CN1739751A - Chinese medicine prepn for invigorating spleen and benefiting vital energy and its prepn process and quality control method - Google Patents
Chinese medicine prepn for invigorating spleen and benefiting vital energy and its prepn process and quality control method Download PDFInfo
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- CN1739751A CN1739751A CN 200510032134 CN200510032134A CN1739751A CN 1739751 A CN1739751 A CN 1739751A CN 200510032134 CN200510032134 CN 200510032134 CN 200510032134 A CN200510032134 A CN 200510032134A CN 1739751 A CN1739751 A CN 1739751A
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Abstract
The Chinese medicine preparation for invigorating spleen and benefiting vital energy is prepared with ginseng, tuckahoe, white atractylodes rhizome, Chinese yam, white hyacinth bean and other five kinds of Chinese medicinal materials, and is prepared into dripping pill, micro pill or capsule. The preparation process includes water extracting white atractylodes rhizome or extracting volatile oil and water extracting medicine dreg; crushing amomum fruit or extracting volatile oil and water extracting medicine dreg; water extracting Chinese yam or crushing partial Chinese yam and crushing partial Chinese yam; crushing or water extracting ginseng and lotus seed; water extracting the other Chinese medicinal materials; mixing the extracts, medicine powder and supplementary material, and preparing into granule, tablet, micro pill or capsule. The present invention has the advantages of high bioavailability, high controllability, high stability, etc.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of Chinese medicine preparation and preparation method thereof and method of quality control of invigorating the spleen and replenishing QI.
Background technology:
Through patent retrieval, Chinese patent nineteen ninety-five discloses (publication number: CN1107056) ginseng fuling and root of herbaceous peony oral liquid and preparation technology thereof, disclosed that (publication number: CN1362215) nanometer ginseng Siberian cocklebur bighead atractylodes rhizome medicine and preparation method thereof, not seeing has drop pill or micropill or pellet capsule or soft capsule patent and bibliographical information in 2002.
Drop pill in the Chinese medicine preparation or micropill or pellet capsule or soft capsule, change dosage form or technology and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The existing dosage form of this product is ball, granule, powder, capsule, oral liquid.
The Chinese medicine preparation ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae ball of existing invigorating the spleen and replenishing QI has been listed Chinese traditional patent formulation preparation promulgated by the ministries or commissions of the Central Government (the 4th) in, and its process characteristic is: get ten flavors in the prescription, be ground into fine powder, sieve, mixing is used water pill, drying, promptly.
Existing ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae ball has bioavailability low, and onset is slow, shortcoming such as is difficult for taking.
The Chinese medicine preparation SHENLING BAISHU SAN of existing invigorating the spleen and replenishing QI, list in " Chinese pharmacopoeia 2005 editions, its process characteristic is: gets ten flavors in the prescription, is ground into fine powder, sieve, mixing, promptly.Existing SHENLING BAISHU SAN has easy moisture and deteriorate, is difficult for preserving, and takes shortcomings such as inconvenience.
The Chinese medicine preparation granule containing ginseng, Siberian cocklebur, lagehead atractylodes of existing invigorating the spleen and replenishing QI has been listed Chinese traditional patent formulation preparation promulgated by the ministries or commissions of the Central Government (the 20) in, and its process characteristic is: get Fructus Amomi, the Rhizoma Atractylodis Macrocephalae extracts volatile oil, and the aqueous solution after distillation device is in addition collected; Eight flavors such as medicinal residues and all the other Radix Ginsengs decoct with water, and decocting liquid filters, and filtrate and above-mentioned aqueous solution merge, and are concentrated into cream.1 part of qinghuo reagent, 2 parts of sucrose, 2.5 parts in dextrin and ethanol are made granule in right amount, and drying adds the volatile oil of the above-mentioned Rhizoma Atractylodis Macrocephalae, Fructus Amomi, mixing, promptly.
