CN101088550A - Medicine micropill and its prepn process - Google Patents
Medicine micropill and its prepn process Download PDFInfo
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- CN101088550A CN101088550A CN 200610087399 CN200610087399A CN101088550A CN 101088550 A CN101088550 A CN 101088550A CN 200610087399 CN200610087399 CN 200610087399 CN 200610087399 A CN200610087399 A CN 200610087399A CN 101088550 A CN101088550 A CN 101088550A
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Abstract
The present invention relates to one kind of heart stabilizing medicine micropill and its preparation process. The heart stabilizing medicine micropill is prepared with Dangshen 700-1100 weight portions, solomoseal 1000-1400 weight portions, notoginseng 140-220 weight portions, amber 80-160 weight portions, spikenard 500-700 weight portions, starch 100-300 weight portions, and beta-cyclodextrin 50-200 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. It possesses the functions of benefiting qi, nourishing yin, eliminating palpitate and promoting blood circulation to disperse blood clots.
Description
Technical field
The present invention relates to a kind of pellet preparations and preparation technology thereof, particularly relate to a kind of medicine micropill and preparation technology thereof.
Background technology
The WENXIN KELI that existing market is sold is the national standard WS of National Drug Administration
3-205 (x-029)-99 (z) by forming when Radix Codonopsis, Rhizoma Polygonati, Radix Notoginseng, succinum, Radix Et Rhizoma Nardostachyos five kinds of Chinese medicine, have supplementing QI and nourishing YIN, the multiple arteries and veins of throbbing with fear surely, the effect of blood circulation promoting and blood stasis dispelling.It is early rich etc. to be mainly used in hold concurrently palpitation and uneasiness, shortness of breath and fatigue, dizzy cardiopalmus, feeling of oppression and pain in the chest, arrhythmia, ventricular premature contraction, room due to the heart arteries and veins stasis of blood resistance of deficiency of both QI and YIN clinically.
The WENXIN KELI prescription is as follows: Radix Codonopsis 300g, Rhizoma Polygonati 400g, Radix Notoginseng 60g, succinum 40g, Radix Et Rhizoma Nardostachyos 200g.WENXIN KELI preparation technology is as follows: the above five tastes, and Succinum powder is broken into fine powder, and Radix Et Rhizoma Nardostachyos extracts volatile oil, and the aqueous solution after distillation device is in addition collected; Radix Notoginseng powder is broken into coarse powder, with 80% alcohol reflux twice, and each 2 hours, filter, merging filtrate is evaporated to the clear paste of relative density 1.25～1.30 (60 ℃), Radix Notoginseng, Radix Et Rhizoma Nardostachyos medicinal residues and Radix Codonopsis, Rhizoma Polygonati decocts with water secondary together, and 2 hours for the first time, 1.5 hours for the second time, aqueous solution after collecting decoction and the distillation of above-mentioned Radix Et Rhizoma Nardostachyos, filter, filtrate is concentrated into the clear paste that relative density is 1.20～1.25 (60 ℃), adds ethanol and makes and contain the alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant is evaporated to the clear paste of relative density 1.25～1.30 (60 ℃), merge with the Radix Notoginseng clear paste, mixing adds above-mentioned succinum fine powder, sucrose 518g, beta-schardinger dextrin-100g, aspartame 6.5g, dextrin is an amount of, mixing, make granule, drying, spray Radix et Rhizoma Nardostachyos volatile oil, mixing, make 1000g, promptly.
The granule ubiquity mouthfeel of Chinese medicine is not so good, and the easy moisture absorption of granule is softening, and caking goes mouldy, and poor stability is made troubles for packing, transportation and storage etc., and contained sucrose in the preparations shaping, is unfavorable for that diabetes and obese patient take.
Summary of the invention
, caking softening for the not so good and easy moisture absorption of mouthfeel that solves above-mentioned WENXIN KELI existence goes mouldy, and adopts sucrose in the preparations shaping, is unfavorable for problem and shortage such as diabetes and obese patient take.The invention provides a kind of medicine micropill, and the preparation technology of this micropill is provided.
