CN1775243A - Zhanhua hairy Antler formulation and new preparing method - Google Patents
Zhanhua hairy Antler formulation and new preparing method Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine composition and its preparation process. In particular, it relates to a Chinese medicine prescription for curing the diseases of vacuity detriment, breakdown of the normal physiological coordination between the heart and the kidney, impotence, female gynecological disease, pain in waist and lower extremities, etc. and its preparation process. Said Chinese medicine composition can be made into dripping pills and soft capsule preparation.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of weakness that is used for, disarmony between the heart and kidney, the sexual impotence erectile problem, hernia stomachache, woman's leukorrhagia, born of the same parents are cold sterile, the prescription of waist and leg ache and preparation technology thereof.
Background technology:
Weakness, disarmony between the heart and kidney, sexual impotence erectile problem, hernia stomachache, woman's leukorrhagia, born of the same parents are cold sterile, and waist and leg ache is clinical common sympton, and the traditional Chinese medical science is often taked benefiting qi and nourishing blood, hold up kidney and enhancing body, the means of regulating menstruation cold relieving are treated it, and evident in efficacy, and the Zhanhua hairy Antler ball is 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 weakness, disarmony between the heart and kidney, the sexual impotence erectile problem, hernia stomachache, woman's leukorrhagia, born of the same parents are cold sterile, waist and leg ache.
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:
33.5～435.5 parts of Cornu Cervi Pantotrichum (unhairing) 27～351 parts of Semen Ziziphi Spinosaes of 33.5～435.5 parts of Radix Angelicae Sinensis (stir-fry)
33.5～435.5 parts of 33.5～435.5 parts of Radix Rehmanniae Preparata of 33.5～435.5 parts of Semen Platycladi of Cornu Cervi Degelatinatum
33.5～435.5 parts of 33.5～435.5 parts of Radixs Astragali of 33.5～435.5 parts of Colla cornus cervis of Herba Cistanches
7～91 parts of Radix Aconiti Lateralis Preparatas (system)
Preferably:
67 parts of Cornu Cervi Pantotrichum (unhairing) 54 parts of Semen Ziziphi Spinosaes of 67 parts of Radix Angelicae Sinensis (stir-fry)
67 parts of 67 parts of Radix Rehmanniae Preparata of 67 parts of Semen Platycladi of Cornu Cervi Degelatinatum
67 parts of 67 parts of Radixs Astragali of 67 parts of Colla cornus cervis of Herba Cistanches
14 parts of Radix Aconiti Lateralis Preparatas (system)
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, soft capsule, granule, chewable tablet, mixture.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get 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 30～70min gets clathrate;
(2) get Herba Cistanches, Radix Rehmanniae Preparata, the Radix Astragali, Radix Aconiti Lateralis Preparata four Chinese medicine material (Radix Aconiti Lateralis Preparata is decocted first), decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get prescription residue medical material, soaked 30～90 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～5 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials beats powder and is used as medicine;
(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.
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, xylol causes the influence of mice ear
Press table 1 grouping administration, in 7d, irritate stomach every day 1 time, matched group is irritated stomach equal-volume distilled water, 30min after the last administration, dimethylbenzene is dripped in mouse right ear, behind the 15min, put to death animal, punch in left and right sides ear same area with the 6mm card punch, as the swelling level index, the results are shown in Table 1 with two auricle weight differences.
Table 1 xylol causes the influence (x ± s) of mice ear
| Group | Number of animals (only) | Dosage (g/kg) | Two auricle weight differences (mg) | Press down swollen rate (%) |
| Matched group technology is 2. extractum group of extractum group technology 1. | 10 10 10 | - 0.17 0.49 | 8.6±2.51 3.8±2.00 **4.6±2.02 * | 55 47 |
Compare with the blank group
*P＜0.05,
*P＜0.01,
* *P＜0.001 (down together)
2, Dichlorodiphenyl Acetate causes the influence of mouse writhing reaction
Press table 2 grouping administration, in 7d, irritate stomach every day 1 time, matched group is irritated stomach equal-volume distilled water, and 1h after the last administration injects 0.6% acetum with whole mouse peritoneals, and the number of times of writhing response takes place in 10min the record mice, the results are shown in Table 2.
