CN101032572A - Sanguisorba huaijiao agent and the novel preparing method - Google Patents
Sanguisorba huaijiao agent and the novel preparing method Download PDFInfo
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Abstract
The present invention relates to Chinese medicine, and is especially one kind of Chinese medicine composition for treating substantive heat of viscera, exuberated fire of large intestine, melena due to intestinal affection, etc. and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill or soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of internal organs excess-heat that is used for, the large intestine fire is contained discharging fresh blood stool, hemorrhoid anal fistula, damp and hot constipation, the prescription of swelling and pain of anus and preparation technology thereof.
Background technology:
The internal organs excess-heat, large intestine fire is contained, discharging fresh blood stool, the hemorrhoid anal fistula, damp and hot constipation, swelling and pain of anus is clinically to see that symptom, the traditional Chinese medical science are often taked the dispelling wind removing heat from blood, the means of moisturizing of purging heat are treated it more, and evident in efficacy.Diyu huaijiao pills 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 internal organs excess-heat, the large intestine fire is contained, discharging fresh blood stool, the hemorrhoid anal fistula, damp and hot constipation, swelling and pain of anus.
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:
79～381.5 parts in 119～572 parts of Flos Sophoraes of 79～381.5 parts of Fructuss Sophorae of Radix Sanguisorbae (charcoal) (processed with honey) (stir-fry)
79～381.5 parts of 79～381.5 portions of Radix Rehmanniae of 39.5～191 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
10～48 parts on 39.5～191 parts of Flos Carthamis of 39.5～191 parts of Radix Paeoniae Rubra of Radix Angelicae Sinensis
39.5～191 parts of Radix Saposhnikoviae 39.5～191 parts of Fructus Aurantiis of 39.5～191 parts of Herba Schizonepetaes (parched with bran).
Preferably:
209 parts in 313 parts of Flos Sophoraes of 209 parts of Fructuss Sophorae of Radix Sanguisorbae (charcoal) (processed with honey) (stir-fry)
209 parts of 209 portions of Radix Rehmanniae of 104 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
26 parts on 104 parts of Flos Carthamis of 104 parts of Radix Paeoniae Rubra of Radix Angelicae Sinensis
104 parts of Radix Saposhnikoviae 104 parts of Fructus Aurantiis of 104 parts of Herba Schizonepetaes (parched with bran).
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, fluid extract and extractum, soft extract, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Radix Scutellariae, Radix Paeoniae Rubra medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) get the residue medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 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 various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Radix Scutellariae, Radix Paeoniae Rubra, flos carthami 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, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
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 antiinflammatory experiment (adopting the scorching method of mice caused by dimethylbenzene xylene)
Get 40 of Kunming mouses, be divided into 4 groups at random, 10 every group, i.e. 1. 2. extractum group (0.16g/kg) of extractum group (0.1g/kg), technology of normal saline matched group (0.2ml/10g), aspirin group (0.2g/kg), technology.Irritate the stomach medication, every 12h1 time, contact left ear 5s with the dimethylbenzene cotton balls behind the 3rd medication 30min, behind the 15min mice is all put to death, with card punch the mice ears are downcut with the position homalographic, precision takes by weighing weight; Auris dextra weight as 100%, is calculated left otitis disease weightening finish percentage rate, the results are shown in Table 1.
Table 1 mouse ear cause scorching experimental result relatively (%, x ± s, n=10)
| Group | The inflammation rate of body weight gain | P |
| Matched group aspirin group technology is 2. extractum group of extractum group technology 1. | 57.3±4.8 38.7±5.6 34.1±4.7 33.2±4.5 | ＜0.01 ＜0.01 ＜0.01 |
By table 1 as seen, aspirin group, extractum group and matched group more all have significant difference, illustrate that medicine has good antiinflammatory action.
