CN1748774A - Brain tonifying preparation and new preparing method - Google Patents
Brain tonifying preparation and new preparing method Download PDFInfo
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- CN1748774A CN1748774A CNA2005101091812A CN200510109181A CN1748774A CN 1748774 A CN1748774 A CN 1748774A CN A2005101091812 A CNA2005101091812 A CN A2005101091812A CN 200510109181 A CN200510109181 A CN 200510109181A CN 1748774 A CN1748774 A CN 1748774A
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Abstract
The present invention relates to a Chinese medicine composition, and especially a kind of Chinese medicine composition for treating amnesia, hypomnesia, dizziness, tinnitus, insomnia, palpitation, etc and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of treatment fascination is forgetful, hypomnesis, dizziness and tinnitus, vexed insomnia, palpitation and uneasiness, epilepsy headache, the prescription of restlessness and chest distress and preparation technology thereof.
Background technology:
Confuse forgetful, hypomnesis, dizziness and tinnitus, vexed insomnia, palpitation and uneasiness, the epilepsy headache, restlessness and chest distress is clinical common sympton, the traditional Chinese medical science is often taked nourishing essence-blood, nourishing the brain and improving intelligence, it is relieving convulsion to calm the nerves, and the means of eliminating phlegm and calming wind are treated it, and evident in efficacy, and cerebral tonic pill 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, capsule, tablet, it is forgetful that its pill that makes can be used for curing mainly fascination, hypomnesis, dizziness and tinnitus, vexed insomnia, palpitation and uneasiness, epilepsy headache, restlessness and chest distress.
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:
60～1200 parts of Radix Angelicae Sinensis 15～300 parts of Semen Ziziphi Spinosaes of 37.5～750 parts of Arisaema Cum Bile (stir-fry)
22.5～450 parts of 22.5～450 parts of 30～600 parts of Semen Platycladi of Fructus Lycii (stir-fry) of Fructus Alpiniae Oxyphyllae (salt stir-fry)
30～600 parts of Os Draconis (forging) 15～300 parts of Herba Cistanches of 15～300 parts of Rhizoma Acori Graminei (steaming)
15～300 parts of 30～600 parts of Concretio Silicea Bambusaes of 22.5～450 portions of Semen Juglandis of Fructus Schisandrae Chinensis (stewed with wine)
15～300 parts in 15～300 parts of Rhizoma Gastrodiaes of 15～300 parts of succinums of Radix Polygalae (system)
Preferably:
120 parts of Radix Angelicae Sinensis 30 parts of Semen Ziziphi Spinosaes of 75 parts of Arisaema Cum Bile (stir-fry)
45 parts of 45 parts of 60 parts of Semen Platycladi of Fructus Lycii (stir-fry) of Fructus Alpiniae Oxyphyllae (salt stir-fry)
60 parts of Os Draconis (forging) 30 parts of Herba Cistanches of 30 parts of Rhizoma Acori Graminei (steaming)
30 parts of 60 parts of Concretio Silicea Bambusaes of 45 portions of Semen Juglandis of Fructus Schisandrae Chinensis (stewed with wine)
30 parts in 30 parts of Rhizoma Gastrodiaes of 30 parts of succinums of Radix Polygalae (system)
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 the 1-2 bag at every turn, can take altogether 62.5～125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet, tablet, capsule.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Semen Platycladi, Semen Juglandis, succinum four Chinese medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get residue medical material (Os Draconis are smashed and are decocted first), 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) clathrate and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) volatile oil component extracts the same;
(2) get the residue medical material, (Os Draconis are smashed and are decocted first) soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, and each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5～10, and preferred ratio is 1: 2～4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture, or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4～1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8～1.2.Wherein the weight proportion between active component and the pharmaceutically useful organic solvent is: the content of active component is 50mg-500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A, get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B, get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of the empty animal model of caused by cyclophosphamide kidney yang (essence)
Get 50 of 18-22g healthy mices, administration and grouping see Table 1, and administering mode is irritated stomach, and water 17h is can't help in fasting.Divide five groups at random by body weight, 10 every group, ♀
Half and half, the 1-4 group is pressed literature method intraperitoneal injection of cyclophosphamide 80mg/kg.Once a day, injected continuously five days, make kidney yang (essence) virtual model.The 2-3 group began gastric infusion in second day at the injection cyclophosphamide, once a day, and successive administration 7d.
