CN103340836A - Panax notoginoside pulsatile controlled release tablet prescription and preparation method thereof - Google Patents
Panax notoginoside pulsatile controlled release tablet prescription and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a panax notoginoside pulsatile controlled release tablet prescription and a preparation method thereof. The panax notoginoside pulsatile controlled release tablet disclosed by the invention has a function of releasing medicines through pulses at regular time. A core of the tablet consists of panax notoginoside, sodium carboxymethyl starch as a disintegrating agent, lactose a filling agent, magnesium stearate as a lubricating agent and 75% ethanol as a wetting agent according to effective treatment amounts; and a coating of the tablet consists of eudragit L100 and ethylcellulose according to a ratio of 1.5:1. The finished product prepared by the preparation method disclosed by the invention can release medicines at regular time, and the production process is simple and is suitable for mass production.
Description
Technical field
The present invention relates to prescription of a kind of XUESAITONG pulsatile release tablets and preparation method thereof, belong to field of pharmaceutical preparations.
Background technology
The Incidence of CHD height, hazardness is big, and its prevention and treatment are one of problem of medical circle emphasis tackling key problem for many years always.The main component of XUESAITONG PIAN is Radix Notoginseng total arasaponins, improves the regional myocardial microcirculation, corrects myocardial ischemia, thereby reaches the purpose for the treatment of myocardial ischemia.The research of XUESAITONG drop pill, dispersible tablet, injection has successfully solved the problem of quick-effective preparation.Yet desirable therapeutic drug of coronary heart disease not only needs quick-effective preparation, but also need change characteristics according to the biorhythm of human body, according to the needs of physiology and the treatment novel drug-supplying system of release at regular time and quantity.XUESAITONG coating pulsatile release tablets is in conjunction with the novel drug-supplying system preparation of the requirement of clinical needs and modern medicinal agents dosage form.External existing pulsatile release tablets listing.Domestic research in this respect at present still is in the starting stage, yet there are no this type of formulation products listing.The pulse timing medicine-releasing system of research and development treatment coronary heart disease has become pressing for and development trend of the modernization of Chinese medicine, causes domestic and international expert's concern day by day.
Summary of the invention
The prescription and the preparation method that the purpose of this invention is to provide a kind of new XUESAITONG pulsatile release tablets, the pulse timing medicine-releasing system of exploitation treatment coronary heart disease.
The concrete technical scheme of the present invention is as follows:
XUESAITONG pulsatile release tablets of the present invention is made up of label and coating.Its label comprises Radix Notoginseng total arasaponins, disintegrating agent, filler, lubricant and the wetting agent of effective therapeutic dose.Wherein disintegrating agent is carboxymethyl starch sodium, and filler is lactose, and lubricant is magnesium stearate, and wetting agent is 75% ethanol.Coating is that polyacrylic resin L100 (Eudragit L100) and ethyl cellulose are formed by a certain percentage.
Per 1000 label of XUESAITONG pulsatile release tablets of the present invention is write out a prescription as follows:
Per 1000 label of XUESAITONG pulsatile release tablets of the present invention is write out a prescription as follows:
Per 1000 label of XUESAITONG pulsatile release tablets of the present invention is write out a prescription as follows:
Per 1000 label of XUESAITONG pulsatile release tablets of the present invention is write out a prescription as follows:
Per 1000 label of XUESAITONG pulsatile release tablets of the present invention is write out a prescription as follows:
Per 1000 coating fluid prescription of XUESAITONG pulsatile release tablets of the present invention is as follows:
XUESAITONG pulsatile release tablets of the present invention, its preparation method may further comprise the steps:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
Discover that by external release the time lag time of the XUESAITONG pulsatile release tablets of the present invention's preparation can reach more than the 6h, and conventional tablet expands rapidly in gastric juice, medicine discharges substantially fully in 3 hours.
Find by pharmacokinetic, with commercially available conventional tablet be matched group, the relative bioavailability of XUESAITONG pulsatile release tablets of the present invention is Cmax, AUC between 102.12%, two group
0-∝T assay P＞0.05, show that pulse-controlled release preparations do not have obviously influence to reach peak concentration, the bioavailability etc. of medicine, and the more commercially available conventional tablet significant prolongation of release time lag of XUESAITONG coating pulse sheet, peak time lag behind (P＜0.01).
