CN101332178B - Medicinal preparation for oral darifenacin or medicine salt thereof - Google Patents
Medicinal preparation for oral darifenacin or medicine salt thereof Download PDFInfo
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- CN101332178B CN101332178B CN200810128225XA CN200810128225A CN101332178B CN 101332178 B CN101332178 B CN 101332178B CN 200810128225X A CN200810128225X A CN 200810128225XA CN 200810128225 A CN200810128225 A CN 200810128225A CN 101332178 B CN101332178 B CN 101332178B
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Abstract
The present invention relates to an oral preparation, in particular to a medical preparation containing darifenacin, or darifenacin salt and specific medicinal accessories. The preparation not only takes effect fast to ensure that the medicine is delivered to diseased part at certain speed and keeps certain concentration in body, but also improves the bioavailability and reduces the toxic and side effect of the medicine.
Description
Technical field
The present invention relates to a kind of oral pharmaceutical preparation that is used for, relate in particular to the suitable oral pharmaceutical preparation of a kind of darifenacin or its pharmaceutical salts.
Background technology
Darifenacin or its pharmaceutical salts are a kind of effective muscarinic receptor antagonists, play a role by blocking-up M3 receptor, help to reduce the urinary incontinence outbreak, increase bladder storage urine amount, reduce the frequent micturition number of times, reduce urgent micturition relevant urinate pressure and urgency.In order to increase its bioavailability, ZL96196977.6 discloses the slow releasing preparation of darifenacin or its pharmaceutical salts, though wherein the preparation of the most preferred embodiment embodiment 3 can make medicine be discharged into lower gastrointestinal tract part morely, increase bioavailability of medicament, reduce side effect, could onset but need for a long time, increased the waiting time after the patient takes medicine, greatly increased patient's misery.Need the deficiency of long period onset in order to overcome preparation among the ZL96196977.6, improve bioavailability simultaneously, the present invention has selected suitable adjuvant and proportioning, not only make the very fast onset of preparation, guaranteed that medicine is transported to disease sites and keeps finite concentration in vivo with certain speed, and increased bioavailability, and obtain expected effect, reduced the toxic and side effects of medicine.
Summary of the invention
The present invention aims to provide a kind of pharmaceutical preparation that is suitable for oral administration, it comprises darifenacin or its pharmaceutical salts and pharmaceutic adjuvant, the weight ratio that it is characterized in that darifenacin or its pharmaceutical salts and rapid release adjuvant is 1: 0.4-1.2, with the weight ratio of slow-release auxiliary material be 1: 5.5-17, wherein, the rapid release adjuvant is a lactose, sucrose, glucose, fructose, mannitol, sorbitol, pregelatinized Starch, starch, in dextrin or the microcrystalline Cellulose one or more, slow-release auxiliary material are hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, in the sodium carboxymethyl cellulose one or more.
The weight ratio of preferred darifenacin or its pharmaceutical salts and rapid release adjuvant is 1: 0.5-1.1, the weight ratio of preferred darifenacin or its pharmaceutical salts and slow-release auxiliary material is 1: 7-16.5.
Preferably, when darifenacin or its pharmaceutical salts and rapid release adjuvant weight ratio be 1: during 0.5-1.1, the weight ratio of darifenacin or its pharmaceutical salts and slow-release auxiliary material is 1: 7-16.5.
Preferably in preparation of the present invention, the darifenacin pharmaceutical salts is the form of its hydrobromate, and the rapid release adjuvant is preferably lactose, and slow-release auxiliary material is preferably methylcellulose.The weight ratio that preparation of the present invention is preferably darifenacin hydrobromide and lactose is about 1: 0.51 or 1: 1.02, and the weight ratio of darifenacin hydrobromide and methylcellulose is about 1: 7.17 or 14.34.Preparation of the present invention, the weight ratio that most preferably is darifenacin hydrobromide and lactose is about at 1: 0.51 o'clock, is about 1: 7.17 with the weight ratio of methylcellulose; When the weight ratio of darifenacin hydrobromide and lactose is about 1: 1.02, be about 1: 14.34 with the weight ratio of methylcellulose.
