CN101088530A - Medicine micropill and its prepn process - Google Patents
Medicine micropill and its prepn process Download PDFInfo
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- CN101088530A CN101088530A CN 200610087400 CN200610087400A CN101088530A CN 101088530 A CN101088530 A CN 101088530A CN 200610087400 CN200610087400 CN 200610087400 CN 200610087400 A CN200610087400 A CN 200610087400A CN 101088530 A CN101088530 A CN 101088530A
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- fructus schisandrae
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Abstract
The present invention relates to one kind of medicine micropill and its preparation process. The medicine micropill is prepared with Southern schisandra fruit 500-600 weight portions, Dangshen 150-200 weight portions, astragalus root 300-400 weight portions, fried wild jujube seed 60-120 weight portions, and microcrystalline cellulose 400-600 weight portions. It has diameter smaller than 0.05 mm, good disintegrating and dissolving performance, fast acting, stable medicine release, high bioavailability and other advantages.
Description
Technical field
The present invention relates to a kind of medicine micropill and preparation technology thereof.
Background technology
The SHENQI WUWEIZI PIAN that existing market is sold for " 2005 editions kinds of recording of Chinese pharmacopoeia have the spleen invigorating QI invigorating, the effect of mind tranquilizing and the heart calming, be used for due to insufficiency of vital energy and blood, the deficiency of both the heart and spleen insomnia, dreaminess, forgetful, cardiopalmus, breathe hard, card such as spontaneous perspiration.
The prescription of SHENQI WUWEIZI PIAN is as follows: Fructus Schisandrae Sphenantherae 180g, Radix Codonopsis 60g, Radix Astragali 120g, Semen Ziziphi Spinosae (parched) 30g.The preparation method of SHENQI WUWEIZI PIAN is as follows: above four flavors, and Radix Codonopsis and Fructus Schisandrae Sphenantherae 60g are ground into fine powder; The Radix Astragali, Semen Ziziphi Spinosae (parched) and remaining Fructus Schisandrae Sphenantherae are sent out (appendix IO) according to the percolation under fluid extract and the extractum item and are made solvent with 45% ethanol, 70% ethanol and 60% ethanol respectively, flood and carry out percolation after 24 hours, collect percolate, merge behind the recovery ethanol, be concentrated into an amount of, add above-mentioned fine powder and an amount of adjuvant, mixing is made granule, dry, be pressed into 1000, or sugar coating, promptly.
After tablet is gone into stomach, can be attached at some points of coat of the stomach, therefore tablet is very high at the drug level that the gastric partial points forms, chemical stimulation and mechanical stimulus to stomach are all very big, may cause diseases such as gastritis, ulcer, should not take for a long time, especially have the patient of gastropathy and old people all the more so for some.
Summary of the invention
The medicine that exists at above-mentioned SHENQI WUWEIZI PIAN is very high at the drug level that the gastric partial points forms, and is big to the chemical stimulation and the mechanical stimulus of stomach, and drug effect discharges problems such as slow, the invention provides a kind of medicine micropill.The present invention also provides the preparation technology of described medicine micropill.
Technical scheme of the present invention is as follows:
The invention provides a kind of medicine micropill, it is characterized in that 44: described medicine micropill is by Fructus Schisandrae Sphenantherae 500-600 weight portion, Radix Codonopsis 150-200 weight portion, Radix Astragali 300-400 weight portion, Semen Ziziphi Spinosae (parched) 60-120 weight portion, microcrystalline Cellulose 400-600 weight portion is prepared from as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder;
2) Fructus Schisandrae Sphenantherae of the Radix Astragali, Semen Ziziphi Spinosae (parched) and remaining 2/3rds described amounts of described amount is made solvent with 70% ethanol of 45% ethanol of 8 times of volumes, 8 times of volumes and 60% ethanol of 8 times of volumes respectively by percolation, flood and carry out percolation after 24 hours, collect percolate, be concentrated into relative density and be 1.30～1.35 clear paste;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds the microcrystalline Cellulose of 400-600 weight portion, and mixing is with the ethanol system soft material of 30-50%, pill.
