CN1824144A - Shiertaibao medicinal preparation and its new preparation method - Google Patents
Shiertaibao medicinal preparation and its new preparation method Download PDFInfo
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Abstract
A composite Chinese medicine in the form of dripping pill and soft capsule for treating the qi and blood disharmony and excessive fetal movement of gravida and preventing abortion, and its preparing process are disclosed.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of anemia of pregnant woman's qi and blood disorder that is used for, frequent fetal movement, the prescription of prevention of miscarriage and preparation technology thereof.
Background technology:
Anemia of pregnant woman's qi and blood disorder, frequent fetal movement, prevention of miscarriage are clinically to see symptom more, and the traditional Chinese medical science is often taked regulating the flow of QI to alleviate depression, and the means of nourishing blood and preventing abortion are treated it, and evident in efficacy.12 hooligan's balls are that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
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, mixture, its pill that makes can be used for curing mainly anemia of pregnant woman's qi and blood disorder, frequent fetal movement, prevention of miscarriage.
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 prepared from by following proportion raw material:
80～618 parts of 161～1238 parts of 116～892 parts of Semen Cuscutae of Radix Angelicae Sinensis (processed with salt) of the Radix Paeoniae Alba (wine stir-fry)
65～502 parts of 70～538 portions of Herba Schizonepetae of 80～618 parts of Radixs Astragali of Bulbus Fritillariae Thunbergii (processed with wine)
50～388 parts of 55～426 parts of Fructus Aurantiis of 55～426 parts of Cortex Magnoliae Officinalis of Folium Artemisiae Argyi (vinegar stir-fry) (face stir-fry)
41～312 parts of 121～932 portions of Rhizoma Et Radix Notopterygiis of 41～312 parts of Rhizoma Chuanxiongs of Radix Glycyrrhizae (processed with wine)
Preferably:
309 parts of 619 parts of 446 parts of Semen Cuscutae of Radix Angelicae Sinensis (processed with salt) of the Radix Paeoniae Alba (wine stir-fry)
251 parts of 269 portions of Herba Schizonepetae of 309 parts of Radixs Astragali of Bulbus Fritillariae Thunbergii (processed with wine)
194 parts of 213 parts of Fructus Aurantiis of 213 parts of Cortex Magnoliae Officinalis of Folium Artemisiae Argyi (vinegar stir-fry) (face stir-fry)
156 parts of 466 portions of Rhizoma Et Radix Notopterygiis of 156 parts of Rhizoma Chuanxiongs of Radix Glycyrrhizae (processed with wine)
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, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100～500 bags, 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 doses,, make 125 bags, take 1～2 bag at every turn, can take altogether 62.5～125 times 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, capsule, granule, tablet, mixture, unguentum, syrup, suppository, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) get the Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) get Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction, filter, filtrate is condensed into certain volume, stirs evenly with 5～15 times of amount 50～95% ethanol, leaves standstill 5～72h, filter, filtrate decompression is condensed into thick extractum, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～90min gets clathrate.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get 1/4～3/4 dozen of powder of Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials and be used as medicine, remaining part is handled the same;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule 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 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
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; 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:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. 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 the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of 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, the mice acetic acid is caused the analgesic activity of pain model
Get male mice 16～20g, the back of weighing is by table 1 grouping and gavage administration.The equal lumbar injection acetic acid of each treated animal of 30min 40mg/kg causes pain after the last administration, and interior each Mus of 15min is turned round the body number of times after observing injection acetic acid, organizes a t check.The result shows, what the extractum group can reduce obviously all that acetic acid causes the pain model mice turns round the body number of times.Compare with the blank group, have the statistics difference (P＜0.01) of highly significant, illustrate that medicine truly has analgesic activity preferably, the results are shown in Table 1.
