CN1530104A - Sustained releasing talbets for radioactive and chemical therpay and preparation thereof - Google Patents
Sustained releasing talbets for radioactive and chemical therpay and preparation thereof Download PDFInfo
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- CN1530104A CN1530104A CNA031197639A CN03119763A CN1530104A CN 1530104 A CN1530104 A CN 1530104A CN A031197639 A CNA031197639 A CN A031197639A CN 03119763 A CN03119763 A CN 03119763A CN 1530104 A CN1530104 A CN 1530104A
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Abstract
A slow-releasing micropill 'Angdansiqiong' for treating the vomiting caused by chemicotherapy or radiotherapy is composed of pill core, enclosing layer, slow-releasing layer and surficial enclosing layer. It is prepared from Angdansiqiong as core (6.4-7.8 wt.%), acrylic resin (3.1-3.8), pore-forming agent (0.5-1.1), antisticking agent (0.6-1.1) and filler (86.2-89.3). Its advantages are durable action (more than 24 hr) and high curative effect.
Description
Technical field
The present invention relates to that a kind of treatment is put, the slow-release micro-pill of emesis of chemotherapy and preparation method thereof.
Background technology
Method treatment cancer with radiotherapy or chemotherapy is accompanied by undesirable side effect usually, and nausea and vomiting makes the patient be difficult to stand, and produces fear.Nausea and vomiting can be divided into acute, chronic and three kinds of predictabilitys after the chemotherapy, and ondansetron is 5-HT
3The strong selectivity blocker of receptor all has above several nausea and vomitings and to put in advance and therapeutical effect.
At present, the common formulations of this medicine has injection, ordinary tablet and capsule clinically, after patient's vomiting outbreak in a single day, needs frequent drug administration, all makes troubles for patient and nursing staff, and sustained-release preparation can reduce administration number of times, thereby increases compliance of patients.Therefore taking the slow/controlled release preparation to the patient in advance will be a very good medication.
The oral usual amounts of ondansetron is 8mg/ time, and 3 times/day, pharmacokinetic studies shows that the terminal elimination half-life of the human body of ondansetron is 2.5-5.4h, therefore can not keep this medicine for a long time in blood in human body in medicine valid density, influences the therapeutic effect of this medicine.There is result of study to show that ondansetron is necessary to make the slow/controlled release preparation, to guarantee under the prerequisite that reduces patient's medication number of times, to keep the effective blood drug concentration of longer time.
Summary of the invention
The object of the present invention is to provide a kind of micropill with treatment chemicotherapy vomiting of slow-release function, it can keep ondansetron for a long time in blood in human body in medicine valid density.Another object of the present invention is to provide the preparation method of this slow-release micro-pill.
A kind of ondansetron slow-release micro-pill for the treatment of the chemicotherapy vomiting, each component is formed from inside to outside and is contained pill core, pastille confining bed not, sustained-release coating layer and seal-coat layer (not pastille confining bed and seal-coat layer wherein can be arranged, can be not pastille confining bed and seal-coat layer).Contain following component (below be weight percentage):
Ondansetron 6.4%-7.8%
Acrylic resin 3.1%-3.8%
Porogen 0.5%-1.1%
Antiplastering aid 0.6%-1.1%
Other filler 86.2%-89.3%
Wherein ondansetron ball core can be prepared by following three kinds of preparation methoies:
Method one is mixed by 50%-70% microcrystalline Cellulose, 25%-40% lactose and 5-10% ondansetron, and preparation contains pill core in extruding spheronizator.
