CN1775235A - Pseudo-ginseng blood-circulation-invigovating preparation and new preparing method - Google Patents

Pseudo-ginseng blood-circulation-invigovating preparation and new preparing method Download PDF

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CN1775235A
CN1775235A CNA2005101159904A CN200510115990A CN1775235A CN 1775235 A CN1775235 A CN 1775235A CN A2005101159904 A CNA2005101159904 A CN A2005101159904A CN 200510115990 A CN200510115990 A CN 200510115990A CN 1775235 A CN1775235 A CN 1775235A
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parts
preparation
radix
active component
extract
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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

The present invention relates to a Chinese medicine composition and its preparation process. In particular, it relates to a prescription for curing traumatic injury and its preparation process. It can be made into dripping pills and soft capsule preparation.

Description

Pseudo-ginseng blood-circulation-invigovating preparation and new preparation method
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of traumatic injury that is used for, the prescription and the preparation technology thereof of fracture initial stage swelling severe patient.
Background technology:
Traumatic injury, fracture initial stage swelling severe patient is clinical common sympton, and the traditional Chinese medical science often takes the means of collateral dredging dissipating blood stasis that it is treated, and evident in efficacy, and the pseudo-ginseng blood-circulation-invigovating 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, hard capsule, its pill that makes can be used for curing mainly traumatic injury, fracture initial stage swelling severe patient.
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:
85~595 parts on 64~446 parts of Flos Carthamis of 85~595 parts of Rhizoma Drynariae of Radix Notoginseng (stir-fry)
42.5~298 parts of Oletum Trogopterori 64~446 parts of Radix Et Rhizoma Rhei of 42.5~298 parts of Radix Dipsacis (system)
42.5~298 parts of 42.5~298 parts of Pollen Typhaes of 42.5~298 parts of Radix Aucklandiae of Lignum Sappan
42.5~298 parts of 42.5~298 parts of Pheretimas of 42.5~298 parts of Radix Paeoniae Rubra of Myrrha (processed)
42.5~298 parts of Radix Angelicae Sinensis
Preferably:
170 parts on 127.5 parts of Flos Carthamis of 170 parts of Rhizoma Drynariae of Radix Notoginseng (stir-fry)
85 parts of Oletum Trogopterori 127.5 parts of Radix Et Rhizoma Rhei of 85 parts of Radix Dipsacis (system)
85 parts of 85 parts of Pollen Typhaes of 85 parts of Radix Aucklandiae of Lignum Sappan
85 parts of 85 parts of Pheretimas of 85 parts of Radix Paeoniae Rubra of Myrrha (processed)
85 parts of Radix Angelicae Sinensis
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, the Radix Aucklandiae, Myrrha three 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 the residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, 2~4 times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
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 Angelicae Sinensis, the Radix Aucklandiae, Myrrha handles the same;
(2) get prescription residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft 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, the influence that mouse writhing is reacted
Get 40 of mices, the male and female dual-purpose, be divided into 4 groups at random, matched group (isometric(al) normal saline), positive control aspirin group (0.2g/kg), technology is 2. extractum group (0.25g/kg) of extractum group (0.21g/kg), technology 1., every day 1 gastric infusion, successive administration 3d injects 0.3% acetum 0.2ml/kg in last administration 30min pneumoretroperitoneum, observe and turn round the body number of times in every mice 30min, the results are shown in Table 1.Compare with matched group, medicine can obviously reduce the mouse writhing number of times due to the acetic acid.
The influence of table 1 Dichlorodiphenyl Acetate induced mice writhing response (x ± s)
Group Number of animals (only) Dosage (g/kg) Turn round the body number of times
Matched group technology is 2. extractum group aspirin of extractum group technology 1. 10 10 10 10 - 0.21 0.25 0.20 15.7±8.8 4.8±2.8 ** 5.3±3.1 ** 4.7±3.6 **
Compare with the blank group *P<0.05, *P<0.01, * *P<0.001 (down together)
2, the influence that the mice thermostimulation is reacted
Choose 40 of female mices, body weight 16~20g, reference literature is measured also and is screened each Mus pain threshold before the experiment, will screen qualified mice and be divided into 4 groups at random, 10 every group, repeat to measure two subnormal threshold of pain meansigma methodss as this Mus administration before pain threshold.The same successive administration 3d, 15min after the last administration, 30min, 60min surveys pain threshold respectively on constant temperature analgesia analyzer, and still reactionless as 60s, its pain threshold calculates with 60s, the results are shown in Table 2.Compare with negative control group, medicine can obviously improve the pain threshold of mice.
The influence of table 2 pair thermostimulation induced mice pain threshold (x ± s)
Group Dosage (g/kg) Pain threshold (S) before the administration Different time pain threshold (S) after the administration