Shortcomings such as inconvenience, easily the moisture absorption, bioavailability be low are taken, carried to existing granule containing ginseng, Siberian cocklebur, lagehead atractylodes.
The Chinese medicine preparation ginseng fuling and root of herbaceous peony oral liquid of existing invigorating the spleen and replenishing QI, the national drug standards new drug standard (the 36) of becoming a full member, its technology features is: adopt Radix Ginseng alcohol extraction, the Rhizoma Atractylodis Macrocephalae and Fructus Amomi water distillation and extraction volatile oil, all the other seven flavor medicines to decoct and extract, add an amount of Tween 80 and sorbitol and make.
Existing ginseng fuling and root of herbaceous peony oral liquid carries, transports, stores inconvenience, goes mouldy easily, shortcoming such as mouthfeel difference.
Summary of the invention:
The Chinese medicine preparation and preparation method thereof and the method for quality control that the purpose of this invention is to provide a kind of invigorating the spleen and replenishing QI overcome the drawback of prior art, improve quality and the curative effect and the bioavailability of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
A kind of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is that main component is ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or the soft capsule of Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Semen Lablab Album (stir-fry), Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodonis, Radix Glycyrrhizae.
Its preparation method is:
(1) medicine main component and weight proportion thereof are as follows:
Respectively 50～150 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 50～100 parts of Semen Lablab Albums (stir-fry), respectively 30～70 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
The preferred weight proportioning of its main component is:
Respectively 80～120 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 60～90 parts of Semen Lablab Albums (stir-fry), respectively 40～60 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
The optimum weight proportioning of its main component is:
Respectively 100 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, each 75 parts of Semen Lablab Albums (stir-fry), respectively 50 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss.
(2) get Fructus Amomi, the Rhizoma Atractylodis Macrocephalae and extract volatile oil, the aqueous solution after the distillation, medicinal residues, volatile oil are standby;
(3) get eight flavors such as the medicinal residues of (2) gained and all the other Radix Ginsengs, decoct with water 1～4 time, each 0.5～4 hour, collecting decoction, filter, filtrate merges with the aqueous solution of (2) gained, is concentrated into the clear paste of relative density 1.10～1.30 (50～65 ℃), drying is ground into fine powder, and is standby;
(4) get the fine powder of (3) gained, add suitable adjuvant, spray into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, mixing gets hybrid medicine, and is standby;
(5) with one or more or other suitable auxiliary material of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188, use with by arbitrary proportion, add (4) gained hybrid medicine after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, with the drop pill drop of molding to the greatest extent and remove coolant, dry coationg promptly;
(6) get the fine powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and sprays into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is following one or more combinations or other suitable adjuvant, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
(7) get the fine powder of (3) gained, add suitable adjuvant, mix homogeneously sprays into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, compacting or drip and make soft capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
The preparation method of its micropill or pellet capsule can also be:
(1) medicine main component and weight proportion thereof are as follows:
Respectively 50～150 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 50～100 parts of Semen Lablab Albums (stir-fry), respectively 30～70 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
The preferred weight proportioning of its main component is:
Respectively 80～120 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 60～90 parts of Semen Lablab Albums (stir-fry), respectively 40～60 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
The optimum weight proportioning of its main component is:
Respectively 100 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 75 parts of Semen Lablab Albums (stir-fry), respectively 50 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
(2) get 40～60% of Radix Ginseng, Semen Nelumbinis, Fructus Amomi and Rhizoma Dioscoreae weight portion and be ground into fine powder, standby;
(3) get Six-elements such as residue Rhizoma Dioscoreae and all the other Poria, decoct with water 1～4 time, collecting decoction filters, and filtrate is condensed into thick paste, adds the fine powder of (2) gained, and drying is pulverized, and gets mixed powder, and is standby;
(4) get the mixed powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose.
