CN1748775A - Nujin preparation and new preparing method - Google Patents
Nujin preparation and new preparing method Download PDFInfo
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- CN1748775A CN1748775A CNA2005101091884A CN200510109188A CN1748775A CN 1748775 A CN1748775 A CN 1748775A CN A2005101091884 A CNA2005101091884 A CN A2005101091884A CN 200510109188 A CN200510109188 A CN 200510109188A CN 1748775 A CN1748775 A CN 1748775A
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Abstract
The present invention relates to a Chinese medicine composition, and especially a kind of Chinese medicine composition for treating menoxenia, dysmenorrhea, lower abdominal pain and distension, lumbago and scelalgia caused by malnutrition, stagnation of the vital energy and blood stasis, and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of treatment nutrient QI and blood being insufficient, the menoxenia of caused by energy stagnation and blood stasis, dysmenorrhea, lower abdominal distention pain, the prescription of waist and leg ache and preparation technology thereof.
Background technology:
Menoxenia, dysmenorrhea are gynecological's common symptons, and the traditional Chinese medical science thinks that dysmenorrhea is many because of QI-blood circulation due to the smooth or deficiency of qi and blood.Clinical common have qi depression to blood stasis, cold coagulation uterus, deficient qi and blood, diseases such as damp invasion of lower energizer.The traditional Chinese medical science is often taked regulating menstruation and nourishing blood, and the means of regulating QI to relieve pain are treated it, and evident in efficacy, and NVJIN WAN is that it represents medicine.But in the practice, because this medicine is directly medical material to be beaten powder to be used as medicine, impurity is many, and dosage is big, has had a strong impact on Clinical Application.
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, capsule, tablet, its pill that makes can be used for curing mainly nutrient QI and blood being insufficient, the menoxenia of caused by energy stagnation and blood stasis, dysmenorrhea, lower abdominal distention pain, waist and leg ache.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
35～210 parts of 35～210 parts of Rhizoma Chuanxiongs of 70～420 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
35～210 parts of Radix Rehmanniae Preparata 27～165 parts of Rhizoma Atractylodis Macrocephalaes of 35～210 parts of Radix Codonopsis (stir-fry)
35～210 parts of 35～210 portions of Cortex Cinnamomis of 35～210 portions of Radix Glycyrrhizaes of Poria
35～210 parts of 35～210 parts of Myrrha (processed) of 100～600 parts of Cortex Moutans of Herba Leonuri
35～210 parts of 35～210 parts of Radixs Angelicae Dahuricae of 35～210 parts of Rhizoma Ligusticis of Rhizoma Corydalis (vinegar system)
75～450 parts of 35～210 portions of 35～210 portions of Rhizoma Cyperis of Radix Cynanchi Atrati of Radix Scutellariae (vinegar system)
35～210 parts of Fructus Amomi 70～420 parts of Halloysitum Rubrums of 25～150 parts of Pericarpium Citri Reticulataes (forging)
35～210 parts in 75～450 parts of Colla Corii Asini of Cornu Cervi Degelatinatum
Preferably:
70 parts of 70 parts of Radix Rehmanniae Preparata of 70 parts of Rhizoma Chuanxiongs of 140 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
70 parts in 70 portions of Radix Glycyrrhizaes of 70 parts of Poria of 55 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis (stir-fry)
70 parts of 70 parts of Myrrha (processed) of 200 parts of Cortex Moutans of 70 parts of Herba Leonuris of Cortex Cinnamomi
70 parts of 70 parts of Radix Scutellariaes of 70 parts of Radixs Angelicae Dahuricae of 70 parts of Rhizoma Ligusticis of Rhizoma Corydalis (vinegar system)
140 parts of 50 parts of Pericarpium Citri Reticulataes of 150 parts of Fructus Amomis of 70 portions of Rhizoma Cyperis of Radix Cynanchi Atrati (vinegar system)
70 parts in 150 parts of Colla Corii Asini of 70 parts of Cornu Cervi Degelatinatums of Halloysitum Rubrum (forging)
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, tablet, capsule or pill.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Myrrha seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h 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 prescription residue medical material (Halloysitum Rubrum is smashed and is decocted first), soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump 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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6～15 times water extraction is 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure 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.
