CN103316220B - A kind of active compound composition and preparation method and preparation thereof and application - Google Patents
A kind of active compound composition and preparation method and preparation thereof and application Download PDFInfo
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Abstract
The invention discloses a kind of active compound composition and preparation method and preparation thereof and application, described active compound composition is by weight the following raw material of proportioning: the Poria of 1 ~ 90%, the Ganoderma of 1 ~ 90%, the Herba Dendrobii of 1 ~ 90% and the macro fungi of surplus are obtained through extracting.The preparation method of described active compound composition, comprise get the raw materials ready, extract, concentrate drying, testing sequence, specifically comprise: extracted respectively by raw material, dry, pulverize, mixing, pulverized 80 mesh sieves, sterilizing subpackage, pick test, provides report.Preparation of the present invention is that described active compound composition adds pharmaceutically acceptable adjuvant and makes powder, tablet, granule, capsule, pill.Described active compound composition can be applicable to prepare antitumor drug.The present invention is with non-harmful medical material for raw material, and the course of processing farthest remains medical material functional component, and simple process, environmental protection, safety and cost is low, product bioavailability is higher, can compare the effect fully playing each medical material.
Description
Technical field
The invention belongs to field of medicine preparing technology, be specifically related to a kind of pharmaceutical composition of micronizing and preparation method and preparation thereof and application.
Background technology
Poria, is commonly called as Poria, Song Ling, Poria, and for colonizing in the fungi plant on pinaster root, shape is as Rhizoma Dioscoreae esculentae, and crust pitchy, the inside is white or pink.Its protozoa is the dry sclerotia of On Polyporaceae Poria, and multiparasitization is in the root of Pinus massoniana Lamb or Pinus densiflora.Originate in the ground such as Yunnan, Anhui, Hubei, Henan, Sichuan.Ancients claim Poria to be " when four god medicine ", because its effect widely, regardless of the four seasons, by it and various compatibility of drugs, no matter cold, temperature, wind, wet all diseases, can play its unique effects.Poria sweet in the mouth, light, property are put down, and are used as medicine and have the function of promoting diuresis to eliminate damp pathogen, strengthening the spleen stomach function regulating, mind tranquilizing and the heart calming.Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
Ganoderma, also known as Ganoderma lucidum seu Japonicum, Ganoderma, Ganoderma lucidum seu Japonicum, Herba mesonae chinensis, Ganoderma, is the Herb of Polyporaceae plant Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma.Be best with Ganoderma sinense Zhao Xu et Zhang drug effect, Ganoderma originates in east Asia, distribution in China the widest in Jiangxi, Ganoderma is as the Chinese tradition valuable ingredient of Chinese medicine having thousands of years medicinal histories, possesses very high medical value, modern pharmacology research through scientific research institution's many decades confirms, Ganoderma, for enhancing body immunity, regulates blood glucose, control blood pressure, adjuvant therapy chemicotherapy, hepatoprotective, the aspects such as hypnotic all have significant curative effect.
Herba Dendrobii, one of orchid, is mainly distributed in Tropical Asian and subtropical zone, and Australia and Pacific Islands, China's major part is distributed in the ground such as southwest, south China, Taiwan.The principal item of Herba Dendrobii has Dendrobium nobile, dendrobium, Dendrobium chrysotoxum etc.Can be used as medicine, Herba Dendrobii by name, drives solution deficiency-heat to human body, the curative effects such as beneficial smart reinforcing YIN-essence.
Macro fungi is the class fungus forming large-scale sporophore in fungus, makes a general reference sensu lato mushroom
mushroomor mushroom fungus
macrofungi.Macro fungi refers to the sporophore or sclerotium that can form meat or colloid, and great majority belong to Basidiomycotina, and minority belongs to Ascomycotina.Macro fungi grows in substrate or the size of the sporophore of underground is enough to allow naked eyes identification and free-hand harvesting.Macro fungi is an important monoid in fungus, and many types have higher nutritive value and medical value, is the class having development prospect in current fungus most.
At present, Chinese medicine decoction pieces decocts trouble, it is inconvenient to use, quality unstable easily go mouldy infested, be difficult to keeping, bottleneck that the low several shortcoming of bioavailability becomes prepared slices of Chinese crude drugs development, therefore, develop a kind of bioavailability high, save Chinese material medicine resource, quality controllable, hygienic and convenient, compatibility is flexible, and efficient active compound composition is very important.