A kind of method of quality control of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is the method for quality control of ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or soft capsule:
Differentiate: get this product 5～20g, the 20～60ml that adds diethyl ether, reflux, extract, 20～40 minutes filters, and filtrate evaporate to dryness, residue add the 1ml n-hexane dissolution, as need testing solution; Other gets Poria control medicinal material 1～3g, with the method operation, makes control medicinal material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned two solution, 10～30 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (30～60 ℃)-acetone-ethyl acetate (6～10: 0.5～3: 0.05～2) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of same color is arranged;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (80～120: 300～500) be mobile phase; The detection wavelength is 200～208nm.Number of theoretical plate calculates by the ginsenoside Re peak should be not less than 2500;
The preparation of reference substance solution, precision takes by weighing the ginsenoside Rg
1Reference substance, ginsenoside Re's reference substance add methanol and make every 1ml respectively and contain the ginsenoside Rg
10.1 the solution of～0.8mg, ginsenoside Re 0.1～0.6mg, promptly;
The preparation of need testing solution; get this product 2～10g; accurate claim is surely put in the apparatus,Soxhlet's, adds the chloroform reflux 2～4 hours; discard chloroform solution; medicinal residues are flung to chloroform, with 60～80% alcohol refluxs 2～6 hours, reclaim ethanol after; reuse 60～80% ethanol are settled to 15～30ml, and accurate absorption 1～3ml adds to neutral AL
2O
3In the post,, collect eluent 20～30ml with 60～80% ethanol elutions, put evaporate to dryness in the water-bath,, and go in the separatory funnel with water saturated n-butyl alcohol 2～6ml dissolving, wash 1～3 time with the saturated 0.1mol/L sodium hydroxide solution of n-butyl alcohol, the 0.01mol/L hydrochloric acid solution that the reuse n-butyl alcohol is saturated is washed 1 time, and the water saturated n-butanol extraction of reuse 1～3 time merges n-butyl alcohol liquid, put evaporate to dryness in the water-bath, add dissolve with methanol, be settled to 5ml, as need testing solution;
Algoscopy, accurate respectively above-mentioned two kinds of reference substance solution, each 5～20ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly.
Specific embodiments:
The present invention further specifies in conjunction with specific embodiments, can be for reference, do not limit the scope of the invention:
A kind of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is that main component is ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or the soft capsule of Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Semen Lablab Album (stir-fry), Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodonis, Radix Glycyrrhizae.
Chinese medicine preparation function of the present invention cures mainly and is tonifying the spleen and stomach, lung benefiting gas.Be used for weakness of the spleen and stomach, anorexia and loose stool, the cough of breathing hard, lassitude of the limbs and weakness.
The preparation method of Chinese medicine preparation of the present invention is:
(1) ingredient and weight consumption are as follows:
Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, each 100g of Radix Glycyrrhizae, Semen Lablab Album (stir-fry) 75g, Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, each 50g of Radix Platycodonis;
(2) get Fructus Amomi, the Rhizoma Atractylodis Macrocephalae and extract volatile oil, the aqueous solution after the distillation, medicinal residues, volatile oil are standby;
(3) get eight flavors such as the medicinal residues of (2) gained and all the other Radix Ginsengs, decoct with water three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction, filter, filtrate merges with the aqueous solution of (2) gained, is concentrated into the clear paste of relative density 1.20～1.25 (55 ℃), drying, be ground into fine powder, standby;
(4) get the fine powder of (3) gained, add suitable adjuvant, spray into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, mixing gets hybrid medicine, and is standby;
(5) a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill, its preparation method is taking polyethylene glycol PEG6000100g, stearic acid 30g, Poloxamer188 15g, treat to add (4) gained hybrid medicine after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying promptly.
(6) a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae micropill, its preparation method is a fine powder of getting (3) gained, with 80g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, and be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, spray into the Fructus Amomi of (2) gained, the Rhizoma Atractylodis Macrocephalae extracts volatile oil, promptly.