1.2 analgesic experiment (adopting the white mice writhing method)
40 of Kunming mouses are divided into 4 groups at random, 10 every group, male and female half and half.Normal saline matched group (0.2ml/10g), aspirin group (0.2g/kg), technology is 2. extractum group (0.16g/kg) of extractum group (0.1g/kg), technology 1..Gastric infusion 3d, 1 time/d.Inject 5% acetic acid solution (0.2ml/ only) in the 3rd day last medication 30min pneumoretroperitoneum, observe the writhing response number of times of 15min mice continuously, the results are shown in Table 2.
Table 2 mice acetic acid cause pain turn round the body experimental result relatively (inferior, x ± s, n=10)
| Group | Writhing response | P |
| Matched group aspirin group technology is 2. extractum group of extractum group technology 1. | 37.6±6.5 12.1±3.4 7.2±2.1 8.5±3.0 | ＜0.01 ＜0.01 ＜0.01 |
By table 2 as seen, aspirin group, extractum group all have obvious analgesic activity, and latter's analgesic activity is stronger, with matched group significant difference is arranged more all.
1.3 hemostasis experiment
Get 40 of healthy mices, male and female all can, be divided into 4 groups at random, 10 every group.Be matched group (normal saline 0.2ml/10g); Radix Notoginseng powder group (1g/kg); Technology is 2. extractum group (0.16g/kg) of extractum group (0.1g/kg), technology 1..Each group is pressed above therapeutic regimen continuous irrigation stomach 3d, 1 time/d respectively.30min after last 1 administration cuts off mouse tail point 0.5cm place, and in the record bleeding time, every 15s inhales to dehematize with filter paper and drips 1 time, and until stopped bleeding, the gained data see Table 3.
The anastalsis of table 3 pair mice (min, x ± s, n=10)
| Group | Stop the bleeding time | P |
| Matched group Radix Notoginseng powder group technology is 2. extractum group of extractum group technology 1. | 9.4±1.6 4.7±1.3 3.9±1.2 4.8±1.1 | ＜0.01 ＜0.01 ＜0.01 |
By table 3 as seen, the bleeding time of extractum group mice is significantly shorter than matched group.The technology 1. haemostatic effect of extractum group is better than the Radix Notoginseng powder group.
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 a kind of good treatment internal organs excess-heat, the large intestine fire is contained discharging fresh blood stool, hemorrhoid anal fistula, damp and hot constipation, the medicine of swelling and pain of anus, and change preparation technology can obviously strengthen its dispelling wind removing heat from blood, purge heat and clinical efficacy such as moisturize, its hypotoxicity in addition, therefore prolonged application safety, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Sanguisorbae (charcoal) the 79g Fructus Sophorae (processed with honey) 119g Flos Sophorae (stir-fry) 79g
Radix Et Rhizoma Rhei 39.5g Radix Scutellariae 79g Radix Rehmanniae 79g
Radix Angelicae Sinensis 39.5g Radix Paeoniae Rubra 39.5g Flos Carthami 10g
Radix Saposhnikoviae 39.5g Herba Schizonepetae 39.5g Fructus Aurantii (parched with bran) 39.5g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil 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 Scutellariae, Radix Paeoniae Rubra medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) get the residue medical material, soaked 30 minutes earlier with 70% 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:
Radix Sanguisorbae (charcoal) the 417.5g Fructus Sophorae (processed with honey) 626g Flos Sophorae (stir-fry) 417.5g
Radix Et Rhizoma Rhei 209g Radix Scutellariae 417.5g Radix Rehmanniae 417.5g
Radix Angelicae Sinensis 209g Radix Paeoniae Rubra 209g Flos Carthami 52g
Radix Saposhnikoviae 209g Herba Schizonepetae 209g Fructus Aurantii (parched with bran) 209g
PEG400 580g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil 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 Scutellariae, Radix Paeoniae Rubra medical material, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) get the residue medical material, soaked 30 minutes earlier with 70% 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:
Radix Sanguisorbae (charcoal) the 381.5g Fructus Sophorae (processed with honey) 572g Flos Sophorae (stir-fry) 381.5g
Radix Et Rhizoma Rhei 191g Radix Scutellariae 381.5g Radix Rehmanniae 381.5g
Radix Angelicae Sinensis 191g Radix Paeoniae Rubra 191g Flos Carthami 48g
Radix Saposhnikoviae 191g Herba Schizonepetae 191g Fructus Aurantii (parched with bran) 191g
Make 1000g
Preparation method:
(1) gets Radix Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil 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) getting Radix Scutellariae, Radix Paeoniae Rubra, flos carthami beats powder and is used as medicine;
(3) get the residue medical material, soaked 30 minutes earlier with 70% 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 is merged, add aspartame 5.0g, dextrin 300.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Sanguisorbae (charcoal) the 209g Fructus Sophorae (processed with honey) 313g Flos Sophorae (stir-fry) 209g
Radix Et Rhizoma Rhei 104g Radix Scutellariae 209g Radix Rehmanniae 209g
Radix Angelicae Sinensis 104g Radix Paeoniae Rubra 104g Flos Carthami 26g
Radix Saposhnikoviae 104g Herba Schizonepetae 104g Fructus Aurantii (parched with bran) 104g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil 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) getting Radix Scutellariae, Radix Paeoniae Rubra, flos carthami beats powder and is used as medicine;
(3) get the residue medical material, soaked 30 minutes earlier with 70% 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 is merged, add aspartame 3.0g, mannitol 220.0g, 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:
79～381.5 parts in 119～572 parts of Flos Sophoraes of 79～381.5 parts of Fructuss Sophorae of Radix Sanguisorbae (charcoal) (processed with honey) (stir-fry)
79～381.5 parts of 79～381.5 portions of Radix Rehmanniae of 39.5～191 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
10～48 parts on 39.5～191 parts of Flos Carthamis of 39.5～191 parts of Radix Paeoniae Rubra of Radix Angelicae Sinensis
39.5～191 parts of Radix Saposhnikoviae 39.5～191 parts of Fructus Aurantiis of 39.5～191 parts of Herba Schizonepetaes (parched with bran).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
209 parts in 313 parts of Flos Sophoraes of 209 parts of Fructuss Sophorae of Radix Sanguisorbae (charcoal) (processed with honey) (stir-fry)
209 parts of 209 portions of Radix Rehmanniae of 104 parts of Radix Scutellariaes of Radix Et Rhizoma Rhei
26 parts on 104 parts of Flos Carthamis of 104 parts of Radix Paeoniae Rubra of Radix Angelicae Sinensis
104 parts of Radix Saposhnikoviae 104 parts of Fructus Aurantiis of 104 parts of Herba Schizonepetaes (parched with bran).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, 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 Angelicae Sinensis, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Radix Scutellariae, Radix Paeoniae Rubra medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) get the residue medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 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 various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Radix Scutellariae, Radix Paeoniae Rubra, flos carthami 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, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
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, Radix Saposhnikoviae, Herba Schizonepetae, Fructus Aurantii 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; The volatile oil β-CDBao He, optimised process is: β-CD is 1: 6～12 with the water ratio, and oil is 1: 4～12 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get Radix Scutellariae, Radix Paeoniae Rubra medical material, decoct with water 2～5 times, each 0.5～3 hour, collecting decoction filtered, and it is standby that filtrate is condensed into thick extractum;
(3) get the residue medical material, soaked 30～90 minutes earlier with 50～95% ethanol, reheat reflux, extract, 2～6 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 various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting Radix Scutellariae, Radix Paeoniae Rubra, flos carthami 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, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
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.
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| CN 200610057276 CN101032572A (en) | 2006-03-10 | 2006-03-10 | Sanguisorba huaijiao agent and the novel preparing method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101406587B (en) * | 2008-11-18 | 2011-07-27 | 逯萍 | Oral medicament for treating hemorrhoid |
| CN105012471A (en) * | 2015-08-04 | 2015-11-04 | 庞英杰 | Cushion |
-
2006
- 2006-03-10 CN CN 200610057276 patent/CN101032572A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101406587B (en) * | 2008-11-18 | 2011-07-27 | 逯萍 | Oral medicament for treating hemorrhoid |
| CN105012471A (en) * | 2015-08-04 | 2015-11-04 | 庞英杰 | Cushion |
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