Preparation provided by the invention, ratio by control darifenacin or its pharmaceutical salts and specific pharmaceutic adjuvant, not only can make the part principal agent rapid release of going ahead of the rest reach rapid-action purpose, thereby avoided not reaching the deficiency of treatment concentration onset time prolongation owing to release in the certain hour is too little, and can continue to pass through slow releasing function, greatly improve bioavailability, thereby reduced the untoward reaction of medicine, brought into play the pharmacological action of darifenacin better.1 hour release of preparation of the present invention is 10%-25%; 8 hours release 40%-70%, release was more than or equal to 70% and less than 100% in 24 hours.
Preparation provided by the invention not only can onset within a short period of time, but also has increased the bioavailability of darifenacin, thereby has reduced its toxic and side effects, and this is beat all.
The pharmaceutical preparation of suitable oral administration described here comprises tablet, capsule, pellet etc., preferred tablet, and this tablet can be painted with conventional method.Described pharmaceutical preparation, preferred for preparation become the agent of skeleton matrix, are skeleton with in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, the sodium carboxymethyl cellulose one or more promptly, and darifenacin or its pharmaceutical salts are contained in skeleton.Pharmaceutical preparation provided by the invention is suitable for being administered once every day, and described pharmaceutic adjuvant also comprises the adjuvant that other filleies well known in the art, binding agent, disintegrating agent, lubricant etc. are commonly used.Here the viscosity of hydroxypropyl emthylcellulose preferably is not less than 4000cPa.s, and the viscosity of methylcellulose is preferably 4000cPa.s.
The specific embodiment
To help to understand the present invention by following embodiment, but not limit content of the present invention.
Embodiment 1
Prescription darifenacin hydrobromide 8.90 grams, glucose 3.56 grams, hydroxypropyl emthylcellulose (4000cPa.s) 48.95 grams, magnesium stearate 2g, calcium hydrogen phosphate 37 grams are made 1000 altogether.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and hydroxypropyl emthylcellulose, calcium hydrogen phosphate, glucose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity hydroxypropyl methylcellulose, calcium hydrogen phosphate, the abundant mixing of glucose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 2
Prescription darifenacin hydrobromide 8.90 grams, sucrose 7 grams, mannitol 1.5 grams, sorbitol 2.18 grams, hydroxypropyl cellulose 50.3 grams and methylcellulose (4000cPa.s) 101 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 18 grams are made 1000 altogether.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, hydroxypropyl cellulose, methylcellulose, sucrose, mannitol, sorbitol are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity calcium hydrogen phosphate, hydroxypropyl cellulose, methylcellulose, sucrose, mannitol, the abundant mixing of sorbitol, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 3
Prescription darifenacin hydrobromide 17.86 grams, pregelatinized Starch 9.11 grams, hydroxypropyl emthylcellulose (15000cPa.s) 30 grams, hydroxypropyl cellulose 40 grams and methylcellulose (4000cPa.s) 58.06 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 13 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and 80 mesh sieves are crossed in calcium hydrogen phosphate, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, pregelatinized Starch, and are standby.Take by weighing recipe quantity calcium hydrogen phosphate, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, the abundant mixing of pregelatinized Starch, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 4
Prescription darifenacin hydrobromide 8.90 grams, lactose 9.08 grams, methylcellulose (4000cPa.s) 127.54 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 48 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, methylcellulose, lactose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity methylcellulose, calcium hydrogen phosphate, the abundant mixing of lactose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 5
Prescription darifenacin hydrobromide 8.90 grams, lactose 4 grams and microcrystalline Cellulose 3.12 grams, sodium carboxymethyl cellulose 87.22 grams, magnesium stearate 2 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and sodium carboxymethyl cellulose, lactose and microcrystalline Cellulose are crossed 80 mesh sieves, and be standby.Take by weighing the abundant mixing of recipe quantity sodium carboxymethyl cellulose, lactose and microcrystalline Cellulose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 6
