CN1824110A - Western bovine bezoar mind clearing medicinal preparation and its new preparation method - Google Patents

Western bovine bezoar mind clearing medicinal preparation and its new preparation method Download PDF

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Publication number
CN1824110A
CN1824110A CN 200510134440 CN200510134440A CN1824110A CN 1824110 A CN1824110 A CN 1824110A CN 200510134440 CN200510134440 CN 200510134440 CN 200510134440 A CN200510134440 A CN 200510134440A CN 1824110 A CN1824110 A CN 1824110A
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preparation
active component
radix
medicine
parts
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Chinese (zh)
Inventor
刘露
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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

A composite Chinese medicine in the form of dripping pill and soft capsule for treating bitter mouth, dry tongue, sore throat, chest distress with qi stagnation, dizziness and tinnitus, and its preparing process are disclosed.

Description

Western bovine bezoar mind clearing preparation and new preparation method
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, the particularly a kind of bitter taste dryness of the tongue that accumulated heat in the lung and stomach causes, laryngopharynx swelling and pain dysphoria, stagnation of QI fullness in the chest, the prescription of dizziness and tinnitus and preparation technology thereof of being used for.
Background technology:
The bitter taste dryness of the tongue that accumulated heat in the lung and stomach causes, the laryngopharynx swelling and pain dysphoria, stagnation of QI fullness in the chest, dizziness and tinnitus is clinically to see symptom more, and the traditional Chinese medical science is often taked clearing throat, and the means of analgesic relieving restlessness are treated it, and evident in efficacy.The Western bovine bezoar mind clearing 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, its pill that makes can be used for curing mainly the bitter taste dryness of the tongue that accumulated heat in the lung and stomach causes, the laryngopharynx swelling and pain dysphoria, stagnation of QI fullness in the chest, dizziness and tinnitus.
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:
42~300 parts of 126~900 portions of Radix Tinosporaes of 42~300 parts of Radix Scutellariaes of Fructus chebulae immaturus
42~300 parts of 84~600 portions of Semen Arecaes of 42~300 parts of Radixs Stephaniae Tetrandrae of Fructus Gardeniae
17~120 parts of 84~600 parts of Mentholums of 42~300 portions of Radix Glycyrrhizaes of the Radix Aucklandiae
12.6~90 parts of Borneolum Syntheticums
Preferably:
150 parts of 450 portions of Radix Tinosporaes of 150 parts of Radix Scutellariaes of Fructus chebulae immaturus
150 parts of 300 portions of Semen Arecaes of 150 parts of Radixs Stephaniae Tetrandrae of Fructus Gardeniae
60 parts of 300 parts of Mentholums of 150 portions of Radix Glycyrrhizaes of the Radix Aucklandiae
45 parts of Borneolum Syntheticums
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, soft extract, fluid extract and extractum, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Aucklandiae medical material, adopt steam distillation (or supercritical extraction):, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height the medical material chopping; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Tinosporae, Semen Arecae, Radix Stephaniae Tetrandrae, till the medicinal liquid inanimate object alkali reaction, collect acid water extracting liquid, be condensed into thick paste with 0.3~0.7% hydrochloric acid percolation (or dipping);
(3) get the residue medical material, soaked 30~60 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 and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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) getting Radix Aucklandiae medical material beats powder and is used as medicine;
(2) get the residue medical material, soaked 30~60 minutes earlier with 50~95% 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;
(3) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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, pharmacological research
1.1 influence to rabbit anus temperature due to the TAB/VAC
Get 16 of the big ear white race rabbit of body weight 2.0~2.5kg Japan, the male and female dual-purpose is divided equally 4 groups (n=4) at random.Survey 3 anus temperature continuously, each 3min, 1h at interval; 3 results are got its meansigma methods as basal body temperature,, gavage administration when treating 0.5 ℃ of anus temperature rise then by auricular vein injection TAB/VAC 1mL/kg.Administration group dosage sees Table 1, and matched group gavages the equal-volume distilled water.After the test administration 1,2,3, the anus temperature of each treated animal of 4h, with the significance of t value method check medicine group and matched group effect.
Table 1 pair TAB/VAC cause rabbit anus temperature influence (℃, x ± s, n=4)
Group Dosage (g/kg) Basal body temperature Anus temperature after the pyrogenicity Anus temperature after the administration
0.5h 1h 2h 3h
