CN106266949A - A kind of compound Chinese medicinal preparation and its preparation method and application - Google Patents

A kind of compound Chinese medicinal preparation and its preparation method and application Download PDF

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Publication number
CN106266949A
CN106266949A CN201610757090.8A CN201610757090A CN106266949A CN 106266949 A CN106266949 A CN 106266949A CN 201610757090 A CN201610757090 A CN 201610757090A CN 106266949 A CN106266949 A CN 106266949A
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rhizoma
relative density
add
gained
ethanol
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周仲瑛
金妙文
唐德才
金路
花健
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
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    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract

The invention discloses a kind of compound Chinese medicinal preparation, be made up of following raw materials by weight portion proportioning: Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Bombyx Batryticatus, Sargassum, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum.The dosage form of described preparation is decoction, mixture, oral liquid, tablet, granule, hard capsule or soft capsule.Present invention firstly provides that invigorating liver and spleen, Qinghua is damp and hot, expectorant blood stasis dispelling method, the treatment damp and hot phlegm and blood stasis of fatty liver, the basic pathogenesis of caused by liver and kidney deficiency card, clinical practice is evident in efficacy, and zoopery also proves it to have substantially to reduce blood fat, eliminates the effects such as liver fat accumulation.

Description

A kind of compound Chinese medicinal preparation and its preparation method and application
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of compound Chinese medicinal preparation, particularly relate to prepare with Chinese herbal medicine as raw material Obtain a kind of compound Chinese medicinal preparation, and this compound Chinese medicinal preparation is at preparation the treatment damp and hot phlegm and blood stasis of fatty liver, caused by liver and kidney deficiency Application in disease drug.
Background technology
Fatty liver is the intrahepatic fat dysbolismus caused by many reasons, causes liver fat sexually transmitted disease (STD) to become.Fat, ethanol Poisoning and diabetes are the three big reasons that fatty liver is common, are secondly nutritional disorder, drug intoxication etc..Fatty liver is the literary composition in the present age Bright disease, sickness rate substantially rises in recent years, it has also become commonly encountered diseases.Owing to some patients can develop into fat hepatitis regulating liver-QI fibre Dimension, even results in liver cirrhosis and various complication, primary disease currently there is no specific treatment, the current many employings of western medical treatment primary disease Blood lipid-lowering medicine, vitamin etc..In order to improve the curative effect for the treatment of fatty liver, therefore develop a kind of efficient, without obvious toxicity New product of Chinese medicine, meet the demand that primary disease is treated by society.
Summary of the invention
Solve the technical problem that: in order to overcome the defect of prior art, it is thus achieved that a kind of high specificity, and make without substantially poison is secondary Chinese medicine preparation, the invention provides a kind of compound Chinese medicinal preparation and its preparation method and application.
Technical scheme:
A kind of compound Chinese medicinal preparation, is made up of following raw materials by weight portion proportioning: Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Herba Artemisiae Scopariae, and the summer is withered Grass, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Bombyx Batryticatus, Sargassum, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum.
Described Bombyx Batryticatus can be Bombyx Batryticatus(processed), Bombyx Batryticatus (parched) or Bombyx Batryticatus (parch);Described Rhizoma Polygonati can be stir-baked RHIZOMA POLYGONATI with yellow rice wine or Rhizoma Polygonati (wine System);Described Rhizoma Cyperi can be Rhizoma Cyperi (processed), Rhizoma Cyperi (processed with vinegar) or Rhizoma Cyperi (vinegar system).
Preferably, during Clinical practice, described compound Chinese medicinal preparation is made up of following raw materials by weight portion proportioning: Radix Polygoni Multiflori Preparata 3~30 parts, Rhizoma Polygonati 5~30 parts, Herba Artemisiae Scopariae 3~30 parts, Spica Prunellae 5~30 parts, Radix Salviae Miltiorrhizae 5~30 parts, Fructus Crataegi 3~30 Part, Ramulus Euonymi 2~25 parts, Bombyx Batryticatus 3~20 parts, Sargassum 3~25 parts, Rhizoma Alismatis 5~30 parts, Rhizoma Cyperi 3~25 parts, Rhizoma Wenyujin Concisum 3~25 Part.
