CN1742862A - Guipi preparation and new preparing method therefor - Google Patents

Guipi preparation and new preparing method therefor Download PDF

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Publication number
CN1742862A
CN1742862A CNA2005101053365A CN200510105336A CN1742862A CN 1742862 A CN1742862 A CN 1742862A CN A2005101053365 A CNA2005101053365 A CN A2005101053365A CN 200510105336 A CN200510105336 A CN 200510105336A CN 1742862 A CN1742862 A CN 1742862A
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preparation
parts
radix
extraction
active component
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刘露
严轶东
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Abstract

The present invention relates to a prescription of Chinese medicine preparation for effectively curing the diseases of deficiency of qi and blood in the heart and spleen, short breath and cardio palmus, insomnia and dreamful sleep, dizziness, myasthenia of limbs, anorexia and metrorrhagia and metrostaxis, etc. and its preparation process. Said prescription includes 11 Chinese medicinal materials of pilose asiabell root, bighead atracty lodes rhizome, astragalus root, licorice, poria and others. Said invention also provides the concrete steps of its preparation method.

Description

Return spleen preparation and new preparation method
Technical field:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, particularly a kind of treatment deficiency of both the heart and spleen, the cardiopalmus of breathing hard, insomnia and dreamful sleep, dizzy dizzy, lassitude of the limbs and weakness, inappetence, preparation recipe that metrorrhagia is had blood in stool and preparation technology thereof.
Background technology:
Deficiency of both the heart and spleen, the cardiopalmus of breathing hard, insomnia and dreamful sleeps etc. are clinical common symptons, much more general use GUIPI WAN, and in practice, the weak point of GUIPI WAN is that preparation technology is outmoded, and dosage form is a pill, uses inconvenience, gives always, the patient of children and dysphagia brings many troubles.The present invention adopts high-efficient extraction technology, the GUIPI WAN preparation is transformed, transformation process has overcome the difficulty that Chinese medicine preparation faces in the modified form process, as moisture absorption, instability, defective such as technology is loaded down with trivial details is groped through screening and technology, under the constant situation of Chinese medicine preparation, prepared a kind of Chinese medicine and returned the spleen novel formulation with quick therapeutical effect.
Radix Codonopsis spleen reinforcing lung qi is enriched blood among the we, promotes the production of body fluid; Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, the dampness diuresis, hidroschesis, antiabortive; Radix Astragali spleen invigorating invigorating middle warmer, ascending up spleen-Qi and Yang, benefit is defended consolidating superficial resistance, diuresis, promoting pus discharge and tissue regeneration strengthening; The Radix Glycyrrhizae invigorating the spleen and replenishing QI, expelling phlegm for arresting cough, relieving spasm to stop pain, heat clearing away is analgesic, coordinating the actions of various ingredients in a prescription; Replenishing QI to invigorate the spleen, nourishing blood to tranquillize the mind.Many medicines share, and play replenishing QI to invigorate the spleen altogether, the effect of nourishing blood to tranquillize the mind.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, capsule, tablet, pill, its pill that makes can be used for curing mainly deficiency of both the heart and spleen, the cardiopalmus of breathing hard, insomnia and dreamful sleep, dizzy dizzy, lassitude of the limbs and weakness, inappetence, metrorrhagia is had blood in stool.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is made up of following proportion raw material and adjuvant:
40~500 parts of 80~1000 parts of Radix Astragali Preparatas of 40~500 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis
80~1000 parts of Radix Glycyrrhizae Preparata 80~1000 parts of Radix Polygalaes of 20~250 parts of Poria (system)
80~1000 parts of 40~500 portions of Arillus Longans of Semen Ziziphi Spinosae (stir-fry)
20~250 parts in Radix Angelicae Sinensis 20~250 portions of Fructus Jujubaes of 80~1000 parts of Radix Aucklandiae (enucleation)
Preferably:
40 parts of 80 parts of Radix Glycyrrhizae Preparatas of 160 parts of Radix Astragali Preparatas of 80 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis
80 parts of 160 parts of Semen Ziziphi Spinosaes of 160 parts of Radix Polygalaes of Poria (system) (stir-fry)
40 parts in Arillus Longan 160 parts of Radix Angelicae Sinensis, 40 portions of Fructus Jujubaes of 160 parts of Radix Aucklandiae (enucleation)