Method two, the model that adopts NP PHARM company to produce in ebullated bed is the celphere of PF008, the outside comprises the medicine confining bed, makes ondansetron ball core.Containing pill core is made up of following component:
Ondansetron 5%-10%
Celphere 89%-90%
Hydroxypropyl emthylcellulose 1-5%
Method three, in centrifugal granulating coating machine, the model of producing with NP PHARM company is that the celphere of PF006 is a parent nucleus, the outside comprises the medicine confining bed, makes ondansetron ball core.Containing pill core is made up of following component:
Ondansetron 5%-10%
Celphere 50%-70%
Sucrose 10%-20%
Microcrystalline Cellulose 9%-20%
Hydroxypropyl emthylcellulose 1%-5%
Sustained-release coating layer can be made up of following component:
Acrylic resin 50%-90%
Porogen 5%-25%
Antiplastering aid 5%-25%
Can be from the ratio of Eudragit E udragit NE30D and Eudragit E udragit FS30D 100: 0,95: 5,90: 10,80: 20, choose any one kind of them as the sustained release coating material in 70: 30.The seal-coat layer is made up of following component:
Hydroxypropyl emthylcellulose 55%-90%
Antiplastering aid 10%-45%
Wherein celphere is that NP PHARM company produces, and commodity are called SUGLETS, and model is PF008 and PF006, and by the sucrose of 62.5%-91.5%, all the other compositions are that corn starch is formed.Antiplastering aid can be Pulvis Talci, Kaolin, magnesium stearate, silicon dioxide or titanium dioxide.Porogen is lactose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and Polyethylene Glycol PEG4000, polyethylene glycol 6000, PVP, sucrose is chosen any one kind of them in the mannitol or two or more mixture.
Acrylic resin is Eudragit NE30D, Eudragit FS30D.
Eudragit NE30D is ethyl acrylate-methyl methacrylate latex solution, and molecular weight is about 80000.Its structural formula is:
Eudragit FS30D is acrylic acid-acrylic acid methyl ester .-methyl methacrylate latex solution.Its structural formula is:
The specific embodiment
The preparation method of treatment chemicotherapy vomiting slow-release micro-pill of the present invention, form by following steps successively:
(1) contains the preparation of pill core
Method one: crude drug is crossed 100 mesh sieves, with equivalent progressively increase dilution method and microcrystalline Cellulose mixing, then with the lactose mixing.Add an amount of distilled water and make soft material, make micropill on the spheronizator extruding, 55 ℃ of dryings 3 hours, sieve is got 18-24 order micropill in order to coating.
Method two:
(a) preparation of medicated layer coating suspension
(1) preparation of suspension: 2-10 was restrained hydroxypropyl emthylcellulose in 20-120ml80-90 ℃ of distilled water immersion 2-8 hour, add 0.2-10 gram antiplastering aid and 100-180ml95% ethanol then, stir, 200 mesh sieves filter.
(2) preparation of pastille coating suspension: 2-6 is restrained ondansetron add the 55-160ml95% dissolve with ethanol, add the 6.0-47ml suspension again, stir.
(b) preparation of pastille confining bed
After the model that adopts NP PHARM company to produce is the celphere 50-150 gram drying of PF008, that 63-215ml medicated layer coating suspension spray coating is in celphere, and then dry.
Method three:
The preparation of binding agent: 10 gram hydroxypropyl emthylcelluloses in 40ml80-90 ℃ of distilled water immersion 2 hours, are added 160ml water then, stir.
Ondansetron, MCC and Icing Sugar are crossed 60 mesh sieve mix homogeneously in 1.2: 10: 10 ratios, in centrifugal granulating coating machine, taking by weighing 140g places for the powder chamber, the model of producing with 200g NP PHARM company is that the celphere of PF006 is a parent nucleus, with the suspension is binding agent, and the ratio of regulating whitewashing speed and confession powder speed is about 1: 1.The following parameter engine speed 180r/min that immobilizes, jet flow 17L/min, whiff pressure 0.5Mpa, air blast flux 8 * 20L/min.Make micropill continue rolling 2min in pot after supplying powder to finish, dry naturally the back that takes the dish out of the pot.
(2) the not preparation of pastille confining bed
Use the 5-18ml suspension, spray coating is in containing pill core, drying in ebullated bed.
