CN1775261A - Mingmu-Dihuang preparation and new preparing method - Google Patents
Mingmu-Dihuang preparation and new preparing method Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine composition and its preparation process. In particular, it relates to a Chinese medicine prescription for curing the diseases of deficiency of liver-yin and kidney-yin, dry eyes and photophobia, poor vision, blurring of vision and epiphora induced by wind etc, and its preparation process. It can be made into dripping pills and soft capsule preparation.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of hepatic and renal YIN deficiency that is used for, the puckery photophobia of order, blurred vision, the prescription of epiphora induced by wind and preparation technology thereof.
Background technology:
The hepatic and renal YIN deficiency, the puckery photophobia of order, blurred vision, epiphora induced by wind are clinical common symptons, the traditional Chinese medical science is often taked nourishing kidney, nourishing the liver, the means that make eye bright are treated it, and evident in efficacy, and Radix Rehmanniae Pilulae for Improving Eyesight is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, mixture, its pill that makes can be used for curing mainly the hepatic and renal YIN deficiency, the puckery photophobia of order, blurred vision, epiphora induced by wind.
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:
30～150 parts of 40～200 parts of Cortex Moutans of 80～400 parts of Fructus Corni of Radix Rehmanniae Preparata (system)
30～150 parts of 30～150 portions of Rhizoma Alismatis of 40～200 parts of Poria of Rhizoma Dioscoreae
30～150 parts of 30～150 parts of Radix Angelicae Sinensis of 30～150 parts of Flos Chrysanthemis of Fructus Lycii
40～200 parts of the Radix Paeoniae Alba 30～150 parts of Concha Haliotidis of 30～150 portions of Fructus Tribulis (forging)
Preferably:
80 parts of 60 portions of Rhizoma Dioscoreaes of 80 parts of Cortex Moutans of 160 parts of Fructus Corni of Radix Rehmanniae Preparata (system)
60 parts of 60 parts of Flos Chrysanthemis of 60 parts of Fructus Lycii of 60 portions of Rhizoma Alismatis of Poria
80 parts of Radix Angelicae Sinensis 60 portions of Radix Paeoniae Albas, 60 parts of Concha Haliotidis of 60 portions of Fructus Tribulis (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, mixture.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Fructus Tribuli two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) 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, 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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Fructus Tribuli, Concha Haliotidis medical material beats powder and is used as medicine;
(2) get prescription 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 the various preparations except that drop pill and soft capsule of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5～10, and preferred ratio is 1: 2～4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4～1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8～1.2; The content of active component is 50mg～500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of mice swimming endurance
Get Kunming mouse, body weight 20 ± 2g, the male and female dual-purpose is divided into 3 groups at random.Technology is extractum group 0.29g/kg 1., and technology is extractum group 0.63g/kg 2., and blank group gives normal saline, and every day, gastric infusion was 2 times, 7d continuously, and gastric infusion is once again for 1h before experiment.The experiment beginning is got 2 mices from each group successively and is together put into 28 ℃ of water at mouse tail root load (10%), observes the mice swimming endurance, in the time of can not floating to the water surface to avale, is swimming time, result's t inspection statistics.Experimental result shows, administration group and matched group have relatively all increased swimming time, have strengthened endurance, and technology 1. the extractum group 2. the effect of extractum group is strong than technology, the results are shown in Table 1.
The influence of table 1 pair mice swimming endurance (x ± s)
| Group | Number of animals (only) | Dosage (g/kg) | Swimming time (min) |
| Matched group technology is 2. extractum group of extractum group technology 1. | 20 20 20 | - 0.29 0.63 | 52.3±6.85 79.30±12.26 *** 65.75±8.19 ** |
Compare with matched group:
*P＜0.01
* *P＜0.001.
2, to the influence of mice autonomic activities
Experiment grouping and medication are the same.After the preceding administration of experiment 1 time, measure the autonomic activities number of times of mice 5min with GL-1 photoelectricity numeration instrument, every group of mice all before administration 7d measure autonomic activities number of times before the medicine with same method, the result shows that the administration group all has the maincenter sedation that suppresses the mice autonomic activities.The results are shown in Table 2.
The influence of table 2 pair mice autonomic activities (x ± s, n=20)
| Group | Dosage (g/kg) | Movable number of times (inferior/5min) | Reduce number of times | |
| Before the medicine | Behind the medicine | |||
| Matched group technology is 2. extractum group of extractum group technology 1. | - 0.29 0.63 | 217.2±37.2 201.3±27.1 210.9±19.6 | 200.8±30.7 141.3±15.6 ** 168.6±17.3 ** | 16.5±10.0 60.0±34.3 29.7±17.7 |
Compare with matched group:
*P＜0.01.