15min 30min 60min
Matched group technology is 2. extractum group aspirin of extractum group technology 1. - 0.21 0.25 0.20 20.37±4.80 20.24±3.57 20.12±2.17 19.98±4.41 16.48±2.74 26.58±5 .65 ** 26.31±8.53 ** 25.57±7.64 ** 16.74±2.78 28.57±8.9 * 28.11±14.37 * 25.47±8.09 ** 16.37±7.49 28.61±13.84 * 28.10±10.27 * 28.10±14.37
3, to the influence of rabbit experiment union of fracture effect
Get the big white family of ear of the healthy Japan of body weight 1.5~2.5kg and exempt from 40, the male and female dual-purpose, intravenous injection pentobarbital sodium 30mg/kg, after the anesthesia, the cropping of animal foreleg, with iodine tincture and alcohol disinfecting, perform the operation under aseptic condition, cause bilateral radius stage casing 4mm complete collyriculum, art finishes sew up wound, will not apply the lid wrapping, 3d gives penicillin 50,000 a units/intramuscular injection infection before the postoperative.After the modeling, animal is divided into 4 groups at random,, under identical conditions, feeds, and observe following index in the administration different time with experiment 1 administration.1. the X sheet is observed: 10d after the administration, and 20d, 30d takes the photograph the X-ray sheet in 50KV, GE500MA.0.03S, 70cm condition, adopts Shanghai orthopaedics institute X sheet evaluation criterion to each sample evaluation, the results are shown in Table 3.Behind the extractum group administration 10d, have significantly that the X line changes, the fracture end trend is fuzzy, and slight periosteal reaction is arranged, and indivedual specimen have callus formation in a small amount, and that the specimen of matched group shows as fracture end is fuzzy, slight periosteal reaction, and no callus is as seen.The 20th, extractum group periosteal reaction and callus formation were more obvious, and the 30th day, 50% specimen demonstration fracture edge complete obiteration is arranged in each extractum group, callus density and cortical bone are approaching, reach knitting basically, and matched group all do not reach this degree; 2. histological observation: administration 30d puts to death house and exempts from, get the long segment mark of the damaged 2cm of place this, through 10% formalin fixed, the formic acid decalcification, dehydration of alcohol, dimethylbenzene is transparent, paraffin embedding, make the section of 6~7 μ m,, mainly observe the variation of callus with HE dyeing, press literature method, the healing degree of osseous tissue is divided into level Four, each specimen is estimated, the results are shown in Table 4.Damaged place is the area of new bone girder, and is woven into net, and part new life's bone trabecula rearranges according to the major axis of bone, and close proximity, makes original gap become tiny crack, forms cortical bone wrinkle shape, and bone cavity road again appears in central part.And the union of fracture degree of matched group is considerably slower than the medicine group.
Table 3 couple union of fracture x-ray observation result
Group Dosage (g/kg) 10d 20d 30d
+ ++ +++ ++++ + ++ +++ ++++ + ++ +++ ++++
Matched group technology is 1. extractum winding bone notoginseng-containing tablet of extractum group technology 1. - 0.05 0.06 4.0 8 6 5 5 2 2 3 3 0 2 2 2 0 0 0 0 2 0 0 0 5 4 4 5 3 4 5 5 0 2 1 0 0 0 0 0 2 0 0 0 7 5 5 5 1 5 5 5
The table 4 pair histological influence of rabbit fracture model callus (n=10)
Group Dosage (g/kg) Number of animals (only) Callus is in the number of animals of levels at different levels
I II III IV
Matched group technology is 1. extractum winding bone notoginseng-containing tablet of extractum group technology 1. - 0.05 0.06 4.0 10 10 10 10 0 0 0 0 2 0 0 0 6 5 5 5 3 5 5 5
4, to the influence of hemorheology of rat
Get 40 of SD rats, the male and female dual-purpose is divided into 4 groups at random, behind the successive administration 15d, and the anesthesia of 25% urethane, carotid artery blood-letting 5ml measures the blood flow variate in the heparin test tube, the results are shown in Table 5.Compare with matched group, can reduce plasma viscosity, can improve hemorheological property.
The influence (n=10) of table 5 pair hemorheology of rat
Group Dosage (g/kg) Whole blood viscosity (maps) Plasma viscosity (mpas)
15.3(l/s) 11.5(l/s) 230(l/s)
Matched group technology is the extractum group 1. - 0.10 12.15±4.19 10.27±2.18 6.39±1.11 5.62±0.67 2.88±0.48 2.12±0.31 ***
Technology is extractum winding bone notoginseng-containing tablet 1. 0.13 4.0 10.32±1.71 10.15±1.67 5.54±0.66 6.01±0.58 2.20±0.21 *** 2.38±0.24 **
5, 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 traumatic injury, the medicine of fracture initial stage swelling severe patient, and change preparation technology, can obviously strengthen clinical efficacies such as its collateral dredging dissipating blood stasis, 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 Notoginseng 95g Rhizoma Drynariae (stir-fry) 71g Flos Carthami 95g
Oletum Trogopterori 48g Radix Dipsaci 71g Radix Et Rhizoma Rhei (system) 48g
Lignum Sappan 48g Radix Aucklandiae 48g Pollen Typhae 48g
Myrrha (processed) 48g Radix Paeoniae Rubra 48g Pheretima 48g
Radix Angelicae Sinensis 48g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, the Radix Aucklandiae, Myrrha three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 30min gets clathrate;