Above experimental result shows that XUESAITONG pulsatile release tablets of the present invention compares commercially available conventional tablet and can reach the purpose that discharges medicine at regular time and quantity.
Description of drawings
The drug release of Fig. 1 four kinds of new system XUESAITONG pulsatile release tablets and commercially available ordinary tablet compares, and A: example 1 makes; B: example 2 makes; C: example 3 makes; D: example 4 makes; E: commercially available ordinary tablet.
Fig. 2 blood drug level and curve, blood drug level are that the summation with ginsenoside Rb1, ginsenoside Rg1, three kinds of materials of arasaponin R1 is that Radix Notoginseng total arasaponins calculates.
The specific embodiment
Following embodiment is convenient to understand better the present invention, but does not limit the present invention.
Exemplifying embodiment 1
1. write out a prescription
1000 label prescription is as follows:
1000 coating fluid prescription is as follows:
2 preparation processes:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
Exemplifying embodiment 2
1. write out a prescription
1000 label prescription is as follows:
1000 coating fluid prescription is as follows:
2 preparation processes:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
Exemplifying embodiment 3
1. write out a prescription
1000 label prescription is as follows:
1000 coating fluid prescription is as follows:
2 preparation processes:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
Exemplifying embodiment 4
1. write out a prescription
1000 label prescription is as follows:
1000 coating fluid prescription is as follows:
2 preparation processes:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
The external release of exemplifying embodiment 5 XUESAITONG pulsatile release tablets and commercially available ordinary tablet relatively
The external release of four kinds of XUESAITONG pulsatile release tablets that treating excess syndrome executes that example 1,2,3,4 makes and commercially available ordinary tablet compares
The release experiment is with reference to " Chinese pharmacopoeia version appendix in 2010 the XC three therapeutic methods of traditional Chinese medicine (little agar diffusion method) rotating speed 100r/min, temperature is 37 ℃ ± 0.5 ℃, get XUESAITONG pulsatile release tablets or commercially available ordinary tablet, be release medium with hydrochloric acid (9 → 1000) earlier, place the 250mL medium, behind the running 2h, be release medium with phosphate buffer (pH6.8).Respectively 2,4,6,10, the 14h 5mL that takes a sample, filter, and in time replenish the equal volume respective media.Concentrating sample liquid is used the 1ml dissolve with methanol as required, and 0.45 μ m filtering with microporous membrane namely gets need testing solution.Adopt high performance liquid chromatography that the Radix Notoginseng total arasaponins in the test sample is measured, high-efficient liquid phase chromatogram condition is: chromatographic column: Agilent C
18(250mm * 4.6mm, 5um), mobile phase: water-acetonitrile, gradient elution, 0～25min, acetonitrile 18%～38%, 25～30min, acetonitrile 38%; Column temperature: 25 ℃, the detection wavelength is 203nm, and flow velocity is 1.0mlmin
-1, sample size is 20 μ l.Theoretical cam curve is not less than 20000.The record chromatogram is pressed external standard method with calculated by peak area.Press
Calculate the cumulative release percentage rate Q of Radix Notoginseng total arasaponins, C is for discharging index constituent concentration (μ g/mL) in the liquid; V is the volume (mL) of release medium; D is extension rate; W is the weight (mg) of tablet; F is the percentage composition (%) of index components in preparation.
The cumulative release rate of the Radix Notoginseng total arasaponins of more commercially available ordinary tablet and XUESAITONG pulsatile release tablets.
2 results
Experimental result sees that the drug release of description Fig. 1 four kinds of new system XUESAITONG pulsatile release tablets and commercially available ordinary tablet compares.
Show that according to Fig. 1 result the time lag time of the XUESAITONG pulsatile release tablets of four kinds of new systems can reach more than the 6h, and conventional tablet expands rapidly in gastric juice, medicine discharges substantially fully in 3 hours.Prove absolutely that XUESAITONG pulsatile release tablets of the present invention compares commercially available conventional tablet and can reach the purpose that discharges medicine at regular time and quantity.
