CN1823992A - Ginseny spleen invigorating preparation and its new preparation method - Google Patents
Ginseny spleen invigorating preparation and its new preparation method Download PDFInfo
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Abstract
A composite Chinese medicine in the form of dripping pill and soft capsule for treating palpitation, insomnia, hypomnesia, anorexia, hematochezia, uterine bleeding, morbid leukorrhea, etc, and its preparing process are disclosed.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, cardiopalmus, palpitation with a distress feeling due to the particularly a kind of deficiency of both the heart and spleen that is used for, insufficiency of vital energy and blood, insomnia forgetfulness, the lack of appetite body is tired, having blood in stool due to shallow complexion and the failure of the spleen to keep the blood flowing within the vessels, metrorrhagia, the prescription of diseases such as leukorrhagia and preparation technology thereof.
Background technology:
Deficiency of both the heart and spleen, cardiopalmus due to the insufficiency of vital energy and blood, palpitation with a distress feeling, insomnia forgetfulness, the lack of appetite body is tired, having blood in stool due to shallow complexion and the failure of the spleen to keep the blood flowing within the vessels, metrorrhagia, and diseases such as leukorrhagia are clinical common symptons, the traditional Chinese medical science is often taked vigorate qi and replenish the blood, the means of invigorating spleen and nourishing heart are treated it, and evident in efficacy, and Renshen Guipi Wan is that it represents medicine.But in the practice, because this medicine is the part 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 deficiency of both the heart and spleen, cardiopalmus due to the insufficiency of vital energy and blood, palpitation with a distress feeling, insomnia forgetfulness, the lack of appetite body is tired, having blood in stool due to shallow complexion and the failure of the spleen to keep the blood flowing within the vessels, metrorrhagia, diseases such as leukorrhagia.
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:
80～278 parts in 80～278 parts of Poria of 40～139 parts of Rhizoma Atractylodis Macrocephalaes of Radix Ginseng (parched with bran)
80～278 parts of 40～139 parts of Radix Angelicae Sinensis of 20～70 parts of Radixs Astragali of Radix Glycyrrhizae (processed with honey) (processed with honey)
80～278 parts of 80～278 portions of Arillus Longans of 20～70 parts of Radix Polygalaes of the Radix Aucklandiae (going do willingly grass to process)
40～139 parts of Semen Ziziphi Spinosaes (stir-fry)
Preferably:
160 parts in 160 parts of Poria of 80 parts of Rhizoma Atractylodis Macrocephalaes of Radix Ginseng (parched with bran)
160 parts of 80 parts of Radix Angelicae Sinensis of 40 parts of Radixs Astragali of Radix Glycyrrhizae (processed with honey) (processed with honey)
160 parts of 160 portions of Arillus Longans of 40 parts of Radix Polygalaes of the Radix Aucklandiae (going do willingly grass to process)
80 parts of Semen Ziziphi Spinosaes (stir-fry)
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 the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae 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 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 2～6 times, each 0.5～3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5～10, and preferred ratio is 1: 2～4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4～1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8～1.2; The content of active component is 50mg～500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of hard capsule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, and drying, mixing is filled and is promptly got hard capsule.
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 effect of blood deficiency mice
Get the mice of body weight 18～22g, the about 0.5ml of every rathole socket of the eye blood sampling surveys Hb and RBC number simultaneously, gets blood behind the 24h that loses blood again and surveys Hb and RBC number.The model of blood dificiency mice is divided into blood deficiency matched group, GUIPI WAN group (11.6g/kg), Ginseny spleen invigorating 1. extractum group (0.24g/kg), 2. extractum group (0.7g/kg) at random.Gastric infusion, 8d surveys Fib and RBC number in blood sampling in the 9th day continuously.
The influence of table 1 couple blood deficiency mice Hb, RBC (x ± s, n=14)
| Group | Hb(g/L) | RBC(10 12/L) | ||||
| Before losing blood | After losing blood | After the administration | Before losing blood | After losing blood | After the administration | |
| Blood deficiency matched group GUIPI WAN group technology is 2. extractum group of extractum group technology 1. | 81.2±4.0 80.6±2.6 81.9±7.3 78.1±4.2 | 71.9±10.0 ## 68.0±6.6 ## 68.6±9.6 ## 66.9±11.1 ## | 76.1±4.9 84.0±5.3 ** 81.5±5.7 ** 84.2±7.0 ** | 9.39±0.48 9.01±0.50 9.26±0.89 9.20±0.61 | 7.28±0.51 ## 6.85±0.48 ## 6.89±0.59 ## 6.43±0.89 ## | 6.71±0.49 8.07±0.50 ** 8.44±0.47 ** 8.86±0.86 ** |
Annotate: with the preceding comparison of losing blood,
##P＜0.01; Compare with the blood deficiency matched group,
*P＜0.01
The result: before mice Hb after losing blood and RBC all were starkly lower than and lose blood, 1. 2. extractum group and GUIPI WAN group all can increase Hb and RBC number (seeing Table 1) to Ginseny spleen invigorating.
