dregs were subjected to two heat extractions; 10 times and 8 times of water were added to the dregs respectively, and the extraction temperature was 98 ° C, and the extraction time was 2 hours and 1 hour respectively; the four aqueous extracts obtained were combined. Using the same concentration and drying equipment and conditions as in Example 1, the aqueous extract was first concentrated to a clearing paste (40 ° C) having a density of 1.08 g/cm ³ , and then dried under reduced pressure at a low temperature (50 ° C). The worm extract was prepared by the above method. 481 g of aqueous extract of leeches, 262 g of aqueous extract of locusts, 50 g of water extract of hydrazine, 255 g of water extract of cockroach, and 152 g of water extract of cockroach. The extract was a total of 1200 g.

According to the prescription, 1100g of ginseng medicinal materials were taken. The ginseng medicinal materials were extracted three times with 10 times, 8 times and 6 times of 70% ethanol. The extraction time was 2 hours, 2 hours and 1 hour respectively. The extraction temperature was At 95 °C, combine the extracts, recover the ethanol to an alcohol-free taste, add water to 10 times the amount of the drug, let stand for 12 hours, filter, and pass the filtrate through the processed AB-8 macroporous adsorption resin column (by Wuxi Xuelang Pharmaceutical) Produced by Chemical Equipment Factory), the ratio of ginseng medicinal materials to resin is 1: 2 (g/ml), and the diameter ratio of the resin column is 1:9. Rinse the resin column with 4 column volumes of water until colorless, discard the water wash solution, then rinse the resin column with 5 column volumes of 70% ethanol. The resulting eluate is passed through an alumina column (ginseng medicinal material and oxidation). 5克。 The ginseng column purified product 34. 5g. The ginseng column purified product was obtained. 950g of red peony root was taken according to the prescription, pulverized into coarse powder, and extracted three times with 10 times, 8 times and 6 times of 50% ethanol, and the extraction time was 2 hours, 1.5 hours and 1 hour respectively. The extraction temperature was 95 ° C, the combined extracts were recovered, and the obtained supernatant was passed through a treated AB-8 macroporous resin column. The ratio of the amount of the red peony to the resin is 1: 2. 3 (g/ml), and the diameter ratio of the resin column is 1:10. Rinse the resin column with 5 column volumes of water until it is colorless, discard the water wash solution, then rinse the resin column with 8 column volumes of 50% ethanol. The eluate is concentrated to an alcohol-free taste and spray dried to obtain red. 5克。 After passing through the column refined material 94. 5g.

According to the prescription, 925g of jujube seed was taken and pulverized. It was extracted three times with 8 times, 8 times and 6 times of 80% ethanol. The extraction time was 2 hours, 2 hours and 1 hour respectively. The extraction temperature was 95. °C, the extracts were combined, and the ethanol was recovered to an alcohol-free taste. The obtained supernatant was passed through a treated HPD-400 macroporous resin column (manufactured by Zhangzhou Baoen Chemical Co., Ltd.). The ratio of the medicinal material to the resin was 1: 2 (g/ml), and the diameter ratio of the resin column was 1:8. Rinse the resin column with 5 times column of water until colorless. Discard the water wash solution, then wash it with 7 times column volume 80% ethanol. The eluate is concentrated and dried to obtain 34g of refined jujube kernel.

According to the prescription, 475g of fragrant incense, 450g of sandalwood, 450g of frankincense, supercritical C0 ₂ extraction, adding 95% ethanol, which accounts for 30% of the medicinal material, as an entraining agent, and collecting the extract, to obtain 205g of total extract.

Take 275g of borneol according to the prescription, and grind it.