Table 2 Dichlorodiphenyl Acetate causes the influence (x ± s) of mouse writhing reaction
| Group | Number of animals (only) | Dosage (g/kg) | Writhing response number of times (inferior) |
| Matched group technology is 2. extractum group of extractum group technology 1. | 10 10 10 | - 0.17 0.49 | 37±3.81 10±3.54 ***11±3.01 *** |
3, to the influence of mouse monokaryon macrophage phagocytic ability
Press table 3 grouping administration, in 7 days, matched group is irritated stomach equal-volume distilled water, 1h after the last administration, and with whole mouse tail vein injection prepared Chinese ink (1: 4) 0.1ml/ only, respectively at injection back 2min and 5min, eye socket is got blood 10 μ l, adds 0.1%Na
2CO
3Among the solution 2ml,, behind sacrifice of animal, get liver and spleen is weighed, calculate phagocytic index K value and a value, the results are shown in Table 3 at 600nm place photometry density value.
The influence of table 3 pair mouse monokaryon macrophage phagocytic ability (x ± s, n=10)
| Group | Dosage (g/kg) | Phagocytic index K value | Phagocytic index a value |
| Matched group technology is 2. extractum group of extractum group technology 1. | - 0.17 0.49 | 0.021±0.00201 0.030±0.00501 * 0.029±0.00514 * | 5.01±0.302 5.7±0.381 **5.65±0.584 * |
4, 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 weakness, disarmony between the heart and kidney, sexual impotence erectile problem, hernia stomachache, woman's leukorrhagia, born of the same parents are cold sterile, the medicine of waist and leg ache, and change preparation technology can obviously strengthen its benefiting qi and nourishing blood, holds up kidney and enhancing body, clinical efficacies such as regulating menstruation cold relieving, its hypotoxicity in addition, prolonged application safety, therefore, 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:
Cornu Cervi Pantotrichum (unhairing) 106g Radix Angelicae Sinensis 85g Semen Ziziphi Spinosae (stir-fry) 106g
Cornu Cervi Degelatinatum 106g Semen Platycladi 106g Radix Rehmanniae Preparata 106g
Herba Cistanches 106g Colla cornus cervi 106g Radix Astragali 106g
Radix Aconiti Lateralis Preparata (system) 22g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Herba Cistanches, Radix Rehmanniae Preparata, the Radix Astragali, Radix Aconiti Lateralis Preparata four Chinese medicine material (Radix Aconiti Lateralis Preparata is decocted first), decoct with water 3 times, each 1 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 95% ethanol of 10 times of amounts, stirs, leave standstill, deepfreeze 12h filters, and filtrate is condensed into thick paste;
(3) get prescription residue medical material, soaked 60 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;
(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:
Cornu Cervi Pantotrichum (unhairing) 435.5g Radix Angelicae Sinensis 351g Semen Ziziphi Spinosae (stir-fry) 435.5g
Cornu Cervi Degelatinatum 435.5g Semen Platycladi 435.5g Radix Rehmanniae Preparata 435.5g
Herba Cistanches 435.5g Colla cornus cervi 435.5g Radix Astragali 435.5g
Radix Aconiti Lateralis Preparata (system) 91g
PEG400 490g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 6 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Herba Cistanches, Radix Rehmanniae Preparata, the Radix Astragali, Radix Aconiti Lateralis Preparata four Chinese medicine material (Radix Aconiti Lateralis Preparata is decocted first), decoct with water 3 times, each 1 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 95% ethanol of 10 times of amounts, stirs, leave standstill, deepfreeze 12h filters, and filtrate is condensed into thick paste;
(3) get prescription residue medical material, soaked 60 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;
(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:
Cornu Cervi Pantotrichum (unhairing) 268g Radix Angelicae Sinensis 216g Semen Ziziphi Spinosae (stir-fry) 268g
Cornu Cervi Degelatinatum 268g Semen Platycladi 268g Radix Rehmanniae Preparata 268g
Herba Cistanches 268g Colla cornus cervi 268g Radix Astragali 268g
Radix Aconiti Lateralis Preparata (system) 56g
Make 1000g
Preparation method:
(1) getting Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials beats powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component is merged, add aspartame 5.0g, dextrin 280.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Cornu Cervi Pantotrichum (unhairing) 113g Radix Angelicae Sinensis 91g Semen Ziziphi Spinosae (stir-fry) 113g
Cornu Cervi Degelatinatum 113g Semen Platycladi 113g Radix Rehmanniae Preparata 113g
Herba Cistanches 113g Colla cornus cervi 113g Radix Astragali 113g