The technique effect that the present invention realized is as follows:
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, the bioavailability height, and local irritation is little, the pill outward appearance is neat and artistic, and hygroscopicity is little, transports, stores, carries etc. all more convenient.Has invigorating the spleen and benefiting QI, the effect of mind tranquilizing and the heart calming.Be used for due to insufficiency of vital energy and blood, the deficiency of both the heart and spleen insomnia, dreaminess, forgetful, weak, breathe hard, disease such as spontaneous perspiration.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only is indicative, means that never it limits the scope of the invention by any way.
Carry out carrying out preliminary experiment earlier before the following embodiment, determine the preparation method of proper supplementary material and micropill soft material.
The selection of adjuvant:
In preliminary experiment, selecting starch, dextrin, microcrystalline Cellulose respectively for use is diluent, and the result is the best with the effect of microcrystalline Cellulose.Starch and dextrin but because be difficult for reasons such as mixing, hygroscopicity are strong, cause being not easy molding when pill.Therefore, to select microcrystalline Cellulose for use be adjuvant to micropill provided by the present invention.
Wetting agent preferred:
Distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose etc. are binding agent commonly used or wetting agent, the present invention tests it respectively, and its concentration carried out preferably, preferred standard is that the soft material that makes reaches the effect of " holding agglomerating, loosing of pinching ".Final selected ethanol is as wetting agent and determined suitable concentration, and the result is as follows for part concentration of alcohol optimization experiment:
| Tested number | Concentration of alcohol | System soft material situation |
| 1 2 3 | 75% ethanol, 45% ethanol, 15% ethanol | The moderate soft material of the not enough soft material of soft material viscosity easily bonds |
Embodiment 1:
The parts by weight of each component are as follows in the prescription that present embodiment adopted:
Fructus Schisandrae Sphenantherae 500;
Radix Codonopsis 200;
The Radix Astragali 300;
Semen Ziziphi Spinosae (parched) 120.
Present embodiment provides the preparation method of medicine micropill as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder;
2) with the Fructus Schisandrae Sphenantherae of the Radix Astragali, Semen Ziziphi Spinosae (parched) and remaining 2/3rds described amounts of described amount according to the percolation under fluid extract and the extractum item (" 2005 editions appendix IO of Chinese pharmacopoeia), make solvent with 45% ethanol, 70% ethanol and 60% ethanol of 10 times of amounts respectively, flood and carry out percolation after 24 hours, collect percolate, merge after reclaiming ethanol, be concentrated into the clear paste that relative density is about 1.20 (60 ℃), standby;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds about 400 parts of microcrystalline Cellulose, mixing, with 30% ethanol system soft material, pill is drying to obtain.
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 51%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment spontaneous perspiration and night sweat efficacy analysis:
Method: there is the inpatient of spontaneous perspiration and night sweat (being called for short antiperspirant disease) to be divided into observation group and matched group at random 158 routine clinical manifestations, treatment group (A group) 78 examples, matched group (B group) 80 examples, A organizes 1 bag of oral medicine micropill one time, and 10 days is a course of treatment.The B group is used 3/time of ZHENQI FUZHENG JIAONANG, and three times on the one, organize with A the course of treatment.The result: observation group's total effective rate is 98.75%, and the matched group total effective rate is 36.25%, two group of relatively P＜0.01, and significant difference is arranged.
Conclusion: medicine micropill is remarkable for antiperspirant disease (spontaneous perspiration or the night sweat) clinical efficacy of prolonged illness deficient qi and blood, the heart spleen deficiency of the lung, is worth of widely use.
Embodiment 2:
The weight portion of each component is as follows in the prescription that present embodiment adopted:
Fructus Schisandrae Sphenantherae 600;
Radix Codonopsis 150;
The Radix Astragali 400;
Semen Ziziphi Spinosae (parched) 60.
Present embodiment provides the preparation method of medicine micropill as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder, standby;
2) with the Radix Astragali of described amount, Semen Ziziphi Spinosae (parched) and remaining Fructus Schisandrae Sphenantherae according to the percolation under fluid extract and the extractum item (" 2005 editions appendix IO of Chinese pharmacopoeia), make solvent with 45% ethanol, 70% ethanol and 60% ethanol of 12 times of amounts respectively, flood and carry out percolation after 24 hours, collect percolate, merge after reclaiming ethanol, be concentrated into the clear paste that relative density is about 1.25 (60 ℃), standby;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds 450 parts microcrystalline Cellulose, mixing, with 60% ethanol system soft material, pill is drying to obtain.