Table 1 pair mice acetic acid causes the analgesic activity (n=15) of pain model
| Group | Dosage (g/kgd) | Turn round the body number of times behind the acetic acid in the 15min |
| NS technology is 2. extractum group indomethacin of extractum group technology 1. | - 0.08 0.11 0.60 | 8.89±4.15 1.65±2.12 ** 2.21±2.85 ** 0.49±0.65 ** |
*Compare P＜0.01 with the blank group
2, whole blood coagulation time in mice (CT) is influenced
Get 16～20g kunming mice, male and female half and half, by table 2 grouping with gavage administration, each treated animal all behind time medicine 1h pluck eyeball and get blood, drip on microscope slide, choosing the blood streak with syringe needle is the blood coagulation terminal time, between organizing relatively.The result shows that medicine can make mice CT obviously shorten, and compares significant difference (P＜0.05) with NS.Prove this medicine to shorten clotting time and play anastalsis, the results are shown in Table 2.
The influence (n=15) of table 2 pair clotting time of mice
| Group | Dosage (g/kgd) | CT(Sec) |
| NS VitK 4Technology is 2. extractum group indomethacin of extractum group technology 1. | - 0.12 0.08 0.11 0.60 | 136.8±43.1 95.1±33.5 * 102.5±33.6 * 107.3±42.4 * 240.6±48.3 * |
*Organize than P＜0.05 with NS
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 anemia of pregnant woman qi and blood disorders, frequent fetal movement, the medicine of prevention of miscarriage, and change preparation technology can obviously strengthen its regulating the flow of QI to alleviate depression, clinical efficacies such as nourishing blood and preventing abortion, 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:
The Radix Paeoniae Alba (wine stir-fry) 161g Radix Angelicae Sinensis 116g Semen Cuscutae (processed with salt) 80g
The Bulbus Fritillariae Thunbergii 80g Radix Astragali (processed with wine) 70g Herba Schizonepetae 65g
Folium Artemisiae Argyi (vinegar stir-fry) 55g Cortex Magnoliae Officinalis 55g Fructus Aurantii (face stir-fry) 50g
Radix Glycyrrhizae 41g Rhizoma Chuanxiong (processed with wine) 121g Rhizoma Et Radix Notopterygii 41g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) get the Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) get Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into certain volume, stirs evenly with 8 times of amount 95% ethanol, leaves standstill 12h, filters, and filtrate decompression is condensed into thick extractum, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(4) with above-mentioned extract obtained, the PEG4000 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:
The Radix Paeoniae Alba (wine stir-fry) 557g Radix Angelicae Sinensis 401g Semen Cuscutae (processed with salt) 278g
The Bulbus Fritillariae Thunbergii 278g Radix Astragali (processed with wine) 242g Herba Schizonepetae 226g
Folium Artemisiae Argyi (vinegar stir-fry) 192g Cortex Magnoliae Officinalis 192g Fructus Aurantii (face stir-fry) 175g
Radix Glycyrrhizae 140g Rhizoma Chuanxiong (processed with wine) 419g Rhizoma Et Radix Notopterygii 140g
PEG400 430g
Make 1000
Preparation method:
(1) get the Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) get Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into certain volume, stirs evenly with 8 times of amount 95% ethanol, leaves standstill 12h, filters, and filtrate decompression is condensed into thick extractum, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(4) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
The Radix Paeoniae Alba (wine stir-fry) 928.5g Radix Angelicae Sinensis 669g Semen Cuscutae (processed with salt) 463.5g
The Bulbus Fritillariae Thunbergii 463.5g Radix Astragali (processed with wine) 403.5g Herba Schizonepetae 376.5g
Folium Artemisiae Argyi (vinegar stir-fry) 319.5g Cortex Magnoliae Officinalis 319.5g Fructus Aurantii (face stir-fry) 291g
Radix Glycyrrhizae 234g Rhizoma Chuanxiong (processed with wine) 699g Rhizoma Et Radix Notopterygii 234g
Make 1000g
Preparation method:
(1) get 1/4 dozen of powder of Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials and be used as medicine, remaining part decocts with water 3 times, and each 1 hour, collecting decoction, filter, filtrate is condensed into certain volume, stirs evenly with 8 times of amount 95% ethanol, leaves standstill 12h, filter, filtrate decompression is condensed into thick extractum, and is standby;
(2) get the Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(4) above active component is merged, add aspartame 5.0g, dextrin 160.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
The Radix Paeoniae Alba (wine stir-fry) 557g Radix Angelicae Sinensis 401g Semen Cuscutae (processed with salt) 278g
The Bulbus Fritillariae Thunbergii 278g Radix Astragali (processed with wine) 242g Herba Schizonepetae 226g
Folium Artemisiae Argyi (vinegar stir-fry) 192g Cortex Magnoliae Officinalis 192g Fructus Aurantii (face stir-fry) 175g
Radix Glycyrrhizae 140g Rhizoma Chuanxiong (processed with wine) 419g Rhizoma Et Radix Notopterygii 140g
Make 1000
Preparation method:
(1) get 1/4 dozen of powder of Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials and be used as medicine, remaining part decocts with water 3 times, and each 1 hour, collecting decoction, filter, filtrate is condensed into certain volume, stirs evenly with 8 times of amount 95% ethanol, leaves standstill 12h, filter, filtrate decompression is condensed into thick extractum, and is standby;
(2) get the Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(4) above active component is merged, add aspartame 3.0g, mannitol 170.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.