(7) a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae pellet capsule, its preparation method is a fine powder of getting (3) gained, with 80g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, spray into the Fructus Amomi of (2) gained, the Rhizoma Atractylodis Macrocephalae extracts volatile oil, the micropill that makes is incapsulated, promptly get pellet capsule.
(8) a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae soft capsule, its preparation method is a fine powder of getting (3) gained, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, plant, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, spray into the Fructus Amomi of (2) gained, the Rhizoma Atractylodis Macrocephalae extracts volatile oil, suppresses or drips and make soft capsule.
(9) a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae micropill or pellet capsule, its preparation method is:
1. Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, each 100g of Radix Glycyrrhizae, Semen Lablab Album (stir-fry) 75g, Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, each 50g of Radix Platycodonis;
2. get Radix Ginseng, Semen Nelumbinis, Fructus Amomi and Rhizoma Dioscoreae 93g and be ground into fine powder, mixing, standby;
3. get Six-elements such as residue Rhizoma Dioscoreae and all the other Poria, decoct with water three times, collecting decoction filters, and filtrate is condensed into thick paste, adds 2. gained fine powder, and drying is pulverized, and gets mixed powder, and is standby;
4. get 3. gained mixed powder and 75g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepare 60 purpose granules and make parent nucleus, and be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, promptly get and join Siberian cocklebur Rhizoma Atractylodis Macrocephalae micropill.
5. get 3. gained mixed powder and 75g dextrin mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, incapsulate, promptly get and join Siberian cocklebur Rhizoma Atractylodis Macrocephalae pellet capsule.
A kind of method of quality control of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is the method for quality control of ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or soft capsule:
Differentiate: get this product 10g, the 50ml that adds diethyl ether, reflux, extract, 30 minutes filters, and filtrate evaporate to dryness, residue add the 1ml n-hexane dissolution, as need testing solution.Other gets Poria control medicinal material 2g, with the method operation, makes control medicinal material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned two solution, 20 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with petroleum ether (30～60 ℃)-acetone-ethyl acetate (8.5: 1.5: 0.1), launches, take out, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of same color is arranged;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (100: 400) is a mobile phase; The detection wavelength is 203nm.Number of theoretical plate calculates by the ginsenoside Re peak should be not less than 2500;
The preparation of reference substance solution, precision takes by weighing the ginsenoside Rg
1Reference substance, ginsenoside Re's reference substance add methanol and make every 1ml respectively and contain the ginsenoside Rg
10.5mg, the solution of ginsenoside Re 0.4mg, promptly;
This product 5g is got in the preparation of need testing solution, and accurate the title decides, and puts in the apparatus,Soxhlet's, added the chloroform reflux 3 hours, and discarded chloroform solution, medicinal residues were flung to chloroform, with 70% alcohol reflux 5 hours, after reclaiming ethanol, reuse 70% ethanol is settled to 25ml, and the accurate 1ml that draws adds to neutral AL
2O
3In the post, use 70% ethanol elution, collect eluent 25ml, put evaporate to dryness in the water-bath,, and go in the separatory funnel with water saturated n-butyl alcohol 5ml dissolving, wash 2 times with the saturated 0.1mol/L sodium hydroxide solution of n-butyl alcohol, the 0.01mol/L hydrochloric acid solution that the reuse n-butyl alcohol is saturated is washed 1 time, and the water saturated n-butanol extraction of reuse 2 times merges n-butyl alcohol liquid, put evaporate to dryness in the water-bath, add dissolve with methanol, be settled to 5ml, as need testing solution;
Algoscopy, accurate respectively above-mentioned two kinds of each 10ul of reference substance solution and the need testing solution 20ul of drawing injects chromatograph of liquid, measures, promptly.
You point of the present invention is:
Carry, taking convenience, the bioavilability height, controllability and good stability, You are beneficial to the raising curative effect.