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 51%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill Cure for insomnia 136 examples.
Method: the treatment group adopts medicine micropill (Fructus Schisandrae Chinensis, Radix Codonopsis, the Radix Astragali, Semen Ziziphi Spinosae (parched) etc.) Cure for insomnia 136 examples, and matched group adopts treatment 120 examples such as oryzanol, vitamin, estazolam.
The result: treatment group total effective rate is 94.12%, 91.67%, two group of there was no significant difference of matched group (P＞0.05).
Prompting: medicine micropill Cure for insomnia safety, reliable, determined curative effect.
Embodiment 3:
The weight portion of each component is as follows in the prescription that present embodiment adopted:
Fructus Schisandrae Sphenantherae 500;
Radix Codonopsis 150;
The Radix Astragali 400;
Semen Ziziphi Spinosae (parched) 120.
Present embodiment provides the preparation method of medicine micropill as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder, standby;
2) with the Radix Astragali of described amount, Semen Ziziphi Spinosae (parched) and remaining Fructus Schisandrae Sphenantherae according to the percolation under fluid extract and the extractum item (" 2005 editions appendix IO of Chinese pharmacopoeia), make solvent with 45% ethanol, 70% ethanol and 60% ethanol of 8 times of amounts respectively, flood and carry out percolation after 24 hours, collect percolate, merge after reclaiming ethanol, be concentrated into the clear paste that relative density is about 1.30～1.35 (60 ℃), standby;
3) the step 2) clear paste of gained adds above-mentioned fine powder, mixing, and vacuum drying is pulverized, and adds part 600 microcrystalline Cellulose, mixing, with 45% ethanol system soft material, pill is drying to obtain.
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 51%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Ginseng stilbene Fructus Schisandrae Chinensis treatment negative symptoms of schizophrenia observation of curative effect:
Method: the above negative symptoms of 60 examples for the main chronic schizophrenia patient of being in hospital who shows takes ginseng stilbene Schisandrae Pill (micropill), by a definite date 8 weeks, is carried out own control.With brief psychiatric rating scale (BPRS), negative symptoms rating scale (SANS), Clinical Global Impression (CGI) evaluation curative effect, and observe the side reaction that may occur.
The result: treat back BPRS and SANS and divide significantly reduction, onset time is about 4 weeks, and total effective rate is 65.0%, and evanescent eruption, drowsiness, abnormal liver function appear in individual patients.The very fast improvement after general the processing.
Conclusion: ginseng stilbene Fructus Schisandrae Chinensis is a kind of safe and effective Chinese patent medicine, can be used as the treatment negative symptoms of schizophrenia, and its mechanism of action remains further to be explored.
Embodiment 4:
The weight portion of each component is as follows in the prescription that present embodiment adopted:
Fructus Schisandrae Sphenantherae 540;
Radix Codonopsis 180;
The Radix Astragali 360;
Semen Ziziphi Spinosae (parched) 90.
Present embodiment provides the preparation method of medicine micropill as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder, standby;
2) with the Radix Astragali of described amount, Semen Ziziphi Spinosae (parched) and remaining 2/3rds Fructus Schisandrae Sphenantherae according to the percolation under fluid extract and the extractum item (" 2005 editions appendix IO of Chinese Pharmacopoeia), make solvent with 45% ethanol, 70% ethanol and 60% ethanol of 6 times of amounts respectively, flood and carry out percolation after 24 hours, collect percolate, merge after reclaiming ethanol, be concentrated into the clear paste that relative density is about 1.35 (60 ℃), standby;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds 600 parts of microcrystalline Cellulose, mixing, with 50% ethanol system soft material, pill is drying to obtain.
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 51%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment neurasthenia 32 routine efficacy analysis:
Method: 32 examples are met the patient of CCMD-3 neurasthenia diagnostic criteria, give the medicine micropill treatment, in 4 weeks of the course of treatment,, carry out (TESS) side reaction scale during end and mark respectively at carrying out Self-reporting inventory (SCL-90) evaluation before and after the treatment.