The comparison of exemplifying embodiment 6 XUESAITONG pulse slow-releasing sheets and commercially available ordinary tablet pharmacokinetic parameters
1, method
1.1 experiment grouping and medication
Adopt single dose binary cycle trial design.6 rabbit are divided into two groups at random, and the 1st group (tested number 1-3) feeds commercially available conventional tablet, feeds self-control XUESAITONG pulse sheet for the 2nd group, and twice dosing interval is a week.Fasting 12h before the experiment, in 8:00 administration in early morning, full wafer is swallowed.The few oils and fats food of feeding is not limit drinking-water behind the administration 6h.Gavage commercially available conventional tablet group in 0,0.5,1.0,1.5,2.0,2.5,3,4,5,6,8,10,12,24h extracts each 3mL of forelimb venous blood, gavage XUESAITONG pulse sheet group in 0,2,2.5,3,3.5,4,4.5,5,5.5,6,7,8,10,12,24h gets blood 3mL, to the heparinization centrifuge tube, centrifugal immediately, separate upper plasma,-20 ℃ of preservations, the blood supply concentration is measured.
1.2 blood sample is handled
Precision is measured 500 μ L pastille blood plasma and is placed 3mL tool plug centrifuge tube, the accurate 500 μ L acetonitriles that add, and vortex fully mixes back 6 * 10
3Rmin
-1Centrifugal 10min gets supernatant, and 500 μ L dichloromethane vortexs fully mix back 6 * 10
3Rmin
-1Centrifugal 10min gets the supernatant sample introduction.
1.3 ginsenoside Rb1, ginsenoside Rg1, three kinds of material release in vitro of arasaponin R1 degree detect
Detect ginsenoside Rb1, ginsenoside Rg1, three kinds of material release in vitro of arasaponin R1 degree by high-efficient liquid phase color, chromatographic condition and system suitability, chromatographic column: Agilent C18 (250mm * 4.6mm, 5um), mobile phase: mobile phase: water-acetonitrile, gradient elution, 0～25min, acetonitrile 18%～38%, 25～30min, acetonitrile 38%; Column temperature: 25 ℃, the detection wavelength is 203nm, and flow velocity is 1.0mlmin-1, and sample size is 20 μ l.Theoretical cam curve is not less than 20000.
The accurate absorption contains the ginsenoside Rb1, the ginsenoside Rg1, arasaponin R1 is respectively 1.5mgml-1,1.5mgml-1,0.4mgml-1 reference substance solution 2.0,5.0,8.0,10.0,20.0,30.0,40.0 μ L injects chromatograph of liquid, the record chromatogram, peak area (A) is to concentration (C, μ gml-1) carries out linear regression analysis, the ginsenoside Rb1, the ginsenoside Rg1, the standard curve equation of arasaponin R1 is respectively Y=325.4X-22.33 (r=0.99997, n=7), Y=589.9X+19.65 (r=0.99996, n=7) and Y=197.6X+31.28 (r=0.99998, n=7).
2, result
Blood drug level-time graph: the healthy rabbits single dose gavages the plasma concentration curve of commercially available conventional tablet and XUESAITONG pulse coating sustained-release tablet and sees Fig. 2, described blood drug level is that the summation with ginsenoside Rb1, ginsenoside Rg1, three kinds of materials of arasaponin R1 is that Radix Notoginseng total arasaponins calculates, and computational methods are consistent with the release in vitro degree.Adopt 3P97 pharmacokinetics software that blood drug level-time data is analyzed, and obtain serial pharmacokinetic parameters, relative bioavailability is calculated with formula.The major impetus mathematic(al) parameter t assay of two kinds of preparations sees Table 1:
The major impetus mathematic(al) parameter t assay of two kinds of preparations of table 1
Annotate: Tmax: peak reaching time of blood concentration, Cmax: reach peak concentration, Tlag: time lag time, AUC
0-∝: lower area of blood concentration-time curve, MRT: mean residence time in the body, Relative B.A: relative bioavailability.