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, granule 1000g etc. also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50-1000 taking dose,, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet, tablet, capsule or pill.
The above new technology of the present invention may further comprise the steps:
Method a:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, use supercritical fluid extraction, extraction kettle pressure is 25MPa, and the pressure of extraction-container I is 8MPa, and the pressure of extraction-container II is 6MPa; CO 2Flow is about 18kg/h, and extraction 4h gets extract; Merge Borneolum Syntheticum, β-CDBao He gets clathrate;
(2) get the residue medical material, place container, the adding aqueous solution is an amount of, and supersound extraction certain hour (about 30~45 minutes) is put to room temperature, adds aqueous solution to scale, shakes up, and filters, and gets filtrate, reclaims promptly.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, " method of an appendix XD of Chinese pharmacopoeia was extracted volatile oil, extraction time 6h, extract β-CDBao He with the atmospheric steam way of distillation with reference to version in 2000; Borneolum Syntheticum is ground into fine powder, and is standby;
(2) get the residue medical material, place container, add 8 times of water gagings and decoct each 1.5 hours 2 times.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5~10, and preferred ratio is 1: 2~4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 complete 10000 Polyethylene Glycol and their mixture, as suitable other auxiliary elements such as glycerol, gelatin or the stearic acid sodium etc. of making drop pill of PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.
Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4~1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8~1.2.Wherein the weight proportion between active component and the pharmaceutically useful organic solvent is: the content of active component is 50mg-500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
1. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
2. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation such as granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.; Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture; Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of normal mouse memory behavior
1.1 darkness avoidance test: 30 of male mices, body weight 20.0 ± 1.2g divides equally three groups, and technology is 2. extractum group (105mg/kg) of extractum group (72mg/kg) and technology 1., and once a day, continuous 15 days, matched group waited the capacity normal saline, and administering mode is for irritating stomach.Press literature method, the errors number of animal in the darkness avoidance test device in training and the record certain hour.The results are shown in Table 1.
The table 1 pair influence that normal mouse memory power obtains
Medicine Dosage (mg/kg) Number of animals (only) Errors number (x ± s) P
Normal saline technology is 2. extractum group of extractum group technology 1. Deng capacity 72 105 10 10 10 3.6±1.26 1.9±1.10 2.0±1.05 <0.01 <0.01
1.2 diving tower method: 30 of male mices, divide equally three groups, 10 every group.Technology is 2. extractum group (105mg/kg) of extractum group (72mg/kg) technology 1., and once a day, continuous 15 days, matched group waited the capacity normal saline, and administering mode is for irritating stomach.
Press literature method, training and the errors number of record animal in the diving tower subtraction unit.The results are shown in Table 2.
The table 2 pair influence that normal mouse memory power obtains
Medicine Dosage (mg/kg) Number of animals (only) Errors number (x ± s) P
Normal saline technology is 2. extractum group of extractum group technology 1. Deng capacity 72 105 10 10 10 3.6±0.84 1.9±0.99 2.0±0.72 <0.01 <0.01
From table 1 and table 2 result as can be seen, extractum has the effect that tangible enhancing normal mouse memory obtains.
2, to the inhibitory action of mouse brain, liver lipid peroxidation
Mice male and female dual-purpose, technology be 2. extractum group (105mg/kg) of extractum group (72mg/kg) technology 1., and once a day, continuous 15 days, matched group waited the capacity normal saline, and administering mode is for irritating stomach.In the 16th day sacrificed by decapitation mice, get tissue rapidly and make 5% liver homogenate and 10% brain homogenate.The list of references method develops the color with Malony Ithiourea, colorimetric determination.With the tetraethoxypropane is the growing amount of criterion calculation lipid peroxide, the results are shown in Table 3.
The influence that table 3 pair mouse brain and liver endoperoxides lipid generate (x ± s)
Group Dosage (mg/kg) Lipid peroxide content (nmol/g tissue wet)
Brain Liver
Matched group technology is 2. extractum group of extractum group technology 1. Normal saline 72 105 54.42±3.00 42.72±3.05 * 44.10±2.76 * 206.70±5.20 177.90±40.20 ** 170.20±31.12 **
Annotate: compare with normal saline *P<0.01, *P<0.05