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.Wherein the weight proportion between active component and the pharmaceutically useful organic solvent is: 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 oxytocin induced mice dysmenorrhea is reacted
Female mice, 25～30g40 only, be divided into the normal saline matched group at random, technology is extractum 0.16g/kg group 1., and technology is extractum 0.19g/kg group and YIMUCAO CHONGJI 3g/kg group 2., administering mode is irritated stomach, successive administration 4 times, respectively at administration the 2nd, 3d, every group of mice all gives diethylstilbestrol 0.5mg/kg, subcutaneous injection, fasting 10h.Last administration 90min, ip oxytocin 1u/kg observes owing to the uterus excess shrinkage, and the incubation period that the reaction of mice " dysmenorrhea " sample occurs, a statistical is organized in the t check, the results are shown in Table 1.
The influence of table 1 pair oxytocin induced mice dysmenorrhea reaction (x ± s)
| Group | Dosage (g/kg) | Number of animals (only) | Incubation period (t/mim) | P |
| Matched group technology extractum group technology extractum group YIMUCAO CHONGJI | - 0.16 0.19 3.0 | 10 10 10 10 | 4.05±1.32 6.60±1.27 6.89±2.01 6.54±1.31 | ＜0.01 ＜0.01 ＜0.01 |
Know that by table 1 reaction has tangible mitigation to each extractum group to oxytocin induced mice dysmenorrhea, prolongs its response latency.
2, to the influence of rat at the body uterine smooth muscle
40 of 200～220g female rats. be divided into the normal saline matched group at random, technology is extractum 0.08g/kg group 1., and technology is extractum 0.09g/kg group and YIMUCAO CHONGJI 2g/kg group 2., and administering mode is for irritating stomach, administration 3 times.24h before the experiment, rat all gives diethylstilbestrol 4mg/kg, SC fasting 8h, last administration 90min, rat is anaesthetized by the 40mg/kg barbital sodium, do 5cm sagittal otch along ventrimeson, separating uterus gently is by T type support, fixedly right side cornua uteri and ovary end, the seam separated time is connected with XY type tonotransducer, and the fast automatic balance recorder of the fast type of XW is stablized 10min.The contraction movement of record rat uterus smooth muscle, record 5min, chart speed 5cm/min, then by vena femoralis injection oxytocin 0.02u/kg, and write down 5min, and respectively organizing the uterine smooth muscle shrinkage degree of rat injection oxytocin front and back and inject finger height on the baseline of back, t compares between checking and organizing.The results are shown in Table 2.
Table 2 pair rat is at the influence of body uterine smooth muscle (x ± s)
| Group | Number of animals | Uterine contraction degree V/ml | Lift l/mm on the baseline | |
| Before the injection | After the injection | |||
| Matched group technology extractum group technology is the extractum YIMUCAO CHONGJI 2. | 10 10 10 10 | 6.45±1.30 5.28±0.91 * 5.05±1.12 * 5.15±1.27 * | 7.56±1.15 5.38±1.32 ** 5.21±1.01 ** 5.33±1.24 ** | 10.25±4.12 5.84±1.77 ** 5.29±1.43 ** 5.43±1.27 ** |
Compare with matched group
*P＜0.05,
*P＜0.01
3, to the influence of mice whole blood viscosity
30 of 25～31g female mices, grouping and administration see Table 3, successive administration 7d, last administration 2h, heart extracting blood.Heparin is anti-condensation, and the NXE-l cone and plate viscometer is surveyed 75S
-1, 37S
-1Cut the whole blood viscosity under the speed.The results are shown in Table 3.The obvious blood viscosity lowering of extractum group is described.