Prescription darifenacin hydrobromide 8.90 grams, starch 5 grams, dextrin 4.79 grams, hydroxypropyl cellulose 146.85 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 20 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, hydroxypropyl cellulose, starch, dextrin are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity calcium hydrogen phosphate, hydroxypropyl cellulose, starch, the abundant mixing of dextrin, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 7
Prescription darifenacin hydrobromide 8.90 grams, lactose 8.01 grams, methylcellulose (4000cPa.s) 111.25 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 20 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, methylcellulose, lactose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity methylcellulose, calcium hydrogen phosphate, the abundant mixing of lactose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 8
Prescription darifenacin hydrobromide 8.93 grams, lactose 6.43 grams, methylcellulose (4000cPa.s) 84.8 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 50 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, methylcellulose, lactose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity methylcellulose, calcium hydrogen phosphate, the abundant mixing of lactose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 9
Prescription darifenacin hydrobromide 17.86 grams, lactose 9.08 grams, methylcellulose (4000cPa.s) 128 grams, magnesium stearate 2 grams, calcium hydrogen phosphate 43 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, methylcellulose, lactose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity methylcellulose, calcium hydrogen phosphate, the abundant mixing of lactose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 10 (relatively using quick-release tablet)
Prescription darifenacin hydrobromide 17.86 grams, lactose 200 grams, starch 80g, magnesium stearate 2 grams, calcium hydrogen phosphate 43 grams are prepared into 1000 in tablet.
The preparation darifenacin hydrobromide is crossed 100 mesh sieves, and calcium hydrogen phosphate, starch, lactose are crossed 80 mesh sieves, and be standby.Take by weighing recipe quantity calcium hydrogen phosphate, starch, the abundant mixing of lactose, add the darifenacin hydrobromide of recipe quantity again, evenly mixed.Get the recipe quantity magnesium stearate and add above powder, mixing.Use φ 8mm scrobicula to dash, the heavy and pressure of adjustment sheet, tabletting.
Embodiment 11 (relatively using)
Preparation according to 3 preparations of embodiment among the ZL96196977.6.
The mensuration of embodiment 12 release in vitro degree
Embodiment 1-9 and 11 preparation are measured its release in vitro degree according to drug release determination method (2005 editions two appendix X D of Chinese Pharmacopoeia, first method).Adopt the device of dissolution method (two appendix X of appendix Chinese Pharmacopoeia version in 2005 C) first method, release medium is water 900ml, rotating speed is that per minute 100 changes, operation in accordance with the law, got solution 5ml respectively at 1 hour, 8 hours, 24 hours, filter with microporous filter membrane, subsequent filtrate is as need testing solution.Precision takes by weighing the about 10mg of darifenacin hydrobromide reference substance, puts in the 100ml measuring bottle, adds that ethanol 10ml is ultrasonic to make dissolving, and thin up shakes up to scale, and precision is measured 5ml and put in the 50ml measuring bottle, and thin up shakes up to scale, in contrast product solution.
Measure need testing solution, each 20gl of reference substance solution respectively, measure with the HPLC method.Octadecylsilane chemically bonded silica is a filler; Methanol-phosphate buffer (is got sodium dihydrogen phosphate (NaH
2PO
42H
2O) 1.56g adds water and dissolves in right amount, adds triethylamine 2.5ml, adds water to 1000ml, shake up, and with phosphoric acid adjust pH to 3.6, (55:45) be mobile phase promptly); The detection wavelength is 230nm.Number of theoretical plate is not less than 2000 by the darifenacin hydrobromide peak; The separating degree of darifenacin hydrobromide peak and adjacent impurity peaks should meet the requirements.Press external standard method with every release of calculated by peak area in different time points.The result of release in vitro degree is as follows:
| 1 hour release (%) | 8 hours releases (%) | 24 hours releases (%) | |
| Embodiment 1 | 10.1 | 40.3 | 71.0 |
| Embodiment 2 | 20.3 | 58.5 | 87.2 |
| Embodiment 3 | 14.1 | 54.1 | 85.9 |
| Embodiment 4 | 16.9 | 58.7 | 92.0 |
| Embodiment 5 | 15.9 | 49.6 | 88.7 |
| Embodiment 6 | 23.9 | 66.1 | 94.5 |
| Embodiment 7 | 13.9 | 53.1 | 87.6 |
| Embodiment 8 | 16.5 | 55.9 | 91.6 |
| Embodiment 9 | 13.6 | 36.8 | 86.5 |
| Embodiment 11 | 5.9 | 38．0 | 83．2 |
The result shows that 1 hour release of preparation provided by the invention is 10%-25%, 8 hours release 40%-70%, and release was more than or equal to 70% and less than 100% in 24 hours.From above-mentioned data as can be seen, 1 hour release is significantly greater than the release of embodiment among the ZL96196977.6 3 at 1 hour, thereby onset is very fast, and can continue to bring into play by slow releasing function the pharmacological action of darifenacin.