Preferably, in drug production process, described compound Chinese medicinal preparation is made up of following raw materials by weight portion proportioning: Radix Polygoni Multiflori Preparata 100~450 parts, Rhizoma Polygonati 100~450 parts, Herba Artemisiae Scopariae 150~650 parts, Spica Prunellae 100~550 parts, Radix Salviae Miltiorrhizae 150~ 650 parts, Fructus Crataegi 150~650 parts, Ramulus Euonymi 150~650 parts, Bombyx Batryticatus 100~450 parts, Sargassum 100~450 parts, Rhizoma Alismatis 150~ 650 parts, Rhizoma Cyperi 100~450 parts, Rhizoma Wenyujin Concisum 100~450 parts.
Preferably, the dosage form of described preparation is decoction, mixture, oral liquid, tablet, granule, hard capsule or soft capsule Agent.
Preferably, described decoction is prepared by following methods:
(1) each raw material is assorted according to single times amount prescription drug amount;
(2) Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum, Rhizoma Polygonati, deadlock are taken Silkworm, Sargassum, add 1~20 times of soak by water 1~6 times, each 0.5~3 hour, and collecting decoction filters, obtains decoction.
Preferably, described mixture is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.5% sorbic acid or 0.1%~0.5% benzoic acid, by water adjustment total amount to the medicinal liquid of 120L~180L, stirs evenly;
(7) medicinal liquid that step (6) obtains is carried out sub-bottle fill, use boiling method or circulation vapor method sterilizing, during sterilizing Airtight, obtain mixture.
Preferably, described oral liquid is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.15% sorbic acid or 0.1%~0.2% benzoic acid, by water adjustment total amount to the medicinal liquid of 30L~60L, stirs evenly;
(7) step (6) gained medicinal liquid is carried out fill, use boiling method or circulation vapor method sterilizing, obtain oral liquid.
Preferably, described tablet is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, be dried, obtain dry extract, be ground into medicine Extract powder, crosses 60~100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the drug extract powder of step (6) gained, step (3) are extracted and β- Cyclodextrin clathrate merges, mixes, pelletizes, granulate, tabletted, then carries out thin film or sweet tablet, inspection, and subpackage obtains sheet Agent;
Preferably, described granule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract;
(7) taking the dry extract that step (5) obtains, add dextrin mixing, pelletize, granulate must do granule, is used by volatile oil After the dilution of ethanol equimultiple, spray in dry granule, mix to obtain drug particles, subpackage, obtain granule.
(8) drug particles is carried out granulate, fill hard capsule, polishing, inspection, subpackage, obtain granule.
Preferably, described hard capsule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis are taken, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, crosses 60 ~100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the dry extract of step (6) gained, step (3) are extracted and β-ring Cyclodextrin inclusion compound merges, mixes, pelletizes, granulate, fill hard capsule, polishing, inspection, and subpackage obtains hard capsule.
Preferably, described soft capsule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis are taken, add 3~15 times 50~95% second Alcohol, reflux, extract, 1~6 times, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, being condensed into relative density is The extractum of 1.25~1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and vapor distillation 0.5~12 hours, extraction is waved Hair oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 1~20 times of soak by water 1~ 6 times, each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, crosses 60 ~100 mesh sieves
(7) taking polyethylene glycol and glycerol composition double solvents, wherein Polyethylene Glycol and glycerol by volume 50~ 95:5~50 mixing, adds the volatile oil of step (3) gained and the extract powder of step (6) gained in solvent, is heated to 50 DEG C ~60 DEG C, and it is maintained at this temperature 2 hours~3 hours, make drug extract powder fully leach;
(8) extract powder after step (7) fully leaches is carried out quantitatively, fill soft capsule, polishing, inspection, subpackage, i.e. Obtain soft capsule.
Described compound Chinese medicinal preparation answering in preparation the treatment damp and hot phlegm and blood stasis of fatty liver, caused by liver and kidney deficiency disease drug With.