Mix the above extract, extract and borneol fine powder uniformly; according to the ratio of the drug: matrix = 1: 2, melt the base shield PEG6000, then add the drug evenly, heat at 70 ° C, add water and volatile oil Stir well, add 40 drops/min to the liquid paraffin, collect the dropping pills, and remove the paraffin as the cooling liquid with the filter paper to obtain the pills. A total of 200000 pills, each weighing 27mg. Dosage: 20 - 40 pills once a day, 2 _ 3 times a day. Comparative example 1

The comparative example illustrates: a capsule of a traditional Chinese medicine composition prepared by a method in which a medicinal powder is used as a medicine.

According to the prescription amount, 103.75g of water medicinal herbs, 68.75 g of scorpion medicinal materials, 13.75g of medicinal herbs, 68.75g of medicinal herbs, 68.75 g of medicinal herbs, and 80% of medicinal materials are obtained by mechanical pulverization. The target insect medicine powder is 318g.

Take 55g of ginseng medicinal materials according to the prescription, pulverize, extract 3 times with 10, 8 and 6 times 70% ethanol, the extraction time is 2 hours, 2 hours, 1 hour respectively, combine the extracts, recover the ethanol, after recovering the ethanol The residue was concentrated and dried to obtain 11 g of ginseng extract.

According to the prescription, the red peony medicinal material was taken in 47.5 g, pulverized, extracted with 10, 8 and 6 times of 50% ethanol for 3 times, and the extraction time was 2, 1, and 1 hour respectively, and the combined extracts were recovered, and the ethanol was recovered. 8克。 The residue was concentrated and dried to obtain red peony extract 12. 8g.

According to the prescription, the jujube seed medicine 46. 25g, crushed, extracted with 10, 8 and 6 times 80% ethanol for 3 times, the extraction time is 2, 2, 1 hour respectively, the combined extracts recover ethanol, and the residue obtained is concentrated and dried. 5克。 The sour jujube kernel extract 6. 5g.

The scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented scented

According to the prescription, frankincense medicine 22. 50g, crushed into 60 mesh fine powder.

According to the prescription, take the borneol 13. 5g, grind finely, add 14g of molten matrix PEG6000 (polyethylene glycol-6000, provided by Tianjin Guangfu Fine Chemical Research Institute), add the volatile oil prepared in the above step, stir evenly 5克。 The ice slab and the volatile oil inclusion complex 27. 5g.

Combine the above-mentioned insect powder and ginseng, red peony, jujube kernel, scent, sandalwood extract, granulate with 70% ethanol, then add the inclusion compound of emulsified milk powder, borneol and volatile oil, mix, fill the rubber嚢 1000 tablets, that is, the traditional Chinese medicine composition product D1 is obtained. Comparative example 2

The comparative example illustrates: low temperature ultrasonic extraction of the insect medicine, and the obtained extract is used to prepare a traditional Chinese medicine composition.

According to the prescription, 103. 75g of water medicinal herbs, 68.75 g of scorpion medicinal materials, 13.75g of medicinal herbs, 68.75g of medicinal herbs, 68.75 g of medicinal herbs, crushed through a 24 mesh sieve, and the coarse powder was placed. Ultrasonic extraction tank, adding 6 times of water, ultrasonic vibration extraction, extraction time is 50 minutes, ultrasonic vibration power and oscillation frequency are 250W, 40KHZ, control extraction temperature is 20 ° C, extraction 3 times, combined extraction Liquid, filtered, the filtrate obtained is rotated with a rotary scraper The instrument was concentrated, the temperature was controlled at 65 ° C, and dried, and 32 g of ultrasonic water extract was obtained. The amounts of ginseng, red peony, jujube kernel, frankincense, scent, sandalwood, borneol and preparation method were the same as in Example 1.

Combine insecticide, ginseng, red peony, jujube kernel, scent, sandalwood extract, granulate with 70% ethanol, add clathrate powder, water tablet and volatile oil inclusion compound, mix hook, fill rubber嚢 1000 tablets, that is, the traditional Chinese medicine composition product D2 is obtained. Comparative example 3

This comparative example illustrates a capsule of a traditional Chinese medicine composition prepared by a method in which a medicinal powder is used as a medicine.