2, to the influence of spontaneous activity in mice
Grouping, dosage and medication be with 1, before the administration mice placed lucite case endoadaptation 1min after, mice is walked about the number of times lifted on time and the forelimb as normal value in the record 2min.Every then Mus gastric infusion thing.The number of times of praising according to walk about in the 30min mice 2min after the administration of preceding method record time and forelimb.The results are shown in Table 2,3.
The influence of the spontaneous time of walking about of table 2 pair mice (x ± s)
| Group | Number of animals (only) | Dosage (g/kg) | Before the administration | After the administration |
| Blood deficiency matched group GUIPI WAN group technology is 2. extractum group of extractum group technology 1. | 10 10 10 10 | - 11.6 0.24 0.7 | 98.33±0.53 103.22±10.20 99.11±7.42 97.78±7.56 | 95.44±11.40 63.11±14.9 49.56±15.51 ** 54.33±21.60 ** |
Annotate: compare with the blood deficiency matched group
*P＜0.05;
*P＜0.01
3, to effect of immunologic function
Every Mus lumbar injection 5% normal saline chicken red blood cell suspension 0.2ml carries out immunity, each group is given the mouse stomach administration simultaneously behind the 3d, the blank group is given normal saline, cyclophosphamide group and administration group be the 1st, 3 day difference intramuscular injection cyclophosphamide 0.01g/kg after immunity, press literature method and measure serum hemolysin, the result shows, Ginseny spleen invigorating 1., 2. the hemolysin of extractum group and GUIPI WAN group is respectively 0.92 ± 0.2,0.8 ± 0.1,0.95 ± 0.2, with 0.44 ± 0.3 of cyclophosphamide group significant differences (P＜0.01) is arranged more all.
4, to the influence of mice endurance
Animal and grouping are with 1.Every group of every Mus irritated the stomach medicine 1 time by corresponding dosage every day, successive administration 10d, and behind the fasting 16h, every Mus Mus tail heavy burden 1g puts into bucket with mice and carries out swimming test.The result shows, Ginseny spleen invigorating 1. 2. the swimming time of extractum group and GUIPI WAN group be respectively 85.4 ± 26.3,77.5 ± 26.5,69.6 ± 27.1 (min), with 38.3 ± 12.7 (min) of blank group significant difference (P＜0.05) is arranged more all.
5, to the influence of mice stress
Grouping and administration are with 1, and 30min after administration in the 10th day with the single 250ml wide mouthed bottle that sodica calx is housed of putting into of mice, observes and the record anoxia in mice death time.As a result, Ginseny spleen invigorating is 2. extractum group and return the normal pressure hypoxia endurance time of Pi ball group to be respectively 16.0 ± 2.2min, 16.5 ± 2.2min, 15.8 ± 2.7min 1., with 12.3 ± 2.3rain of blank group significant difference (P＜0.05) is arranged more all.