Technical scheme of the present invention is as follows:
The invention provides a kind of medicine micropill, it is characterized in that: by Radix Codonopsis 700-1100 weight portion, Rhizoma Polygonati 1000-1400 weight portion, Radix Notoginseng 140-220 weight portion, succinum 80-160 weight portion, Radix Et Rhizoma Nardostachyos 500-700 weight portion, starch 100-300 weight portion, beta-schardinger dextrin-50-200 weight portion is prepared from according to following steps:
1) Succinum powder of getting described amount becomes fine powder standby;
2) with the Radix Et Rhizoma Nardostachyos distillating extracting oil of described amount, volatile oil adopts beta-schardinger dextrin-to comprise, dry for standby, and the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder of described amount becomes coarse powder, uses 80% alcohol reflux, merges ethanol extract, filters, and it is standby to be concentrated into relative density and to be 1.20～1.35 clear paste;
4) with step 2) and the medicinal residues of step 3) decoct with water with Radix Codonopsis, the Rhizoma Polygonati of described amount, collecting decoction filters, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, it is 1.1～1.30 clear paste that filtrate is concentrated into relative density, standby;
5) with the clear paste of step 4), add ethanol and make the alcohol amount of containing reach 65% (volume ratio), stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol is concentrated into relative density and is 1.20～1.35 clear paste;
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, described amount starch, and vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 50%～90% ethanol system soft material, pill.
As prioritization scheme, medicine micropill provided by the present invention is by Radix Codonopsis 800-1000 weight portion, Rhizoma Polygonati 1100-1300 weight portion, Radix Notoginseng 150-200 weight portion, succinum 100-140 weight portion, Radix Et Rhizoma Nardostachyos 580-620 weight portion, starch 160-240 weight portion, beta-schardinger dextrin-100-180 weight portion is prepared from according to following steps:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 6 times of volume water, soaked 30 minutes, distillating extracting oil, volatile oil adopt beta-schardinger dextrin-to comprise, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder of described amount becomes coarse powder, with 8 times of volumes, 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, it is standby to be concentrated into relative density and to be 1.20～1.30 clear paste;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 10 times of water gagings decocted 2 hours, for the second time adding 8 times of volume decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.1～1.30 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol is concentrated into relative density and is 1.20～1.25 clear paste;
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch, and vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 65% ethanol system soft material, 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, the curative effect performance is fast, and release is stable, the bioavailability height, local irritation is little, the pill outward appearance is neat and artistic, and the patient is glad to take, and hygroscopicity is little, transport, store, carry etc. all more convenient, has supplementing QI and nourishing YIN, the multiple arteries and veins of throbbing with fear surely, the effect of blood circulation promoting and blood stasis dispelling.Be mainly used in deficiency of both QI and YIN hold concurrently palpitation and uneasiness, shortness of breath and fatigue, dizzy cardiopalmus, feeling of oppression and pain in the chest due to the heart arteries and veins stasis of blood resistance clinically, be applicable to arrhythmia, above-mentioned disease person such as ventricular premature contraction, room are early rich.And to adopt starch in the preparations shaping be adjuvant, do not adopt sucrose, is beneficial to diabetes and the obese patient takes
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits the scope of the invention by any way.
Embodiment 1:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 900;
Rhizoma Polygonati 1200;
Radix Notoginseng 180;
Succinum 120;
Radix Et Rhizoma Nardostachyos 600;
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 6 times of water gagings, soaked 30 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-50 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 8 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.25 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 10 times of water gagings decocted 2 hours, for the second time adding 8 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and it is 1.1～(60 ℃) clear paste that filtrate is concentrated into relative density, standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.20 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 100 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 65% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill is to the curative effect of different TCM Syndrome Type ventricular premature contractions:
Method: selected ventricular premature contraction patient 166 examples are distinguished respectively and are type of deficiency of both QI and YIN 45 examples, type of failure of the heart and kidney integrating 25 examples, liver-kidney yin deficiency 16 examples, stagnation of damp caused by insufficiency of YANG type 34 examples, qi stagnation and blood stasis type 46 examples.The patient all takes 1 bag of medicine micropill, every day 3 times.During unsatisfactory curative effect, dosage adds to 2 bags gradually, every day 3 times.4 weeks of the course of treatment.All patients all make resting electrocardiogram inspection or 24h dynamic ecg recordings examination before and after treatment, carry out various ECG curative effect relatively after finishing the course of treatment.
