CN1775258A - Womb-warming pregnancy-aiding preparation and new preparing method - Google Patents
Womb-warming pregnancy-aiding 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 blood, stagnation of qi, soreness of waist, lumbago, irregular menstruation, leukorrhea with reddish discharge, uterine cold and infertility 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 blood deficiency stagnation of QI that is used for, soreness of waist pain, irregular menstruation, leucorrhea with red and white discharge, cold uterus, the prescription and the preparation technology thereof of disease such as fail to be impregnated for a long time.
Background technology:
The blood deficiency stagnation of QI, soreness of waist pain, irregular menstruation, leucorrhea with red and white discharge, cold uterus, disease such as fail to be impregnated for a long time is clinical common sympton, the traditional Chinese medical science is often taked nourishing YIN and benefiting blood, dispelling cold by warming the meridian, the means of promoting the circulation of QI to relieve pain are treated it, and evident in efficacy, and the Womb-warming pregnancy-aiding ball 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 the blood deficiency stagnation of QI, soreness of waist pain, irregular menstruation, leucorrhea with red and white discharge, cold uterus, disease such as fail to be impregnated for a long time.
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:
45～263.5 parts of 60～351.5 parts of Radix Angelicae Sinensis of 120～703 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (processed with vinegar)
30～176 parts in 30～176 parts of Colla Corii Asini of 45～263.5 portions of Radix Paeoniae Albas of Rhizoma Chuanxiong (wine stir-fry)
45～263.5 parts of 60～351.5 parts of Radix Dipsacis of 45～263.5 parts of Cortexs Eucommiae of Folium Artemisiae Argyi (stir-fry) (stir-fry)
30～176 parts of Radix Scutellariaes
Preferably:
90 parts of 120 parts of Radix Angelicae Sinensis of 240 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (processed with vinegar)
60 parts in 60 parts of Colla Corii Asini of 90 portions of Radix Paeoniae Albas of Rhizoma Chuanxiong (wine stir-fry)
90 parts of 120 parts of Radix Dipsacis of 90 parts of Cortexs Eucommiae of Folium Artemisiae Argyi (stir-fry) (stir-fry)
60 parts of Radix Scutellariaes
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 Rhizoma Chuanxiong, Radix Angelicae Sinensis 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 residue medical material except that Colla Corii Asini, decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get Colla Corii Asini heating molten, add in the above-mentioned thick paste mixing.
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 Rhizoma Chuanxiong, Radix Angelicae Sinensis two 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, hard capsule 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 young female mouse vagina superficial cell
Get 40 of body weight 29.53 ± 2.65g female mices, be divided into four groups at random, i.e. the normal saline group, estradiol group (0.03ml/ is only), technology is extractum group (0.28g/kg) 1., and technology is extractum group (0.57g/kg) 2., administering mode is for irritating stomach, and successive administration seven days the results are shown in Table 1.
The influence of table 1 pair young female mice superficial cell (x ± s)
| Group | The epithelial influence of keratinization after the administration/ | ||||||
| The 1st day | The 2nd day | The 3rd day | The 4th day | The 5th day | The 6th day | The 7th day | |
| Normal saline group estradiol group technology is 2. extractum group of extractum group technology 1. | 1.70±1.25 55.30±0.71 33.50±22.29 41.40±19.86 | 1.20±0.79 65.40±11.63 56.90±31.55 50.30±19.20 | 2.10±1.66 94.96±8.06 76.30±26.12 51.40±20.06 | 1.40±1.26 92.10±6.76 71.20±24.93 62.40±16.30 | 120±0.92 97.10±2.79 52.90±28.1 35.60±12.0 | 1.40±1.07 90.00±13.19 5 50.10±26.94 38.30±13.26 | 2.50±1.23 81.60±20.89 50.60±27.78 45.00±19.10 |
The result shows, mirror is observed down behind the animal via vaginal smear, normal saline control animals superficial cell number is less, the more estradiol group of leukocyte, two extractum groups, the vaginal smear mirror shows that down a large amount of superficial cells generate, each group more all has significant difference (P＜0.01) with the normal saline matched group, and prompting extractum group has the effect that improves young female mice body inner estrogen level.
