CN100522210C - Medicinal composition for treating aphronesia and preparing process thereof - Google Patents
Medicinal composition for treating aphronesia and preparing process thereof Download PDFInfo
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- CN100522210C CN100522210C CNB2004100938899A CN200410093889A CN100522210C CN 100522210 C CN100522210 C CN 100522210C CN B2004100938899 A CNB2004100938899 A CN B2004100938899A CN 200410093889 A CN200410093889 A CN 200410093889A CN 100522210 C CN100522210 C CN 100522210C
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Abstract
A Chinese medicine in the form of gel skeleton tablet for treating dementia is prepared from astragalus root, red sage root, Chuan-xiong rhizome and hydroxypropyl methylcellulose. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of gel matrix tablet for the treatment of dementia disease and preparation method thereof.
Background technology
Dementia is common senile disease, it also is the difficult treatment that current the world of medicine generally acknowledges, according to World Health Organization (WHO), among the old people of over-65s, people's intelligence generation obstacle of 10% is arranged, and wherein dementia takes place in 60% people, and along with the increasing of age, its dull-witted sickness rate is the trend that rises significantly.The dementia that geratic period takes place, the speed that develops according to symptom can divide chronic and acute two big classes: chronic dementia accounts for about 80% of senile dementia, is called senile chronic brain syndrome again.It comprises alzheimer disease, vascular dementia and both simultaneous Combination dementias.Also have some rare dementias in addition, as creutzfeldt-Jakob disease, parkinson etc.Psychoplegia is called old acute brain syndrome again, accounts for about 20% of whole dementias.This class dementia is secondary to general metabolism disorder, disease and drug intoxication and wound etc. more.It is many to cause that the dull-witted cause of disease has, and wherein main reason has two kinds---Alzheimer (AD) and vascular dementia (VD).Vascular dementia mainly is the dementia by caused by cerebrovascular disease.
Clinically, the inventor finds to have treatment treatment dementia well by the prescription that Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Rhizoma Atractylodis etc. are formed, chronic dementia, vascular dementia, senile dementia, Alzheimer, chronic cerebral dysfunction syndrome, learning and memory ability obstacle, the effect of the diseases such as disturbance of consciousness that cerebral thrombosis, cerebral arteriosclerosis, brain trauma, apoplexy, encephalitis cause.But because common preparation makes active component wherein be faced with a series of problem, frequent as the clinical administration number of times, use inconvenience, patient's compliance (compliance) difference etc.
Summary of the invention
The object of the invention has been to provide a kind of gel matrix tablet of the treatment dementia with slow release function completely newly.
Another object of the present invention is to provide the preparation method of this gel matrix tablet.
The prescription of pharmaceutical composition of the present invention is (in a weight percentage):
The Radix Astragali 8.5-25.5, Radix Salviae Miltiorrhizae 8.5-25.5, Rhizoma Chuanxiong 5-15, Rhizoma Atractylodis 5-15, Rhizoma Acori Graminei 5-15, Rhizoma Coptidis 1.5-7.5, Borneolum Syntheticum 0.01-0.8
Be preferably (in weight percentage):
The Radix Astragali 12-20, Radix Salviae Miltiorrhizae 12-20, Rhizoma Chuanxiong 7-12, Rhizoma Atractylodis 7-12, Rhizoma Acori Graminei 7-12, Rhizoma Coptidis 2-5, Borneolum Syntheticum 0.03-0.08
Best is (in weight percentage):
The Radix Astragali 16.7, Radix Salviae Miltiorrhizae 16.7, Rhizoma Chuanxiong 10, Rhizoma Atractylodis 10, Rhizoma Acori Graminei 10, Rhizoma Coptidis 3.3, Borneolum Syntheticum 0.0667.
Said medicine prescription proportioning is the weight proportion of institute's uses crude drug, need further process and suitable adjuvant be made gel matrix tablet described medical material if be made into preparation.
Can select that wherein independent the or mixed extraction of medical materials such as the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong and Rhizoma Coptidis is processed into extract extracting method wherein and be selected from (but being not limited to this): decoction and alcohol sedimentation technique, supercritical extraction etc.
For the ease of understanding, existing extracting method with Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Rhizoma Coptidis three flavor medical materials is described below for example, but is not limited to this.
The (+)-Astragenol extraction method: get Milkvetch Root, pulverize, add alcohol reflux, collect backflow, reclaim alcohol, concentrate Radix Astragali extract.