Embodiment 13 clinical prodrugs are for dynamic test
Experimental animal
6 of Beagle Canis familiaris L.s, male, at 9～1O monthly age, healthy one-level is provided by Military Medical Science Institute's animal center, carries out pre-raising of two weeks after buying.The raising condition: raise separately with metal Canis familiaris L. cage, freely drink water, give the granule dog feed, 25 ± 1 ℃ of room temperatures, humidity 60 ± 10%, illumination 150～200Lx, light and shade replaced in 12 hours, noise＜50dB.Body weight 10～11kg when being used to test.
The design of binary cycle dual crossing random experiment is adopted in test, to offset the influence to result of the test of test period and individual variation.6 Beagle Canis familiaris L.s are divided into 2 groups at random, every group 3, fasting 12 hours, give 1 in the tablet of embodiment 9 one group of morning, before administration, get blank blood, behind the medicine 0.5h, 1h, 1.5h, 2h, 4h, 6h, 8h, 10h, 12h, 16h and 24h extracting vein blood 3ml in anticoagulant tube, separated plasma, put-20 ℃ and place survey fully, but 2 hours feedings after the administration; Another group gives 1 in the tablet of embodiment 10, get blank blood before the administration, in obeying back 15min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h and 12h extracting vein blood 3ml in anticoagulant tube, separated plasma, put-20 ℃ and place survey fully, but 2 hours feedings after the administration.10 days clean after dates, blood sample is collected in two treated animal cross matchings as stated above.
Tablet (R) AUC of the tablet of embodiment 9 (T) and embodiment 10 is compared as follows:
Ratio＝AUC
0-t/AUC
0-∞×100％
The AUC of two kinds of preparations
0-t/ AUC
0-∞* 100%＞80%, meet the requirement of pharmacokinetic studies.
According to the AUC value of the quick-release tablet of the tablet (T) of embodiment 9 and embodiment 10, calculate the relative bioavailability (F) of the tablet of embodiment 9, i.e. F=AUC (T)/AUC (R) * 100%.The relative bioavailability F of the tablet of embodiment 9 (T) presses AUC
0-tCalculate F
0-tBe 115.36 ± 8.39%; Press AUC
0-∞Calculate F
0-∞Be 109.89 ± 9.12%.
Data show that preparation provided by the invention is compared with quick releasing formulation, and bioavailability significantly improves.
Claims (9)
1. pharmaceutical preparation that is suitable for oral administration, it is by darifenacin or its pharmaceutical salts, the rapid release adjuvant, slow-release auxiliary material, magnesium stearate and calcium hydrogen phosphate are formed, the weight ratio that it is characterized in that darifenacin or its pharmaceutical salts and rapid release adjuvant is 1: 0.4-1.2, with the weight ratio of slow-release auxiliary material be 1: 5.5-17, the rapid release adjuvant is 0.4 with the ratio of slow-release auxiliary material: 5.5-1.1: 16.5, wherein, the rapid release adjuvant is a lactose, sucrose, glucose, mannitol, sorbitol, pregelatinized Starch, starch, in the dextrin one or more, slow-release auxiliary material are hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, in the sodium carboxymethyl cellulose one or more.
2. the described preparation of claim 1, the weight ratio of darifenacin or its pharmaceutical salts and rapid release adjuvant is 1: 0.5-1.1.
