CN105853862A

CN105853862A - Ginseng tablet capable of strengthening spleen and preparation method thereof

Info

Publication number: CN105853862A
Application number: CN201610272827.7A
Authority: CN
Inventors: 韩志强
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-04-28
Filing date: 2016-04-28
Publication date: 2016-08-17

Abstract

The invention discloses a ginseng tablet capable of strengthening the spleen and a preparation method thereof. The ginseng tablet capable of strengthening the spleen is prepared from ginseng, white atractylodes rhizome, licorice, Chinese yam, lotus seeds, semen dolichoris album, costus roots, alpinia katsumadai hayata, dried orange peel, green tangerine peel, medicated leaven, rice sprouts, hawthorn fruits, euryale seeds, coix seeds, angelica and bitter orange. The preparation method of the ginseng tablet capable of strengthening the spleen comprises the following steps: carrying out ultra-micro grinding on the ginseng, white atractylodes rhizome, licorice, lotus seeds, semen dolichoris album, euryale seeds and angelica; carrying enzymolysis on the Chinese yam, medicated leaven and coix seeds by using complex enzymes, and then carrying out decocting; and carrying out supercritical extraction on the rest of raw medicines. The ginseng tablet and the preparation method thereof have the advantages that a right amount of disintegrating agent is added in the improved process, and the tablet prepared after the disintegrating agent is added has short disintegration time; according to the process, effective ingredients are not damaged, more complete effective ingredients of the medicines can be extracted, the dissolution rate of drugs is high, the retention time of the drug effect is long, the bioavailability is high, and the stability is better; and according to the method, the extracts are purified, and the curative effect is obviously increased in comparison with the traditional process.

Description

A kind of Renshenjianpi Tablet and preparation method thereof

Technical field

The present invention relates to the pharmaceutical formulation of a kind of field of medicaments, particularly relate to a kind of Renshenjianpi Tablet and preparation side thereof Method.

Background technology

Renshenjianpi Tablet is that Chinese Pharmacopoeia records kind.By ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, Chinese yam, lotus seeds, Semen Lablab Album, the banksia rose, In one's early teens, dried orange peel, rascal, Medicated Leaven, rice sprout, hawthorn, Gorgon fruit, coix seed, Radix Angelicae Sinensis and Fructus Aurantii be prepared from, there is tonifying Qi and be good for Spleen, appetite-stimulating indigestion-relieving, for the anorexia and loose stool caused by water retention due to hypofunction of the spleen or tell or rush down, abdominal fullness and distention, limbs fatigue, sallow complexion etc. Disease.

At present Renshenjianpi Tablet preparation technology is substantially and continues to use Conventional processing methods, by ginseng, Medicated Leaven, in one's early teens, paddy Bud is ground into fine powder, remaining bulk drug boiling or alcohol extract.Owing to common grinder is that open pulverizing can exist system During grain, particle diameter is big, can cause heavy metal pollution, and drug-eluting speed is slow, the shortcomings such as bioavilability is low.Owing to bulk drug mixes By common decoction extracting method, the effective ingredient that can promote its single bulk drug is unstable, and common decoction extracting method meeting The effective ingredient recovery rate making its bulk drug is substantially reduced, and the most inevitably proposes a large amount of water-solubility impurities.Traditional Chinese medicine disease prevention is controlled The content of the amount of sick effect and extract and wherein active ingredient has direct relation.If extraction process is unreasonable, not science, Destruction and the loss of active ingredient certainly will be caused, thus affect the quality of preparation, curative effect.Additionally, the collapsing of existing Renshenjianpi Tablet The solution time is longer, after long-term especially placement, has the phenomenon beyond standards of pharmacopoeia, and the long meeting of disintegration time has a strong impact on the suction of medicine Receive.

Along with improving constantly drug quality, effect requirements and the development of pharmaceutical technology clinically, this technique is Can not meet current demand, a kind of extracts active ingredients of urgent need is more complete, the higher preparation process of content, preferably to play people The medical value of ginseng spleen-strengtheningtablet tablet classics prescription.

Summary of the invention

It is an object of the invention to for the deficiencies in the prior art, it is provided that a kind of extracts active ingredients more completely, contain Measure higher, drug-eluting speed is fast, bioavilability is high and the preparation technology of the Renshenjianpi Tablet of good stability, thus preferably Play the medical value of this tradition proved recipe.

Present invention aim at providing a kind of ginseng spleen strengthening tablet preparation.

Another object of the present invention is to provide the preparation method of a kind of Renshenjianpi Tablet.

The present invention is achieved through the following technical solutions:

Renshenjianpi Tablet of the present invention is made up of following bulk drug and auxiliary material:

Renshenjianpi Tablet of the present invention is preferably as follows bulk drug and auxiliary material forms:

The further preferably following bulk drug of Renshenjianpi Tablet of the present invention and auxiliary material composition:

The present invention provides a kind of Renshenjianpi Tablet, and this Renshenjianpi Tablet is prepared from by following methods:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively and soaks with the water of 2-4 times amount Pulling out after 5-15 hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free ,-18 DEG C～-22 DEG C after freezing 1-3 hour at-4 DEG C ～the environment of-8 DEG C carries out ultramicro grinding obtain micropowders；After ultramicro grinding, the grain size of micropowder of more than 80% is micro-less than 6 Rice；By Chinese yam water soaking 15-45 minute of 4-12 times amount, add 6-18 weight portion complex enzyme, described complex enzyme be 3:1 α- Amylase and phosphoprotein phosphatase, first carry out the 20-60 DEG C of enzymolysis of 15-45 minute, then decoct, and decocts 1.5-for the first time 4.5 hours, filtering, obtain filtrate, the dregs of a decoction with soak by water 1-3 hour of 3-9 times amount, filter to get filtrate, merge twice filtrate again, filter Crossing, filtrate is concentrated into 70-90 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stands, take supernatant Reclaim ethanol, and be concentrated into 60-80 DEG C survey relative density be the extractum A of 1.25-1.30；Medicated Leaven is added the water logging of 4-12 times amount Steeping 15-45 minute, add the complex enzyme of 4-12 weight portion, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, advanced 20-60 DEG C of enzymolysis of 15-45 minute of row, then decocts, and decocts 1-3 hour for the first time, filters to get filtrate；3-used again by the dregs of a decoction The soak by water of 9 times amount 1-2 hour, filters, obtains filtrate, merge twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, Centrifugal 2-6 minute, separating supernatant, water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 4-12 times amount water logging Steeping 15-45 minute, add the complex enzyme of 8-24 weight portion, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, advanced 20-60 DEG C of enzymolysis of 15-45 minute of row, then decocts twice, each 0.5-1.5 hour, merges twice decocting liquid, filters, filtrate It is concentrated into 25-75 DEG C and surveys the medicinal extract C that relative density is 1.35～1.40；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn With Fructus Aurantii ultramicro grinding to 20-60 mesh, Ultramicro-powder is placed on CO₂Extraction kettle soaks 1.5-4.5 hour, controls extraction kettle is pressed Power is 20-30MPa, and the Ultramicro-powder after soaking separates in separating still, and controlling separating pressure value in separating still is 3- 9MPa, is heated up to 20-60 DEG C, keeps 2.5-7.5 hour, CO₂Flow maintain 20-40Kg/h；Extract after separation enters Row is drying to obtain extract D；Extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer are stirred Uniformly, add ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders and stir, finally add phosphorus Acid hydrogen calcium and PVPP mixing and stirring, make particle, tabletted, film coating sheet.