2, to the influence of mouse uterine weight
Grouping, dosage and medication are with 1, each treated animal all the last time after the administration 24h put to death with the cervical vertebra dislocation, back of the body position is fixing, open the abdominal cavity, take out whole uterus and be laid in the plate, carefully remove fatty tissue and ovary around the uterus by shape in the body, at scales/electronic balance weighing, be converted into the per kilogram of body weight uterus weight rapidly.The result shows, the estradiol group, technology is the extractum group 1., the technology 2. uterus weight of extractum group per kilogram of body weight is respectively: 6.6490 ± 1.0915g, 4.29320 ± 0.6323g, 4.1291 ± 0.963g, compare with matched group 2.6951 ± 0.3619g, utmost point significant difference (P＜0.01) is all arranged, show that each administration group all can increase uterus weight, points out this extractum can improve estrogenic level.
3, young female rat induced ovulation is reached the influence that corpus luteum is formed
The results are shown in Table 2.
Table 2 pair young female rat induced ovulation and influence that corpus luteum is formed (x ± s)
| Group | Number of animals (only) | Dosage (g/kg) | Number of eggs ovulated (individual) | Corpus luteum number (individual) |
| Normal saline group ovulation model group clomiphene group technology is 2. extractum group of extractum group technology 1. | 10 10 10 10 10 | - 15IUHCG 0.005 0.14 0.28 | 0 22.20±6.03 △△30.90±9.96 **33.20±10.00 **32.60±9.93 ** | 0 12.85±6.10 △△14.45±7.15 **10.60±4.61 **14.50±5.36 ** |
Annotate: model group and normal saline group compare,
△ △P＜0.01 administration group and matched group are relatively
*P＜0.05;
*P＜0.01 result shows that the normal saline group is not seen ovulation, all has ovulation to take place by each treated animal of gastric infusion, and the extractum group more all has significant difference (P＜0.01) with the ovulation model group, shows that the extractum group has obvious ovulation effect to the young female rat.Normal saline matched group ovary is not seen corpus luteum under mirror, and each treated animal of administration all has corpus luteum to form, but there was no significant difference between each administration group points out this extractum that corpus luteum is formed no obvious dependency.
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 blood deficiency stagnation of QIs, soreness of waist pain, irregular menstruation, leucorrhea with red and white discharge, cold uterus, the medicine of disease such as fail to be impregnated for a long time, and change preparation technology, can obviously strengthen its nourishing YIN and benefiting blood, dispelling cold by warming the meridian, clinical efficacies such as promoting the circulation of 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 Rehmanniae Preparata 156g Rhizoma Cyperi (processed with vinegar) 78g Radix Angelicae Sinensis 58.5g
The Rhizoma Chuanxiong 58.5g Radix Paeoniae Alba (wine stir-fry) 39g Colla Corii Asini 39g
Folium Artemisiae Argyi (stir-fry) the 58.5g Cortex Eucommiae (stir-fry) 78g Radix Dipsaci 58.5g
Radix Scutellariae 39g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Rhizoma Chuanxiong, Radix Angelicae Sinensis 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: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get residue medical material except that Colla Corii Asini, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into certain volume, added 95% ethanol of 10 times of amounts, stirred, and left standstill, and deepfreeze 12h filters, and filtrate is condensed into thick paste;
(3) get Colla Corii Asini heating molten, add in the above-mentioned thick paste mixing;
(4) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Rehmanniae Preparata 703g Rhizoma Cyperi (processed with vinegar) 351.5g Radix Angelicae Sinensis 263.5g
The Rhizoma Chuanxiong 263.5g Radix Paeoniae Alba (wine stir-fry) 176g Colla Corii Asini 176g
Folium Artemisiae Argyi (stir-fry) the 263.5g Cortex Eucommiae (stir-fry) 351.5g Radix Dipsaci 263.5g
Radix Scutellariae 176g
PEG400 450g
Make 1000
Preparation method:
(1) gets Rhizoma Chuanxiong, Radix Angelicae Sinensis 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: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get residue medical material except that Colla Corii Asini, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into certain volume, added 95% ethanol of 10 times of amounts, stirred, and left standstill, and deepfreeze 12h filters, and filtrate is condensed into thick paste;