(3) preparation of sustained release coating liquid
The 2-4g porogen is dissolved in water, adds 2-4g antiplastering aid and acrylic resin aqueous dispersion 12-24g then, add water to 50-100g, stir, 200 mesh sieves filter.
(4) preparation of sustained-release coating layer
With 5-18ml sustained release coating liquid, spray coating in ebullated bed.Or with 100-300ml sustained release coating liquid, spray coating in centrifugal granulating coating machine, drying.
(5) preparation of seal-coat layer
With the 5-18ml suspension in ebullated bed spray coating, drying.
Wherein antiplastering aid has been crossed 200 mesh sieves.
Spray coating carries out in ebullated bed coating machine, and the working condition of ebullated bed coating machine is baking temperature 20-25 ℃, and atomisation pressure is 0.8---3.0bar, and the wriggling pump speed is 0.2-5ml/min.
Spray coating carries out in centrifugal granulating coating machine, and the working condition of centrifugal granulating coating machine is engine speed 180r/min, jet flow 17L/min, whiff pressure 0.5-3bar, air blast flux 8 * 20L/min.
The present invention treats the slow-release micro-pill of chemicotherapy vomiting and can effectively keep more than 24 hours in vitro tests, compare with ondansetron, can suitably control the rate of release of medicament, can prolong this medicine the keeping of blood medicine valid density in carcinosis radiotherapy and chemotherapy patient body, improve the therapeutic effect of this medicine.
Embodiment 1
(1) contains the preparation of pill core
See the preparation method one that contains pill core.
(2) the not preparation of pastille confining bed
The preparation of suspension: 2 gram hydroxypropyl emthylcelluloses in 20ml80-90 ℃ of distilled water immersion 2 hours, are added 0.2 gram antiplastering aid and 100ml95% ethanol then, stir, 200 mesh sieves filter.
To contain pill core 50g, after 50 ℃ of dryings, that 5ml suspension ebullated bed spray coating is in celphere, and then dry.
(3) preparation of sustained release coating liquid
The 2.4g porogen is dissolved in water, adds 1.8g antiplastering aid and acrylic resin aqueous dispersion (NE30D) 16g then, add water to 60g.Stir, 200 mesh sieves filter.
(4) preparation of sustained-release coating layer
With 18ml sustained release coating liquid, under 23 ℃, continue spray coating in ebullated bed, drying.
(5) preparation of seal-coat layer
Continue spray coating in ebullated bed, drying with the 5ml suspension.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
Embodiment 2
(1) contains the preparation of pill core
(1) preparation of medicated layer coating suspension
(a) preparation of suspension: 2 gram hydroxypropyl emthylcelluloses in 20ml 80-90 ℃ distilled water immersion 2 hours, are added 0.2 gram antiplastering aid and 100ml95% ethanol then, stir, 200 mesh sieves filter.
(b) preparation of pastille coating suspension: 4.5 gram ondansetrons are added the 55ml95% dissolve with ethanol, add the 6.0ml suspension again, stir.
(2) preparation of pastille confining bed
After the model that adopts NP PHARM company to produce is the celphere 50 gram dryings of PF008, that 63ml medicated layer coating suspension spray coating is in celphere, and then dry.
(2) the not preparation of pastille confining bed
To contain pill core 50g, after the drying, that 63ml suspension ebullated bed spray coating is in celphere, and then dry.
(3) preparation of sustained release coating liquid
The 2.4g porogen is dissolved in water, adds 1.8g antiplastering aid and acrylic resin aqueous dispersion Eudragit NE30D 16g then, add water to 60g, stir, 200 mesh sieves filter.
(4) preparation of sustained-release coating layer
With 15ml sustained release coating liquid, continue spray coating in ebullated bed, drying.
(5) preparation of seal-coat layer
Continue spray coating in ebullated bed, drying with the 5ml suspension.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
Embodiment 3
(1) contains the preparation of pill core
See the preparation method one that contains pill core.