Radix Astragali microwave extraction method: after getting Radix Astragali pulverizing, put into flask, and this flask is put in people's microwave reactor, alcohol reflux is adjusted microwave power and is extracted, and collects extracting solution, gets Radix Astragali extract.
Rhizoma Chuanxiong ethanol adds resin method: get the Rhizoma Chuanxiong decoction pieces, pulverize, ethanol is reflux, extract, in Soxhlet reflux, extract, device, sucking filtration, sucking filtration liquid is evaporated to dried, adds suitable quantity of water again, and heating makes dissolving, filter, filtrate is added on the macroporous resin column of having handled well, first water eluting, reuse ethanol elution, after reclaiming ethanol, continue to concentrate Rhizoma Chuanxiong extract.
The Rhizoma Chuanxiong ethanol extraction method: get the Rhizoma Chuanxiong medical material, suitably pulverize, add the ethanol extraction several times, merge extractive liquid, filters, and reclaims ethanol, concentrate Rhizoma Chuanxiong extract.
The Radix Salviae Miltiorrhizae water extraction: get red rooted salvia, 20 mesh sieves are pulverized, extracting in water 2 times, the water logging bubble that adds for the first time 9～10 times of amounts, heating extraction 1.5 hours adds 5～7 times of water gagings, heating extraction 1 hour for the second time, merge extractive liquid,, suitably concentrate, add 95% ethanol, make to contain alcohol amount arrival 50%～70%, concentrate and reclaim ethanol, get Radix Salviae Miltiorrhizae extract.
The tanshinol extraction method: get red rooted salvia, 20 mesh sieves are pulverized, and 7～9 times of amount 70% alcohol heating reflux extract 2 times, each 1 hour, merge extractive liquid,, concentrate Radix Salviae Miltiorrhizae extract.
The extraction of active component of red sage root: get red rooted salvia, 20 mesh sieves are pulverized, water or ethanol extraction concentrate, and add ethanol precipitation, be dissolved in water after reclaiming ethanol, last macroporous resin chromatography separates, after water elution is removed impurity, ethanol elution to effective ingredient fully till, reclaim ethanol, get exsiccant Radix Salviae Miltiorrhizae extract.
The Rhizoma Coptidis alcohol extraction is followed the example of: get the Rhizoma Coptidis Chinese crude drug, chopping is put in people's round-bottomed flask, adds ethanol, and reflux, extract, reclaims ethanol, continues to concentrate to obtain Rhizoma Coptidis extract.
Preferred extracting method is that the Radix Astragali and Radix Salviae Miltiorrhizae add the water reflux, extract; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei extracting in water volatile oil, medicinal residues reuse water extraction mix with the extracting solution of the aforementioned Radix Astragali, Radix Salviae Miltiorrhizae extraction gained again, concentrate back precipitate with ethanol twice, reclaim ethanol, get extract; Rhizoma Coptidis is extracted separately; Borneolum Syntheticum is pulverized.
Be specially:
(1): the Radix Astragali, Radix Salviae Miltiorrhizae add 6-14 times of water gagings, reflux, extract, 1-4 times, and each 0.5-3 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 6-14 times of water gagings and extracted volatile oil 4-12 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 6-14 times of water gagings again and extracted 0.5-3 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates 0.5-3g crude drug, cool, add 86-99% ethanol, making determining alcohol is 70-85%, after the standing over night, filter, reclaim ethanol and approximate 1-5g crude drug, adding 86-99% ethanol to 1ml, making determining alcohol is 70-85%, after the standing over night, filter, reclaim ethanol, under 40-80 ℃ of conditions, concentrate out cream, to relative density 1.10～1.45;
(2): Rhizoma Coptidis adds 4-12 times of amount 50-95% alcohol reflux 1-4 times, each 1-4 hours, merge extractive liquid,, filter, reclaim ethanol and be about 0.1-0.5g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,0-8 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 60-90 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves.
Preferred extracting method is:
(1): the Radix Astragali, Radix Salviae Miltiorrhizae add 8-12 times of water gagings, reflux, extract, 1-3 times, and each 1-2 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 8-12 times of water gagings and extracted volatile oil 6-10 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 8-12 times of water gagings again and extracted 1-2 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates 0.8-1.5g crude drug, cool, add 90-96% ethanol, making determining alcohol is 75-83%, after the standing over night, filter, reclaim ethanol and approximate 2-4g crude drug, adding 90-96% ethanol to 1ml, making determining alcohol is 75-83%, after the standing over night, filter, reclaim ethanol, under 55-65 ℃ of conditions, concentrate out cream, to relative density 1.20～1.35;
(2): Rhizoma Coptidis adds 6-10 times of amount 70-80% alcohol reflux twice, each 1-3 hours, merge extractive liquid,, filter, reclaim ethanol and be about 0.2-0.4g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,3-6 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 75-85 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves.