(3) get Colla Corii Asini heating molten, add in the above-mentioned thick paste mixing;
(4) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Rehmanniae Preparata 600g Rhizoma Cyperi (processed with vinegar) 300g Radix Angelicae Sinensis 225g
The Rhizoma Chuanxiong 225g Radix Paeoniae Alba (wine stir-fry) 150g Colla Corii Asini 150g
Folium Artemisiae Argyi (stir-fry) the 225g Cortex Eucommiae (stir-fry) 300g Radix Dipsaci 225g
Radix Scutellariae 150g
Make 1000g
Preparation method:
(1) getting Rhizoma Chuanxiong, Radix Angelicae Sinensis two flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component is merged, add aspartame 5.0g, dextrin 200.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of hard capsule of the present invention:
Prescription:
Radix Rehmanniae Preparata 240g Rhizoma Cyperi (processed with vinegar) 120g Radix Angelicae Sinensis 90g
The Rhizoma Chuanxiong 90g Radix Paeoniae Alba (wine stir-fry) 60g Colla Corii Asini 60g
Folium Artemisiae Argyi (stir-fry) the 90g Cortex Eucommiae (stir-fry) 120g Radix Dipsaci 90g
Radix Scutellariae 60g
Make 1000
Preparation method:
(1) getting Rhizoma Chuanxiong, Radix Angelicae Sinensis two flavor medical materials beats powder and is used as medicine;
(2) the residue medical material is handled the same;
(3) above active component is merged, add aspartame 3.0g, mannitol 200.0g, 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:
45～263.5 parts of 60～351.5 parts of Radix Angelicae Sinensis of 120～703 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (processed with vinegar)
30～176 parts in 30～176 parts of Colla Corii Asini of 45～263.5 portions of Radix Paeoniae Albas of Rhizoma Chuanxiong (wine stir-fry)
45～263.5 parts of 60～351.5 parts of Radix Dipsacis of 45～263.5 parts of Cortexs Eucommiae of Folium Artemisiae Argyi (stir-fry) (stir-fry)
30～176 parts of Radix Scutellariaes.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
90 parts of 120 parts of Radix Angelicae Sinensis of 240 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (processed with vinegar)
60 parts in 60 parts of Colla Corii Asini of 90 portions of Radix Paeoniae Albas of Rhizoma Chuanxiong (wine stir-fry)
90 parts of 120 parts of Radix Dipsacis of 90 parts of Cortexs Eucommiae of Folium Artemisiae Argyi (stir-fry) (stir-fry)
60 parts of Radix Scutellariaes.
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 Rhizoma Chuanxiong, Radix Angelicae Sinensis 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 residue medical material except that Colla Corii Asini, decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get Colla Corii Asini heating molten, add in the above-mentioned thick paste mixing.
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 Rhizoma Chuanxiong, Radix Angelicae Sinensis two 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 Rhizoma Chuanxiong, Radix Angelicae Sinensis 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 residue medical material except that Colla Corii Asini, decoct with water 2～6 times, each 0.5～3 hour, collecting decoction, filter, filtrate is condensed into certain volume, adds 60～95% ethanol of 3～15 times of amounts, stirs, leave standstill, deepfreeze 6～60h filters, and filtrate is condensed into thick paste;
(3) get Colla Corii Asini heating molten, add in the above-mentioned thick paste mixing.
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 Rhizoma Chuanxiong, Radix Angelicae Sinensis two 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510115975 CN1775258A (en) | 2005-11-18 | 2005-11-18 | Womb-warming pregnancy-aiding preparation and new preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101428106B (en) * | 2008-12-24 | 2011-05-25 | 张铎 | Medicament composition for treating female infertility, and uses thereof |
| CN104758783A (en) * | 2015-03-26 | 2015-07-08 | 慕常松 | Traditional Chinese medicine composition for treating infertility |
| CN106902214A (en) * | 2017-04-07 | 2017-06-30 | 刘文巧 | The infertile Chinese medicine composition for the treatment of, preparation and application |
-
2005
- 2005-11-18 CN CN 200510115975 patent/CN1775258A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101428106B (en) * | 2008-12-24 | 2011-05-25 | 张铎 | Medicament composition for treating female infertility, and uses thereof |
| CN104758783A (en) * | 2015-03-26 | 2015-07-08 | 慕常松 | Traditional Chinese medicine composition for treating infertility |
| CN106902214A (en) * | 2017-04-07 | 2017-06-30 | 刘文巧 | The infertile Chinese medicine composition for the treatment of, preparation and application |
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