The result:
(1) improve " kidney yang (essence) void " symptom: the moulding animal is behind injection cyclophosphamide 3d, engender lazy moving, hair is loose to tarnish, and extremity and tail point are sent out cold, body constitution tired unable grade " kidney yang (essence) void " symptom that disappears, normal control group white mice does not have above-mentioned symptom.Result of the test as seen, each extractum group " kidney yang (essence) void " symptom is light than model control group, animal subject does not have death.And during the model control group off-test, dead 1 of animal subject.
(2) to red, the leukocytic influence of animal pattern blood: the results are shown in Table 1.
Table 1 is to " kidney just (essence) void " red, leukocytic influence of animal pattern blood (x ± s)
| Group | Dosage (g/kg) | Red blood cell count(RBC) (ten thousand/mm 3) | (hundred/mm of total white blood cellses 3) |
| Model control group technology is 2. extractum group ANSHEN BUNAO YE blank group of extractum group technology 1. | - 0.20 0.17 20ml/kg - | 602.4±55.8 *** 631.4±833 * 657.9±63.0 654.8±65.6 710.8±41.9 | 14.7±6.6 ** 18.4±6.9 *** 18.1±8.8 *** 17.6±6.8 *** 56.1±14.9 |
Compare with the blank group
*P＜0.05,
*P＜0.01,
* *P＜0.001
(3) to animal pattern body weight and spleen, the influence of thymus weight in wet base sees Table 2.
Table 2 is to the influence of " kidney just (essence) void " model white mice body weight and spleen, thymus weight in wet base (x ± s)
| Group | Dosage (g/kg) | Body weight (g) | Heavy (mg) (the spleen weight/body weight %) of spleen | Heavy (mg) (the spleen weight/body weight %) of thymus | ||
| Before the test | After the test | |||||
| Model control group technology is 2. extractum group ANSHEN BUNAO YE blank group of extractum group technology 1. | - 0.20 0.17 20ml/kg - | 19.8±1.7(10) 19.6±1.0(10) 19.5±1.2(10) 19.9±1.3(10) 19.5±1.7(10) | 18.5±1.5(9) 18.3±1.5(9) 19.2±2.4(10) 18.9±2.0(10) 23.0±1.5(10) | 31.2±8.1 3(0.169) 34.1±1.3 3(0.186) 35.5±8.6 3(0.185) 31.8±10.1 3(0.168) 165.0±29.5(0.717) | 10.7±2.9 3(0.058) 13.0±4.5 3(0.071) 14.2±3.0 3(0.074) 1.52±4.3 3(0.061) 66.5±3.3(0.289) | |
Annotate: compare with the blank group
3Numeral is a number of animals in P＜0.001, left-hand bracket, and numeral is spleen index or thymus index in the unquote
2, syngignoscism
Get 50 of 18-22g healthy mices, administration and grouping see Table 1, and administering mode is irritated stomach, carry out the hypnosis test by literature method, the results are shown in Table 3.
The influence (n=10) of table 3 pair white mice syngignoscism
| Group | Dosage (g/kg) | Sleep number of animals (only) | End sleep number of animals (only) | Sleep percentage rate (%) | |
| Blank group technology is 2. extractum group ANSHEN BUNAO YE diazepam of extractum group technology 1. | - 0.20 0.17 20ml/kg 2.75mg/kg | 2 8 7 4 9 | 8 2 3 6 1 | 20 80 * 70 * 40 90 | |
Compare with the blank group
*P＜0.05
3, 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 that a kind of good treatment fascination is forgetful, hypomnesis, dizziness and tinnitus, vexed insomnia, palpitation and uneasiness, epilepsy headache, the medicine of restlessness and chest distress, and change preparation technology can obviously strengthen its nourishing essence-blood, nourishing the brain and improving intelligence, calm the nerves clinical efficacies such as relieving convulsion, eliminating phlegm and calming wind, its hypotoxicity in addition, therefore prolonged application safety, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Angelicae Sinensis 75g Arisaema Cum Bile 30g Semen Ziziphi Spinosae (stir-fry) 120g
Fructus Alpiniae Oxyphyllae (salt stir-fry) 45g Fructus Lycii 60g Semen Platycladi (stir-fry) 45g
Os Draconis (forging) 30g Rhizoma Acori Graminei 30g Herba Cistanches (steaming) 60g
Fructus Schisandrae Chinensis (stewed with wine) 45g Semen Juglandis 60g Concretio Silicea Bambusae 30g
Radix Polygalae (system) 30g succinum 30g Rhizoma Gastrodiae 30g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Semen Platycladi, Semen Juglandis, succinum four Chinese medicine material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 40min gets clathrate;