Best extracting method is:
(1): the Radix Astragali, Radix Salviae Miltiorrhizae add 10 times of water gagings, reflux, extract, 2 times, and each 1.5 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei add 10 times of water gagings and extracted volatile oil 8 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 10 times of water gagings again and extracted 1.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1g crude drug, cool, add 95% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 80%, after the standing over night, filter, reclaim ethanol, concentrate out cream, 60 ℃ of conditions down to relative density 1.25～1.33;
(2): Rhizoma Coptidis adds 8 times of amount 75% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.3g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves.
Gel matrix tablet of the present invention prepares by following method:
1. by the following weight proportion material of getting it filled,
The Radix Astragali 8.5-25.5, Radix Salviae Miltiorrhizae 8.5-25.5, Rhizoma Chuanxiong 5-15, Rhizoma Atractylodis 5-15, Rhizoma Acori Graminei 5-15, Rhizoma Coptidis 1.5-7.5, Borneolum Syntheticum 0.01-0.8
Medical material wherein is processed into extract, and other gets hydroxypropyl emthylcellulose, lactose and magnesium stearate, and is standby;
2. with above-mentioned medicinal substances extract and lactose mix homogeneously, adopt an amount of 70% ethanol moistening, granulate drying, granulate;
3. the granule and the hydroxypropyl emthylcellulose mix homogeneously that obtain of above-mentioned steps 2;
4. use the mixture in the lubricated step 3 of magnesium stearate, tabletting.
Wherein, constant in order to guarantee gel matrix tablet of the present invention curative effect when slowly discharging, the sheet of the gel matrix tablet of method for preparing heavily is 0.50g～0.70g/ sheet, preferred 0.56g/ sheet.
In motherland's medical science to record that pill has " the ball person is slow also, releives and controls it ... " (Li Gao, 1180-1251).As seen Ancient Times in China medicine man early has recognized that and has used practice of pharmacy, reaches the purpose of steadily lasting curative effect.
Conventional dosage forms, most drug release process is all undertaken by first order kinetics, and the blood drug level of its medicine might be lower than minimum effective blood drug concentration and hold time short shortcoming in treatment concentration.For reaching therapeutic purposes and reducing side effect and often take repeatedly medicining mode, the compliance that makes the patient take medicine like this descends.Slow releasing preparation has overcome the deficiency of conventional formulation just, and steady, persistent blood drug level is provided.
Gel matrix tablet of the present invention has adopted the design principle of Western medicine slow releasing preparation to obtain achievement at aspects such as adjuvant selection, quality evaluations, for the research of Chinese medicine slow releasing preparation is used for reference.
The following beneficial effect by the gel matrix tablet of the present invention of external release description of test
By changeing the basket method, adopt the content of astragaloside in the high effective liquid chromatography for measuring Radix Astragali, come the difference of comparison compound astragalus membranaceus gel matrix tablet of the present invention and the external release of conventional tablet.
Instrument and reagent:
Day island proper Tianjin LC-10A high performance liquid chromatograph, R1-6A detector, CLASS-10A chromatographic work station, CQ-250 type ultrasonic cleaner.Methanol is chromatographically pure, and water is distilled water, and other reagent are analytical pure.Astragaloside (Nat'l Pharmaceutical ﹠ Biological Products Control Institute), gel matrix tablet of the present invention (hereinafter to be referred as, " refreshment slow releasing tablet ") provide by Tianjin Tianlishi Group Co.,Ltd's modern Chinese medicine institute again, prepare according to embodiment 2 methods.Conventional tablet (hereinafter to be referred as, " Awake ") provide by Tianjin Tianlishi Group Co.,Ltd's modern Chinese medicine institute, prepare according to embodiment 1 method.
Experimental technique:
Chromatographic condition, chromatographic column are HypersilODS2 (200mm * 4.6mm, 5 μ m), and mobile phase is methanol-water (67:33), and flow velocity is 1mL/min, and column temperature is 35 ℃.