3, to the influence of the experimental high intraocular pressure bulbar Conjunctiva Microcirculation of rabbit
24 of healthy new zealand white rabbits, body weight 2.0～3.0kg, male and female are regardless of, technology is extractum group 0.07g/kg 1., technology is extractum group 0.16g/kg 2., and blank group gives normal saline, and every day, gastric infusion was 2 times, according to literature method: rabbit is fixed in the experiment frame, 0.5% tetracaine eye dripping 2-3 time, eyelid left by eye speculum, annotates people 0.5ml 1:1000 Chymetin by the corneoscleral junction bright zone in the anterior chamber, survey intraocular pressure behind the 30min, intraocular pressure is maintained more than the 50mmHg.The administration group is gastric infusion after high intraocular pressure is kept 10d, continuous 3 weeks.High intraocular pressure continues the 10th, 20,30d carries out the conjunctiva microcirculation respectively and detects result's t inspection statistics.Experimental result shows, matched group blood capillary in continuing high intraocular pressure 10～30d is tapered, most blood capillaries engender branch's cutout, dry, pipe Zhou Mingxian oozes out, hemorrhage, tubular fuzzy gradually, blood flow rate slows down in the pipe, performances such as severe microcirculation disturbance such as last visible red cell, platelet aggregation, blood stasis, and treatment group microcirculatory vascular increases slightly, there is not obvious branch cutout phenomenon, pipe oozes out in week, hemorrhage alleviating, and tubular edges is clear, and blood flow rate is accelerated, erythrocyte, platelet aggregation and blood stasis disappear, and blood flow is unobstructed.
4, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD
50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment hepatic and renal YIN deficiency, the puckery photophobia of order, blurred vision, the medicine of epiphora induced by wind, and change preparation technology, can obviously strengthen its nourishing kidney, nourishing the liver, clinical efficacy such as make eye bright, 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 Rehmanniae Preparata 115g Fructus Corni (system) 58g Cortex Moutan 43g Rhizoma Dioscoreae 58g
Poria 43g Rhizoma Alismatis 43g Fructus Lycii 43g Flos Chrysanthemi 43g
Radix Angelicae Sinensis 43g Radix Paeoniae Alba 43g Fructus Tribuli 43g Concha Haliotidis (forging) 58g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Fructus Tribuli two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) 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, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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 Rehmanniae Preparata 400g Fructus Corni (system) 200g Cortex Moutan 150g Rhizoma Dioscoreae 200g
Poria 150g Rhizoma Alismatis 150g Fructus Lycii 150g Flos Chrysanthemi 150g
Radix Angelicae Sinensis 150g Radix Paeoniae Alba 150g Fructus Tribuli 150g Concha Haliotidis (forging) 200g
PEG400 350g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Fructus Tribuli two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) 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, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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 Rehmanniae Preparata 400g Fructus Corni (system) 200g Cortex Moutan 150g Rhizoma Dioscoreae 200g
Poria 150g Rhizoma Alismatis 150g Fructus Lycii 150g Flos Chrysanthemi 150g
Radix Angelicae Sinensis 150g Radix Paeoniae Alba 150g Fructus Tribuli 150g Concha Haliotidis (forging) 200g
Make 1000g
Preparation method:
(1) getting Radix Angelicae Sinensis, Fructus Tribuli, Concha Haliotidis medical material beats powder and is used as medicine;
(2) get prescription residue medical material, 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) above active component is merged, add aspartame 5.0g, dextrin 230.0g, 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 Rehmanniae Preparata 211g Fructus Corni (system) 105g Cortex Moutan 79g Rhizoma Dioscoreae 105g
Poria 79g Rhizoma Alismatis 79g Fructus Lycii 79g Flos Chrysanthemi 79g
Radix Angelicae Sinensis 79g Radix Paeoniae Alba 79g Fructus Tribuli 79g Concha Haliotidis (forging) 105g
Make 1000
Preparation method:
(1) getting Radix Angelicae Sinensis, Fructus Tribuli, Concha Haliotidis medical material beats powder and is used as medicine;
(2) get prescription residue medical material, 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) above active component is merged, add aspartame 3.0g, mannitol 100.0g, 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:
30～150 parts of 40～200 parts of Cortex Moutans of 80～400 parts of Fructus Corni of Radix Rehmanniae Preparata (system)
30～150 parts of 30～150 portions of Rhizoma Alismatis of 40～200 parts of Poria of Rhizoma Dioscoreae
30～150 parts of 30～150 parts of Radix Angelicae Sinensis of 30～150 parts of Flos Chrysanthemis of Fructus Lycii
40～200 parts of the Radix Paeoniae Alba 30～150 parts of Concha Haliotidis of 30～150 portions of Fructus Tribulis (forging).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
80 parts of 60 portions of Rhizoma Dioscoreaes of 80 parts of Cortex Moutans of 160 parts of Fructus Corni of Radix Rehmanniae Preparata (system)
60 parts of 60 parts of Flos Chrysanthemis of 60 parts of Fructus Lycii of 60 portions of Rhizoma Alismatis of Poria
80 parts of Radix Angelicae Sinensis 60 portions of Radix Paeoniae Albas, 60 parts of Concha Haliotidis of 60 portions of Fructus Tribulis (forging).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, mixture.