Control group technology is 2. medicinal extract group aspirin of medicinal extract group technology 1. - 0.09 0.13 0.1 39.50±0.12 39.32±0.15 39.43±0.17 39.42±0.18 40.81±0.27 40.64±0.32 40.87±0.23 40.45±0.41 41.15±0.27 40.06±0.52 * 40.85±0.27 40.12±0.21 ** 41.21±0.14 39.74±0.17 * 40.22±0.31 40.07±0.19 ** 40.89±0.27 39.61±0.45 * 39.53±0.18 ** 39.77±0.16 ** 40.61±0.21 39.35±0.13 ** 39.45±0.15 ** 39.51±0.09 **
Annotate: compare with matched group, *P<0.05, *P<0.01
1.2 to 2, the influence of 2, 4-dinitrophenol pyrogenicity rat
Get 48 of body weight 170~220g rats, the male and female dual-purpose is tested the anus temperature every day 1 time (anus thermometre insertion depth 3cm), continuously 3d.Get the variation of anus temperature and be no more than 0.5 rat, be divided into 4 groups (n=12) at random.The medicine group be technology 1., 2. extractum group, positive controls gavages aspirin 0.1g/kg; Matched group gavages the equal-volume distilled water.The every Mus of 1h back subcutaneous injection 2 after administration, 2, 4-dinitrophenol 20mg/kg per hour tests rat anus temperature 1 time then, and follow-on test 4h is with the significance of t value method check medicine group and matched group effect.
Table 2 pairs 2, the influence of 2, 4-dinitrophenol pyrogenicity rat (℃, x ± s, n=12)
Group Dosage (g/kg) Basal body temperature Anus temperature after the pyrogenicity Anus temperature after the administration
0.5h 1h 2h 3h
Control group technology is 2. medicinal extract group aspirin of medicinal extract group technology 1. - 0.18 0.26 0.1 37.84±0.42 37.67±0.45 37.95±0.17 37.95±0.48 39.15±0.67 39.16±0.37 38.98±0.72 38.55±0.42 39.94±0.63 38.48±0.61 ** 39.01±0.67 38.38±0.24 ** 40.31±0.11 38.18±0.17 ** 38.79±0.41 * 38.17±0.29 ** 40.34±0.87 38.06±0.33 * 38.38±0.18 ** 38.21±0.26 ** 39.64±0.91 37.64±0.73 ** 38.10±0.45 ** 38.69±0.29 **
Annotate: compare with matched group, *P<0.05, *P<0.01
1.3 influence to Oleum Tiglii induced mice ear swelling
Get 40 of body weight (20 ± 2) g mices, male and female half and half are divided equally 4 groups (n=10) at random.The technology that drug component does not use big low dose 1., 2. extractum group, positive controls gavages prednisone 25mg/kg, 1/d, 3d continuously; Matched group gavages the equal-volume distilled water.1h after the last administration, every Mus left side ear is coated with Oleum Tiglii mixture 0.02ml, put to death behind the 4h, cut two ears, lay auricle with diameter 0.8cm card punch at the same position of ear, take by weighing two auricle weight respectively, as the swelling degree, check the significance of medicine group and matched group effect with t value method with the weight difference.
The influence of table 3 pair Oleum Tiglii induced mice ear swelling (mg, x ± s, n=10)
Group Dosage (g/kg) The swelling degree
Matched group technology is 2. extractum group prednisone of extractum group technology 1. - 0.36 0.52 0.025 25.76±3.21 31.17±1.12 ** 26.81±2.43 * 12.87±5.14 **
Annotate: compare with matched group, *P<0.05, *P<0.01
2, 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 the bitter taste dryness of the tongue that a kind of good treatment accumulated heat in the lung and stomach causes, the laryngopharynx swelling and pain dysphoria, stagnation of QI fullness in the chest, the medicine of dizziness and tinnitus, and change preparation technology, can obviously strengthen its clearing throat, clinical efficacies such as analgesic relieving restlessness, 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:
Fructus chebulae immaturus 42g Radix Scutellariae 126g Radix Tinosporae 42g
Fructus Gardeniae 42g Radix Stephaniae Tetrandrae 84g Semen Arecae 42g
Radix Aucklandiae 42g Radix Glycyrrhizae 84g Mentholum 17g
Borneolum Syntheticum 12.6g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Aucklandiae medical material, adopt steam distillation (or supercritical extraction):, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height the medical material chopping; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 8 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Radix Tinosporae, Semen Arecae, Radix Stephaniae Tetrandrae, till the medicinal liquid inanimate object alkali reaction, collect acid water extracting liquid, be condensed into thick paste with 0.5% hydrochloric acid percolation;
(3) get the residue medical material, 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;
(4) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump together, and 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:
Fructus chebulae immaturus 184.5g Radix Scutellariae 553.5g Radix Tinosporae 184.5g
Fructus Gardeniae 184.5g Radix Stephaniae Tetrandrae 369g Semen Arecae 184.5g
Radix Aucklandiae 184.5g Radix Glycyrrhizae 369g Mentholum 74g
Borneolum Syntheticum 55g
PEG400 460g
Make 1000
Preparation method:
(1) gets Radix Aucklandiae medical material, adopt steam distillation (or supercritical extraction):, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height the medical material chopping; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 8 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get Radix Tinosporae, Semen Arecae, Radix Stephaniae Tetrandrae, till the medicinal liquid inanimate object alkali reaction, collect acid water extracting liquid, be condensed into thick paste with 0.5% hydrochloric acid percolation;
(3) get the residue medical material, 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;