The result: medicine micropill is 73.49% to ventricular premature contraction resting electrocardiogram total effective rate, is 61.32% to 24h ambulatory electrocardiogram total effective rate.The ECG curative effect of its 5 TCM Syndrome Type relatively has significant difference (P＜0.01, P＜0.05), type of deficiency of both QI and YIN, qi stagnation and blood stasis type, stagnation of damp caused by insufficiency of YANG type three more all have significant difference (P＜0.05 or P＜0.01) respectively and between the type of failure of the heart and kidney integrating, liver-kidney yin deficiency, but there was no significant difference (P＞0.05) relatively between the type of deficiency of both QI and YIN, qi stagnation and blood stasis type, stagnation of damp caused by insufficiency of YANG type three.
Conclusion: medicine micropill has curative effect preferably to ventricular premature contraction, and the curative effect of different TCM Syndrome Type ventricular premature contractions is had notable difference.
Medicine micropill is to the influence of acute exacerbation phase pulmonary heart disease hemorheology and hypercoagulability
Method is selected chronic cardiopulmonary disease acute exacerbation phase patient's 100 examples, is divided into treatment at random and organizes 52 examples, matched group 48 examples.Matched group is according to the conventional therapy way: oxygen uptake, infection, antitussive, eliminate the phlegm, heart tonifying, diuresis etc.; The treatment group gives medicine micropill 1 bag mouth clothes, every day 3 times on the conventional therapy basis.Be for 4 weeks 2 groups of courses of treatment, detect hemorheology, plasma D-dimer content, hemoglobin, packed cell volume, observed and recorded curative effect and side reaction in the treatment before the treatment and after finishing the course of treatment.The total effective rate of treatment group as a result 92.3%, matched group are 68.8%, 2 group relatively significant differences (P＜0.01).The 2 groups of hemorheologys in treatment back all make moderate progress, and the treatment group is improved more remarkable (P＜0.05) than matched group.Treatment group plasma D-dimer content, hemoglobin and hematocrit are than obviously descending (P＜0.05 or P＜0.01) before the treatment, than obviously descend after the treatment of control group (P＜0.05).Treatment group complication and case fatality rate are starkly lower than matched group (P＜0.05), and untoward reaction is slight.
Conclusion: the medicine micropill treatment pulmonary heart disease acute exacerbation phase is evident in efficacy, obviously improve the blood samples of patients rheology, obviously reduce D-dimer, hemoglobin, packed cell volume and Fibrinogen, obviously reduce arrhythmia, pulmonary encephalopathy, shock incidence rate and case fatality rate, improve patient's prognosis.
Embodiment 2:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 700;
Rhizoma Polygonati 1400;
Radix Notoginseng 140;
Succinum 140;
Radix Et Rhizoma Nardostachyos 500;
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 8 times of water gagings, soaked 60 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-100 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 10 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.25 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 8 times of water gagings decocted 2 hours, for the second time adding 6 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.30 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.20 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 160 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 90% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment coronary heart disease merges the ventricular arrhythmia clinical observation on the therapeutic effect
Method: 158 routine coronary heart disease are merged the premature ventricular beat patient that takes place frequently be divided into 3 groups (A, B, C), A group: 1 bag of medicine micropill, every day 3 times; The B group; Mexiletine 150mg changes 100mg into every day 3 times behind the 2w, every day 3 times.The C group: 1 bag of medicine micropill, every day 3 times, mexiletine 150, changes 100mg at every day 3 times behind the 2w.Every day 3 times, be 1 month the course of treatment.
Result: A, B, three groups of effective percentage of C are respectively 70.18%, 66.04%, 93.75%, and two groups of differences of A, B do not have significance (P＜0.05), but A group effective percentage is higher than the B group, and the c group obviously is better than two groups of A, B (P＜0.05).
Conclusion: medicine micropill merges ventricular arrhythmia to coronary heart disease good therapeutical effect, and medicine micropill and mexiletine share, and synergism is arranged, and can obviously improve curative effect.
Medicine micropill treatment tachy-arrhythmia 46 routine observation of curative effect
Method: 92 routine tachy-arrhythmia patients are divided into two groups at random, and 46 examples are organized in treatment.Oral medicine micropill), each 1 bag, 8h1 time, totally 4 weeks.Matched group 46 examples, oral propafenone, each 150mg, 8h1 time, totally 4 weeks.Have an electro-cardiogram and 24h Holter monitoring and evaluation curative effect before and after the medication, monitor adverse effect simultaneously.
The result: medicine micropill group total effective rate is 78.3%, and propafenone group total effective rate is 73.9% (P＞0.05).The medicine micropill group also can significantly be improved patients'blood rheology index.
Conclusion: medicine micropill is a kind of medicine of safe and effective treatment tachy-arrhythmia.