The preparation of standard curve takes by weighing the astragaloside reference substance 1.0022mg of drying to constant weight, with dissolve with methanol and standardize solution in the 2mL volumetric flask, the astragaloside reference substance solution.Accurate this solution 2,6,10,14,18,20 μ L that draw, sample introduction is each 3 times respectively, with concentration C honeybee area average A is obtained equation of linear regression: A=2.868 * 10
1C+1174, r=0.9996, the range of linearity is 1-10 μ g.
Chinese Pharmacopoeia version appendix in 2000 the XD drug release determination method first method pertinent regulations, measure fresh degassing distilled water 900ml and inject each container, regulating and controlling temperature is (37 ± 0.1) ℃, rotating speed is 50r/min, respectively at dropping into 1 of compound Salviae Miltiorrhizae gel matrix tablet in each container, totally 6, and respectively 0.5,1,2,3,4,5,6,7,8,10, the 12h sampling, ask its cumulative release amount, get the release curve; With the conventional tablet dissolution behind the method mensuration desaccharide clothing, every interval 15min sampling gets the release curve with method, sees Fig. 1.
The result shows that the compound astragalus membranaceus gel matrix tablet of adopting HPMC to prepare has good external release effect.
Description of drawings
Fig. 1 the present invention treats dull-witted gel matrix tablet and the external release curve of conventional tablet
Specific embodiment
The present invention will be further described below in conjunction with Comparative Examples and embodiment, and following each embodiment only is used to the present invention is described and is not limitation of the present invention.
The preparation of embodiment 1 conventional tablet
Take off the row medical material: Radix Astragali 16.7g, Radix Salviae Miltiorrhizae 16.7g, Rhizoma Chuanxiong 10g, Rhizoma Atractylodis 10g, Rhizoma Acori Graminei 10g, Rhizoma Coptidis 3.3g, Borneolum Syntheticum 0.0667g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 10 times of water gagings, reflux, extract, 2 times, each 1.5 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 10 times of water gagings and extracted volatile oil 8 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 10 times of water gagings again and extracted 1.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1g crude drug, cool, add 95% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.25～1.33; Rhizoma Coptidis adds 10 times of amount 75% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.3g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and Borneolum Syntheticum fine powder, the homogenization material is made active component of the present invention, adds adjuvant lactose mix homogeneously, adopting 70% ethanol is binding agent, granulate oven dry, granulate, the magnesium stearate of adding 0.3%, tabletting.
Take off the row medical material, Radix Astragali 16.7g, Radix Salviae Miltiorrhizae 16.7g, Rhizoma Chuanxiong 10g, Rhizoma Atractylodis 10g, Rhizoma Acori Graminei 10g, Rhizoma Coptidis 3.3g, Borneolum Syntheticum 0.0667g;
The Radix Astragali, Radix Salviae Miltiorrhizae add 10 times of water gagings, reflux, extract, 2 times, and each 1.5 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 10 times of water gagings and extracted volatile oil 8 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 10 times of water gagings again and extracted 1.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1g crude drug, cool, add 95% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.25～1.33; Rhizoma Coptidis adds 10 times of amount 75% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.3g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil are added Rhizoma Coptidis extract, and heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 80～85 ℃, makes active component of the present invention;
The preparation of gel matrix tablet: get above-mentioned active component 5.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 25.5g, Radix Salviae Miltiorrhizae 25.5g, Rhizoma Chuanxiong 15g, Rhizoma Atractylodis 15g, Rhizoma Acori Graminei 15g, Rhizoma Coptidis 7.5g, Borneolum Syntheticum 0.8g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 14 times of water gagings, reflux, extract, 2 times, each 3 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 12 times of water gagings and extracted volatile oil 12 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 12 times of water gagings again and extracted 3 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1.5g crude drug, cool, add 98% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 4g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.10～1.45; Rhizoma Coptidis adds 12 times of amount 95% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.5g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,8 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 70 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil are added Rhizoma Coptidis extract, and heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 60～90 ℃, makes active component of the present invention;
The preparation of gel matrix tablet: get above-mentioned Radix Paeoniae Alba extract 5.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 8.5g, Radix Salviae Miltiorrhizae 8.5g, Rhizoma Chuanxiong 5g, Rhizoma Atractylodis 5g, Rhizoma Acori Graminei 5g, Rhizoma Coptidis 2g, Borneolum Syntheticum 0.01g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 8 times of water gagings, reflux, extract, 2 times, each 2 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 8 times of water gagings and extracted volatile oil 4 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 10 times of water gagings again and extracted 2 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 0.5g crude drug, cool, add 90% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 80%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.25～1.33; Rhizoma Coptidis adds 8 times of amount 90% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.2g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,0 ℃ of cold preservation is spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 80～85 ℃, makes active component of the present invention;