The present invention provides a kind of Renshenjianpi Tablet, and the preferred following methods of this Renshenjianpi Tablet is prepared from:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 10 with the water of 3 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, surpasses after 2 hours-20 DEG C of freezings in the environment of-6 DEG C Crushing of Ultrafine obtains micropowders；After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water logging of 8 times amount Steeping 30 minutes, add 12 weight portion complex enzymes, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C The enzymolysis of 30 minutes, then decocts, and decocts 3 hours for the first time, filters, obtains filtrate, and the dregs of a decoction are again with the soak by water 2 of 6 times amount Time, filtering to get filtrate, merge twice filtrate, filter, filtrate is concentrated into 80 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes Alcohol content reaches 65%, stands, and takes supernatant and reclaims ethanol, and be concentrated into 70 DEG C to survey relative densities be the extractum A of 1.25-1.30； Medicated Leaven is added the water soaking 30 minutes of 8 times amount, adds the complex enzyme of 8 weight portions, described complex enzyme be 3:1 AMS and Phosphoprotein phosphatase, first carries out 40 DEG C of enzymolysis of 30 minutes, then decocts, and decocts 2 hours for the first time, filters to get filtrate；Medicine Slag with the soak by water 1.5 hours of 6 times amount, filters, obtains filtrate, merge twice filtrate again, filters, filtrate centrifugation, 3000rpm Centrifugal, centrifugal 4 minutes, separate supernatant, water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water loggings Steeping 30 minutes, add the complex enzyme of 16 weight portions, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 The enzymolysis of DEG C 30 minutes, then decocts twice, each 1 hour, merges twice decocting liquid, filters, and filtrate is concentrated into 50 DEG C and surveys relatively Density is the medicinal extract C of 1.35～1.40；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding be to 40 Mesh, is placed on CO by Ultramicro-powder₂Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa, the Ultramicro-powder after soaking Separating in separating still, controlling separating pressure value in separating still is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Stream Amount maintains 30Kg/h；Extract after separation is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and overcritical Extraction extract D homogenizer is stirred uniformly, adds ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and works as Return micropowders to stir, finally add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, be pressed into Sheet, film coating sheet.

The preparation method of Renshenjianpi Tablet of the present invention is: by ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis Cleaning respectively and pull out after carrying out soaking 5-15 hour with the water of 2-4 times amount, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free ,-18 DEG C～-22 DEG C in the environment of-4 DEG C～-8 DEG C, carry out ultramicro grinding after freezing 1-3 hour and obtain micropowders；After ultramicro grinding The grain size of micropowder of more than 80% is less than 6 microns；By Chinese yam water soaking 15-45 minute of 4-12 times amount, add 6-18 weight Part complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out the 20-60 DEG C of enzymolysis of 15-45 minute, Then decocting, decoct 1.5-4.5 hour for the first time, filter, obtain filtrate, the dregs of a decoction are little with the soak by water 1-3 of 3-9 times amount again Time, filtering to get filtrate, merge twice filtrate, filter, filtrate is concentrated into 70-90 DEG C and surveys relative density is 1.15-1.18, adds ethanol Make alcohol content reach 65%, stand, take supernatant and reclaim ethanol, and be concentrated into 60-80 DEG C to survey relative density be the leaching of 1.25-1.30 Cream A；Medicated Leaven adding water soaking 15-45 minute of 4-12 times amount, adds the complex enzyme of 4-12 weight portion, described complex enzyme is 3: The AMS of 1 and phosphoprotein phosphatase, first carry out the 20-60 DEG C of enzymolysis of 15-45 minute, then decoct, and decocts for the first time 1-3 hour, filter to get filtrate；The dregs of a decoction with soak by water 1-2 hour of 3-9 times amount, filter, obtain filtrate, merge twice filtrate, mistake again Filter, filtrate centrifugation, 3000rpm is centrifuged, centrifugal 2-6 minute, separates supernatant, and water bath method is concentrated into 1.25-1.30's Medicinal extract B；Coix seed adding 4-12 times amount water soaking 15-45 minute, add the complex enzyme of 8-24 weight portion, described complex enzyme is 3: The AMS of 1 and phosphoprotein phosphatase, first carry out the 20-60 DEG C of enzymolysis of 15-45 minute, then decoct twice, each 0.5-1.5 Hour, merging twice decocting liquid, filter, filtrate is concentrated into 25-75 DEG C and surveys the medicinal extract C that relative density is 1.35～1.40；By the banksia rose, In one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 20-60 mesh, Ultramicro-powder is placed on CO₂Extraction kettle soaks 1.5-4.5 hour, controlling pressure in extraction kettle was 20-30MPa, and the Ultramicro-powder after soaking separates in separating still, control In separating still processed, separating pressure value is 3-9MPa, is heated up to 20-60 DEG C, keeps 2.5-7.5 hour, CO₂Flow maintain 20- 40Kg/h；Extract after separation is dried and i.e. obtains extract D；Extractum A, medicinal extract B, medicinal extract C and supercritical extract are extracted Thing D homogenizer is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis ultra tiny Powder stirs, and finally adds calcium monohydrogen phosphate and PVPP mixing and stirring, makes particle, tabletted, wraps thin Film garment piece.

The preparation method of Renshenjianpi Tablet of the present invention be preferably: by ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis respectively clean, carry out soaking 10 hours with the water of 3 times amount after pull out, clear solid carbon dioxide divides, holding Chinese medicine dry tack free ,- 20 DEG C of freezings carry out ultramicro grinding in the environment of-6 DEG C after 2 hours and obtain micropowders；After ultramicro grinding, 90%-95%'s is micro- Powder footpath is 4-6 micron；By the Chinese yam water soaking 30 minutes of 8 times amount, adding 12 weight portion complex enzymes, described complex enzyme is 3: The AMS of 1 and phosphoprotein phosphatase, first carry out 40 DEG C of enzymolysis of 30 minutes, then decoct, and decocts 3 hours for the first time, Filtering, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filter to get filtrate, merge twice filtrate, filtration, filtrate is concentrated into 80 DEG C are surveyed relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, takes supernatant and reclaim ethanol, and be concentrated into 70 DEG C are surveyed relative density is the extractum A of 1.25-1.30；Medicated Leaven is added the water soaking 30 minutes of 8 times amount, adds 8 weight portions Complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then carries out Decoct, decoct 2 hours for the first time, filter to get filtrate；The dregs of a decoction with the soak by water 1.5 hours of 6 times amount, filter, obtain filtrate again, merge Twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, centrifugal 4 minutes, separates supernatant, and water bath method is concentrated into The medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 minutes, add the complex enzyme of 16 weight portions, described complex enzyme For AMS and the phosphoprotein phosphatase of 3:1, first carry out 40 DEG C of enzymolysis of 30 minutes, then decoct twice, each 1 hour, close And twice decocting liquid, filtering, filtrate is concentrated into 50 DEG C and surveys the medicinal extract C that relative density is 1.35～1.40；By the banksia rose, in one's early teens, old Ultramicro-powder, to 40 mesh, is placed on CO by skin, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding₂Extraction kettle soaks 3 hours, controls extraction Taking pressure in still is 25MPa, and the Ultramicro-powder after soaking separates in separating still, controls separating pressure value in separating still and is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；Extract after separation is dried i.e. to obtain and carries Take thing D；It is stirred uniformly, adding people by extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders stir, and finally add calcium monohydrogen phosphate and crosslinking PVP mixing and stirring, makes particle, tabletted, film coating sheet.