Claims (6)
1, a kind of Chinese medicine preparation of invigorating the spleen and replenishing QI is characterized in that it is that main component is ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or the soft capsule of Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Semen Lablab Album (stir-fry), Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodonis, Radix Glycyrrhizae.
2, a kind of preparation method of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or preparation of soft capsule method, it is characterized in that:
(1) medicine main component and weight proportion thereof are as follows:
Respectively 50～150 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 50～100 parts of Semen Lablab Albums (stir-fry), respectively 30～70 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
(2) get Fructus Amomi, the Rhizoma Atractylodis Macrocephalae and extract volatile oil, the aqueous solution after the distillation, medicinal residues, volatile oil are standby;
(3) get eight flavors such as the medicinal residues of (2) gained and all the other Radix Ginsengs, decoct with water 1～4 time, each 0.5～4 hour, collecting decoction, filter, filtrate merges with (2) obtained aqueous solution, is concentrated into the clear paste of relative density 1.10～1.30 (50～65 ℃), drying is ground into fine powder, and is standby;
(4) get the fine powder of (3) gained, add suitable adjuvant, spray into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, mixing gets hybrid medicine, makes drop pill or micropill or pellet capsule or soft capsule;
The preparation method of its drop pill is: with one or more or other suitable auxiliary material of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188, use with by arbitrary proportion, add (4) gained hybrid medicine after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
The preparation method of its micropill or pellet capsule is: get the fine powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and sprays into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is following one or more combinations or other suitable adjuvant, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its preparation of soft capsule method is: get the fine powder of (3) gained, add suitable adjuvant, mix homogeneously sprays into the volatile oil of (2) gained Rhizoma Atractylodis Macrocephalae, Fructus Amomi, compacting or drip and make soft capsule;
Adjuvant is following one or more combinations or other suitable adjuvant, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
3, according to the preparation method of the Chinese medicine preparation of the described a kind of invigorating the spleen and replenishing QI of claim 2, it is characterized in that the preparation method of joining Siberian cocklebur Rhizoma Atractylodis Macrocephalae micropill or pellet capsule can also be:
(1) ingredient and weight proportion thereof are as follows:
Respectively 50～150 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 50～100 parts of Semen Lablab Albums (stir-fry), respectively 30～70 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss;
(2) get 40～60% of Radix Ginseng, Semen Nelumbinis, Fructus Amomi and Rhizoma Dioscoreae weight portion and be ground into fine powder, standby;
(3) get Six-elements such as residue Rhizoma Dioscoreae and all the other Poria, decoct with water 1～4 time, collecting decoction filters, and filtrate is condensed into thick paste, adds the fine powder of (2) gained, and drying is pulverized, and gets mixed powder, and is standby;
(4) get the mixed powder of (3) gained, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Micropill or pellet capsule adjuvant are following one or more combinations or other suitable adjuvant, use with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose.