Claims (10)
1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
80～618 parts of 161～1238 parts of 116～892 parts of Semen Cuscutae of Radix Angelicae Sinensis (processed with salt) of the Radix Paeoniae Alba (wine stir-fry)
65～502 parts of 70～538 portions of Herba Schizonepetae of 80～618 parts of Radixs Astragali of Bulbus Fritillariae Thunbergii (processed with wine)
50～388 parts of 55～426 parts of Fructus Aurantiis of 55～426 parts of Cortex Magnoliae Officinalis of Folium Artemisiae Argyi (vinegar stir-fry) (face stir-fry)
41～312 parts of 121～932 portions of Rhizoma Et Radix Notopterygiis of 41～312 parts of Rhizoma Chuanxiongs of Radix Glycyrrhizae (processed with wine).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
309 parts of 619 parts of 446 parts of Semen Cuscutae of Radix Angelicae Sinensis (processed with salt) of the Radix Paeoniae Alba (wine stir-fry)
251 parts of 269 portions of Herba Schizonepetae of 309 parts of Radixs Astragali of Bulbus Fritillariae Thunbergii (processed with wine)
194 parts of 213 parts of Fructus Aurantiis of 213 parts of Cortex Magnoliae Officinalis of Folium Artemisiae Argyi (vinegar stir-fry) (face stir-fry)
156 parts of 466 portions of Rhizoma Et Radix Notopterygiis of 156 parts of Rhizoma Chuanxiongs of Radix Glycyrrhizae (processed with wine).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, unguentum, syrup, suppository, powder.
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 Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) get Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction, filter, filtrate is condensed into certain volume, stirs evenly with 5～15 times of amount 50～95% ethanol, leaves standstill 5～72h, filter, filtrate decompression is condensed into thick extractum, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～90min gets clathrate.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get 1/4～3/4 dozen of powder of Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials and be used as medicine, remaining part is handled the same;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
6, the Chinese medicine preparation of claim 5 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, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
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.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, 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 Radix Paeoniae Alba, Bulbus Fritillariae Thunbergii two flavor medical materials, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(2) get Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction, filter, filtrate is condensed into certain volume, stirs evenly with 5～15 times of amount 50～95% ethanol, leaves standstill 5～72h, filter, filtrate decompression is condensed into thick extractum, and is standby;
(3) get prescription residue medical material, adopt supercritical extraction (or steam distillation), 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; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～90min gets clathrate.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get 1/4～3/4 dozen of powder of Semen Cuscutae, the Radix Astragali, Radix Glycyrrhizae three flavor medical materials and be used as medicine, remaining part is handled the same;
(2) getting prescription residue medical material handles the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule 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, and coolant temperature is-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: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510134420 CN1824144A (en) | 2005-12-15 | 2005-12-15 | Shiertaibao medicinal preparation and its new preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510134420 CN1824144A (en) | 2005-12-15 | 2005-12-15 | Shiertaibao medicinal preparation and its new preparation method |
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| CN1824144A true CN1824144A (en) | 2006-08-30 |
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| CN 200510134420 Pending CN1824144A (en) | 2005-12-15 | 2005-12-15 | Shiertaibao medicinal preparation and its new preparation method |
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