Renshenjianpi Tablet of the present invention is made up of following bulk drug, auxiliary material and preparation method:

Described weight portion is with g as unit of account；

Preparation method is:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 10 with the water of 3 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, surpasses after 2 hours-20 DEG C of freezings in the environment of-6 DEG C Crushing of Ultrafine obtains micropowders；After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water logging of 8 times amount Steeping 30 minutes, add 12g complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C 30 minutes Enzymolysis, then decoct, decoct 3 hours for the first time, filter, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filtration Obtaining filtrate, merge twice filtrate, filter, filtrate is concentrated into 80 DEG C and surveys relative densities is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, take supernatant reclaim ethanol, and be concentrated into 70 DEG C survey relative densities be the extractum A of 1.25-1.30；By Medicated Leaven Adding the water soaking 30 minutes of 8 times amount, add the complex enzyme of 8g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first Carry out 40 DEG C of enzymolysis of 30 minutes, then decoct, decoct 2 hours for the first time, filter to get filtrate；The dregs of a decoction are again by 6 times amount Soak by water 1.5 hours, filters, obtains filtrate, merge twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, centrifugal 4 points Clock, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 minutes, add The complex enzyme of 16g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then Decocting twice, each 1 hour, merge twice decocting liquid, filter, filtrate is concentrated into 50 DEG C and surveys the leaching that relative density is 1.35～1.40 Cream C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 40 mesh, Ultramicro-powder is placed on CO₂Extraction Soaking 3 hours in still, controlling pressure in extraction kettle is 25MPa, and the Ultramicro-powder after soaking separates in separating still, controls In separating still, separating pressure value is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；After separation Extract is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer It is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders and stirring, finally Add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, tabletted, film coating sheet, every Weight 0.51g.

Renshenjianpi Tablet of the present invention preparation treatment water retention due to hypofunction of the spleen caused by anorexia and loose stool or tell or rush down, abdominal fullness and distention, four Limb is weak or application in the medicine of sallow complexion.

Inventor finds in screening process, and only ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are respectively Ultramicro-powder is broken into fine powder, will decoct after Chinese yam, Medicated Leaven and coix seed complex enzyme zymohydrolysis, and remaining bulk drug carries out overcritical extraction The form the taken yield obtained that is used as medicine is the highest, makes tablet effective, will not mutually destroy effective ingredient so that effective ingredient is more Stable.If be used as medicine with raw material fine powder form less than above-mentioned amount, yield improves inconspicuous, is used as medicine higher than above-mentioned content of starting materials fine powder, The granule made can not reach the specification of regulation, and granulating efficiency is bad.Bulk drug is merged together decoction simultaneously, can phase Destroy effective ingredient mutually so that effective ingredient is unstable, and yield is low.If all with multiplex-enzyme extraction, compound Chinese patent medicine Extract component is insufficient, and volatile oil is drawn is incomplete, gets half the result with twice the effort on the contrary.Through substantial amounts of screening test, inventor first screens The kind of complex enzyme and proportioning, then in the case of determining complex enzyme, screened the kind of complex enzyme, and to complex enzyme Ratio screen.While carrying out substantial amounts of option screening, sum up experimental data, weigh extract yield, extraction On the basis of the indexs such as whether composition is completely, active ingredient is the most stable, it is determined that with ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, the most flat Beans, Gorgon fruit and Radix Angelicae Sinensis are used as medicine with micropowders, are used as medicine to decoct after Chinese yam, Medicated Leaven and coix seed complex enzyme zymohydrolysis, remaining Bulk drug carries out the form of supercritical extract and is used as medicine for preferred plan.

The advantage of Renshenjianpi Tablet of the present invention is, ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis is divided Other ultramicro grinding, pretreatment soaking before pulverizing, freezing, and ultramicro grinding at low ambient temperatures, abrasive body is in very short time Interior can acquisition effectively cools down, and makes pulverized Chinese medicine reach the effect of ultramicro grinding in very short time and keep high life Thing activity.And the grain size of micropowder of ultramicro grinding is little, owing to ultramicro grinding process materials temperature is less than-18 DEG C；And at low temperature environment Lower Chinese medicine Ultramicro-powder after ultramicro grinding, pollution-free, the heavy metal break flour such as Chrome-free, nickel, cadmium, titanium, iron, copper, zinc, lead, arsenic Particulate peels off and disengages.Separately Chinese yam, Medicated Leaven and coix seed are extracted with complex enzyme respectively so that its extracts active ingredients is more Completely, content is higher, stability is more preferable, and extract is purified by the method, and curative effect there has also been aobvious with tradition technics comparing Write and improve, be also greatly reduced production cost；Remaining bulk drug carries out supercritical extract so that its active ingredient is not destroyed, The effective ingredient extracting medicine is more complete, and dissolution rate height, drug effect retention time length and the bioavilability of medicine are high.The present invention Technique after improvement also added appropriate disintegrant, and tablet disintegration times made after adding disintegrant, at about 8 minutes, adds Speed was also disintegrated at about 10 minutes after placing 6 months completely.Effectively prevent and be disintegrated the slow adverse effect that curative effect is caused.

The most constantly there is the application in traditional Chinese medicine extraction of people's studying enzyme, and achieve good effect.The present invention adopts This advanced technology, is optimized according to the character feature of bulk drug active ingredient traditional decoction technique and improves.For enzyme Lot of experiments has been done in the selection of kind and consumption.Finally give the tablet that above-mentioned preparation method and this method prepare.The method Being purified extract, in the case of decreasing a large amount of impurity, the extract (medicinal extract) obtained improves than conventional method Significantly, and the most former traditional handicraft of active ingredient is stably, and curative effect being more also significantly increased with traditional handicraft is also substantially reduced Production cost.

Different bulk drugs, the enzyme and the consumption that are suitable for are not quite similar.The weak effect of enzymolysis when the consumption of enzyme is on the low side, Along with the concentration of enzyme raises, increasing with the contact area of substrate, enzyme digestion reaction speed increases, but the highest more good, when enzyme reaches To then producing inhibitory action during a certain concentration, enzyme is not fully utilized, and causes waste.Therefore, inventor's kind to enzyme And consumption investigated, find that difference on effect is obvious.Wherein with the AMS of 3:1 and answering of phosphoprotein phosphatase ratio combination Synthase best results, make the extracts active ingredients of Chinese yam, Medicated Leaven and coix seed more completely, content is higher, stability is more preferable, this Extract is purified by method, and curative effect there has also been with tradition technics comparing and significantly improves.