3. claim 1 or 2 described preparations, the weight ratio of darifenacin or its pharmaceutical salts and slow-release auxiliary material is 1: 7-16.5.
4. the described preparation of claim 1, wherein the rapid release adjuvant is a lactose, slow-release auxiliary material is a methylcellulose.
5. the described preparation of claim 4, wherein the darifenacin pharmaceutical salts is a darifenacin hydrobromide.
6. the described preparation of claim 5, the weight ratio of darifenacin hydrobromide and lactose is 1: 0.51 or 1: 1.02.
7. the described preparation of claim 5, the weight ratio of darifenacin hydrobromide and methylcellulose is 1: 7.17 or 1: 14.34.
8. the described preparation of claim 5, the weight ratio of darifenacin hydrobromide and lactose is 1: 0.51, the weight ratio of darifenacin hydrobromide and methylcellulose is 1: 7.17.
9. the described preparation of claim 5, the weight ratio of darifenacin hydrobromide and lactose is 1: 1.02, the weight ratio of darifenacin hydrobromide and methylcellulose is 1: 14.34.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810128225XA CN101332178B (en) | 2007-06-29 | 2008-06-30 | Medicinal preparation for oral darifenacin or medicine salt thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710118125.4 | 2007-06-29 | ||
| CN 200710118125 CN101084891A (en) | 2007-06-29 | 2007-06-29 | Darifenacin or its pharmaceutical salt pharmaceutical preparation for oral |
| CN200810128225XA CN101332178B (en) | 2007-06-29 | 2008-06-30 | Medicinal preparation for oral darifenacin or medicine salt thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101332178A CN101332178A (en) | 2008-12-31 |
| CN101332178B true CN101332178B (en) | 2010-12-15 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200710118125 Pending CN101084891A (en) | 2007-06-29 | 2007-06-29 | Darifenacin or its pharmaceutical salt pharmaceutical preparation for oral |
| CN200810128225XA Expired - Fee Related CN101332178B (en) | 2007-06-29 | 2008-06-30 | Medicinal preparation for oral darifenacin or medicine salt thereof |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200710118125 Pending CN101084891A (en) | 2007-06-29 | 2007-06-29 | Darifenacin or its pharmaceutical salt pharmaceutical preparation for oral |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107811980B (en) | 2009-10-30 | 2021-06-18 | Ix 生物医药有限公司 | Fast dissolving solid dosage form |
| CN102600096B (en) * | 2011-12-29 | 2016-08-10 | 北京科信必成医药科技发展有限公司 | A kind of darifenacin slow releasing preparation and preparation method thereof |
| CN104814939A (en) * | 2015-05-21 | 2015-08-05 | 中国药科大学 | Novel solifenacin succinate preparation suitable for oral administration |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1195984A (en) * | 1995-09-15 | 1998-10-14 | 辉瑞研究及发展公司 | Pharmaceutical formulations containing darifenacin |
| CN1604777A (en) * | 2001-12-14 | 2005-04-06 | 诺瓦提斯国际药物有限公司 | Method of treatment |
-
2007
- 2007-06-29 CN CN 200710118125 patent/CN101084891A/en active Pending
-
2008
- 2008-06-30 CN CN200810128225XA patent/CN101332178B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1195984A (en) * | 1995-09-15 | 1998-10-14 | 辉瑞研究及发展公司 | Pharmaceutical formulations containing darifenacin |
| CN1604777A (en) * | 2001-12-14 | 2005-04-06 | 诺瓦提斯国际药物有限公司 | Method of treatment |
Non-Patent Citations (4)
| Title |
|---|
| 毕殿洲.药剂学 第四版.人民卫生出版社,1999,316-321. |
| 毕殿洲.药剂学 第四版.人民卫生出版社,1999,316-321. * |
| 颜耀东.缓释控释制剂的设计与开发 第1版.中国医药科技出版社,2006,55，70，73. |
| 颜耀东.缓释控释制剂的设计与开发 第1版.中国医药科技出版社,2006,55,70,73. * |
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| Publication number | Publication date |
|---|---|
| CN101084891A (en) | 2007-12-12 |
| CN101332178A (en) | 2008-12-31 |
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