(2) get residue medical material (Os Draconis are smashed and are decocted first), 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 Angelicae Sinensis 270g Arisaema Cum Bile 108g Semen Ziziphi Spinosae (stir-fry) 432g
Fructus Alpiniae Oxyphyllae (salt stir-fry) 162g Fructus Lycii 216g Semen Platycladi (stir-fry) 162g
Os Draconis (forging) 108g Rhizoma Acori Graminei 108g Herba Cistanches (steaming) 216g
Fructus Schisandrae Chinensis (stewed with wine) 162g Semen Juglandis 216g Concretio Silicea Bambusae 108g
Radix Polygalae (system) 108g succinum 108g Rhizoma Gastrodiae 108g
PEG400 370g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Semen Platycladi, Semen Juglandis, succinum four Chinese medicine material, adopt supercritical extraction: in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract: β-CDBao He, and 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 residue medical material (Os Draconis are smashed and are decocted first), 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 Angelicae Sinensis 750g Arisaema Cum Bile 300g Semen Ziziphi Spinosae (stir-fry) 1200g
Fructus Alpiniae Oxyphyllae (salt stir-fry) 450g Fructus Lycii 600g Semen Platycladi (stir-fry) 450g
Os Draconis (forging) 300g Rhizoma Acori Graminei 300g Herba Cistanches (steaming) 600g
Fructus Schisandrae Chinensis (stewed with wine) 450g Semen Juglandis 600g Concretio Silicea Bambusae 300g
Radix Polygalae (system) 300g succinum 300g Rhizoma Gastrodiae 300g
Make 1000g
Preparation method:
(1) volatile oil component extracts the same;
(2) get the residue medical material, (Os Draconis are smashed and are decocted first) soaked 40 minutes earlier with 65% ethanol, reheat reflux, extract, three times, and 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 200.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Angelicae Sinensis 270g Arisaema Cum Bile 108g Semen Ziziphi Spinosae (stir-fry) 432g
Fructus Alpiniae Oxyphyllae (salt stir-fry) 162g Fructus Lycii 216g Semen Platycladi (stir-fry) 162g
Os Draconis (forging) 108g Rhizoma Acori Graminei 108g Herba Cistanches (steaming) 216g
Fructus Schisandrae Chinensis (stewed with wine) 162g Semen Juglandis 216g Concretio Silicea Bambusae 108g
Radix Polygalae (system) 108g succinum 108g Rhizoma Gastrodiae 108g
Make 1000
Preparation method:
(1) volatile oil component extracts the same;
(2) get the residue medical material, (Os Draconis are smashed and are decocted first) soaked 40 minutes earlier with 65% ethanol, reheat reflux, extract, three times, and 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 210.0g, 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:
60～1200 parts of Radix Angelicae Sinensis 15～300 parts of Semen Ziziphi Spinosaes of 37.5～750 parts of Arisaema Cum Bile (stir-fry)
22.5～450 parts of 22.5～450 parts of 30～600 parts of Semen Platycladi of Fructus Lycii (stir-fry) of Fructus Alpiniae Oxyphyllae (salt stir-fry)
30～600 parts of Os Draconis (forging) 15～300 parts of Herba Cistanches of 15～300 parts of Rhizoma Acori Graminei (steaming)
15～300 parts of 30～600 parts of Concretio Silicea Bambusaes of 22.5～450 portions of Semen Juglandis of Fructus Schisandrae Chinensis (stewed with wine)
15～300 parts in 15～300 parts of Rhizoma Gastrodiaes of 15～300 parts of succinums of Radix Polygalae (system)
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
120 parts of Radix Angelicae Sinensis 30 parts of Semen Ziziphi Spinosaes of 75 parts of Arisaema Cum Bile (stir-fry)
45 parts of 45 parts of 60 parts of Semen Platycladi of Fructus Lycii (stir-fry) of Fructus Alpiniae Oxyphyllae (salt stir-fry)
60 parts of Os Draconis (forging) 30 parts of Herba Cistanches of 30 parts of Rhizoma Acori Graminei (steaming)
30 parts of 60 parts of Concretio Silicea Bambusaes of 45 portions of Semen Juglandis of Fructus Schisandrae Chinensis (stewed with wine)
30 parts in 30 parts of Rhizoma Gastrodiaes of 30 parts of succinums of Radix Polygalae (system)
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Semen Platycladi, Semen Juglandis, succinum four Chinese medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get residue medical material (Os Draconis are smashed and are decocted first), 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) clathrate and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) volatile oil component extracts the same;