Beneficial effect: present invention firstly provides that invigorating liver and spleen, Qinghua is damp and hot, expectorant blood stasis dispelling method, treats fatty liver wet hot phlegm The stasis of blood is tied mutually, the basic pathogenesis of caused by liver and kidney deficiency card, and clinical practice is evident in efficacy, zoopery also prove it to have substantially to reduce blood fat, Eliminate the effects such as liver fat accumulation.
Detailed description of the invention
Following example further illustrate present disclosure, but should not be construed as limitation of the present invention.Without departing substantially from In the case of present invention spirit and essence, the amendment that the inventive method, step or condition are made and replacement, belong to the present invention Scope.If not specializing, the conventional means that technological means used in embodiment is well known to those skilled in the art.
Embodiment 1
A kind of compound Chinese medicinal preparation, is made up of following raw materials by weight portion proportioning: Radix Polygoni Multiflori Preparata 10 parts, Rhizoma Polygonati 10 parts, Herba Artemisiae Scopariae 15 parts, Spica Prunellae 12 parts, Radix Salviae Miltiorrhizae 15 parts, Fructus Crataegi 15 parts, Ramulus Euonymi 15 parts, Bombyx Batryticatus 10 parts, Sargassum 10 parts, Rhizoma Alismatis 15 parts, Rhizoma Cyperi 10 parts, Rhizoma Wenyujin Concisum 10 parts.
The dosage form of described preparation is decoction, mixture, oral liquid, tablet, granule, hard capsule or soft capsule.
Described decoction is prepared by following methods:
(1) each raw material is assorted according to single times amount prescription drug amount;
(2) Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum, Rhizoma Polygonati, deadlock are taken Silkworm, Sargassum, add 10 times of soak by water 3 times, each 1 hour, collecting decoction, filters, obtains decoction.
Described mixture is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.5% sorbic acid or 0.1%~0.5% benzoic acid, by water adjustment total amount to the medicinal liquid of 120L~180L, stirs evenly;
(7) medicinal liquid that step (6) obtains is carried out sub-bottle fill, use boiling method or circulation vapor method sterilizing, during sterilizing Airtight, obtain mixture.
Described oral liquid is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.15% sorbic acid or 0.1%~0.2% benzoic acid, by water adjustment total amount to the medicinal liquid of 30L~60L, stirs evenly;
(7) step (6) gained medicinal liquid is carried out fill, use boiling method or circulation vapor method sterilizing, obtain oral liquid.
Described tablet is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, be dried, obtain dry extract, be ground into medicine Extract powder, crosses 60~100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the drug extract powder of step (6) gained, step (3) are extracted and β- Cyclodextrin clathrate merges, mixes, pelletizes, granulate, tabletted, then carries out thin film or sweet tablet, inspection, and subpackage obtains sheet Agent;
Described granule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract;
(7) taking the dry extract that step (5) obtains, add dextrin mixing, pelletize, granulate must do granule, is used by volatile oil After the dilution of ethanol equimultiple, spray in dry granule, mix to obtain drug particles, subpackage, obtain granule.
(8) drug particles is carried out granulate, fill hard capsule, polishing, inspection, subpackage, obtain granule.
Described hard capsule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, crosses 60 ~100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the dry extract of step (6) gained, step (3) are extracted and β-ring Cyclodextrin inclusion compound merges, mixes, pelletizes, granulate, fill hard capsule, polishing, inspection, and subpackage obtains hard capsule.
Described soft capsule is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) taking Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 10 times of 60% ethanol, backflow carries Take 3 times, each 1.5 hours, merge ethanol, filter, reclaim ethanol, be condensed into the extractum that relative density is 1.25~1.35, Relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 10 times of water soakings 4 hours, vapor distillation 6 hours, extract volatile oil, the water after distillation The another device of solution is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and be added thereto to 10 times of soak by water 3 times, often Secondary 2 hours, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, be concentrated into relative density be 1.25~ The clear paste of 1.35, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, crosses 60 ~100 mesh sieves
(7) taking polyethylene glycol and the double solvents of glycerol composition, wherein Polyethylene Glycol and glycerol 85:15 by volume Mixing, adds the volatile oil of step (3) gained and the extract powder of step (6) gained in solvent, is heated to 50 DEG C~60 DEG C, and It is maintained at this temperature 2 hours~3 hours, makes drug extract powder fully leach;
(8) extract powder after step (7) fully leaches is carried out quantitatively, fill soft capsule, polishing, inspection, subpackage, i.e. Obtain soft capsule.