(4) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump together, and 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:
Fructus chebulae immaturus 225g Radix Scutellariae 675g Radix Tinosporae 225g
Fructus Gardeniae 225g Radix Stephaniae Tetrandrae 450g Semen Arecae 225g
Radix Aucklandiae 225g Radix Glycyrrhizae 450g Mentholum 90g
Borneolum Syntheticum 67.5g
Make 1000g
Preparation method:
(1) getting Radix Aucklandiae medical material beats powder and is used as medicine;
(2) get the residue medical material, 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) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump together, and add aspartame 5.0g, dextrin 230.0g, granulate, and drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Fructus chebulae immaturus 117g Radix Scutellariae 351g Radix Tinosporae 117g
Fructus Gardeniae 117g Radix Stephaniae Tetrandrae 234g Semen Arecae 117g
Radix Aucklandiae 117g Radix Glycyrrhizae 234g Mentholum 47g
Borneolum Syntheticum 35g
Make 1000
Preparation method:
(1) getting Radix Aucklandiae medical material beats powder and is used as medicine;
(2) get the residue medical material, 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) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump together, and add aspartame 3.0g, mannitol 200.0g, 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 preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
42~300 parts of 126~900 portions of Radix Tinosporaes of 42~300 parts of Radix Scutellariaes of Fructus chebulae immaturus
42~300 parts of 84~600 portions of Semen Arecaes of 42~300 parts of Radixs Stephaniae Tetrandrae of Fructus Gardeniae
17~120 parts of 84~600 parts of Mentholums of 42~300 portions of Radix Glycyrrhizaes of the Radix Aucklandiae
12.6~90 parts of Borneolum Syntheticums.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
150 parts of 450 portions of Radix Tinosporaes of 150 parts of Radix Scutellariaes of Fructus chebulae immaturus
150 parts of 300 portions of Semen Arecaes of 150 parts of Radixs Stephaniae Tetrandrae of Fructus Gardeniae
60 parts of 300 parts of Mentholums of 150 portions of Radix Glycyrrhizaes of the Radix Aucklandiae
45 parts of Borneolum Syntheticums.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, soft extract, fluid extract and extractum, 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) gets Radix Aucklandiae medical material, adopt steam distillation (or supercritical extraction):, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height the medical material chopping; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Tinosporae, Semen Arecae, Radix Stephaniae Tetrandrae, till the medicinal liquid inanimate object alkali reaction, collect acid water extracting liquid, be condensed into thick paste with 0.3~0.7% hydrochloric acid percolation (or dipping);
(3) get the residue medical material, soaked 30~60 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 and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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) getting Radix Aucklandiae medical material beats powder and is used as medicine;
(2) get the residue medical material, soaked 30~60 minutes earlier with 50~95% 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;
(3) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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) gets Radix Aucklandiae medical material, adopt steam distillation (or supercritical extraction):, extract according to an appendix XD of pharmacopeia in 2005 essential oil extraction method, till no longer increasing to the volatile oil height the medical material chopping; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~12 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Tinosporae, Semen Arecae, Radix Stephaniae Tetrandrae, till the medicinal liquid inanimate object alkali reaction, collect acid water extracting liquid, be condensed into thick paste with 0.3~0.7% hydrochloric acid percolation (or dipping);
(3) get the residue medical material, soaked 30~60 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 and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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) getting Radix Aucklandiae medical material beats powder and is used as medicine;
(2) get the residue medical material, soaked 30~60 minutes earlier with 50~95% 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;
(3) above active component and Mentholum, Borneolum Syntheticum (smash and be used as medicine) lump 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.
CN 200510134440 2005-12-15 2005-12-15 Western bovine bezoar mind clearing medicinal preparation and its new preparation method Pending CN1824110A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102228180A (en) * 2011-07-12 2011-11-02 中国热带农业科学院椰子研究所 Betelnut buccal tablet and preparation method thereof
CN102743323A (en) * 2011-04-22 2012-10-24 韩全贵 Chewing tablet

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102743323A (en) * 2011-04-22 2012-10-24 韩全贵 Chewing tablet
CN102743323B (en) * 2011-04-22 2013-07-31 韩全贵 Chewing tablet
CN102228180A (en) * 2011-07-12 2011-11-02 中国热带农业科学院椰子研究所 Betelnut buccal tablet and preparation method thereof

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