(2) get the residue medical material, (Os Draconis are smashed and are decocted first) soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, and each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
6, the Chinese medicine preparation of claim 5, it is characterized in that: described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that: described soft capsule, and its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1～9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make, wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) gets Radix Angelicae Sinensis, Semen Platycladi, Semen Juglandis, succinum four Chinese medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get residue medical material (Os Draconis are smashed and are decocted first), 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) clathrate and water extract lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) volatile oil component extracts the same;
(2) get the residue medical material, (Os Draconis are smashed and are decocted first) soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, three times, and each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
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| CNA2005101091812A CN1748774A (en) | 2005-10-20 | 2005-10-20 | Brain tonifying preparation and new preparing method |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101057948B (en) * | 2006-04-21 | 2010-05-12 | 北京因科瑞斯生物制品研究所 | Traditional Chinese medicinal preparation with intelligence promoting and nourishing the heart to calm the mind function and its preparation method |
| US7968128B2 (en) | 2008-11-03 | 2011-06-28 | Viva Pharmaceutical Inc. | Plant extract compositions for affecting sleep |
| CN101401854B (en) * | 2008-10-31 | 2012-07-18 | 张江元 | Medicament formulation for treating epilepsy and preparation thereof |
| CN104324251A (en) * | 2014-11-21 | 2015-02-04 | 郝建国 | Intelligence-reinforcing and nerve-calming medicine for treating congenital atelencephalia and preparation method |
| CN105362531A (en) * | 2015-11-25 | 2016-03-02 | 禤燕华 | Traditional Chinese medicine composition for treating tinnitus and preparation method thereof |
| CN109432341A (en) * | 2018-12-17 | 2019-03-08 | 徐修信 | The application of Chinese medicine composition and Chinese materia medica preparation and they |
| CN110478456A (en) * | 2019-09-18 | 2019-11-22 | 上海医药集团青岛国风药业股份有限公司 | A kind of preparation method of brain tonic bolus of drug |
| CN112915142A (en) * | 2021-01-28 | 2021-06-08 | 河南省中医院（河南中医药大学第二附属医院） | Traditional Chinese medicine scraping medium and preparation method thereof |
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2005
- 2005-10-20 CN CNA2005101091812A patent/CN1748774A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101057948B (en) * | 2006-04-21 | 2010-05-12 | 北京因科瑞斯生物制品研究所 | Traditional Chinese medicinal preparation with intelligence promoting and nourishing the heart to calm the mind function and its preparation method |
| CN101401854B (en) * | 2008-10-31 | 2012-07-18 | 张江元 | Medicament formulation for treating epilepsy and preparation thereof |
| US7968128B2 (en) | 2008-11-03 | 2011-06-28 | Viva Pharmaceutical Inc. | Plant extract compositions for affecting sleep |
| CN104324251A (en) * | 2014-11-21 | 2015-02-04 | 郝建国 | Intelligence-reinforcing and nerve-calming medicine for treating congenital atelencephalia and preparation method |
| CN105362531A (en) * | 2015-11-25 | 2016-03-02 | 禤燕华 | Traditional Chinese medicine composition for treating tinnitus and preparation method thereof |
| CN109432341A (en) * | 2018-12-17 | 2019-03-08 | 徐修信 | The application of Chinese medicine composition and Chinese materia medica preparation and they |
| CN110478456A (en) * | 2019-09-18 | 2019-11-22 | 上海医药集团青岛国风药业股份有限公司 | A kind of preparation method of brain tonic bolus of drug |
| CN110478456B (en) * | 2019-09-18 | 2022-02-22 | 上海医药集团青岛国风药业股份有限公司 | Preparation method of brain-strengthening medicinal pills |
| CN112915142A (en) * | 2021-01-28 | 2021-06-08 | 河南省中医院（河南中医药大学第二附属医院） | Traditional Chinese medicine scraping medium and preparation method thereof |
| CN112915142B (en) * | 2021-01-28 | 2022-01-28 | 河南省中医院（河南中医药大学第二附属医院） | Traditional Chinese medicine scraping medium and preparation method thereof |
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