According to the prescription, 103. 75g of water medicinal herbs, 68.75 g of scorpion medicinal materials, 13.75g of medicinal herbs, 68.75g of medicinal herbs, 68.75 g of medicinal herbs, and 80% of medicinal powders obtained by mechanical pulverization. 318g.

The amounts of ginseng, red peony, jujube kernel, frankincense, scent, sandalwood, borneol and preparation were the same as in Example 1.

Combine insecticide, ginseng, red peony, jujube kernel, P-flavor, sandalwood extract, granulate with 70% ethanol, add clathrate powder, water tablet and volatile oil inclusion compound, mix and fill The capsule is 1000 tablets, that is, the traditional Chinese medicine composition product D3 is obtained. Pharmacological experiment section:

Contrast risk 1

Experimental purposes: The effects of traditional Chinese medicine compositions obtained by different preparation methods on acute myocardial ischemia in rats.

The drug is administered in an amount of 1. 2 g of crude drug / Kg, 0.6 g of crude drug / Kg and 0.3 g of crude drug / Kg; 1 - 3 prepared capsules Dl, D2 and D3, the amount of which was 0. 6 g of crude drug / Kg; another sham operation group and model control group.

Experimental animals: SD rats, clean grade, male and female, 112, weighing 220-240 g, purchased from Beijing Weitong Lihua Experimental Animal Technology Co., Ltd., license number: SCXK (Beijing) 2002-0003. Modeling and index detection methods: After 30 minutes of the last administration, urethane was anesthetized, and the pre-operative II lead electrocardiogram was measured. The skin was cut along the midline of the left clavicle for about ² cm, and the blunt dissection muscles were interposed between the 3rd and 4th intercostals. Layer, open the chest, cut the happy bag, gently press the right thoracic cavity, expose the heart, ligature the left anterior descending coronary artery through the superficial myocardium at the left edge of the pulmonary artery cone and the lower edge of the left atrial appendage. Without ligature), put the heart back into the chest and quickly suture the chest.

Remove the fresh heart, discharge the blood in the heart chamber, rinse with normal saline and absorb the water with filter paper, remove the non-myocardial tissue such as fat blood vessels and weigh it, then freeze at about 4 °C for about 1 hour and then take it out along the atrioventricular groove. The apex of the ventricle was cut into a thickness of about 0.1 cm. The myocardial piece was washed with physiological saline and placed in a solution of 1% TTC (pH 7.4 phosphate buffer solution) at 37 ° C. The cells were stained for 15 minutes under water bath conditions. Immediately after staining, the excess dye was rinsed with distilled water, the infarcted area and the non-infarcted area were separated and weighed, and the myocardial infarct range was calculated. At the same time, the stained myocardial sheet was photographed using an image analyzer. The total area of the myocardium and the area of the infarct area, leaving a typical ischemic myocardium picture, calculated the percentage of area of myocardial infarction.

Statistical methods: The actual t is expressed as the mean soil standard deviation (±SD), and the t test is performed using SPSS 11. 5 software. t is the approximate form of the standard normal distribution and is the basic concept of statistics.

Experimental results: See Table 1 for the specific experimental results.

Analysis: Compared with the model group and the D1-D3 group, the percentage of myocardial ischemic area weight and heart weight in the middle and high dose groups of S1 was significantly lower (P<0.05 or P<0.01); and the model group and Dl - In the D3 group, the percentage of myocardial ischemic area and total myocardial area in the high, medium and low dose groups of S1 was significantly lower (P<0.05). P is the probability, the base used in statistics to describe the likelihood of a random event occurring.