Tablet with Chinese medical extract as chief component, owing to extract component is many and complicated oneself viscosity is higher, General disintegration time is the longest, and after particularly long-term placement, the trend that disintegration time continues to extend is obvious.Therefore, the present invention adds Add calcium monohydrogen phosphate and PVPP (3:1) tablet disintegration times made afterwards at about 8 minutes, accelerated to place 6 months After be also disintegrated completely at about 10 minutes.Effectively prevent and be disintegrated the slow adverse effect that curative effect is caused.

The present inventor investigates different process step and the parameter impact on Chinese medicinal tablet of the present invention by tests below.

Reiterate: tests below is the test of the illustrative in numerous tests in development process of the present invention, is not covered by Be exhausted all experiments that the inventor present invention is done, purpose is only in that and illustrates Chinese medicine tablet of the present invention by those data The partial routine of agent preparation method screening and optimizing and result.

Experimental example one:

1, the selection of disintegrant of the present invention

The present invention implements the processing step (before being not added with auxiliary material) of 1, and disintegrant kind and consumption according to table 1 are sieved Choosing.Result shows, calcium monohydrogen phosphate and PVPP can substantially accelerate disintegration rate, after particularly the two coordinates with 3:1 ratio, Disintegration time significantly shortens.Refer to table 1.

The selection result of table 1 disintegrant

2, the ratio screening of calcium monohydrogen phosphate and PVPP is compared, and is shown in Table 2

The ratio screening test result of table 2 calcium monohydrogen phosphate and PVPP

Group number	Disintegrant	Disintegrant weight	Disintegration time (min)
				1	Calcium monohydrogen phosphate and PVPP (3:1)	20g	8.3
2	Calcium monohydrogen phosphate and PVPP (2:2)	20g	12.9
				3	Calcium monohydrogen phosphate and PVPP (1:3)	20g	13.7

Ratio screening test result according to table 2 calcium monohydrogen phosphate and PVPP shows, group number 1 calcium monohydrogen phosphate and crosslinking PVP can substantially accelerate disintegration rate with the ratio of 3:1, and disintegration time significantly shortens.Therefore calcium monohydrogen phosphate and PVPP The preferred 3:1 of ratio.

3, compare disintegration time limited

3.1 medicament selection

Test sample 1 (preparing according to the embodiment of the present invention 1 method).

Test sample 2 (preparing according to the embodiment of the present invention 2 method)

Test sample 3 (present invention is prepared according to embodiment 3 method)

Reference substance 4 preparation method:

Above 17 tastes, ginseng, Medicated Leaven, in one's early teens, corn sprout powder be broken into fine powder, sieve；The banksia rose, dried orange peel extract volatilization Oil, dregs of a decoction boiling once, filters；Semen Lablab Album, Gorgon fruit, hawthorn, Radix Glycyrrhizae, lotus seeds, Chinese yam, coix seed boiling secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction, filter；Rascal, Radix Angelicae Sinensis, the bighead atractylodes rhizome, Fructus Aurantii are according to liquid extract and extract item Under percolation, with 60% ethanol as solvent, carry out diacolation, collect liquid of filtering, reclaim ethanol.Merge above each liquid, decompression It is condensed into paste, adds the fine powder such as ginseng, Medicated Leaven and sodium carboxymethyl starch 20g, mixing, make particle, be dried at 60 DEG C, Spray adds the banksia rose, Pericarpium Citri Reticulatae volatile oil, mixing, tabletted, every tablet weight 0.25g.

3.2 disintegration time limiteds checked: use Rotating shaker, lift disintegration tester, took test sample 1, test sample 2, test sample 3 and right According to product 4 each 6, observing the situation by screen cloth, percent of pass height then disintegrative is good, more preferably absorption of human body.It is shown in Table 3

Table 3

Group	Disintegration time limited (min) in accelerating to place 1 month	Accelerate to place 6-12 month disintegration time limited (min)
			Test sample 1	8.12	10.01
Test sample 2	8.23	10.12
			Test sample 3	8.16	10.09
Reference substance 4	17.18	25.65

3.3 conclusion

By above-mentioned table 3 it is known that 1 month interior disintegration time is placed in the acceleration of test sample of the present invention 1,2 and 3

It is respectively 8.12,8.23 and 8.16 minutes, accelerates to place 6-12 month disintegration time also at 10.01,10.12 and 10.09 minutes, and reference substance 4 acceleration 1 month interior disintegration time of placement is 17.18 minutes, accelerates to place 6-12 and is disintegrated for individual month Time is 25.65 minutes, and the disintegration time of test sample 1,2 and 3 of the present invention compares with the disintegration time of reference substance 4 significance difference Different.

4, Dissolution experiments

To test sample 1 (preparing according to the embodiment of the present invention 1 method) of the present invention, test sample 2 (according to the embodiment of the present invention 2 Prepared by method), test sample 3 (present invention is prepared according to embodiment 3 method), reference substance 4 is (with the preparation method testing 2 reference substances 4 Identical) carry out dissolution rate investigation, the similarity estimate using FDA to recommend evaluates its dissolution rate.The results are shown in Table 4

Table 4

Group	30min	60min	90min
				Test sample 1	95.9%	94.9%	94.2%
Test sample 2	94.2%	93.5%	92.9%
				Test sample 3	94.5%	94.2%	93.1%
Reference substance 4	61.5%	50.4%	40.1%

Owing to the preparation method of test sample 1,2 and 3 of the present invention all uses ultramicro grinding and supercritical extract, its particle diameter is less than 6 microns, the dissolution rate when 30 minutes is more than 94%, and when 60 minutes, dissolution rate was more than 93%, the dissolution when 90 minutes Degree is more than 92%.And reference substance 4 uses Ordinary pulverization method, its particle diameter is big, is difficult to dissolution, therefore the dissolution when 30 minutes Degree is 61%, and when 60 minutes, dissolution rate was 50%, and when 90 minutes, dissolution rate was 40%.Test sample 1,2 and 3 of the present invention molten Out-degree compares with the dissolution rate of reference substance 4 that there were significant differences.

5, stability experiment

Weigh test sample 1 (preparing according to the embodiment of the present invention 1 method) of the present invention, test sample 2 respectively (according to the present invention in fact Execute example 2 method to prepare), test sample 3 (present invention is prepared according to embodiment 3 method), reference substance 4 is (with the system testing 2 reference substances 4 Preparation Method is identical) each 4g, to inject liquid chromatograph, be measured at 0,2,4,12,24 months respectively, measurement result is as follows: see Table 5

Table 5

As seen from the above table, the stability of test sample 1,2 and 3 of the present invention is fine, and after study on the stability 24 months, it is effective The content of composition is the most unchanged, and reference substance 4 is after study on the stability 24 months, and the content of its effective ingredient has notable change Change, illustrate that the stability of inventive test sample 1,2 and 3 is significantly better than reference substance 4.