(2) the not preparation of pastille confining bed
The preparation of suspension: 2 gram hydroxypropyl emthylcelluloses in 20ml80-90 ℃ of distilled water immersion 2 hours, are added 0.2 gram antiplastering aid and 80ml95% ethanol then, stir, 200 mesh sieves filter.
To contain pill core 50g, after 23 ℃ of dryings, that 63ml suspension ebullated bed spray coating is in celphere, and then dry.
(3) preparation of sustained release coating liquid
The 2.4g porogen is dissolved in water, add then 1.8g antiplastering aid and acrylic resin aqueous dispersion (Eudragit NE30D: Eudragit NE30D FS30D=90: 10) 16g, add water to 60g, stir, 200 mesh sieves filter.
(4) preparation of sustained-release coating layer
With 15ml sustained release coating liquid, continue spray coating in ebullated bed, drying.
(5) preparation of seal-coat layer
Continue spray coating in ebullated bed, drying with the 5ml suspension.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
Embodiment 4
(1) contains the preparation of pill core
See the preparation method one that contains pill core.
(2) the not preparation of pastille confining bed
The preparation of suspension: 6 gram hydroxypropyl emthylcelluloses in 20ml80-90 ℃ of distilled water immersion 2 hours, are added 0.2 gram antiplastering aid and 80ml95% ethanol then, stir, 200 mesh sieves filter.
To contain pill core 50g, after 23 ℃ of dryings, that 63ml suspension ebullated bed spray coating is in celphere, and then dry.
(3) preparation of sustained release coating liquid
The 2.4g porogen is dissolved in water, and (Eudragit NE30D: Eudragit NE30D FS30D=95: 5), stir, 200 mesh sieves filter to add 1.8g antiplastering aid and acrylic resin aqueous dispersion then.
(4) preparation of sustained-release coating layer
With 15ml sustained release coating liquid, continue spray coating in ebullated bed, drying.
(5) preparation of seal-coat layer
Continue spray coating in ebullated bed, drying with the 5ml suspension.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
Embodiment 5
(1) contains the preparation of pill core
See the preparation method three that contains pill core.
(2) preparation of sustained release coating liquid
The 12g porogen is dissolved in water, adds 9g antiplastering aid and acrylic resin aqueous dispersion EudragitNB30D 80g then, add water to 300g, stir, 200 mesh sieves filter.
(3) preparation of sustained-release coating layer
300g is contained pill core in the pelletize centrifuge, and the spray rate of regulating sustained release coating liquid is 8ml/min, sprays 120ml altogether.The following parameter engine speed 180r/min that immobilizes, jet flow 17L/min, whiff pressure 0.5Mpa, air blast flux 8 * 20L/min.After finishing, coating make micropill in pot, continue rolling 2min, drying.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
Embodiment 6
(1) contains the preparation of pill core
See the preparation method one that contains pill core.
(2) the not preparation of pastille confining bed
The preparation of suspension: 2 gram hydroxypropyl emthylcelluloses in 20ml80-90 ℃ of distilled water immersion 2 hours, are added 0.2 gram antiplastering aid and 80ml95% ethanol then, stir, 200 mesh sieves filter.
After will containing pill core 90g drying, that 114ml suspension ebullated bed spray coating is in celphere, and then dry.
(3) preparation of sustained release coating liquid
The 2.4g porogen is dissolved in water, adds 1.8g antiplastering aid and acrylic resin aqueous dispersion Eudragit NE30D 16g then, add water to 60g, stir, 200 mesh sieves filter.
(4) preparation of sustained-release coating layer
With 40ml sustained release coating liquid, continue spray coating in ebullated bed, drying.
(5) preparation of seal-coat layer
Continue spray coating in ebullated bed, drying with the 11ml suspension.Promptly get white slow-release pill, the present invention treats the slow-release micro-pill of chemicotherapy vomiting.
The test of embodiment 7 releases
Get the slow-release micro-pill that makes among the embodiment 1,3, be numbered sample 1, sample 3.