The preparation of gel matrix tablet: get above-mentioned Rhizoma Chuanxiong extract 5.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 20g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 12g, Rhizoma Atractylodis 12g, Rhizoma Acori Graminei 12g, Rhizoma Coptidis 5g, Borneolum Syntheticum 0.08g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 10 times of water gagings, reflux, extract, 2 times, each 2.5 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 10 times of water gagings and extracted volatile oil 4 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 10 times of water gagings again and extracted 2.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1g crude drug, cool, add 90% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol and approximate the 2g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.25～1.33; Rhizoma Coptidis adds 10 times of amount 75% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.3g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material under 80～85 ℃ of conditions, makes active component of the present invention;
The preparation of gel matrix tablet: get above-mentioned Rhizoma Chuanxiong extract 5.46g; Other gets the lactose of 5.46g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 5.46g, add 0.16g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 12g, Radix Salviae Miltiorrhizae 12g, Rhizoma Chuanxiong 7g, Rhizoma Atractylodis 7g, Rhizoma Acori Graminei 7g, Rhizoma Coptidis 2g, Borneolum Syntheticum 0.03g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 6 times of water gagings, reflux, extract, 2 times, each 1 hour, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei adds 6 times of water gagings and extracted volatile oil 5 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 8 times of water gagings again and extracted 1.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1.5g crude drug, cool, add 95% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃ of conditions, be concentrated into relative density 1.20～1.40; Rhizoma Coptidis adds 5 times of amount 80% alcohol reflux twice, each 4 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.5g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 80～85 ℃, makes active component of the present invention;
The preparation of gel matrix tablet: get other medicinal substances extract mix homogeneously of above-mentioned medicinal substances extract 5.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 25.5g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong 12g, Rhizoma Atractylodis 5g, Rhizoma Acori Graminei 7g, Rhizoma Coptidis 5g, Borneolum Syntheticum 0.08g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 9 times of water gagings, reflux, extract, 2 times, each 3 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei add 9 times of water gagings and extracted volatile oil 5 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 8 times of water gagings again and extracted 3 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 0.5g crude drug, cool, add 95% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 95% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, under 60 ℃, be concentrated into relative density 1.25～1.33; Rhizoma Coptidis adds 9 times of amount 95% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.5g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,5 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 80～85 ℃, makes active component of the present invention;
Get above-mentioned active component 5.46g; Other gets the lactose of 6.07g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 6.07g, add 0.17g magnesium stearate tabletting, every heavily is 0.57g.
Take off the row medical material, Radix Astragali 12.5g, Radix Salviae Miltiorrhizae 8.5g, Rhizoma Chuanxiong 7.5g, Rhizoma Atractylodis 8.5g, Rhizoma Acori Graminei 8.5g, Rhizoma Coptidis 4.5g, Borneolum Syntheticum 0.05g;
Get the Radix Astragali, Radix Salviae Miltiorrhizae adds 6 times of water gagings, reflux, extract, 2 times, each 1.5 hours, extracting solution filters, and was standby; Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei add 6 times of water gagings and extracted volatile oil 8 hours with volatile oil extractor, volatile oil is standby, filtrate extract, medicinal residues add 6 times of water gagings again and extracted 1.5 hours, merge the water extract, filtration is evaporated to 1ml with the merging of milkvitch-red sage extracting solution and approximates the 1g crude drug, cool, add 99% ethanol, making determining alcohol is 60%, after the standing over night, filter, reclaim ethanol and approximate the 3g crude drug to 1ml, add 99% ethanol, making determining alcohol is 70%, after the standing over night, filter, reclaim ethanol, concentrate out cream, be concentrated into relative density 1.25～1.33 at 60 ℃; Rhizoma Coptidis adds 6 times of amount 99% alcohol reflux twice, each 2 hours, merge extractive liquid,, filter, reclaim ethanol and be about the 0.4g crude drug to 1ml, the adding concentrated hydrochloric acid is transferred PH1～2,6 ℃ of cold preservations are spent the night, filter, filter cake repeatedly washs with distilled water, 80 ℃ of oven dry, pulverize, cross 80 mesh sieves, Borneolum Syntheticum is pulverized, and crosses 80 mesh sieves;
Get Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei mixed volatilization oil adding Rhizoma Coptidis extract, heating in water bath makes dissolving, adds mixing extractum such as the Radix Astragali, and the Borneolum Syntheticum fine powder, and it is even to change material at 60～90 ℃, makes active component of the present invention;
Get above-mentioned active component 5.46g; Other gets the lactose of 4.37g, adopts an amount of 70% ethanol moistening, and 16 mesh sieves are granulated, drying, granulate; Resulting granules is mixed with the hydroxypropyl emthylcellulose of 4.37g, add 0.14g magnesium stearate tabletting, every heavily is 0.57g.