Animal dose ischemic ischemic area

Quantity g crude drug / kg area percentage weight percentage sham operation group 14 - 0. 0 ± 0. 0 0. 0 ± 0 · 0 model group 14 - 8. 8 ± 4. 9 ^{Δ Δ} 13. 2 ± 3. 7 ^{Δ Δ}

Group S1 14 1. 20 2. 7 ± 2. 2*abc 8. 2 ± 3. 2**

Group S1 14 0. 60 3· 3 ± 1. 2* 8. 6 ± 3. 1*

S1 group 14 0. 30 3. 8 ± 1. 3* 8. 7 ± 5. 1 Dl group 14 0.60 ' 4.5±1· 3 10.7 ±2.7

Group D2 14 0.60 5.2 ±2.0 11.2 ± 3.3

Group D3 14 0.60 4.9±2· 1 9.8 ±2.3 Note: Compared with the model group * Ρ<0.05; **

Δ Δ Ρ<0.01 compared with the sham operation group

Compared with group D1 a P<0.05

Compared with D2 group b P<0.05

Compared with group D3 c P<0.05

Experimental purposes: To investigate the effects of traditional Chinese medicine compositions obtained by different preparation methods on focal cerebral ischemia in rats.

Grouping and administration: 嚢 Use the capsule S1 prepared in Example 1, refer to the human dose of 4.557g of crude drug/day, that is, 0.076 g of crude drug/kg body weight (standard weight 60kg), set three The doses were 2.4g crude drug/kgjday, 1.2g crude drug/kgjday and 0.6g crude drug/kgj day _c. The capsules Dl, D2 and D3 prepared in the proportions of 1-3 were used, and the dosage was 1.2g of crude drug. /kgjday. Another model group and sham operation group are set up.

Experimental animals: Healthy Wistar rats, clean grade, male and female, 140, weighing 160-180g, provided by Beijing Vital Lihua Experimental Animal Center, License No.: SCXK (Beijing) 2003 - 0003, Certificate No.: NO.0048343

Modeling and index detection: After anesthesia with chloral hydrate, fix it on the side. Except for the sham operation group, the other groups underwent the following operations: Cut a small opening at the midline of the eyelid and the external auditory canal, expose the diaphragm, and use the hemostatic forceps to separate the diaphragm and separate it to the sides, taking care not to damage the facial nerve. Exposed to the majority of the squamous bone, and then drilled about 2 in front of the anterior and posterior zygomatic arches. Under the surgical microscope, open a small cranial window with a small straight-legged forceps to reveal the brain. artery. Apply 50% ferric chloride solution (diluted hydrochloric acid is acidic) ΙΟμ 滴 onto a small piece of filter paper, apply it to the middle cerebral artery, place it for about 30 minutes, then remove the filter paper from the middle artery and rinse with saline. Local tissue, sutured layer by layer and returned to cage. The operation group was the same except that the treatment of ferric chloride was not performed.

24 hours after the operation, after the carotid artery was bled, the animal was decapitated to remove the brain, and the olfactory, cerebellum and After the lower brainstem, the coronal cut 4 knives were divided into 5 pieces. The first knife is at the midpoint of the front pole of the brain and the line of intersection, the second knife is at the optic intersection, the third knife is at the funnel handle, and the fourth knife is between the funnel handle and the leaf tail. The brain slices were stained with red tetrazolium (TTC), and the normal tissues were stained red and the infarcted tissues were white. Each brain plane was projected onto a uniform density aluminum foil, and the infarct size was carefully excavated, and the infarct size (%) was taken as the percentage of the weight of the infarct tissue and the weight of the whole brain.

RESULTS: The rats were decapitated 24 h after surgery. After TTC staining, the infarcted areas were weighed and compared. See Table 2 for the specific experimental results.

Analysis: As shown in Table 2, a significant cerebral infarction was observed by TTC staining 24 hours after blockade in rats. There was no change in the surgical group. Compared with the model group and the Dl-D3 group, the infarct size of 2. 4g/kg, 1. 2g/kg, and 0.6g/kg in the S1 group was significantly decreased (P<0.01 or P<0. 05).