6, drug effect compares

Add up the anorexia and loose stool caused by 200 example water retention due to hypofunction of the spleen or tell or rush down, abdominal fullness and distention, limbs fatigue or sallow complexion Patient, the age, wherein 100 examples took control group medicine (preparing according to experimental example 1 reference substance 4 method), separately in 28-65 year 100 example patients take of the present invention group of medicine (preparing according to the embodiment of the present invention 1 method), and instructions of taking and curative effect are as follows: be shown in Table 6

Table 6

Group	Number	Day/time	Each serving consumption	Take number of days	Total effective rate
						Control group	100 people	2 times	4 (0.25g/ sheet)	7	81%
Of the present invention group	100 people	2 times	2 (0.51g/ sheet)	7	98%

Conclusion: control group treatment water retention due to hypofunction of the spleen caused by anorexia and loose stool or tell or rush down, abdominal fullness and distention, limbs fatigue or The total effective rate of sallow complexion 100 example patient is 81%, of the present invention group treatment water retention due to hypofunction of the spleen caused by anorexia and loose stool or tell or Rush down, the total effective rate of abdominal fullness and distention, limbs fatigue or sallow complexion 100 example patient is 98%, the total effective rate of of the present invention group with Control group total effective rate compares that there were significant differences.

Experimental example two, enzyme class and the screening experiment of consumption

1. enzyme or complex enzyme (enzyme class is shown in Table 7) with the proportioning of Chinese yam are: enzyme or complex enzyme 12g, Chinese yam 75g；

By the Chinese yam water soaking 30 minutes of 8 times amount, add enzyme or complex enzyme, first carry out 40 DEG C of enzymolysis of 30 minutes, so After decoct, decoct 3 hours for the first time, filter, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filter to get filtrate, conjunction And twice filtrate, filtering, filtrate is concentrated into 80 DEG C and surveys relative densities is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, quiet Put, take supernatant reclaim ethanol, and be concentrated into 70 DEG C survey relative densities be the medicinal extract of 1.25-1.30；

12 kinds of enzymes or complex enzyme with table 7 extract Chinese yam according to said ratio and extracting method, extract between different enzymes Yield difference is obvious, and the complex enzyme effect wherein coordinated with 3:1 with AMS and phosphoprotein phosphatase is the most notable, with other kinds The enzyme of class compares, and there were significant differences in yield raising.Refer to table 7.

The screening test result (Chinese yam) of table 7 enzyme class

Group number	Enzyme class	Chinese yam yield g	Chinese yam yield %
				1	Cellulase	13.95	18.6%
2	Pectase	16.13	21.5%
				3	Papain	18.08	24.1%
4	Neutral proteinase	17.63	23.5%
				5	AMS	19.65	26.2%
6	Phosphoprotein phosphatase	17.55	23.4%
				7	Pectase+papain (2:2)	22.88	30.5%
8	Cellulase+pectase (3:1)	21.23	28.3%
				9	Papain+pectase+neutral proteinase (3:1:1)	26.33	35.1%
10	Papain+cellulase (2:1)	23.55	31.4%
				11	AMS+phosphoprotein phosphatase (3:1)	47.18	62.9%
12	Pectase+papain+cellulase (3:1:1)	24.3	32.4%

Screening test result according to table 7 enzyme class shows, group number 11 AMS and phosphoprotein phosphatase (3:1) are extracting The yield of Chinese yam is the highest, compares with other enzymes that there were significant differences, therefore the preferred AMS of complex enzyme and phosphoprotein phosphatase (3: 1)。

2, enzyme or complex enzyme with the proportioning of Medicated Leaven are: enzyme or complex enzyme 8g, Medicated Leaven 50g；

Medicated Leaven is added the water soaking 30 minutes of 8 times amount, adds enzyme or complex enzyme, first carry out 40 DEG C of enzymolysis of 30 minutes, Then decoct, decoct 2 hours for the first time, filter to get filtrate；The dregs of a decoction with the soak by water 1.5 hours of 6 times amount, filter again, Filtrate, merges twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, centrifugal 4 minutes, separates supernatant, water bath method It is concentrated into the medicinal extract of 1.25-1.30；

Extract Medicated Leaven with 12 kinds of enzymes in table 8 or complex enzyme according to said ratio and extracting method, carry between different enzymes The yield difference taken is obvious, and the complex enzyme effect wherein coordinated with 3:1 with AMS and phosphoprotein phosphatase is the most notable, with it He compares by the enzyme of kind, and there were significant differences in yield raising.Refer to table 8.

The screening test result (Medicated Leaven) of table 8 enzyme class

Group number	Enzyme class	Medicated Leaven yield g	Medicated Leaven yield %
				1	Cellulase	9.75	19.5%
2	Pectase	11.05	22.1%
				3	Papain	12.4	24.8
4	Neutral proteinase	11.25	22.5%
				5	AMS	13.4	26.8%
6	Phosphoprotein phosphatase	11.85	23.7%
				7	Pectase+papain (2:2)	16.05	32.1%
8	Cellulase+pectase (3:1)	14.35	28.7%
				9	Papain+pectase+neutral proteinase (3:1:1)	17.85	35.7%
10	Papain+cellulase (2:1)	16.8	33.6%
				11	AMS+phosphoprotein phosphatase (3:1)	31.75	63.5%
12	Pectase+papain+cellulase (3:1:1)	17.25	34.5%

Screening test result according to table 8 enzyme class shows, group number 11 AMS and phosphoprotein phosphatase (3:1) are extracting The yield of Medicated Leaven is the highest, compares with other enzymes that there were significant differences, therefore the preferred AMS of complex enzyme and phosphoprotein phosphatase (3: 1)。

3, enzyme or complex enzyme with the proportioning of coix seed are: enzyme or complex enzyme 16g, coix seed 100g；

Coix seed is added 8 times amount water soaking 30 minutes, add enzyme or complex enzyme, first carry out 40 DEG C of enzymolysis of 30 minutes, so Rear decoction twice, each 1 hour, merges twice decocting liquid, filters, and filtrate is concentrated into 50 DEG C and surveys relative density is 1.35～1.40 Medicinal extract；

Extract coix seed with 12 kinds of enzymes in table 9 or complex enzyme according to said ratio and extracting method, carry between different enzymes The yield difference taken is obvious, and the complex enzyme effect wherein coordinated with 3:1 with AMS and phosphoprotein phosphatase is the most notable, with it He compares by the enzyme of kind, and there were significant differences in yield raising.Refer to table 9.

The screening test result (coix seed) of table 9 enzyme class

Group number	Enzyme class	Coix seed yield g	Coix seed yield %
				1	Cellulase	20.5	20.5%
2	Pectase	23.1	23.1%
				3	Papain	24.5	24.5%
4	Neutral proteinase	23.7	23.7%
				5	AMS	29.8	29.8%
6	Phosphoprotein phosphatase	25.6	25.6%
				7	Pectase+papain (2:2)	32.5	32.5%
8	Cellulase+pectase (3:1)	29.4	29.4%
				9	Papain+pectase+neutral proteinase (3:1:1)	36.7	36.7%
10	Papain+cellulase (2:1)	33.5	33.5%
				11	AMS+phosphoprotein phosphatase (3:1)	63.8	63.8%
12	Pectase+papain+cellulase (3:1:1)	34.1	34.1%

Screening test result according to table 9 enzyme class shows, group number 11 AMS and phosphoprotein phosphatase (3:1) are extracting The yield of coix seed is the highest, compares with other enzymes that there were significant differences, therefore the preferred AMS of complex enzyme and phosphoprotein phosphatase (3: 1)。

4, the ratio screening of AMS and phosphoprotein phosphatase.It is shown in Table 10

The ratio screening test result of table 10 AMS and phosphoprotein phosphatase

Ratio screening test result according to table 10 AMS and phosphoprotein phosphatase shows, group number 1 AMS and egg The yield that the ratio of white phosphatase (3:1) obtains when extracting Chinese yam, Medicated Leaven and coix seed respectively is for the highest, with other ratios Relatively there were significant differences.Therefore the preferred 3:1 of the ratio of AMS and phosphoprotein phosphatase.