Be matched group with commercially available conventional tablet, the relative bioavailability of XUESAITONG pulsatile release tablets is Cmax, AUC between 102.12%, two group
0-∝T assay P＞0.05, show that pulse-controlled release preparations do not have obviously influence to reach peak concentration, the bioavailability etc. of medicine, and the more commercially available conventional tablet significant prolongation of the release time lag of XUESAITONG pulsatile release tablets, peak time lag behind (P＜0.01).
Claims (9)
1. an XUESAITONG pulsatile release tablets is characterized in that, is made up of label and coating, and label comprises effective treatment amount Radix Notoginseng total arasaponins, disintegrating agent, filler, lubricant and wetting agent; Wherein disintegrating agent is carboxymethyl starch sodium, and filler is lactose, and lubricant is magnesium stearate, and wetting agent is 75% ethanol; Coating is that polyacrylic resin L100 (Eudragit L100) and ethyl cellulose are formed by a certain percentage.
2. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that the prescription of per 1000 label is as follows:
3. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that the prescription of per 1000 label is as follows:
4. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that the prescription of per 1000 label is as follows:
5. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that the prescription of per 1000 label is as follows:
6. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that the prescription of per 1000 label is as follows:
7. XUESAITONG pulsatile release tablets according to claim 1 is characterized in that per 1000 coating fluid prescription is as follows:
。
8. according to claim 1 and 7 described XUESAITONG pulsatile release tablets, its feature coating solution is that the mass ratio of polyacrylic resin L100 (Eudragit L100) and ethyl cellulose is 1.5: 1.
9. according to the described XUESAITONG pulsatile release tablets of claim 1, it is characterized in that preparation method may further comprise the steps:
(1) preparation of label
Taken by weighing Radix Notoginseng total arasaponins, carboxymethyl starch sodium, the lactose mix homogeneously of crossing 100 mesh sieves 3 times respectively according to recipe quantity, make soft material with 75% ethanol, cross 24 mesh sieves and granulate, after 50～60 ℃ of dryings, cross 24 mesh sieve granulate, add the magnesium stearate mixing, regulate thickness and pressure, direct pressed powder, compacting heavily is about 150mg in flakes, every contains the label that Radix Notoginseng total arasaponins is about 50mg, makes 1000 altogether.
(2) preparation of coating pulse sheet
The dehydrated alcohol of certain volume is added to tool plug grinding triangular bottle, puts on the agitator, stir on the limit, the limit adds coating material Eudragit L100, is mixed with that to contain substrate concentration admittedly be 5% (w/v), after waiting to dissolve, add a certain amount of ethyl cellulose, continue to stir, get coating solution.Label is placed in the coating pan, and preheating 15min, rotating speed are 30r/min, adjust the angle of inclination, and tablet is evenly stirred, and the coating solution of getting above-mentioned preparation is the 0.5ml/min coating with spray gun spray speed, coating weightening finish 9%.Place 50 ℃ of baking oven baking 5h to remove residual solvent coated tablet.Quality * 100% before coating weightening finish (%)=(the preceding quality of quality-coating behind the coating)/coating.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103800301A (en) * | 2013-12-27 | 2014-05-21 | 深圳市健元医药科技有限公司 | Pulsatile delivery composition for treating diabetes mellitus and preparation method thereof |
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| CN1762400A (en) * | 2004-09-24 | 2006-04-26 | 贵阳云岩西创药物科技开发有限公司 | 'Xuesaitong' formulation and its preparation method |
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2013
- 2013-07-03 CN CN2013102761587A patent/CN103340836A/en active Pending
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| CN1634245A (en) * | 2004-09-24 | 2005-07-06 | 贵阳云岩西创药物科技开发有限公司 | Formulation for dredging thrombus and its preparing method |
| CN1762400A (en) * | 2004-09-24 | 2006-04-26 | 贵阳云岩西创药物科技开发有限公司 | 'Xuesaitong' formulation and its preparation method |
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Application publication date: 20131009 |