Medicine micropill share the clinical observation of amiodarone treatment Coronary heart disease ventricular early throb
Method: 30 routine oral medicine micropill+amiodarones are organized in treatment, and matched group 30 routine oral amiodarones were for 4 weeks two groups of courses of treatment.All before treatment, stopped using in 1 week other arrhythmias and may influence the medicine of observed result of two groups of patients.
The result: the treatment group is cured 9 examples, produce effects 9 examples, effective 10 examples, invalid 2 examples, total effective rate 93.33% in the recent period; Matched group is cured 3 examples, produce effects 7 examples, effective 11 examples, invalid 9 examples, total effective rate 70.00% in the recent period.Treatment is organized clinical general curative effect and is improved the hemorheology index aspect and all obviously is better than matched group (P (0.05), and treatment is organized average onset time also obviously faster than matched group (P＜0.01).
Conclusion: medicine micropill and amiodarone share the clinical efficacy of treatment Coronary heart disease ventricular early throb and affirm, single is excellent with amiodarone, are worth further research and extension to be used.
Embodiment 3:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 1100;
Rhizoma Polygonati 1000;
Radix Notoginseng 220;
Succinum 120;
Radix Et Rhizoma Nardostachyos 700;
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 10 times of water gagings, soaked 30 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-180 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 12 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.30 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 12 times of water gagings decocted 2 hours, for the second time adding 8 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.35 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.35 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 240 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 50% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment paroxysmal auricular fibrillation observation of curative effect
Method: choose the paroxysmal auricular fibrillation patient of the court 110 examples, at 18 years old～75 years old age, be divided into metancenter ball (micropill) group (62 example) and propafenone group (48 example) at random.The medicine micropill group is given 1 bag of medicine micropill, every day 3 times; Propafenone group is given Propafenone, and each 150mg is oral, every day 3 times, is for 4 weeks the course of treatment.
Result: 1. effective 48 examples of medicine micropill group (77.42%), effective 39 examples of propafenone group (81.25%), two groups of not statistically significants (P＜0.05) relatively; 2. before and after medicine micropill group left ventricular ejection mark (LVEF) treatment statistical significance (P＜0.05) is arranged relatively; Compare not statistically significant (P＞0.05) before and after the propafenone group treatment; 3. medicine micropill group treatment front and back are except that whole blood viscosity (200L/S) and blood plasma viscosity not statistically significant, and other every indexs all have statistical significance.And the equal not statistically significant of the every index of propafenone group; 1. medicine micropill group generation untoward reaction person is 8 examples, and propafenone group is 11 examples, and two groups relatively have statistical significance.
Conclusion: medicine micropill treatment paroxysmal auricular fibrillation curative effect is suitable with Propafenone, but untoward reaction is few, no arrhythmogenic effect.
Medicine micropill is to the influence of patients of acute myocardial infarction heart rate variability
Method: be divided into medicine micropill treatment group (35 example) and matched group (33 example) after 68 routine patients of acute myocardial infarction are admitted to hospital at random.Promptly give each 1 bag of medicine micropill after the treatment group is admitted to hospital, every day 3 times is oral, two groups of all the other treatment measures are identical.2 all two groups of row 24h dynamic ecg recordings examinations after being admitted to hospital are analyzed time domain index SDNN, SDANN, RMSSD, PNNSO, the variation of scatterplot index VLI, VAI.Carry out statistical procedures with paired t-test.
Result: use the medicine micropill treatment can make the time domain index of patients of acute myocardial infarction, scatterplot index that remarkable increase is all arranged.
Conclusion: micropill provided by the present invention, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, uses medicine micropill can improve patient's heart rate variability fast, significantly to patients of acute myocardial infarction, reduces patient's danger.
Embodiment 4:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 1100;
Rhizoma Polygonati 1400;
Radix Notoginseng 150;
Succinum 100;
Radix Et Rhizoma Nardostachyos 500;
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 10 times of water gagings, soaked 60 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-200 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 8 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.35 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 8 times of water gagings decocted 2 hours, for the second time adding 8 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.35 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.35 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 240 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 80% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
The clinical observation of medicine micropill treatment angina pectoris
Method: whole cases are divided into treatment group (30 example) and matched group (30 example) at random, observe the curative effect of medicine micropill to aspects such as patient's angina pectoris, myocardial ischemia electrocardiogram, hemorheologys.