Radix Aconiti Lateralis Preparata (system) 23.5g
Make 1000
Preparation method:
(1) getting Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials beats powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component is merged, add aspartame 3.0g, mannitol 200.0g, 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:
33.5～435.5 parts of Cornu Cervi Pantotrichum (unhairing) 27～351 parts of Semen Ziziphi Spinosaes of 33.5～435.5 parts of Radix Angelicae Sinensis (stir-fry)
33.5～435.5 parts of 33.5～435.5 parts of Radix Rehmanniae Preparata of 33.5～435.5 parts of Semen Platycladi of Cornu Cervi Degelatinatum
33.5～435.5 parts of 33.5～435.5 parts of Radixs Astragali of 33.5～435.5 parts of Colla cornus cervis of Herba Cistanches
7～91 parts of Radix Aconiti Lateralis Preparatas (system).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
67 parts of Cornu Cervi Pantotrichum (unhairing) 54 parts of Semen Ziziphi Spinosaes of 67 parts of Radix Angelicae Sinensis (stir-fry)
67 parts of 67 parts of Radix Rehmanniae Preparata of 67 parts of Semen Platycladi of Cornu Cervi Degelatinatum
67 parts of 67 parts of Radixs Astragali of 67 parts of Colla cornus cervis of Herba Cistanches
14 parts of Radix Aconiti Lateralis Preparatas (system).
3, claim 1 or any one Chinese medicine preparation of 2 are various suitable dosage forms such as drop pill, soft capsule, granule, chewable tablet, mixture, capsule.
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) gets Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get 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 30～70min gets clathrate;
(2) get Herba Cistanches, Radix Rehmanniae Preparata, the Radix Astragali, Radix Aconiti Lateralis Preparata four Chinese medicine material (Radix Aconiti Lateralis Preparata is decocted first), decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get prescription residue medical material, soaked 30～90 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～5 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials beats powder and is used as medicine;
(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.
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) gets Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get 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 30～70min gets clathrate;
(2) get Herba Cistanches, Radix Rehmanniae Preparata, the Radix Astragali, Radix Aconiti Lateralis Preparata four Chinese medicine material (Radix Aconiti Lateralis Preparata is decocted first), decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get prescription residue medical material, soaked 30～90 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～5 times, each 0.5～3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Semen Platycladi two flavor medical materials beats powder and is used as medicine;
(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.
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 200510115973 CN1775243A (en) | 2005-11-18 | 2005-11-18 | Zhanhua hairy Antler formulation and new preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510115973 CN1775243A (en) | 2005-11-18 | 2005-11-18 | Zhanhua hairy Antler formulation and new preparing method |
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| CN 200510115973 Pending CN1775243A (en) | 2005-11-18 | 2005-11-18 | Zhanhua hairy Antler formulation and new preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641379A (en) * | 2012-05-09 | 2012-08-22 | 甘肃陇神戎发药业股份有限公司 | Seven-ingredient yang-warming soft capsule preparation and preparing technology thereof |
| CN110075182A (en) * | 2019-06-13 | 2019-08-02 | 葵花药业集团北京药物研究院有限公司 | A kind of Zhanhua hairy Antler cream is grown and preparation method thereof |
| JP7440931B2 (en) | 2018-06-08 | 2024-02-29 | 蘇州黛澤堂健康科技有限公司 | Chinese herbal medicine gel composition and its preparation method and use |
-
2005
- 2005-11-18 CN CN 200510115973 patent/CN1775243A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641379A (en) * | 2012-05-09 | 2012-08-22 | 甘肃陇神戎发药业股份有限公司 | Seven-ingredient yang-warming soft capsule preparation and preparing technology thereof |
| CN102641379B (en) * | 2012-05-09 | 2013-11-06 | 甘肃陇神戎发药业股份有限公司 | Seven-ingredient yang-warming soft capsule preparation and preparing technology thereof |
| JP7440931B2 (en) | 2018-06-08 | 2024-02-29 | 蘇州黛澤堂健康科技有限公司 | Chinese herbal medicine gel composition and its preparation method and use |
| CN110075182A (en) * | 2019-06-13 | 2019-08-02 | 葵花药业集团北京药物研究院有限公司 | A kind of Zhanhua hairy Antler cream is grown and preparation method thereof |
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