The impact on mice with spleen deficiency of embodiment 2 compound Chinese medicinal preparation
Experimental technique: take ICR mice 60, male and female half and half, is randomly divided into 6 groups: (1) Normal group;(2) model group; (3) positive group: Spleen Invigorating and Intestine Tonifying Pill, 6g kg-1;(4) compound Chinese medicinal preparation low dose group: 10g kg-1;(5) Chinese medicine compound system Dosage group in agent: 20g kg-1;(6) compound Chinese medicinal preparation high dose group: 40g kg-1.In addition to Normal group, remaining each group All gavages give the Radix Et Rhizoma Rhei decocting liquid of 200%, 0.25ml 10g-1, continuous 10d, replicates Mice with Spleen model[1].Self-supporting Radix Et Rhizoma Rhei Decocting liquid rises on the 5th day, each continuous gastric infusion 6d of group (every day is administered to 1h after Radix Et Rhizoma Rhei decocting liquid).Model and Normal group are given Isopyknic distilled water.The azovan blue 10ml kg of mouse stomach 5% after administration 30min-1, put to death mice after 15min, rapidly Cutting open the belly and take out gastrointestinal section, record azovan blue forward position, to the distance of pylorus, calculates its percentage ratio accounting for small intestinal total length.And take immediately Go out each mouse thymus, spleen, weigh.
The impact on mice with spleen deficiency body weight of table 1 compound Chinese medicinal preparation
Compare with model group: * P < 0.05, * * P < 0.01.
Table 2 compound Chinese medicinal preparation is on mice with spleen deficiency thymus index, the impact of spleen index
Compare with model group: * P < 0.05.
The impact on mice with spleen deficiency Intestinal propulsive rate of table 3 compound Chinese medicinal preparation
Compare with model group: * P < 0.05, * * P < 0.01.
Experimental result shows: the middle and high dosage group of compound Chinese medicinal preparation of the present invention compares with model group, can substantially change Kind above-mentioned insufficiency of the spleen sign, dramatically increases the body weight of mice with spleen deficiency, increases mice with spleen deficiency spleen index, thymus index, regulate insufficiency of the spleen little The gastrointestinal function (P < 0.05,0.01) of Mus.
The impact that mouse small intestine is moved by embodiment 3 compound Chinese medicinal preparation
Take ICR mice 50, male and female half and half, body weight 18~22g, be randomly divided into 5 groups: (1) Normal group, give to wait body Long-pending distilled water;(3) positive group: not husky Billy, 0.0025g kg-1;(4) compound Chinese medicinal preparation low dose group: 12g kg-1; (5) dosage group in compound Chinese medicinal preparation: 24g kg-1;(6) compound Chinese medicinal preparation high dose group: 48g kg-1.Each group gavage is given Give corresponding medicine, 20ml kg-1, continuous 5d.Put to death, take out gastrointestinal section, the distance in record azovan blue forward position to pylorus, meter Calculate its percentage ratio accounting for small intestinal total length.The results are shown in Table 4:
The impact that mouse small intestine is advanced by table 4 compound Chinese medicinal preparation
Compare with matched group: * P < 0.05.
Experimental result shows: compound Chinese medicinal preparation granule high dose group compares with Normal group, can be obviously promoted mice Intestinal motility (P < 0.05).
The impact on chmice acute fatty liver of embodiment 4 compound Chinese medicinal preparation
Experimental technique: take ICR kind mice 78, male and female half and half, is randomly divided into 6 groups: (1) Normal group: give to wait body Long-pending distilled water;(2) model group: give isopyknic distilled water;(3) positive group: change stagnant Rougan Granule, 4g kg-1;(4) in Recurrence due to taking drug square preparation low dose group: 10g kg-1;(5) dosage group in compound Chinese medicinal preparation: 20g kg-1;(6) compound Chinese medicinal preparation High dose group: 40g kg-1.Every day positive group and medication group press 20mL kg-1Body weight gastric infusion, normal group is given with model group Giving normal saline, every day 1 time, be used in conjunction 7d, in addition to Normal group, other respectively organize every average daily hello high lipid food, 7d altogether.Real After testing end, all animals weigh, take blood, survey blood fat TG, CHOL, LDL-C, HDL-C content.Solution takes liver and calculates liver Dirty index, detects TG, CHOL equal size.