Compared with the model group: * ρ<0. 05; ** ρ<0. 01

Compared with the sham operation group: Δ Δ ρ<0. 01

Compared with group D1 a P<0. 05

Compared with group D2 b P<0. 05

Compared with group D3 c P<0. 05

Claims

Rights request

1. A method for preparing a traditional Chinese medicine composition, which comprises weighing a whole scorpion, a leeches, an entertainment mites, a locust, a medlar, a ginseng, a frankincense, a red peony, a scent, a sandalwood, a borneol, and a jujube kernel according to a prescribed amount. Extracting the above-mentioned bulk drug, the obtained extract is mixed and formulated; and the extracting of the whole cockroach, leeches, cockroaches, earthworms, cockroaches comprises the following steps: (1) pulverizing the worms into coarse powder; 2) Add 8 - 12 times of water to the coarse powder, raise the temperature to 25 - 65 ° C, extract 1 - 3 times, each time for 1 - 5 hours, separate the extract and dregs; (3) into the dregs Add 8-12 times of water, raise the temperature to 70-100 ° C, extract 1 - 3 times, each time 1-3 hours, separate the extract and dregs; (4) combine the extract obtained in the above step, The insecticide extract is obtained by concentration and drying.

The method for preparing a traditional Chinese medicine composition according to claim 1, wherein the leeches, cockroaches, ^, soil mites, and cockroaches are separately extracted or co-extracted; and the extraction steps are as follows: Step (1): The above worm is pulverized into a coarse powder of 18-40 mesh;

Step (2): adding 8-10 times of water to the coarse powder; heating to 30 - 50 ° C, extracting 2 - 3 times, each time 1-3 hours, separating the extract and the dregs; Water extraction under pressure or ultrasonic water extraction;

Step (3): adding 8 - 12 times the amount of water to the dregs obtained in the step (2), heating to 75 - 100 Torr, extracting 2 - 3 times, each time 1-3 hours, separating the extract and the dregs;

Step (4): Combine the extract obtained in the above step, and concentrate the extract to a clear paste having a density of 1.05 - 1.20 g/cni ³ at 50-6 (TC), and obtain the obtained at 50 - 60 °C. The clear paste is dried under reduced pressure.

3. The method for preparing a traditional Chinese medicine composition according to claim 2, wherein the extraction step in the step (2) is carried out under a reduced pressure of 0.05 to 0.1 MPa, and simultaneously with the extract. stirring; or ultrasonic water extraction, ultrasonic extraction, and the oscillation frequency of the output power devices are 200- 10000W, 20-80KHz _o

The method for preparing a traditional Chinese medicine composition according to claim 3, wherein the extraction process in the step (2) is carried out by ultrasonic water extraction, and the output power and the oscillation frequency of the ultrasonic extraction device are respectively 1500-8000 W, 30 -60 Ηζ _ο

5. A method of preparing a traditional Chinese medicine composition according to any one of claims 1 to 4, The method for preparing the ginseng, red peony, jujube kernel, scented, sandalwood, frankincense and borneol is as follows:

- by prescription ginseng herbs, pulverized, and extracted twice with 10-fold amount of 70% ethanol was refluxed for two hours each, the extraction temperature was 9 ⁵ ° C, combined extracts, recovering ethanol until no alcohol taste, add water to 8 Double the amount of medicinal material, water for more than 12 hours, filter, filtrate through the processed AB-8 macroporous adsorption resin column, first rinse the resin column with 4 times column volume of water to colorless, discard the water wash, then use 6 The resin column is washed with 70% ethanol in a column volume, and the eluate is concentrated and spray-dried to obtain a ginseng extract;

- Take the red peony medicinal materials according to the prescription, pulverize, extract twice with 10 times 50% ethanol, extract for 2 hours each time, extract the temperature at 95 °C, combine the extracts, recover the ethanol to a non-alcoholic taste, add water to 10 The amount of medicinal material is more than 12 hours, filtered, and the filtrate is passed through the treated AB-8 macroporous adsorption resin column. The resin column is first washed with 4 column volumes of water until colorless, and the water washing solution is discarded. The resin column is washed with 60% ethanol in a volume of column, and the alcohol eluate is concentrated and spray-dried to obtain an extract of red oak;