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, Fructus Tribuli two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating П) 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, 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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Fructus Tribuli, Concha Haliotidis medical material beats powder and is used as medicine;
(2) get prescription 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 the various preparations except that drop pill and soft capsule of the present invention.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1～9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Fructus Tribuli two flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0～4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating П) 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, 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.
Method b:(technology 2.)
(1) getting Radix Angelicae Sinensis, Fructus Tribuli, Concha Haliotidis medical material beats powder and is used as medicine;
(2) get prescription 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 the various preparations except that drop pill and soft capsule of the present invention.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
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| CNA2005101159942A CN1775261A (en) | 2005-11-18 | 2005-11-18 | Mingmu-Dihuang preparation and new preparing method |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899448B (en) * | 2006-07-06 | 2010-09-08 | 浙江大学 | Chinese medicine compound preparation for treating amblyopia and its preparing method |
| WO2012032209A2 (en) | 2010-09-08 | 2012-03-15 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| CN102793848A (en) * | 2012-09-07 | 2012-11-28 | 黄平县润发药业农民专业合作社 | Traditional Chinese medicine powder for treating night blindness |
| CN102824548A (en) * | 2012-09-19 | 2012-12-19 | 北京亚东生物制药有限公司 | Traditional Chinese medicine composition for treating asthenopia and preparation method thereof |
| CN103316224A (en) * | 2013-06-17 | 2013-09-25 | 邓占峰 | Traditional Chinese medicine preparation with functions of nourishing liver and kidney, replenishing essence and blood, invigorating brain and improving eyesight |
| CN103961466A (en) * | 2014-04-24 | 2014-08-06 | 青岛市市立医院 | Oral prescription for treating xerophthalmia |
| CN114796355A (en) * | 2022-05-05 | 2022-07-29 | 银川市中医医院 | Pharmaceutical composition for treating diabetic dry eye |
-
2005
- 2005-11-18 CN CNA2005101159942A patent/CN1775261A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899448B (en) * | 2006-07-06 | 2010-09-08 | 浙江大学 | Chinese medicine compound preparation for treating amblyopia and its preparing method |
| WO2012032209A2 (en) | 2010-09-08 | 2012-03-15 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| EP4268814A2 (en) | 2010-09-08 | 2023-11-01 | Universidad Miguel Hernández De Elche | Pharmaceutical composition for the treatment of dry eye |
| CN102793848A (en) * | 2012-09-07 | 2012-11-28 | 黄平县润发药业农民专业合作社 | Traditional Chinese medicine powder for treating night blindness |
| CN102793848B (en) * | 2012-09-07 | 2013-12-11 | 黄平县润发药业农民专业合作社 | Traditional Chinese medicine powder for treating night blindness |
| CN102824548A (en) * | 2012-09-19 | 2012-12-19 | 北京亚东生物制药有限公司 | Traditional Chinese medicine composition for treating asthenopia and preparation method thereof |
| CN102824548B (en) * | 2012-09-19 | 2014-04-16 | 北京亚东生物制药有限公司 | Traditional Chinese medicine composition for treating asthenopia and preparation method thereof |
| CN103316224A (en) * | 2013-06-17 | 2013-09-25 | 邓占峰 | Traditional Chinese medicine preparation with functions of nourishing liver and kidney, replenishing essence and blood, invigorating brain and improving eyesight |
| CN103961466A (en) * | 2014-04-24 | 2014-08-06 | 青岛市市立医院 | Oral prescription for treating xerophthalmia |
| CN114796355A (en) * | 2022-05-05 | 2022-07-29 | 银川市中医医院 | Pharmaceutical composition for treating diabetic dry eye |
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