The result: to angina pectoris effective rates group is 86.6%.Matched group is that 70.0%, two group of curative effect difference has significance (P＜0.01); To coronary heart disease and myocardial ischemia electrocardiogram effective percentage, treatment group and matched group are respectively 56.7% and 53.3%, two group of comparing difference does not have significance (P＞0.05); Clinical observation shows that also this medicine has the improvement effect to the hemorheology index whole blood viscosity high value of cutting, plasma fibrinogen and plasma viscosity.
Conclusion: micropill provided by the present invention, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, and term pill for curing angina pectoris is the misery of reduction of patient fast.
Embodiment 5:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 800;
Rhizoma Polygonati 1300;
Radix Notoginseng 150;
Succinum 140;
Radix Et Rhizoma Nardostachyos 580;
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 6 times of water gagings, soaked 60 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-180 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 6 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.30 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 10 times of water gagings decocted 2 hours, for the second time adding 8 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.20 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 80%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.30 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 160 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 70% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment premature ventricular beat clinical observation on the therapeutic effect method: 80 routine patients are on the basis of conventional therapy, inactive antiarrhythmic drug is after at least 5 half-life. give the medicine micropill treatment. and each 1 bag (9g), tid, warm boiled water .4 week is 1 course of treatment.
Result: take medicine micropill after 4 weeks, 86.25% patient's symptom is obviously improved, comparing difference not statistically significant (P＞0.05) is to whole premature ventricular beat patient obvious effective rates 58.75% before lab testing and HR, PR interval, QRS time limit, QT interval and the medication, total effective rate be 86.25%. with treatment before comparing difference statistical significance (P＜0.01) is arranged.30 routine functional premature ventricular beat patient obvious effective rates 70.0% wherein, total effective rate 93.3%.
Conclusion: medicine micropill is for the treatment premature ventricular beat. and especially functional premature ventricular beat is evident in efficacy, and should no obvious adverse reaction.
Embodiment 6:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 1000;
Rhizoma Polygonati 1100;
Radix Notoginseng 200;
Succinum 100;
Radix Et Rhizoma Nardostachyos 620.
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 8 times of water gagings, soaked 30 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-180 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 6 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.20 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 10 times of water gagings decocted 2 hours, for the second time adding 6 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.25 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.25 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 150 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 65% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
WENXIN KELI is to the influence of patients with coronary heart disease heart rate variability and dispersion
Method: 68 routine patients are divided into medicine micropill treatment group 35 example and matched group 33 examples at random.Observe the variation of two groups of treatment front and back SDNN, rMSSD and QTd, QTcd respectively.
The result: relatively preceding with treatment, matched group SDNN obviously increases, and QTd, QTcd obviously reduce; Treatment group SDNN, rMSSD obviously increase, and QTd, QTcd obviously reduce.Relatively SDNN, rMSSD, QTd and QTcd have significant difference (P＜0.01) between two groups after the treatment.
Conclusion: the medicine micropill patients with coronary heart disease HRV that can raise, reduce the QT dispersion, thereby reduce the generation of malignant arrhythmia and sudden cardiac death.
Embodiment 7:
The component that the prescription that medicine micropill that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Codonopsis 800;
Rhizoma Polygonati 1100;
Radix Notoginseng 150;
Succinum 140;
Radix Et Rhizoma Nardostachyos 620.
The preparation method of medicine micropill that present embodiment provides is as follows:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 8 times of water gagings, soaked 60 minutes, distillating extracting oil, volatile oil adopts beta-schardinger dextrin-120 weight portion enclose, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder in described amount becomes coarse powder, with 10 times of amount 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, the clear paste that is concentrated into relative density and is 1.25 (60 ℃) is standby;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 8 times of water gagings decocted 2 hours, for the second time adding 6 times of decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and filtrate is concentrated into the clear paste that relative density is 1.30 (60 ℃), and is standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.20 (60 ℃);
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch 160 weight portions, mixing, vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 50% ethanol system soft material, extruding-round as a ball pill, drying, promptly.
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 56%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Medicine micropill treatment congestive heart failure companion ventricular arrhythmia observation of curative effect
Method: congestive heart failure cardiac function III level～IV level merges ventricular arrhythmia patient 58 examples and is divided into medicine micropill group (A group) and matched group (B group) at random, treated for 4 weeks after, check ultrasoundcardiogram, ambulatory electrocardiogram.
The result: the A group is compared with the B group after treating, and cardiac function improves, ventricular arrhythmia improves all statistical significance (P＜0.05).