Claims (8)
1. pharmaceutical composition for the treatment of dementia, extract by by weight ratio the Radix Astragali 8.5-25.5, Radix Salviae Miltiorrhizae 8.5-25.5, Rhizoma Chuanxiong 5-15, Rhizoma Atractylodis 5-15, Rhizoma Acori Graminei 5-15, Rhizoma Coptidis 1.5-7.5, Borneolum Syntheticum 0.01-0.8 medical material is an active component, lactose and hydroxypropyl methylcellulose are that adjuvant is formed, and the weight ratio of active component wherein and lactose and hydroxypropyl methylcellulose is 1:0.8～1.2:0.8～1.2.
2. the described compositions of claim 1, wherein the weight ratio of active component and lactose and hydroxypropyl methylcellulose is 1:1:1.
3. the described compositions of claim 1, the weight proportion of active component crude drug wherein is the Radix Astragali 12-20, Radix Salviae Miltiorrhizae 12-20, Rhizoma Chuanxiong 7-12, Rhizoma Atractylodis 7-12, Rhizoma Acori Graminei 7-12, Rhizoma Coptidis 2-5, Borneolum Syntheticum 0.03-0.08.
4. the described compositions of claim 1, the weight proportion of active component crude drug wherein is the Radix Astragali 16.7, Radix Salviae Miltiorrhizae 16.7, Rhizoma Chuanxiong 10, Rhizoma Atractylodis 10, Rhizoma Acori Graminei 10, Rhizoma Coptidis 3.3, Borneolum Syntheticum 0.0667.
5. the described compositions of claim 1, described active component extract is that the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Acori Graminei, Rhizoma Coptidis medical material extract separately and get, or their mix the back and extract and get, and wherein the Milkvetch Root extract adopts the water extraction alcohol sedimentation method or alcohol extraction is followed the example of or the microwave extraction method prepares; The red rooted salvia extract adopts water extraction method or alcohol extraction is followed the example of or the chromatography preparation; Rhizoma Chuanxiong extract adopts ethanol extraction method or ethanol to add the resin method preparation; Rhizoma Coptidis extract adopts the preparation of alcohol extraction method.
6. the described preparation of compositions method of claim 1 comprises the following steps:
A. by the following weight proportion material of getting it filled: the Radix Astragali 8.5-25.5, Radix Salviae Miltiorrhizae 8.5-25.5, Rhizoma Chuanxiong 5-15, Rhizoma Atractylodis 5-15, Rhizoma Acori Graminei 5-15, Rhizoma Coptidis 1.5-7.5, Borneolum Syntheticum 0.01-0.8, wherein except that Borneolum Syntheticum is pulverized, all the other medical materials are processed into extract, other gets hydroxypropyl emthylcellulose, lactose and magnesium stearate, and is standby;
B. with medicinal substances extract among the step a and lactose mix homogeneously, adopt an amount of 70% ethanol moistening, granulate drying, granulate;
C. the granule and the hydroxypropyl emthylcellulose mix homogeneously that obtain of above-mentioned steps b;
D. use the mixture among the lubricated step c of magnesium stearate, tabletting.
7. the described method of claim 6, wherein the sheet of Zhi Bei gel matrix tablet heavily is 0.50g～0.70g/ sheet.
8. the described method of claim 7, wherein the sheet of Zhi Bei gel matrix tablet heavily is the 0.56g/ sheet.
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| CN113413439B (en) * | 2021-07-12 | 2022-03-29 | 中山创天生物科技有限公司 | Traditional Chinese medicine formula for treating Alzheimer's disease and preparation method of compound preparation of traditional Chinese medicine formula |
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Granted publication date: 20090805 Termination date: 20191210 |