Table 3 is the result show, the extractum group has remarkable inhibitory action to Mouse Liver, the generation of brain lipid peroxide.
3, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD 50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment deficiency of both the heart and spleen, the cardiopalmus of breathing hard, insomnia and dreamful sleep, dizzy dizzy, lassitude of the limbs and weakness, inappetence, the medicine that metrorrhagia is had blood in stool, and change preparation technology can obviously strengthen its replenishing QI to invigorate the spleen, clinical efficacies such as nourishing blood to tranquillize the mind, its hypotoxicity in addition, therefore prolonged application safety, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Codonopsis 80g Rhizoma Atractylodis Macrocephalae 160g Radix Astragali Preparata 80g Radix Glycyrrhizae Preparata 40g
Poria 160g Radix Polygalae (system) 160g Semen Ziziphi Spinosae (stir-fry) 80g
Arillus Longan 160g Radix Angelicae Sinensis 160g Radix Aucklandiae 40g Fructus Jujubae (enucleation) 40g
PEG400 90g
Make 1000 balls
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, use supercritical fluid extraction, extraction kettle pressure is 25MPa, and the pressure of extraction-container I is 8MPa, and the pressure of extraction-container II is 6MPa; CO 2Flow is about 18kg/h, and extraction 4h gets extract; Merge Borneolum Syntheticum, β-CDBao He gets clathrate;
(2) get the residue medical material, place container, the adding aqueous solution is an amount of, and supersound extraction certain hour (about 30~45 minutes) is put to room temperature, adds aqueous solution to scale, shakes up, and filters, and gets filtrate, reclaims promptly;
(3) with above-mentioned extract obtained, the PEG400 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Codonopsis 335g Rhizoma Atractylodis Macrocephalae 670g Radix Astragali Preparata 335g Radix Glycyrrhizae Preparata 168g
Poria 670g Radix Polygalae (system) 670g Semen Ziziphi Spinosae (stir-fry) 335g
Arillus Longan 670g Radix Angelicae Sinensis 670g Radix Aucklandiae 168g Fructus Jujubae (enucleation) 168g
PEG400 350g
Make 1000
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, use supercritical fluid extraction, extraction kettle pressure is 25MPa, and the pressure of extraction-container I is 8MPa, and the pressure of extraction-container II is 6MPa; CO 2Flow is about 18kg/h, and extraction 4h gets extract; Merge Borneolum Syntheticum, β-CDBao He gets clathrate;
(2) get the residue medical material, place container, the adding aqueous solution is an amount of, and supersound extraction certain hour (about 30~45 minutes) is put to room temperature, adds aqueous solution to scale, shakes up, and filters, and gets filtrate, reclaims promptly;
(3) with above-mentioned extract obtained, drying is pulverized, and adds an amount of PEG400 mixing and pulverizing, adds the PEG400 of surplus then, promptly gets medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable splashes in the coolant (liquid paraffin), promptly.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Codonopsis 500g Rhizoma Atractylodis Macrocephalae 1000g Radix Astragali Preparata 500g Radix Glycyrrhizae Preparata 250g
Poria 1000g Radix Polygalae (system) 1000g Semen Ziziphi Spinosae (stir-fry) 500g
Arillus Longan 1000g Radix Angelicae Sinensis 1000g Radix Aucklandiae 250g Fructus Jujubae (enucleation) 250g
Make 1000g
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, " method of an appendix XD of Chinese pharmacopoeia was extracted volatile oil, extraction time 6h, extract β-CDBao He with the atmospheric steam way of distillation with reference to version in 2000; Borneolum Syntheticum is ground into fine powder, and is standby;
(2) get the residue medical material, place container, add 8 times of water gagings and decoct each 1.5 hours 2 times;
(3) with above-mentioned extract obtained, drying is pulverized, and adds aspartame 5.0g, dextrin 230.0g, granulates, and drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Codonopsis 163g Rhizoma Atractylodis Macrocephalae 327g Radix Astragali Preparata 163g Radix Glycyrrhizae Preparata 82g
Poria 327g Radix Polygalae (system) 327g Semen Ziziphi Spinosae (stir-fry) 163g
Arillus Longan 327g Radix Angelicae Sinensis 327g Radix Aucklandiae 82g Fructus Jujubae (enucleation) 82g
Make 1000
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, " method of an appendix XD of Chinese pharmacopoeia was extracted volatile oil, extraction time 6h, extract β-CDBao He with the atmospheric steam way of distillation with reference to version in 2000; Borneolum Syntheticum is ground into fine powder, and is standby;
(2) get the residue medical material, place container, add 8 times of water gagings and decoct each 1.5 hours 2 times;
(3) with above-mentioned extract obtained, drying is pulverized, and adds aspartame 3.0g, mannitol 150.0g, granulation, and drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.