Summary of the invention
The first object of the present invention is to provide a kind of active compound composition; Second object is the preparation method providing described active compound composition; 3rd object is the preparation providing described active compound composition to make; 4th object is to provide described active compound composition preparing the application in Hepatoma therapy medicine.
The first object of the present invention is achieved in that by weight the following raw material of proportioning: the Poria of 1 ~ 90%, the Ganoderma of 1 ~ 90%, the Herba Dendrobii of 1 ~ 90% and the macro fungi of surplus are obtained through extracting.
The second object of the present invention be achieved in that comprise get the raw materials ready, extract, concentrate drying, testing sequence, specifically comprise:
A, to get the raw materials ready: cross the raw material after 10 mesh sieves by weight weighing by through screening, coarse pulverization;
B, extraction: the purified water adding weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract;
C, drying and crushing: each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization;
D, mixture: mixed by each extract after coarse pulverization, obtained objective composition through pulverizing 80 mesh sieves;
E, inspection: objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
The third object of the present invention is achieved in that described active compound composition adds pharmaceutically acceptable adjuvant and makes powder, tablet, granule, capsule, pill.
The fourth object of the present invention is achieved in that described active compound composition is preparing the application in antitumor drug.
In the present invention, Poria slightly sweet flavor is put down, and enters the heart, lung, spleen channel.There is eliminating dampness and diuresis, invigorating the spleen and regulating the stomach, effect of mind tranquilizing and the heart calming.Can control dysuria, edema distension, phlegm retention cough with dyspnea, vomiting, malignant histocytosis, has loose bowels, seminal emission, stranguria with turbid discharge, palpitation with fear, forgetful disease such as grade; Pachyman has obvious antitumor and protects the liver dirty effect; Ganoderma, for enhancing body immunity, regulates blood glucose, and control blood pressure, adjuvant therapy chemicotherapy, hepatoprotective, the aspects such as hypnotic all have significant curative effect.Herba Dendrobii, drives solution deficiency-heat to human body, the curative effects such as beneficial smart reinforcing YIN-essence.
Test proves, after composite, utilizes the mutual synergism of a few class polysaccharide, can strengthen its eliminating dampness and diuresis, mind tranquilizing and the heart calming, antitumor and protect the liver dirty, body immunity, drives effects such as separating deficiency-heat.Active compound composition of the present invention can be processed into various dosage form according to pharmaceutics conventional production process, meets the needs of different dosing patient, and have onset rapid, curative effect is outstanding, has no side effect, feature easy to use.
Accompanying drawing explanation
Fig. 1 is present invention process flow chart.
Detailed description of the invention
Below in conjunction with accompanying drawing, the present invention is further illustrated, but limited the present invention never in any form, and any conversion done based on training centre of the present invention or replacement, all belong to protection scope of the present invention.
Active compound composition of the present invention, is by weight the following raw material of proportioning: the Poria of 1 ~ 90%, the Ganoderma of 1 ~ 90%, the Herba Dendrobii of 1 ~ 90% and the macro fungi of surplus are obtained through extracting.
Described raw material weight matches well than being the Poria of 1 ~ 60%, the Ganoderma of 1 ~ 60%, the Herba Dendrobii of 1 ~ 60% and the macro fungi of surplus.
Described raw material weight matches well than being the Poria of 1 ~ 30%, the Ganoderma of 1 ~ 30%, the Herba Dendrobii of 1 ~ 30% and the macro fungi of surplus.
Described active compound composition is that raw material obtains through pulverizing, extraction, drying, mixture.
The described one be extracted as in water extraction or alcohol extraction.
Described macro fungi is one or more in Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis.
The preparation method of active compound composition of the present invention, it is characterized in that comprising get the raw materials ready, extract, concentrate drying, testing sequence, specifically comprise:
A, to get the raw materials ready: cross the raw material after 10 mesh sieves by weight weighing by through screening, coarse pulverization;
B, extraction: the purified water adding weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract;
C, drying and crushing: each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization;
D, mixture: mixed by each extract after coarse pulverization, obtained objective composition through pulverizing 80 mesh sieves;
E, inspection: objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Described concentration of alcohol is 90 ~ 99%.
Described recovery ethanol is reclaimed by thermal evaporation or embrane method recovery.
Described is filtered into membrane filtration, and filter sizes is 0.2 ~ 15 mm.
Described drying is constant pressure and dry or drying under reduced pressure, takes one or more the combination in spraying dry, lyophilization, microwave drying, forced air drying, hygroscopic desiccation.