5, the consumption of complex enzyme (AMS and the ratio of phosphoprotein phosphatase) screens.It is shown in Table 11-13

Table 11 complex enzyme is for extracting the consumption screening test result of Chinese yam

Group number	Chinese yam consumption	Complex enzyme consumption	Chinese yam yield %
				1	75g	8g	42.5%
2	75g	12g	62.9%
				3	75g	16g	39.7%

Table 12 complex enzyme is for extracting the consumption screening test result of Medicated Leaven

Group number	Medicated Leaven consumption	Complex enzyme consumption	Medicated Leaven yield %
				1	50g	4g	43.7%
2	50g	8g	63.5
				3	50g	12g	41.9%

Table 13 complex enzyme is for extracting the consumption screening test result of coix seed

Group number	Coix seed consumption	Complex enzyme consumption	Coix seed yield %
				1	100g	12g	44.3%
2	100g	16g	63.8%
				3	100g	20g	41.5%

Drawing according to table 11-13 result of the test, the yield extracted is time when for extracting Chinese yam, consumption is at 12g for complex enzyme Height, complex enzyme extract Medicated Leaven time consumption at 8g time extract yield be the highest, complex enzyme extraction coix seed time consumption exist The yield extracted during 16g is the highest.

Following embodiment all can realize the effect of above-mentioned experimental example.

Detailed description of the invention

Embodiment 1

Preparation method is:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 10 with the water of 3 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, surpasses after 2 hours-20 DEG C of freezings in the environment of-6 DEG C Crushing of Ultrafine obtains micropowders；After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water logging of 8 times amount Steeping 30 minutes, add 12g complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C 30 minutes Enzymolysis, then decoct, decoct 3 hours for the first time, filter, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filtration Obtaining filtrate, merge twice filtrate, filter, filtrate is concentrated into 80 DEG C and surveys relative densities is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, take supernatant reclaim ethanol, and be concentrated into 70 DEG C survey relative densities be the extractum A of 1.25-1.30；By Medicated Leaven Adding the water soaking 30 minutes of 8 times amount, add the complex enzyme of 8g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first Carry out 40 DEG C of enzymolysis of 30 minutes, then decoct, decoct 2 hours for the first time, filter to get filtrate；The dregs of a decoction are again by 6 times amount Soak by water 1.5 hours, filters, obtains filtrate, merge twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, centrifugal 4 points Clock, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 minutes, add The complex enzyme of 16g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then Decocting twice, each 1 hour, merge twice decocting liquid, filter, filtrate is concentrated into 50 DEG C and surveys the leaching that relative density is 1.35～1.40 Cream C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 40 mesh, Ultramicro-powder is placed on CO₂Extraction Soaking 3 hours in still, controlling pressure in extraction kettle is 25MPa, and the Ultramicro-powder after soaking separates in separating still, controls In separating still, separating pressure value is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；After separation Extract is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer It is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders and stirring, finally Add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, tabletted, film coating sheet, every Weight 0.51g.Daily 2 times, each 2.

Embodiment 2

Embodiment 3

Embodiment 4

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 13 with the water of 2 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, carries out after 2.5 hours-18 DEG C of freezings in the environment of-5 DEG C Ultramicro grinding obtains micropowders；After ultramicro grinding, the grain size of micropowder of more than 90-95% is less than 4-6 micron；By Chinese yam with 10 The water soaking of times amount 20 minutes, adds 16g complex enzyme, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 30 DEG C of enzymolysis of 40 minutes, then decoct, and decoct 2 hours for the first time, filter, obtain filtrate, and the dregs of a decoction are again with the decocting of 8 times amount Boiling 1.5 hours, filter to get filtrate, merge twice filtrate, filter, filtrate is concentrated into 80 DEG C and surveys relative density is 1.15-1.18, adds Ethanol makes alcohol content reach 65%, stands, and takes supernatant and reclaims ethanol, and be concentrated into 65 DEG C to survey relative densities be 1.25-1.30's Extractum A；Medicated Leaven adding the water soaking 40 minutes of 6 times amount, adds the complex enzyme of 6g, described complex enzyme is the AMS of 3:1 And phosphoprotein phosphatase, first carry out 50 DEG C of enzymolysis of 20 minutes, then decoct, decoct 2.5 hours for the first time, filter to obtain filter Liquid；The dregs of a decoction with the soak by water 2 hours of 4 times amount, filter, obtain filtrate, merge twice filtrate again, filter, filtrate centrifugation, 3000rpm is centrifuged, centrifugal 3 minutes, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 10 Times amount water soaking 20 minutes, adds the complex enzyme of 28g, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 30 DEG C of enzymolysis of 40 minutes, then decoct twice, each 0.5 hour, merge twice decocting liquid, filter, and filtrate is concentrated into 70 DEG C of surveys Relative density is the medicinal extract C of 1.35～1.40；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding extremely 30 mesh, are placed on CO by Ultramicro-powder₂Soaking 4 hours in extraction kettle, controlling pressure in extraction kettle is 22MPa, the ultra micro after soaking Powder separates in separating still, and controlling separating pressure value in separating still is 8MPa, is heated up to 30 DEG C, when keeping 7, CO₂Stream Amount maintains 25Kg/h；Extract after separation is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and overcritical Extraction extract D homogenizer is stirred uniformly, adds ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and works as Return micropowders to stir, finally add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, be pressed into Sheet, film coating sheet, every tablet weight 0.51g.Daily 2 times, each 2.

Embodiment 5

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 6 with the water of 4 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, carries out after 1.5 hours-22 DEG C of freezings in the environment of-8 DEG C Ultramicro grinding obtains micropowders；After ultramicro grinding, the grain size of micropowder of more than 90-95% is less than 4-6 micron；By Chinese yam with 6 times The water soaking of amount 40 minutes, adds 8g complex enzyme, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 50 The enzymolysis of DEG C 20 minutes, then decocts, and decocts 4 hours for the first time, filters, obtains filtrate, and the dregs of a decoction are again with the soak by water of 4 times amount 2.5 hours, filtering to get filtrate, merge twice filtrate, filter, filtrate is concentrated into 75 DEG C and surveys relative density is 1.15-1.18, adds second Alcohol makes alcohol content reach 65%, stands, and takes supernatant and reclaims ethanol, and be concentrated into 75 DEG C to survey relative densities be the leaching of 1.25-1.30 Cream A；Medicated Leaven adding the water soaking 20 minutes of 10 times amount, adds the complex enzyme of 10g, described complex enzyme is the AMS of 3:1 And phosphoprotein phosphatase, first carry out 30 DEG C of enzymolysis of 40 minutes, then decoct, decoct 1.5 hours for the first time, filter to obtain filter Liquid；The dregs of a decoction with the soak by water 1 hour of 8 times amount, filter, obtain filtrate, merge twice filtrate again, filter, filtrate centrifugation, 3000rpm is centrifuged, centrifugal 5 minutes, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 6 times Amount water soaking 40 minutes, adds the complex enzyme of 12g, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 50 The enzymolysis of DEG C 20 minutes, then decocts twice, each 1.5 hours, merges twice decocting liquid, filters, and filtrate is concentrated into 30 DEG C and surveys phases To the medicinal extract C that density is 1.35～1.40；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding be to 50 Mesh, is placed on CO by Ultramicro-powder₂Soaking 2 hours in extraction kettle, controlling pressure in extraction kettle is 28MPa, the Ultramicro-powder after soaking Separating in separating still, controlling separating pressure value in separating still is 4MPa, is heated up to 50 DEG C, keeps 3 hours, CO₂Stream Amount maintains 35Kg/h；Extract after separation is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and overcritical Extraction extract D homogenizer is stirred uniformly, adds ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and works as Return micropowders to stir, finally add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, be pressed into Sheet, film coating sheet.Every tablet weight 0.51g, daily 2 times, each 2.