- Take the jujube seed medicine according to the prescription, pulverize, and extract it twice with 10 times 80% ethanol, the extraction time is 2 hours, the extraction temperature is 95 °C, the extract is combined, the ethanol is recovered to the non-alcoholic taste, and water is added. Up to 8 times the amount of medicinal material, water for more than 12 hours, filter, filtrate through the processed AB-8 macroporous adsorption resin column, first rinse the resin column with 4 times column volume of water to colorless, discard the water wash, then The resin column is washed with 6 column volumes of 80% ethanol, and the alcohol eluate is concentrated and spray-dried to obtain a jujube kernel extract;

- Take the boswellic medicinal materials according to the prescription amount, distill the water for 8 hours in 8 times, collect the volatile oil, and extract the slag with 6 times of ethanol for 2 times, each time for 1 hour, combine the alcohol liquid, and concentrate and dry;

- Take the borneol according to the prescription, grind it, add 2 times the amount of the molten matrix PEG6000, stir rapidly, cool, and pulverize.

6. A traditional Chinese medicine composition product prepared by the method according to any one of claims 1 to 5, wherein the product is selected from the group consisting of: a tablet, an orally disintegrating tablet, a tablet, an effervescent tablet, and a capsule. Any one of a pill, a granule, an oral solution, a pellet, a micro-tank, and a spray.

A method for preparing an extract of an insect medicine, characterized in that the insect medicine is composed of a whole cockroach, a leeches, an entertainment cockroach, a soil mites, and a cockroach, and includes the following extraction steps: (1) an worm medicine Crush into coarse powder; (2) Add 8 - 12 times the amount of water to the coarse powder and raise the temperature to 25 - 65. C, extract 1 - 3 times, 1-5 hours each time, separate the extract and dregs; (3) add 8-12 times the amount of water to the dregs, heat up to 70- ΙΟΟ, extract 1-3 times, The extract and the dregs were separated every 1-3 hours; (4) The extract obtained in the above step was combined, and the extract of the worm was obtained by concentration and drying.

The method according to claim 7, wherein the leeches, the cockroaches, the cockroaches, the mites, the cockroaches, and the cockroaches are separately extracted or co-extracted; and the extraction steps are as follows:

Step (1): pulverizing the above-mentioned insect medicine into a coarse powder of 18-40 mesh;

Step (2): adding 8-12 times of water to the coarse powder; heating to 25 - 50 ° C, extracting 2 - 3 times, each time 1-3 hours, separating the extract and the dregs; Water extraction under pressure or ultrasonic water extraction;

Step (3): adding 8-12 times the amount of water to the obtained dregs of step 2), heating to 75-100 ° C, extracting 2 - 3 times, each time 1-3 hours, separating the extract and the dregs;

Step (4): Combine the extract obtained in the above step, and concentrate the extract to a density of 1.05 - 1.10 g/cm ³ at 50-6 (TC), and obtain the obtained at 50 - 60 ° C. The clear paste is dried under reduced pressure.

The method for preparing an insect drug extract according to claim 7, wherein the extracting step in the step (2) is carried out under a reduced pressure of 0.05 to 0.1 IMPa, and extract while stirring; or ultrasonic water extraction, ultrasonic extraction device and the output power of the oscillation frequencies of 200- 10000W, 20-80KHz _o

The method for preparing an insect drug extract according to claim 9, wherein when the extraction process in the step (2) is carried out by ultrasonic water extraction, the output power and the oscillation frequency of the ultrasonic extraction device are respectively 1500- 8000W, 30-60KHz. .

An insect extract prepared by the method according to any one of claims 7 to 10, wherein the insect extract has a color of brownish yellow to blackish yellow and is savory and salty.