Result: clinical cure rate 53.19%, total effective rate 93.7%.To having sleep disorder, emotion symptom and excited symptom remarkable.
Conclusion: this medicine safety coefficient is big, has no side effect, and patient easily accepts, and is the comparatively ideal medicine of treatment neurasthenia, has alleviated patient's misery greatly.
Embodiment 5:
The weight portion of each component is as follows in the prescription that present embodiment adopted:
Fructus Schisandrae Sphenantherae 520;
Radix Codonopsis 190;
The Radix Astragali 350;
Semen Ziziphi Spinosae (parched) 80.
Present embodiment provides the preparation method of medicine micropill as follows:
1) Radix Codonopsis of described amount is become fine powder with 1/3rd Fructus Schisandrae Sphenantherae powder, standby;
2) with the Radix Astragali of described amount, Semen Ziziphi Spinosae (parched) and remaining 2/3rds Fructus Schisandrae Sphenantherae according to the percolation under fluid extract and the extractum item (" 2005 editions appendix IO of Chinese Pharmacopoeia), make solvent with 45% ethanol, 70% ethanol and 60% ethanol of 10 times of amounts respectively, flood and carry out percolation after 24 hours, collect percolate, merge after reclaiming ethanol, be concentrated into the clear paste that relative density is about 1.35 (60 ℃), standby;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds 500 parts microcrystalline Cellulose, mixing, with 40% ethanol system soft material, pill is drying to obtain.
Medicine micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 51%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill is to side reaction 46 routine observation of curative effect due to the antipsychotic drug:
Method: medicine micropill treatment 46 examples are observed side reaction scale (TESS) and are subtracted the branch situation, and compare with other conventional medicaments because of taking functional lesion patients such as the caused heart of antipsychotic drug, liver, kidney.
The result: medicine micropill treatment group TESS subtracts the branch rate obviously greater than matched group.
Conclusion: medicine micropill is to the caused many internal organs of antipsychotic drug, and the toxicity of multisystem has certain therapeutic effect.Can be used as the clinical adjuvant drug of psychiatric department.
Claims (1)
1. medicine micropill, it is characterized in that: described medicine micropill is by Fructus Schisandrae Sphenantherae 500-600 weight portion, Radix Codonopsis 150-200 weight portion, Radix Astragali 300-400 weight portion, Semen Ziziphi Spinosae (parched) 60-120 weight portion, microcrystalline Cellulose 400-600 weight portion is prepared from as follows:
1) Radix Codonopsis of described amount and the Fructus Schisandrae Sphenantherae powder of 1/3rd described amounts are become fine powder;
2) Fructus Schisandrae Sphenantherae of the Radix Astragali, Semen Ziziphi Spinosae (parched) and remaining 2/3rds described amounts of described amount is made solvent with 70% ethanol of 45% ethanol of 8 times of volumes, 8 times of volumes and 60% ethanol of 8 times of volumes respectively by percolation, flood and carry out percolation after 24 hours, collect percolate, be concentrated into relative density and be 1.30～1.35 clear paste;
3) the step 2) clear paste of gained, the fine powder of adding step 1) gained, mixing, vacuum drying is pulverized, and adds the microcrystalline Cellulose of 400-600 weight portion, and mixing is with the ethanol system soft material of 30-50%, pill.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237055A (en) * | 2016-08-30 | 2016-12-21 | 山东百维药业有限公司 | A kind of its preparation method of the Chinese medicine composition for treating acne |
| CN106310072A (en) * | 2016-08-30 | 2017-01-11 | 山东百维药业有限公司 | Shenqiwuweizi capsules and preparation method thereof |
-
2006
- 2006-06-13 CN CN 200610087400 patent/CN101088530A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237055A (en) * | 2016-08-30 | 2016-12-21 | 山东百维药业有限公司 | A kind of its preparation method of the Chinese medicine composition for treating acne |
| CN106310072A (en) * | 2016-08-30 | 2017-01-11 | 山东百维药业有限公司 | Shenqiwuweizi capsules and preparation method thereof |
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Open date: 20071219 |