Claims

1. a Renshenjianpi Tablet, it is characterised in that this Renshenjianpi Tablet is made up of following bulk drug and auxiliary material:

2. Renshenjianpi Tablet as claimed in claim 1, it is characterised in that this Renshenjianpi Tablet is by following bulk drug and auxiliary material group Become:

3. Renshenjianpi Tablet as claimed in claim 1 or 2, it is characterised in that this Renshenjianpi Tablet is by following bulk drug and auxiliary Material composition:

4. Renshenjianpi Tablet as claimed in claim 1, it is characterised in that this Renshenjianpi Tablet is by following bulk drug and auxiliary material group Become:

Or

5. the Renshenjianpi Tablet as described in one of claim 1-4, it is characterised in that this Renshenjianpi Tablet is prepared by following methods Form:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively and carries out soaking 5-15 with the water of 2-4 times amount Pulling out after hour, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free ,-18 DEG C～-22 DEG C after freezing 1-3 hour at-4 DEG C～-8 DEG C environment in carry out ultramicro grinding and obtain micropowders；After ultramicro grinding, the grain size of micropowder of more than 80% is less than 6 microns；Will Chinese yam water soaking 15-45 minute of 4-12 times amount, adds 6-18 weight portion complex enzyme, and described complex enzyme is the alphalise starch of 3:1 Enzyme and phosphoprotein phosphatase, first carry out the 20-60 DEG C of enzymolysis of 15-45 minute, then decoct, and decocts 1.5-4.5 for the first time little Time, filtering, obtain filtrate, the dregs of a decoction with soak by water 1-3 hour of 3-9 times amount, filter to get filtrate, merge twice filtrate again, filter, filter Liquid is concentrated into 70-90 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, takes supernatant and reclaim second Alcohol, and be concentrated into 60-80 DEG C survey relative density be the extractum A of 1.25-1.30；Medicated Leaven is added the water soaking 15-of 4-12 times amount 45 minutes, adding the complex enzyme of 4-12 weight portion, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 20- 60 DEG C of enzymolysis of 15-45 minute, then decoct, and decoct 1-3 hour for the first time, filter to get filtrate；3-9 times amount used again by the dregs of a decoction Soak by water 1-2 hour, filter, obtain filtrate, merge twice filtrate, filter, filtrate centrifugation, 3000rpm is centrifuged, centrifugal 2- 6 minutes, separating supernatant, water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 4-12 times amount water soaking 15-45 Minute, adding the complex enzyme of 8-24 weight portion, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 20-60 The enzymolysis of DEG C 15-45 minute, then decocts twice, each 0.5-1.5 hour, merges twice decocting liquid, filters, and filtrate is concentrated into Survey the medicinal extract C that relative density is 1.35～1.40 for 25-75 DEG C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii Ultramicro-powder, to 20-60 mesh, is placed on CO by ultramicro grinding₂Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20-30MPa, the Ultramicro-powder after soaking separates in separating still, and controlling separating pressure value in separating still is 3-9MPa, adds Temperature, to 20-60 DEG C, keeps 2.5-7.5 hour, CO₂Flow maintain 20-40Kg/h；Extract after separation is dried i.e. Obtain extract D；Extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer are stirred uniformly, then add Enter ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders to stir, finally add calcium monohydrogen phosphate and PVPP mixing and stirring, makes particle, tabletted, film coating sheet.

6. Renshenjianpi Tablet as claimed in claim 5, it is characterised in that this Renshenjianpi Tablet is prepared from by following methods:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 10 hours with the water of 3 times amount After pull out, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, carries out Ultramicro-powder-20 DEG C of freezings after 2 hours in the environment of-6 DEG C Broken micropowders；After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water soaking 30 of 8 times amount Minute, adding 12 weight portion complex enzymes, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C 30 points The enzymolysis of clock, then decocts, and decocts 3 hours for the first time, filters, obtains filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, and mistake Filtering to obtain filtrate, merge twice filtrate, filter, filtrate is concentrated into 80 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes alcohol content Reach 65%, stand, take supernatant and reclaim ethanol, and be concentrated into 70 DEG C to survey relative densities be the extractum A of 1.25-1.30；By six god Song adds the water soaking 30 minutes of 8 times amount, adds the complex enzyme of 8 weight portions, and described complex enzyme is AMS and the albumen phosphorus of 3:1 Acid enzyme, first carries out 40 DEG C of enzymolysis of 30 minutes, then decocts, and decocts 2 hours for the first time, filters to get filtrate；The dregs of a decoction are again with 6 The soak by water of times amount 1.5 hours, filters, obtains filtrate, merge twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, from The heart 4 minutes, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 points Clock, adds the complex enzyme of 16 weight portions, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C 30 points The enzymolysis of clock, then decocts twice, each 1 hour, merges twice decocting liquid, filters, and filtrate is concentrated into 50 DEG C of survey relative densities and is The medicinal extract C of 1.35～1.40；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 40 mesh, will be super Micro mist is placed on CO₂Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa, and the Ultramicro-powder after soaking is at separating still In separate, controlling separating pressure value in separating still is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；Extract after separation is dried and i.e. obtains extract D；Extractum A, medicinal extract B, medicinal extract C and supercritical extract are extracted Thing D homogenizer is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis ultra tiny Powder stirs, and finally adds calcium monohydrogen phosphate and PVPP mixing and stirring, makes particle, tabletted, wraps thin Film garment piece.