Table 5 compound Chinese medicinal preparation is on the impact of TG, CHOL content in chmice acute fatty liver serum
Compare with model group: * P < 0.05, * * P < 0.01.
Table 6 compound Chinese medicinal preparation is on the impact of HDL-C, LDL-C in chmice acute fatty liver serum
Compare with model group: * P < 0.05, * * P < 0.01.
Table 7 is on TG, CHOL content in chmice acute fatty liver hepatic tissue and the impact of liver fat number
Compare with model group: * P < 0.05, * * P < 0.01.
Experimental result shows: the granule high dose of compound Chinese medicinal preparation of the present invention can substantially reduce in mice serum TG, CHOL, LDL-C content and liver fat number (P < 0.05, P < 0.01), raise mice HDL-C content (P < 0.05).
The impact on rat chronic fatty liver of embodiment 5 compound Chinese medicinal preparation:
Experimental technique: be grouped and be administered: by SD rat 60, female half and half, by being randomly divided into 6 groups, (1) normal control Group: give isopyknic distilled water;(2) model group: give isopyknic distilled water;(3) positive group: change stagnant Rougan Granule, 4g·kg-1;(4) compound Chinese medicinal preparation granule low dose group: 5g kg-1;(5) dosage group in compound Chinese medicinal preparation granule: 10g·kg-1;(6) compound Chinese medicinal preparation granule high dose group: 20.0g kg-1.After administration, take a blood sample from eyeground vein, put to death, Measure body long, weigh the weight of fat, liver weight, detection CHOL, TG etc..
Experimental result: compound Chinese medicinal preparation granule can reduce rat model liver CHOL, TG content (P < 0.05), delays body weight Increase (P < 0.05), reduction rat Lee ' s index (P < 0.05), reduction rat CHOL, TG, LDL-C, AST, ALT content (P < 0.05, P < 0.01), raise HDL-C content (P < 0.01), alleviate the order of severity (P of the pathological change of rat liver steatosis <0.05)。
The impact on chronic Rats with Fatty Liver body weight of table 8 compound Chinese medicinal preparation
Compare with model group: * P < 0.05.
Table 9 compound Chinese medicinal preparation is on chronic Rats with Fatty Liver liver fat number, Lee ' s index, the impact of fat index
Compare with model group: * P < 0.05, * * P < 0.01.
The table 10 impact on chronic Rats with Fatty Liver blood fat
Compare with model group: * P < 0.05, * * P < 0.01.
Table 11 compound Chinese medicinal preparation is on the impact of CHOL, TG in chronic Rats with Fatty Liver serum AST, ALT and liver homogenate
Compare with model group: * P < 0.05, * * P < 0.01.
The impact on chronic Rats with Fatty Liver hepatic tissue pathology of table 12 compound Chinese medicinal preparation

Claims (10)

1. a compound Chinese medicinal preparation, it is characterised in that be made up of following raw material: Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Herba Artemisiae Scopariae, Spica Prunellae, red Ginseng, Fructus Crataegi, Ramulus Euonymi, Bombyx Batryticatus, Sargassum, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum.