Preparation of the present invention is that described active compound composition adds pharmaceutically acceptable adjuvant and makes powder, tablet, granule, capsule, pill.
Of the present inventionly be applied as described active compound composition and preparing the application in antitumor drug.
Advantage of the present invention is: after composite, utilizes the mutual synergism of a few class polysaccharide, can strengthen its eliminating dampness and diuresis, mind tranquilizing and the heart calming, antitumor and protect the liver dirty, body immunity, drives effects such as separating deficiency-heat.Present invention process extracting method that is simple, that set up is strongly professional, reproducible, and uses purified water, alcohol extraction, not only environmental protection, and product safety is reliable simultaneously, and cost is low, is suitable for suitability for industrialized production.
Embodiment 1
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 2
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 3
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 4
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 5
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 6
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 7
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 8
The raw material after 10 mesh sieves is crossed by Poria 90Kg, Ganoderma 90Kg, Herba Dendrobii 90Kg and Lentinus Edodes and Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis 100Kg by through screening, coarse pulverization; Add the purified water of weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract; Each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization; Each extract after coarse pulverization being mixed, obtaining objective composition through pulverizing 80 mesh sieves; Objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
Embodiment 9
In Example 1 ~ 8, any one active compound composition, adds pharmaceutic adjuvant, and subpackage is powder.
Embodiment 10
In Example 1 ~ 8, any one active compound composition, adds pharmaceutic adjuvant, through granulating, drying, is filled in capsule, obtains capsule.
Embodiment 11
Any one active compound composition in Example 1 ~ 8, adds the magnesium stearate of 1%, and mixing, is filled in capsule, obtains capsule.
Embodiment 12
In Example 1 ~ 8, any one active compound composition, adds pharmaceutic adjuvant, through granulating, drying, obtains granule.
Embodiment 13
In Example 1 ~ 8, any one active compound composition, adds pharmaceutic adjuvant, through granulation, tabletting, obtains tablet.
Embodiment 14
In Example 1 ~ 8, any one active compound composition, adds pharmaceutic adjuvant, and pill, oven dry, obtain pill.
Experimental example 1
The contrast test of active compound composition and Ganoderma
1 experiment material
1.1 animal Kunming mouses: weight 18 ~ 22 g, male and female have concurrently (often criticize test and use a kind of sex), are provided, quality certification SCXK (army) 2007-004 by Test Animal Centre, Academy of Military Medical Sciences, P.L.A.
1.2 tumor strain and cell strain: hepatocarcinoma H
22tumor strain, institute of oncology of Shenyang City provides, Kun Ming mice conservation.
1.3 medicines and reagent: active compound composition (Puer Songmao Pharmaceutical Co., Ltd. provides).Drying at room temperature place preserves, and dissolves before use and be diluted to desired concn with distilled water.Ganoderma (Puer Songmao Pharmaceutical Co., Ltd. provides); Cyclophosphamide (CTX), Hualian Pharmaceutical Co., Ltd., Shanghai.
1.4 key instruments: ware electronic balance in FA/JA1004 series: balance equipment factory of upper Nereid section; PH050A type incubator/drying baker: the permanent experimental apparatus company limited in Shanghai one; XDS-1B type inverted biological microscope: Chongqing Photoelectric Instruments Corp..
2 methods and result
2.1 active compound compositions are to mouse bearing liver cancer H
22the impact of growth
Sterile working, gets the hepatocarcinoma H of the 7d that goes down to posterity
22mouse ascites, cell counting is 2 × 107/ml by 0.9% normal saline dilution to concentration, every mice right axil subcutaneous vaccination 0.2ml (4 × 106 /).Next day is divided into 5 groups and administration at random by weight.Administration volume is 20ml/kg.24h after last administration, cervical dislocation puts to death animal, and point another name weight, tumor weight, calculate tumour inhibiting rate, carry out therapeutic evaluation.Result Excel software carries out statistical procedures, and this experiment repeats 3 batches.Result shows, and active compound composition dose-dependently suppresses transplanted hepatoma
h22growth, and administration group Mice Body steady quality increase.In table 1.