The influence of table 3 pair mice whole blood viscosity (x ± s)
| Group | Dosage (g/kg) | Number of animals (only) | 75S -1 | 37S -1 | ||
| Whole blood viscosity | P | Whole blood viscosity | The family | |||
| Matched group technology extractum group technology is extractum aspirin group 2. | - 0.16 019 15mg/kg | 10 10 10 10 | 22.6±1.23 20.57±1.01 20.43±1.51 20.12±1.31 | ＜0.01 ＜0.01 ＜0.01 | 5.24±0.27 4.53±0.53 4.50±0.42 4.21±0.26 | ＜0.01 ＜0.01 ＜0.01 |
4, female reason research
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 nutrient QI and blood being insufficient, the menoxenia of caused by energy stagnation and blood stasis, dysmenorrhea, lower abdominal distention pain, the medicine of waist and leg ache, and change preparation technology can obviously strengthen its regulating menstruation and nourishing blood, clinical efficacies such as regulating QI to relieve pain, 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 Angelicae Sinensis 65.8g Radix Paeoniae Alba 33g Rhizoma Chuanxiong 33g Radix Rehmanniae Preparata 33g
The Radix Codonopsis 26g Rhizoma Atractylodis Macrocephalae (stir-fry) 33g Poria 33g Radix Glycyrrhizae 33g
Cortex Cinnamomi 33g Herba Leonuri 94g Cortex Moutan 33g Myrrha (processed) 33g
Rhizoma Corydalis (vinegar system) 33g Rhizoma Ligustici 33g Radix Angelicae Dahuricae 33g Radix Scutellariae 33g
Radix Cynanchi Atrati 33g Rhizoma Cyperi (vinegar system) 70.5g Fructus Amomi 24g Pericarpium Citri Reticulatae 65.8g
Halloysitum Rubrum (forging) 33g Cornu Cervi Degelatinatum 70.5g Colla Corii Asini 33g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Myrrha seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h 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: 5 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get prescription residue medical material (Halloysitum Rubrum is smashed and is decocted first), soaked 40 minutes earlier with 65% 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 Angelicae Sinensis 265g Radix Paeoniae Alba 132g Rhizoma Chuanxiong 132g Radix Rehmanniae Preparata 132g
The Radix Codonopsis 104g Rhizoma Atractylodis Macrocephalae (stir-fry) 132g Poria 132g Radix Glycyrrhizae 132g
Cortex Cinnamomi 132g Herba Leonuri 378g Cortex Moutan 132g Myrrha (processed) 132g
Rhizoma Corydalis (vinegar system) 132g Rhizoma Ligustici 132g Radix Angelicae Dahuricae 132g Radix Scutellariae 132g
Radix Cynanchi Atrati 132g Rhizoma Cyperi (vinegar system) 284g Fructus Amomi 95g Pericarpium Citri Reticulatae 265g
Halloysitum Rubrum (forging) 132g Cornu Cervi Degelatinatum 284g Colla Corii Asini 132g
PEG400 400g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Myrrha seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h 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: 5 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get prescription residue medical material (Halloysitum Rubrum is smashed and is decocted first), soaked 40 minutes earlier with 65% 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 Angelicae Sinensis 420g Radix Paeoniae Alba 210g Rhizoma Chuanxiong 210g Radix Rehmanniae Preparata 210g
The Radix Codonopsis 165g Rhizoma Atractylodis Macrocephalae (stir-fry) 210g Poria 210g Radix Glycyrrhizae 210g
Cortex Cinnamomi 210g Herba Leonuri 600g Cortex Moutan 210g Myrrha (processed) 210g
Rhizoma Corydalis (vinegar system) 210g Rhizoma Ligustici 210g Radix Angelicae Dahuricae 210g Radix Scutellariae 210g
Radix Cynanchi Atrati 210g Rhizoma Cyperi (vinegar system) 450g Fructus Amomi 150g Pericarpium Citri Reticulatae 420g
Halloysitum Rubrum (forging) 210g Cornu Cervi Degelatinatum 450g Colla Corii Asini 210g
Make 1000g
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 10 times water extraction is 3 times, and each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) the gained active component is merged, add aspartame 5.0g, dextrin 270.0g, 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 Angelicae Sinensis 140g Radix Paeoniae Alba 70g Rhizoma Chuanxiong 70g Radix Rehmanniae Preparata 70g
The Radix Codonopsis 55g Rhizoma Atractylodis Macrocephalae (stir-fry) 70g Poria 70g Radix Glycyrrhizae 70g
Cortex Cinnamomi 70g Herba Leonuri 200g Cortex Moutan 70g Myrrha (processed) 70g
Rhizoma Corydalis (vinegar system) 70g Rhizoma Ligustici 70g Radix Angelicae Dahuricae 70g Radix Scutellariae 70g
Radix Cynanchi Atrati 70g Rhizoma Cyperi (vinegar system) 150g Fructus Amomi 50g Pericarpium Citri Reticulatae 140g
Halloysitum Rubrum (forging) 70g Cornu Cervi Degelatinatum 150g Colla Corii Asini 70g
Make 1000
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 10 times water extraction is 3 times, and each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) the gained active component is merged, add aspartame 3.0g, mannitol 250.0g, 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:
35～210 parts of 35～210 parts of Rhizoma Chuanxiongs of 70～420 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
35～210 parts of Radix Rehmanniae Preparata 27～165 parts of Rhizoma Atractylodis Macrocephalaes of 35～210 parts of Radix Codonopsis (stir-fry)
35～210 parts of 35～210 portions of Cortex Cinnamomis of 35～210 portions of Radix Glycyrrhizaes of Poria
35～210 parts of 35～210 parts of Myrrha (processed) of 100～600 parts of Cortex Moutans of Herba Leonuri
35～210 parts of 35～210 parts of Radixs Angelicae Dahuricae of 35～210 parts of Rhizoma Ligusticis of Rhizoma Corydalis (vinegar system)
75～450 parts of 35～210 portions of 35～210 portions of Rhizoma Cyperis of Radix Cynanchi Atrati of Radix Scutellariae (vinegar system)
35～210 parts of Fructus Amomi 70～420 parts of Halloysitum Rubrums of 25～150 parts of Pericarpium Citri Reticulataes (forging)
35～210 parts in 75～450 parts of Colla Corii Asini of Cornu Cervi Degelatinatum
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
70 parts of 70 parts of Radix Rehmanniae Preparata of 70 parts of Rhizoma Chuanxiongs of 140 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
70 parts in 70 portions of Radix Glycyrrhizaes of 70 parts of Poria of 55 parts of Rhizoma Atractylodis Macrocephalaes of Radix Codonopsis (stir-fry)
70 parts of 70 parts of Myrrha (processed) of 200 parts of Cortex Moutans of 70 parts of Herba Leonuris of Cortex Cinnamomi
70 parts of 70 parts of Radix Scutellariaes of 70 parts of Radixs Angelicae Dahuricae of 70 parts of Rhizoma Ligusticis of Rhizoma Corydalis (vinegar system)
140 parts of 50 parts of Pericarpium Citri Reticulataes of 150 parts of Fructus Amomis of 70 portions of Rhizoma Cyperis of Radix Cynanchi Atrati (vinegar system)
70 parts in 150 parts of Colla Corii Asini of 70 parts of Cornu Cervi Degelatinatums of Halloysitum Rubrum (forging)
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Myrrha seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h 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 prescription residue medical material (Halloysitum Rubrum is smashed and is decocted first), soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump 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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6～15 times water extraction is 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure 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.
6, the Chinese medicine preparation of claim 5, it 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, and 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, Rhizoma Cyperi, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Myrrha seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h 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 prescription residue medical material (Halloysitum Rubrum is smashed and is decocted first), soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump 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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6～15 times water extraction is 2～4 times, and each 0.5～2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure 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.
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: 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005101091884A CN1748775A (en) | 2005-10-20 | 2005-10-20 | Nujin preparation and new preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005101091884A CN1748775A (en) | 2005-10-20 | 2005-10-20 | Nujin preparation and new preparing method |
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| CN1748775A true CN1748775A (en) | 2006-03-22 |
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| CNA2005101091884A Pending CN1748775A (en) | 2005-10-20 | 2005-10-20 | Nujin preparation and new preparing method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309654A (en) * | 2016-08-26 | 2017-01-11 | 徐洪安 | Medicine for treating irregular menstruation and preparation method thereof |
| CN108845040A (en) * | 2018-03-26 | 2018-11-20 | 山东省食品药品检验研究院 | A kind of Nujin Wan whether the discrimination method containing radix cynanchi atrati adulterant Cynanchum Komarrivii AI Iijiniski |
-
2005
- 2005-10-20 CN CNA2005101091884A patent/CN1748775A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309654A (en) * | 2016-08-26 | 2017-01-11 | 徐洪安 | Medicine for treating irregular menstruation and preparation method thereof |
| CN108845040A (en) * | 2018-03-26 | 2018-11-20 | 山东省食品药品检验研究院 | A kind of Nujin Wan whether the discrimination method containing radix cynanchi atrati adulterant Cynanchum Komarrivii AI Iijiniski |
| CN108845040B (en) * | 2018-03-26 | 2021-01-22 | 山东省食品药品检验研究院 | Method for identifying whether Laijin pills contain pseudo-cynanchum atratum and old melon heads |
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