4, a kind of method of quality control of Chinese medicine preparation of invigorating the spleen and replenishing QI, it is the method for quality control of ginseng Siberian cocklebur Rhizoma Atractylodis Macrocephalae drop pill or micropill or pellet capsule or soft capsule, it is characterized in that:
Differentiate: get this product 5～20g, the 20～60ml that adds diethyl ether, reflux, extract, 20～40 minutes filters, and filtrate evaporate to dryness, residue add the 1ml n-hexane dissolution, as need testing solution; Other gets Poria control medicinal material 1～3g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw above-mentioned two solution, 10～30 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (30～60 ℃)-acetone-ethyl acetate (6～10: 0.5～3: 0.05～2) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of same color is arranged;
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (80～120: 300～500) be mobile phase; The detection wavelength is 200～208nm; Number of theoretical plate calculates by the ginsenoside Re peak should be not less than 2500;
The preparation of reference substance solution, precision takes by weighing the ginsenoside Rg
1Reference substance, ginsenoside Re's reference substance add methanol and make every 1ml respectively and contain the ginsenoside Rg
10.1 the solution of～0.8mg, ginsenoside Re 0.1～0.6mg, promptly;
The preparation of need testing solution; get this product 2～10g; accurate claim is surely put in the apparatus,Soxhlet's, adds the chloroform reflux 2～4 hours; discard chloroform solution; medicinal residues are flung to chloroform, with 60～80% alcohol refluxs 2～6 hours, reclaim ethanol after; reuse 60～80% ethanol are settled to 15～30ml, and accurate absorption 1～3ml adds to neutral AL
2O
3In the post,, collect eluent 20～30ml with 60～80% ethanol elutions, put evaporate to dryness in the water-bath,, and go in the separatory funnel with water saturated n-butyl alcohol 2～6ml dissolving, wash 1～3 time with the saturated 0.1mol/L sodium hydroxide solution of n-butyl alcohol, the 0.01mol/L hydrochloric acid solution that the reuse n-butyl alcohol is saturated is washed 1 time, and the water saturated n-butanol extraction of reuse 1～3 time merges n-butyl alcohol liquid, put evaporate to dryness in the water-bath, add dissolve with methanol, be settled to 5ml, as need testing solution;
Algoscopy, accurate respectively above-mentioned two kinds of reference substance solution and each 5～20ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly.
5, the preparation method of the Chinese medicine preparation of a kind of invigorating the spleen and replenishing QI according to claim 2 is characterized in that the preferred weight proportioning of its main component is:
Respectively 80～120 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 60～90 parts of Semen Lablab Albums (stir-fry), respectively 40～60 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss.
6, the preparation method of the Chinese medicine preparation of a kind of invigorating the spleen and replenishing QI according to claim 2 is characterized in that the optimum weight proportioning of its main component is:
Respectively 100 parts in Radix Ginseng, Poria, the Rhizoma Atractylodis Macrocephalae (stir-fry), Rhizoma Dioscoreae, Radix Glycyrrhizae, 75 parts of Semen Lablab Albums (stir-fry), respectively 50 parts of Semen Nelumbinis, Semen Coicis (stir-fry), Fructus Amomi, Radix Platycodoniss.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948030A (en) * | 2014-04-30 | 2014-07-30 | 新时代健康产业（集团）有限公司 | Healthcare food for qi-deficiency constitution and preparation method thereof |
| CN106728796A (en) * | 2015-11-19 | 2017-05-31 | 哈尔滨圣吉药业股份有限公司 | A kind of native Mi Shu invigorates the spleen and benefits qi electuary and preparation method thereof |
| CN110146623A (en) * | 2019-06-13 | 2019-08-20 | 山东孔圣堂制药有限公司 | The method for building up and its standard diagram of Shenlingbaizhu pills HPLC-ELSD finger-print |
| CN115531324A (en) * | 2022-11-23 | 2022-12-30 | 昆明中药厂有限公司 | Ginseng and poria cocos granules with high forming rate, low hygroscopicity and good fluidity and capable of strengthening spleen and stomach |
-
2005
- 2005-09-08 CN CN 200510032134 patent/CN1739751A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948030A (en) * | 2014-04-30 | 2014-07-30 | 新时代健康产业（集团）有限公司 | Healthcare food for qi-deficiency constitution and preparation method thereof |
| CN106728796A (en) * | 2015-11-19 | 2017-05-31 | 哈尔滨圣吉药业股份有限公司 | A kind of native Mi Shu invigorates the spleen and benefits qi electuary and preparation method thereof |
| CN110146623A (en) * | 2019-06-13 | 2019-08-20 | 山东孔圣堂制药有限公司 | The method for building up and its standard diagram of Shenlingbaizhu pills HPLC-ELSD finger-print |
| CN115531324A (en) * | 2022-11-23 | 2022-12-30 | 昆明中药厂有限公司 | Ginseng and poria cocos granules with high forming rate, low hygroscopicity and good fluidity and capable of strengthening spleen and stomach |
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