Conclusion: medicine micropill is to congestive heart failure companion ventricular arrhythmia patient, curative effect preferably arranged aspect cardiac function, the control room arrhythmia improving.
Claims (2)
1. medicine micropill, it is characterized in that: by Radix Codonopsis 700-1100 weight portion, Rhizoma Polygonati 1000-1400 weight portion, Radix Notoginseng 140-220 weight portion, succinum 80-160 weight portion, Radix Et Rhizoma Nardostachyos 500-700 weight portion, starch 100-300 weight portion, beta-schardinger dextrin-50-200 weight portion is prepared from according to following steps:
1) Succinum powder of getting described amount becomes fine powder standby;
2) with the Radix Et Rhizoma Nardostachyos distillating extracting oil of described amount, volatile oil adopts beta-schardinger dextrin-to comprise, dry for standby, and the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder of described amount becomes coarse powder, uses 80% alcohol reflux, merges ethanol extract, filters, and it is standby to be concentrated into relative density and to be 1.20～1.35 clear paste;
4) with step 2) and the medicinal residues of step 3) decoct with water with Radix Codonopsis, the Rhizoma Polygonati of described amount, collecting decoction filters, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, it is 1.1～1.30 clear paste that filtrate is concentrated into relative density, standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol is concentrated into relative density and is 1.20～1.35 clear paste;
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, described amount starch, and vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 50%～90% ethanol system soft material, pill.
2. according to the described medicine micropill of claim 1, it is characterized in that, by Radix Codonopsis 800-1000 weight portion, Rhizoma Polygonati 1100-1300 weight portion, Radix Notoginseng 150-200 weight portion, succinum 100-140 weight portion, Radix Et Rhizoma Nardostachyos 580-620 weight portion, starch 160-240 weight portion, beta-schardinger dextrin-100-180 weight portion is prepared from according to following steps:
1) Succinum powder of getting described amount becomes fine powder standby;
2) Radix Et Rhizoma Nardostachyos of described amount is suitably broken, add 6 times of volume water, soaked 30 minutes, distillating extracting oil, volatile oil adopt beta-schardinger dextrin-to comprise, dry for standby, the aqueous solution after distillation device is in addition collected, and is standby;
3) Radix Notoginseng powder of described amount becomes coarse powder, with 8 times of volumes, 80% alcohol reflux twice, and each 2 hours, merge alcohol extract, filter, decompression recycling ethanol, it is standby to be concentrated into relative density and to be 1.20～1.30 clear paste;
4) with step 2) and the medicinal residues of step 3) decoct with water twice with Radix Codonopsis, the Rhizoma Polygonati of described amount, adding for the first time 10 times of water gagings decocted 2 hours, for the second time adding 8 times of volume decoctings boiled 1.5 hours, collecting decoction, filter, with above-mentioned steps 2) aqueous solution after the Radix Et Rhizoma Nardostachyos distillation merges, and it is 1.1～1.30 clear paste that filtrate is concentrated into relative density, standby;
5) with the clear paste of step 4), add ethanol and make and contain alcohol amount and reach 65%, stir, left standstill 48 hours, the leaching supernatant, decompression recycling ethanol is concentrated into relative density and is 1.20～1.25 clear paste;
6) clear paste of step 5) and the clear paste of step 3) are merged, mixing adds above-mentioned succinum fine powder, starch, and vacuum drying is ground into fine powder, with the beta-schardinger dextrin-mixing of enclose volatile oil, with 65% ethanol system soft material, pill.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101513439B (en) * | 2009-04-07 | 2012-09-05 | 中国中医科学院望京医院 | Notoginseng sodium hyaluronate gel for preventing from adhesion after spine laminectomy |
| CN104730193A (en) * | 2015-03-31 | 2015-06-24 | 天津中医药大学 | Detection method of volatile component in heart stabilizing particles |
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2006
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101513439B (en) * | 2009-04-07 | 2012-09-05 | 中国中医科学院望京医院 | Notoginseng sodium hyaluronate gel for preventing from adhesion after spine laminectomy |
| CN104730193A (en) * | 2015-03-31 | 2015-06-24 | 天津中医药大学 | Detection method of volatile component in heart stabilizing particles |
| CN104730193B (en) * | 2015-03-31 | 2016-06-22 | 天津中医药大学 | The detection method of volatile ingredient in a kind of WENXIN KELI |
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