6, 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 deficiency of both the heart and spleen, cardiopalmus due to the insufficiency of vital energy and blood, palpitation with a distress feeling, insomnia forgetfulness, the lack of appetite body is tired, having blood in stool due to shallow complexion and the failure of the spleen to keep the blood flowing within the vessels, metrorrhagia, the medicine of diseases such as leukorrhagia, and change preparation technology, can obviously strengthen its vigorate qi and replenish the blood, clinical efficacies such as invigorating spleen and nourishing heart, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
The Radix Ginseng 46g Rhizoma Atractylodis Macrocephalae (parched with bran) 93g Poria 93g
Radix Glycyrrhizae (processed with honey) the 23g Radix Astragali (processed with honey) 46g Radix Angelicae Sinensis 93g
Radix Aucklandiae 23g Radix Polygalae (going do willingly grass to process) 93g Arillus Longan 93g
Semen Ziziphi Spinosae (stir-fry) 46g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae 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 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: 5 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get the residue medical material, decoct with water 3 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into 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:
The Radix Ginseng 139g Rhizoma Atractylodis Macrocephalae (parched with bran) 278g Poria 278g
Radix Glycyrrhizae (processed with honey) the 70g Radix Astragali (processed with honey) 139g Radix Angelicae Sinensis 278g
Radix Aucklandiae 70g Radix Polygalae (going do willingly grass to process) 278g Arillus Longan 278g
Semen Ziziphi Spinosae (stir-fry) 139g
PEG400 300g
Make 1000
Preparation method:
(1) gets the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae 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 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: 5 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get the residue medical material, decoct with water 3 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into 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:
The Radix Ginseng 120g Rhizoma Atractylodis Macrocephalae (parched with bran) 240g Poria 240g
Radix Glycyrrhizae (processed with honey) the 60g Radix Astragali (processed with honey) 120g Radix Angelicae Sinensis 240g
Radix Aucklandiae 60g Radix Polygalae (going do willingly grass to process) 240g Arillus Longan 240g
Semen Ziziphi Spinosae (stir-fry) 120g
Make 1000g
Preparation method:
(1) getting the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae three flavor medical materials beats powder and is used as medicine;
(2) get the residue medical material, decoct with water 3 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into thick paste, and is standby;
(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 hard capsule of the present invention:
Prescription:
The Radix Ginseng 64g Rhizoma Atractylodis Macrocephalae (parched with bran) 128g Poria 128g
Radix Glycyrrhizae (processed with honey) the 32g Radix Astragali (processed with honey) 64g Radix Angelicae Sinensis 128g
Radix Aucklandiae 32g Radix Polygalae (going do willingly grass to process) 128g Arillus Longan 128g
Semen Ziziphi Spinosae (stir-fry) 64g
Make 1000
Preparation method:
(1) getting the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae three flavor medical materials beats powder and is used as medicine;
(2) get the residue medical material, decoct with water 3 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into 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, and mixing is filled, and promptly gets 1000 of capsules.
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:
80～278 parts in 80～278 parts of Poria of 40～139 parts of Rhizoma Atractylodis Macrocephalaes of Radix Ginseng (parched with bran)
80～278 parts of 40～139 parts of Radix Angelicae Sinensis of 20～70 parts of Radixs Astragali of Radix Glycyrrhizae (processed with honey) (processed with honey)
80～278 parts of 80～278 portions of Arillus Longans of 20～70 parts of Radix Polygalaes of the Radix Aucklandiae (going do willingly grass to process)
40～139 parts of Semen Ziziphi Spinosaes (stir-fry).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
160 parts in 160 parts of Poria of 80 parts of Rhizoma Atractylodis Macrocephalaes of Radix Ginseng (parched with bran)
160 parts of 80 parts of Radix Angelicae Sinensis of 40 parts of Radixs Astragali of Radix Glycyrrhizae (processed with honey) (processed with honey)
160 parts of 160 portions of Arillus Longans of 40 parts of Radix Polygalaes of the Radix Aucklandiae (going do willingly grass to process)
80 parts of Semen Ziziphi Spinosaes (stir-fry).
3, claim 1 or any one Chinese medicine preparation of 2 are various suitable dosage forms such as drop pill, soft capsule, granule, chewable tablet, mixture, hard 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 the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae 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 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 2～6 times, each 0.5～3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of hard capsule is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, mixing is filled and is promptly got hard capsule.
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 the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae 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 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 2～6 times, each 0.5～3 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) getting the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, the Radix Aucklandiae three flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
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| CN101502634B (en) * | 2009-03-06 | 2011-11-02 | 陈殿红 | Chinese medicinal composition for treating uterine blood flow and preparation method thereof |
| CN102764305A (en) * | 2012-08-15 | 2012-11-07 | 重庆市中药研究院 | Spleen-invigorating combined drug, preparation method and application thereof |
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| CN104073406A (en) * | 2014-06-19 | 2014-10-01 | 苗袁硕 | Lychee wine for promoting sleep |
| CN104056230A (en) * | 2014-06-26 | 2014-09-24 | 余明 | Traditional Chinese medicinal composition for treating heart-spleen deficiency type insomnia |
| CN104056230B (en) * | 2014-06-26 | 2017-06-23 | 余明 | A kind of Chinese medicine composition for treating type of deficiency of both the heart and spleen insomnia |
| CN104845797A (en) * | 2015-04-27 | 2015-08-19 | 于纯淼 | Health-care dark plum-mulberry wine and preparation method thereof |
| CN107669851A (en) * | 2017-11-20 | 2018-02-09 | 刘燕云 | A kind of medicine for treating woman uterine bleeding |
| CN112156140A (en) * | 2020-11-12 | 2021-01-01 | 珂蓝(重庆)化妆品有限公司 | Composition for tonifying qi, enriching blood, strengthening spleen and nourishing heart and application thereof |
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