Claims (10)

1, a kind of Chinese medicine composition is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
40~500 parts of 80~1000 parts of Radix Astragali Preparatas of 40~500 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis
80~1000 parts of Radix Glycyrrhizae Preparata 80~1000 parts of Radix Polygalaes of 20~250 parts of Poria (system)
80~1000 parts of 40~500 portions of Arillus Longans of Semen Ziziphi Spinosae (stir-fry)
20~250 parts in Radix Angelicae Sinensis 20~250 portions of Fructus Jujubaes of 80~1000 parts of Radix Aucklandiae (enucleation)
2, the compound preparation of claim 1~2 is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
40 parts of 80 parts of Radix Glycyrrhizae Preparatas of 160 parts of Radix Astragali Preparatas of 80 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis
80 parts of 160 parts of Semen Ziziphi Spinosaes of 160 parts of Radix Polygalaes of Poria (system) (stir-fry)
40 parts in Arillus Longan 160 parts of Radix Angelicae Sinensis, 40 portions of Fructus Jujubaes of 160 parts of Radix Aucklandiae (enucleation)
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule or pill.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, use supercritical fluid extraction, extraction kettle pressure is 25MPa, and the pressure of extraction-container I is 8MPa, and the pressure of extraction-container II is 6MPa; CO 2Flow is about 18kg/h, and extraction 4h gets extract; Merge Borneolum Syntheticum, β-CDBao He gets clathrate;
(2) get the residue medical material, place container, the adding aqueous solution is an amount of, and supersound extraction certain hour (about 30~45 minutes) is put to room temperature, adds aqueous solution to scale, shakes up, and filters, and gets filtrate, reclaims promptly;
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing drop pill of the present invention and soft capsule preparation;
Method b:(technology 2.)
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, " method of an appendix XD of Chinese pharmacopoeia was extracted volatile oil, extraction time 6h, extract β-CDBao He with the atmospheric steam way of distillation with reference to version in 2000; Borneolum Syntheticum is ground into fine powder, and is standby;
(2) get the residue medical material, place container, add 8 times of water gagings and decoct each 1.5 hours 2 times.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
6, the Chinese medicine preparation of claim 5, it is characterized in that: described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60-115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, coolant temperature is-and 10-5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that: described soft capsule, and its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg-500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that: the preparation process of granule is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of correctives, filler, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that: described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.; Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture; Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1-9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, use supercritical fluid extraction, extraction kettle pressure is 25MPa, and the pressure of extraction-container I is 8MPa, and the pressure of extraction-container II is 6MPa; CO 2Flow is about 18kg/h, and extraction 4h gets extract; Merge Borneolum Syntheticum, β-CDBao He gets clathrate;
(2) get the residue medical material, place container, the adding aqueous solution is an amount of, and supersound extraction certain hour (about 30~45 minutes) is put to room temperature, adds aqueous solution to scale, shakes up, and filters, and gets filtrate, reclaims promptly.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:(technology 2.)
(1) get the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Aucklandiae medical material, " method of an appendix XD of Chinese pharmacopoeia was extracted volatile oil, extraction time 6h, extract β-CDBao He with the atmospheric steam way of distillation with reference to version in 2000; Borneolum Syntheticum is ground into fine powder, and is standby;
(2) get the residue medical material, place container, add 8 times of water gagings and decoct each 1.5 hours 2 times.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60-115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, coolant temperature is-and 10-5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg-500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
CNA2005101053365A 2005-09-23 2005-09-23 Guipi preparation and new preparing method therefor Pending CN1742862A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101234172B (en) * 2008-02-02 2010-06-30 李顺清 Method of preparing Chinese medicine for treating qi-deficiency type metrorrhagia
CN103830707A (en) * 2014-03-12 2014-06-04 张勇 Traditional Chinese medicine for treating aphtha caused by insufficiency of heart and spleen and preparation method thereof
CN104352717A (en) * 2014-11-17 2015-02-18 青岛恒波仪器有限公司 Traditional Chinese medicine preparation for treating spleen-qi weakness type hemafecia and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101234172B (en) * 2008-02-02 2010-06-30 李顺清 Method of preparing Chinese medicine for treating qi-deficiency type metrorrhagia
CN103830707A (en) * 2014-03-12 2014-06-04 张勇 Traditional Chinese medicine for treating aphtha caused by insufficiency of heart and spleen and preparation method thereof
CN104352717A (en) * 2014-11-17 2015-02-18 青岛恒波仪器有限公司 Traditional Chinese medicine preparation for treating spleen-qi weakness type hemafecia and preparation method thereof

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