(2) get the residue medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) 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 Notoginseng 476g Rhizoma Drynariae (stir-fry) 357g flower 476g
Oletum Trogopterori 238g Radix Dipsaci 357g Radix Et Rhizoma Rhei (system) 238g
Lignum Sappan 238g Radix Aucklandiae 238g Pollen Typhae 238g
Myrrha (processed) 238g Radix Paeoniae Rubra 238g Pheretima 238g
Radix Angelicae Sinensis 238g
PEG400 500g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, the Radix Aucklandiae, Myrrha three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 30min gets clathrate;
(2) get the residue medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) 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 Notoginseng 595g Rhizoma Drynariae (stir-fry) 446g Flos Carthami 595g
Oletum Trogopterori 298g Radix Dipsaci 446g Radix Et Rhizoma Rhei (system) 298g
Lignum Sappan 298g Radix Aucklandiae 298g Pollen Typhae 298g
Myrrha (processed) 298g Radix Paeoniae Rubra 298g Pheretima 298g
Radix Angelicae Sinensis 298g
Make 1000g
Preparation method:
(1) getting Radix Angelicae Sinensis, the Radix Aucklandiae, Myrrha handles the same;
(2) get prescription residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component is merged, add aspartame 5.0g, dextrin 250.0g, 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 Notoginseng 241g Rhizoma Drynariae (stir-fry) 181g Flos Carthami 241g
Oletum Trogopterori 121g Radix Dipsaci 181g Radix Et Rhizoma Rhei (system) 121g
Lignum Sappan 121g Radix Aucklandiae 121g Pollen Typhae 121g
Myrrha (processed) 121g Radix Paeoniae Rubra 121g Pheretima 121g
Radix Angelicae Sinensis 121g
Make 1000
Preparation method:
(1) getting Radix Angelicae Sinensis, the Radix Aucklandiae, Myrrha handles the same;
(2) get prescription residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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:
85~595 parts on 64~446 parts of Flos Carthamis of 85~595 parts of Rhizoma Drynariae of Radix Notoginseng (stir-fry)
42.5~298 parts of Oletum Trogopterori 64~446 parts of Radix Et Rhizoma Rhei of 42.5~298 parts of Radix Dipsacis (system)
42.5~298 parts of 42.5~298 parts of Pollen Typhaes of 42.5~298 parts of Radix Aucklandiae of Lignum Sappan
42.5~298 parts of 42.5~298 parts of Pheretimas of 42.5~298 parts of Radix Paeoniae Rubra of Myrrha (processed)
42.5~298 parts of Radix Angelicae Sinensis.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
170 parts on 127.5 parts of Flos Carthamis of 170 parts of Rhizoma Drynariae of Radix Notoginseng (stir-fry)
85 parts of Oletum Trogopterori 127.5 parts of Radix Et Rhizoma Rhei of 85 parts of Radix Dipsacis (system)
85 parts of 85 parts of Pollen Typhaes of 85 parts of Radix Aucklandiae of Lignum Sappan
85 parts of 85 parts of Pheretimas of 85 parts of Radix Paeoniae Rubra of Myrrha (processed)
85 parts of Radix Angelicae Sinensis.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, mixture, hard capsule etc.
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, the Radix Aucklandiae, Myrrha three 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 the residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, 2~4 times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
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 Angelicae Sinensis, the Radix Aucklandiae, Myrrha handles the same;
(2) get prescription residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft 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, the Radix Aucklandiae, Myrrha three 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 the residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, 2~4 times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
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 Angelicae Sinensis, the Radix Aucklandiae, Myrrha handles the same;
(2) get prescription residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft 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.
CNA2005101159904A 2005-11-18 2005-11-18 Pseudo-ginseng blood-circulation-invigovating preparation and new preparing method Pending CN1775235A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102552640A (en) * 2012-02-17 2012-07-11 王功国 Medicine for promoting fracture healing and preparation method thereof
CN103211953A (en) * 2012-02-17 2013-07-24 王功国 Preparation method of medicine for promoting fracture healing
CN104257928A (en) * 2014-10-20 2015-01-07 王艳萍 Traditional Chinese medicine preparation for treating soft tissue injury pain syndromes
CN105168315A (en) * 2015-10-19 2015-12-23 郑州中医骨伤病医院 Zijin blood-dissipating pill for treating soft tissue contusion and early fracture

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102552640A (en) * 2012-02-17 2012-07-11 王功国 Medicine for promoting fracture healing and preparation method thereof
CN102552640B (en) * 2012-02-17 2013-07-10 王功国 Medicine for promoting fracture healing
CN103211953A (en) * 2012-02-17 2013-07-24 王功国 Preparation method of medicine for promoting fracture healing
CN104257928A (en) * 2014-10-20 2015-01-07 王艳萍 Traditional Chinese medicine preparation for treating soft tissue injury pain syndromes
CN105168315A (en) * 2015-10-19 2015-12-23 郑州中医骨伤病医院 Zijin blood-dissipating pill for treating soft tissue contusion and early fracture

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