7. Renshenjianpi Tablet as claimed in claim 1 or 2, it is characterised in that the unit of described weight portion is g, and this ginseng is good for Spleen sheet is made up of following bulk drug, auxiliary material and preparation method:

Preparation method is:

Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned respectively, carried out soaking 10 hours with the water of 3 times amount After pull out, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free, carries out Ultramicro-powder-20 DEG C of freezings after 2 hours in the environment of-6 DEG C Broken micropowders；After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water soaking 30 of 8 times amount Minute, adding 12g complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymes of 30 minutes Solve, then decoct, decoct 3 hours for the first time, filter, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filter to obtain and filter Liquid, merges twice filtrate, filters, and filtrate is concentrated into 80 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, take supernatant reclaim ethanol, and be concentrated into 70 DEG C survey relative densities be the extractum A of 1.25-1.30；By Medicated Leaven Adding the water soaking 30 minutes of 8 times amount, add the complex enzyme of 8g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first Carry out 40 DEG C of enzymolysis of 30 minutes, then decoct, decoct 2 hours for the first time, filter to get filtrate；The dregs of a decoction are again by 6 times amount Soak by water 1.5 hours, filters, obtains filtrate, merge twice filtrate, filters, filtrate centrifugation, and 3000rpm is centrifuged, centrifugal 4 points Clock, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 minutes, add The complex enzyme of 16g, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then Decocting twice, each 1 hour, merge twice decocting liquid, filter, filtrate is concentrated into 50 DEG C and surveys the leaching that relative density is 1.35～1.40 Cream C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 40 mesh, Ultramicro-powder is placed on CO₂Extraction Soaking 3 hours in still, controlling pressure in extraction kettle is 25MPa, and the Ultramicro-powder after soaking separates in separating still, controls In separating still, separating pressure value is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；After separation Extract is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer It is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders and stirring, finally Add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, tabletted, film coating sheet, every Weight 0.51g.

8. the preparation method of the Renshenjianpi Tablet as described in one of claim 1-4, it is characterised in that this preparation method is: will Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis are cleaned after carrying out soaking 5-15 hour with the water of 2-4 times amount respectively Pulling out, clear solid carbon dioxide divides, and keeps Chinese medicine dry tack free ,-18 DEG C～-22 DEG C after freezing 1-3 hour at the ring of-4 DEG C～-8 DEG C Border carries out ultramicro grinding and obtains micropowders；After ultramicro grinding, the grain size of micropowder of more than 80% is less than 6 microns；Chinese yam is used The water soaking of 4-12 times amount 15-45 minute, adds 6-18 weight portion complex enzyme, and described complex enzyme is AMS and the egg of 3:1 White phosphatase, first carries out the 20-60 DEG C of enzymolysis of 15-45 minute, then decocts, and decocts 1.5-4.5 hour for the first time, mistake Filter, obtains filtrate, and the dregs of a decoction with soak by water 1-3 hour of 3-9 times amount, filter to get filtrate, merge twice filtrate again, filters, and filtrate is dense Being reduced to 70-90 DEG C and surveying relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stand, takes supernatant and reclaim ethanol, And be concentrated into 60-80 DEG C survey relative density be the extractum A of 1.25-1.30；The water soaking 15-45 that Medicated Leaven adds 4-12 times amount divides Clock, adds the complex enzyme of 4-12 weight portion, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 20-60 DEG C The enzymolysis of 15-45 minute, then decocts, and decocts 1-3 hour for the first time, filters to get filtrate；The dregs of a decoction are again with the water of 3-9 times amount Decocting 1-2 hour, filter, obtain filtrate, merge twice filtrate, filter, filtrate centrifugation, 3000rpm is centrifuged, and centrifugal 2-6 divides Clock, separates supernatant, and water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed adds 4-12 times amount water soaking 15-45 divide Clock, adds the complex enzyme of 8-24 weight portion, and described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 20-60 DEG C The enzymolysis of 15-45 minute, then decocts twice, each 0.5-1.5 hour, merges twice decocting liquid, filters, and filtrate is concentrated into 25- Survey the medicinal extract C that relative density is 1.35～1.40 for 75 DEG C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultra micro It is crushed to 20-60 mesh, Ultramicro-powder is placed on CO₂Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20- 30MPa, the Ultramicro-powder after soaking separates in separating still, and controlling separating pressure value in separating still is 3-9MPa, heats To 20-60 DEG C, keep 2.5-7.5 hour, CO₂Flow maintain 20-40Kg/h；Extract after separation is dried and get final product Extract D；It is stirred uniformly, adding by extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer Ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders stir, and finally add calcium monohydrogen phosphate and friendship Connection PVP mixing and stirring, makes particle, tabletted, film coating sheet.

9. the preparation method of Renshenjianpi Tablet as claimed in claim 8, it is characterised in that this preparation method is: by ginseng, in vain Art, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis respectively clean, carry out soaking 10 hours with the water of 3 times amount after pull out, clear solid carbon dioxide Point, keep Chinese medicine dry tack free, in the environment of-6 DEG C, carry out ultramicro grinding-20 DEG C of freezings after 2 hours and obtain micropowders； After ultramicro grinding, the grain size of micropowder of 90%-95% is 4-6 micron；By the Chinese yam water soaking 30 minutes of 8 times amount, add 12 weights Amount part complex enzyme, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then Decoct, decoct 3 hours for the first time, filter, obtain filtrate, when the dregs of a decoction are again with the soak by water 2 of 6 times amount, filter to get filtrate, merging Twice filtrate, filters, and filtrate is concentrated into 80 DEG C and surveys relative density is 1.15-1.18, adds ethanol and makes alcohol content reach 65%, stands, Take supernatant reclaim ethanol, and be concentrated into 70 DEG C survey relative densities be the extractum A of 1.25-1.30；Medicated Leaven is added the water of 8 times amount Soaking 30 minutes, add the complex enzyme of 8 weight portions, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 The enzymolysis of DEG C 30 minutes, then decocts, and decocts 2 hours for the first time, filters to get filtrate；The dregs of a decoction are again with the soak by water of 6 times amount 1.5 hours, filtering, obtain filtrate, merge twice filtrate, filter, filtrate centrifugation, 3000rpm is centrifuged, centrifugal 4 minutes, separates Supernatant, water bath method is concentrated into the medicinal extract B of 1.25-1.30；Coix seed is added 8 times amount water soaking 30 minutes, add 16 weight The complex enzyme of part, described complex enzyme is AMS and the phosphoprotein phosphatase of 3:1, first carries out 40 DEG C of enzymolysis of 30 minutes, then Decocting twice, each 1 hour, merge twice decocting liquid, filter, filtrate is concentrated into 50 DEG C and surveys the leaching that relative density is 1.35～1.40 Cream C；By the banksia rose, in one's early teens, dried orange peel, rascal, rice sprout, hawthorn and Fructus Aurantii ultramicro grinding to 40 mesh, Ultramicro-powder is placed on CO₂Extraction Soaking 3 hours in still, controlling pressure in extraction kettle is 25MPa, and the Ultramicro-powder after soaking separates in separating still, controls In separating still, separating pressure value is 6MPa, is heated up to 40 DEG C, keeps 5 hours, CO₂Flow maintain 30Kg/h；After separation Extract is dried and i.e. obtains extract D；By extractum A, medicinal extract B, medicinal extract C and supercritical extract extract D homogenizer It is stirred uniformly, adding ginseng, the bighead atractylodes rhizome, Radix Glycyrrhizae, lotus seeds, Semen Lablab Album, Gorgon fruit and Radix Angelicae Sinensis micropowders and stirring, finally Add calcium monohydrogen phosphate and PVPP mixing and stirring, make particle, tabletted, film coating sheet.

10. the Renshenjianpi Tablet as described in one of claim 1-7 at the anorexia and loose stool caused by preparation treatment water retention due to hypofunction of the spleen or is told Or rush down, application in the medicine of abdominal fullness and distention, limbs fatigue or sallow complexion.