Table 1 active compound composition is to mouse bearing liver cancer H
22the impact (x ± s, n=3) of growth
Note: compare with model group, * P<0.05, * * P<0.01
2.2 active compound compositions are on the impact of immunologic hypofunction mice serum hemolysin level
Choose healthy Kunming mouse 60, be divided into 6 groups at random, be respectively active compound composition 1.04,0.52,
0.26g/kg dosage group and Ganoderma 5.2mg/kg group, model group (giving cyclophosphamide) and blank group.Each group of successive administration, in administration the 5th day, to every Mus lumbar injection 5% chicken erythrocyte suspension 0.2ml.Except blank group, all the other each group, respectively at the 4th day, the 9th day, by 75mg/kg dosage intraperitoneal injection of cyclophosphamide, is caused immunologic hypofunction model.Successive administration 10d, tests on the 11st day.Each group of mice eyeground vein clump gets blood, centrifugalize serum, with normal saline by serum-dilution 50 times, get dilute serum 1ml to add in reaction tube, then add 0.5% chicken erythrocyte suspension 0.5ml, in frozen water, then add 0.5ml complement (10%3 Cavia porcellus pooled serums), solution in reaction tube is shaken up, be placed in 37 DEG C of waters bath with thermostatic control and react 30min, jolting 2 times in course of reaction, after reaction terminates, reaction tube is placed in 0 DEG C of refrigerator cessation reaction.Centrifugal, get supernatant in 722 type spectrophotometer 540nm place colorimetrics, measure absorbance (adjusting 0 with the blank pipe not adding mice serum), represent the height of mice serum hemolysin level with the absorbance of supernatant.Each group of result Excel software carries out statistical procedures.Result shows, and model group mice serum hemolysin level comparatively blank group significantly reduces; Compare with model group, active compound composition group 1.04,0.52g/kg can significantly improve the serum hemolysin of mice, improve the inhibitory action that cyclophosphamide produces mice serum hemolysin level.In table 2.
Table 2 active compound composition is on the impact (x ± S) of immunologic hypofunction mice serum hemolysin level
Note: compare with model group, * P<0.05, * * P<0.01; Compare with blank group, ##P<0.01
This research shows, active compound composition comparatively Ganoderma significantly can reduce hepatocarcinoma H
22the average tumor weight of mice.By observing the change of the multiple index of immune system, investigate the impact of active compound composition on body's immunity, result shows, active compound composition is enhancing human body immunity function by impact immune different link, thus produces anti-tumor activity.
Experimental example 2
1 experiment material
1.1 animal Kunming mouses: weight 36-44g, male and female have concurrently (often criticize test and use a kind of sex), are provided, quality certification SCXK (army) 2007-004 by Test Animal Centre, Academy of Military Medical Sciences, P.L.A.
1.2 tumor strain and cell strain: hepatocarcinoma H
22tumor strain, institute of oncology of Shenyang City provides, Kun Ming mice conservation.
1.3 medicines and reagent: with the obtained active compound composition powder of embodiment 9, with the obtained active compound composition capsule of embodiment 11, with the obtained active compound composition granule of embodiment 12, with the obtained active compound composition tablet of embodiment 13, with the obtained active compound composition pill (Puer Songmao Pharmaceutical Co., Ltd. provides) of embodiment 14.Drying at room temperature place preserves, and dissolves before use and be diluted to desired concn with distilled water.Cyclophosphamide (CTX), Hualian Pharmaceutical Co., Ltd., Shanghai.
1.4 key instruments: ware electronic balance in FA/JA1004 series: balance equipment factory of upper Nereid section; PH050A type incubator/drying baker: the permanent experimental apparatus company limited in Shanghai one; XDS-1B type inverted biological microscope: Chongqing Photoelectric Instruments Corp..
2 methods and result
2.1 active compound compositions are to mouse bearing liver cancer H
22the impact of growth
Sterile working, gets the hepatocarcinoma H of the 7d that goes down to posterity
22mouse ascites, cell counting is 2 × 107/ml by 0.9% normal saline dilution to concentration, every mice right axil subcutaneous vaccination 0.2 ml (4 × 106 /).Next day is divided into 5 groups and administration at random by weight.Administration volume is 20ml/kg.24h after last administration, cervical dislocation puts to death animal, and point another name weight, tumor weight, calculate tumour inhibiting rate, carry out therapeutic evaluation.Result Excel software carries out statistical procedures, and this experiment repeats 3 batches.Result shows, and active compound composition powder, capsule, granule, tablet, pill dependency ground suppresses transplanted hepatoma H
22growth, and administration group Mice Body steady quality increase.And the result of the test of each dosage form closely.