A kind of compound Chinese medicinal preparation the most according to claim 1, it is characterised in that the dosage form of described preparation is decoction, conjunction Agent, oral liquid, tablet, granule, hard capsule or soft capsule.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described decoction is prepared by following methods:
(1) each raw material is assorted according to single times amount prescription drug amount;
(2) Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, Rhizoma Cyperi, Rhizoma Wenyujin Concisum, Rhizoma Polygonati, Bombyx Batryticatus, sea are taken Algae, adds 1~20 times of soak by water 1~6 times, each 0.5~3 hour, and collecting decoction filters, obtains decoction.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described mixture is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.5% sorbic acid or 0.1% ~0.5% benzoic acid, adjust total amount to the medicinal liquid of 120L~180L with water, stir evenly;
(7) medicinal liquid that step (6) obtains is carried out sub-bottle fill, use boiling method or circulation vapor method sterilizing, airtight during sterilizing, Obtain mixture.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described oral liquid is by following methods system :
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, add 0.05%~0.15% sorbic acid or 0.1% ~0.2% benzoic acid use water adjust total amount to the medicinal liquid of 30L~60L, stir evenly;
(7) step (6) gained medicinal liquid is carried out fill, use boiling method or circulation vapor method sterilizing, obtain oral liquid.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described tablet is prepared by following methods:
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) extractum that step (5) gained clear paste obtains with step (2) is merged, be dried, obtain dry extract, be ground into drug extract Powder, crosses 60~100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the drug extract powder of step (6) gained, step (3) are extracted is stuck with paste with β-ring Inclusion compounds merges, mixes, pelletizes, granulate, tabletted, then carries out thin film or sweet tablet, inspection, and subpackage obtains tablet.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described granule is by following methods system :
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract;
(7) taking the dry extract that step (5) obtains, add dextrin mixing, pelletize, granulate must do granule, by volatile oil ethanol After equimultiple dilution, spray in dry granule, mix to obtain drug particles, subpackage, obtain granule.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described hard capsule is by following methods system :
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, cross 60~ 100 mesh sieves;
(7) take magnesium stearate, volatile oil that Pulvis Talci, the dry extract of step (6) gained, step (3) are extracted and beta-schardinger dextrin- Clathrate merges, mixes, pelletizes, granulate, fill hard capsule, polishing, inspection, and subpackage obtains hard capsule.
A kind of compound Chinese medicinal preparation the most according to claim 2, it is characterised in that described soft capsule is by following methods system :
(1) each raw material is assorted according to 1000 times amount prescription drug amounts;
(2) take Radix Polygoni Multiflori Preparata, Herba Artemisiae Scopariae, Spica Prunellae, Radix Salviae Miltiorrhizae, Fructus Crataegi, Ramulus Euonymi, Rhizoma Alismatis, add 3~15 times 50~95% ethanol, return Stream extract 1~6 time, each 0.5~3 hour, merge ethanol, filter, reclaim ethanol, be condensed into relative density be 1.25~ The extractum of 1.35, relative density records in 60 DEG C time;
(3) Rhizoma Cyperi, Rhizoma Wenyujin Concisum add 1~20 times of water soakings 0.5~24 hours, and volatilization is extracted in vapor distillation 0.5~12 hours Oil, the another device of aqueous solution after distillation is collected;
(4) step (3) remaining medicinal residues are mixed with Rhizoma Polygonati, Bombyx Batryticatus, Sargassum, and are added thereto to 1~20 times of soak by water 1~6 times, Each 1~3 hour, collecting decoction, filters, collects filtrate;
(5) aqueous solution step (3) collected merges with step (4) gained filtrate, and being concentrated into relative density is 1.25~1.35 Clear paste, relative density records in 60 DEG C time;
(6) being merged by the extractum that step (5) gained clear paste obtains with step (2), crushed after being dried obtains dry extract, cross 60~ 100 mesh sieves;
(7) taking polyethylene glycol and the double solvents of glycerol composition, wherein Polyethylene Glycol and glycerol by volume 50~95:5 ~50 mixing, in solvent, add the extract powder of volatile oil and step (6) gained of step (3) gained, be heated to 50 DEG C~60 DEG C, and it is maintained at this temperature 2 hours~3 hours, make drug extract powder fully leach;
(8) extract powder after step (7) fully leaches is carried out quantitatively, fill soft capsule, polishing, inspection, subpackage, obtain soft Capsule.
10. the arbitrary described compound Chinese medicinal preparation of claim 1~10 is lost at the preparation treatment damp and hot phlegm and blood stasis of fatty liver, Liver and kidney Application in deficient syndrome medicine.
CN201610757090.8A 2016-08-29 2016-08-29 A kind of compound Chinese medicinal preparation and its preparation method and application Pending CN106266949A (en)

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