2.2 active compound compositions are on the impact of immunologic hypofunction mice serum hemolysin level
Choose healthy Kunming mouse 60, be divided into 6 groups at random, be respectively active compound composition powder, capsule, granule, tablet, pill group, model group (giving cyclophosphamide) and blank group.Each group of successive administration, in administration the 5th day, to every Mus lumbar injection 5% chicken erythrocyte suspension 0.2ml.Except blank group, all the other each group, respectively at the 4th day, the 9th day, by 75mg/kg dosage intraperitoneal injection of cyclophosphamide, is caused immunologic hypofunction model.Successive administration 10d, tests on the 11st day.Each group of mice eyeground vein clump gets blood, centrifugalize serum, with normal saline by serum-dilution 50 times, get dilute serum 1ml to add in reaction tube, then add 0.5% chicken erythrocyte suspension 0.5ml, in frozen water, then add 0.5 ml complement (10%3 Cavia porcellus pooled serums), solution in reaction tube is shaken up, be placed in 37 DEG C of waters bath with thermostatic control and react 30min, jolting 2 times in course of reaction, after reaction terminates, reaction tube is placed in 0 DEG C of refrigerator cessation reaction.Centrifugal, get supernatant in 722 type spectrophotometer 540nm place colorimetrics, measure absorbance (adjusting 0 with the blank pipe not adding mice serum), represent the height of mice serum hemolysin level with the absorbance of supernatant.Each group of result Excel software carries out statistical procedures.Result shows, and model group mice serum hemolysin level comparatively blank group significantly reduces; Compare with model group, each dosage form group 1.04 of active compound composition, 0.52g/kg can significantly improve the serum hemolysin of mice, improve the inhibitory action that cyclophosphamide produces mice serum hemolysin level.And the result of the test of each dosage form closely.
Claims (4)
1. one kind is reduced hepatocarcinoma H
22the active compound composition that tumor is heavy, it is characterized in that described macro fungi is one or more in Lentinus Edodes, Volvariella volvacea (Bull.Ex Franch.) Singer．, Flammulina velutiper (Fr.) Sing, Agaricus bisporus, Pleurotus ostreatus, Auricularia, Tremella, Caulis Bambusae In Taeniam, Gaster caprae seu Ovis with the macro fungi of the Poria of weight proportion 1 ~ 30%, the Ganoderma of 1 ~ 30%, the Herba Dendrobii of 1 ~ 30% and surplus for raw material; Active compound composition preparation method comprise get the raw materials ready, extract, concentrate drying, testing sequence, specifically comprise:
A, to get the raw materials ready: cross the raw material after 10 mesh sieves by weight weighing by through screening, coarse pulverization;
B, extraction: the purified water adding weight ratio 2 ~ 6 times in raw material Poria, reflux, extract, 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, filter, under agitation add ethanol, make alcohol content reach 70 ~ 80%, leave standstill 12 ~ 24h, separate out precipitation, filter, collecting precipitation thing obtains Poria extract; Add 80 ~ 99% ethanol of 2 ~ 5 times in raw material Ganoderma, hot bath backflow 3 ~ 5 times, each 2 ~ 3h, merge extractive liquid, reclaims ethanol, filters to get filtrate, and concentrates to obtain Ganoderma extract; 90 ~ 95 DEG C of purified water lixiviates 1 ~ 3 time of weight ratio 1 ~ 10 times of raw material Herba Dendrobii, each 3 ~ 4h, merges lixiviating solution, filters, and concentratedly to obtain Herba Dendrobii extract; 95 ~ 100 DEG C of purified water lixiviates 2 ~ 3 times of weight ratio 1 ~ 20 times of raw material macro fungi, each 2 ~ 3h, merges lixiviating solution, filters, and concentratedly to obtain macro fungi extract;
C, drying and crushing: each extract is carried out respectively be dried to moisture content 1 ~ 9%, cross 10 mesh sieves through coarse pulverization;
D, mixture: mixed by each extract after coarse pulverization, obtained objective composition through pulverizing 80 mesh sieves;
E, inspection: objective composition is carried out sterilizing subpackage, pick test, provide inspection report.
2. active compound composition according to claim 1, is characterized in that described recovery ethanol to be reclaimed by thermal evaporation or embrane method reclaims; Described is filtered into membrane filtration, and filter sizes is 0.2 ~ 15mm.
3. active compound composition according to claim 1, is characterized in that described drying is constant pressure and dry or drying under reduced pressure, takes one or more the combination in spraying dry, lyophilization, microwave drying, forced air drying, hygroscopic desiccation.
4. the preparation containing active compound composition described in claim 1, is characterized in that described active compound composition adds pharmaceutically acceptable adjuvant and makes powder, tablet, granule, capsule, pill.
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