With reference to 2000 editions two drug release determination methods of Chinese Pharmacopoeia (Chinese Pharmacopoeia version appendix in 2000 XD), the release medium volume is 900ml, select distilled water for use, simulated gastric fluid, simulated intestinal fluid and be simulated gastric fluid in preceding two hours, after to change simulated intestinal fluid into be dissolution medium, basket rotating speed 100rpm, temperature is 37.0 ± 0.5 ℃ of take a sample at regular intervals 5ml and in time additional medium 5ml, with the filtering with microporous membrane of sample with 0.8 μ m, discard filtrate just, measure according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2000), precision is measured 10ul and is injected chromatograph of liquid, the record chromatogram.With calculated by peak area, calculate each time point release by external standard method.
Measurement result such as table 1 are shown in 2.
Table 1 slow-release micro-pill sample number into spectrum 1 release test of the present invention
| Sample time | Average cumulative discharges percentage ratio (%) | |||
| Distilled water | Simulated gastric fluid | Simulated intestinal fluid | Simulated intestinal fluid behind the earlier artificial gastric juice | |
| 2 | ?20.4 | ?15.2 | ?10.6 | ?15.2 |
| 3 | ?33.2 | ?25.3 | ?15.4 | ?20.3 |
| 6 | ?60.5 | ?50.2 | ?34.2 | ?44.6 |
| 12 | ?84.6 | ?80.5 | ?60.5 | ?70.4 |
| 18 | ?99.6 | ?96.8 | ?73.8 | ?83.9 |
Table 1 slow-release micro-pill sample number into spectrum 3 releases test of the present invention
| Sample time | Average cumulative discharges percentage ratio (%) | |||
| Distilled water | Simulated gastric fluid | Simulated intestinal fluid | Simulated intestinal fluid behind the earlier artificial gastric juice | |
| ?2 | ?19.2 | ?12.2 | ?17.1 | ?14.2 |
| ?3 | ?24.7 | ?18.8 | ?25.3 | ?22.7 |
| ?6 | ?47.6 | ?42.5 | ?47.6 | ?45.9 |
| ?12 | ?78.4 | ?68.7 | ?82.4 | ?76.5 |
| ?18 | ?92.8 | ?83.6 | ?93.9 | ?87.4 |
Prove that this slow-release micro-pill is in the external slow release purpose that can reach 24 hours.
Claims (9)
1, a kind of treatment put, the Ondansetron Hydrochloride slow-release micro-pill of chemotherapy, it is characterized in that micropill from inside to outside by contain pill core, pastille confining bed, sustained-release coating layer and seal-coat layer are not formed (not pastille confining bed and seal-coat layer can wherein, can there be not pastille confining bed and seal-coat layer), ondansetron ball core 6.4%-7.8% wherein, acrylic resin 3.1-3.8%, porogen 0.5-1.1%, antiplastering aid 0.6-1.1% the rest is filler (being weight percentage).
2, Ondansetron Hydrochloride slow-release micro-pill as claimed in claim 1 is characterized in that ondansetron ball core can be prepared by following three kinds of preparation methoies:
Method one is mixed by 50%-70% microcrystalline Cellulose, 25%-40% lactose and 5-10% ondansetron, and preparation contains pill core in extruding spheronizator.
Method two, the model that adopts NP PHARM company to produce in ebullated bed is the celphere of PF008, the outside comprises the medicine confining bed, makes ondansetron ball core.
Method three, in centrifugal granulating coating machine, the model of producing with NP PHARM company is that the celphere of PF006 is a parent nucleus, the outside comprises the medicine confining bed, makes ondansetron ball core.
3, Ondansetron Hydrochloride slow-release micro-pill as claimed in claim 1, it is characterized in that can be from the ratio of Eudragit E udragit NE30D and Eudragit E udragit FS30D 100: 0,95: 5,90: 10,80: 20, choose any one kind of them as the sustained release coating material in 70: 30.
4, Ondansetron Hydrochloride slow-release micro-pill as claimed in claim 1 is characterized in that porogen can be from lactose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, Polyethylene Glycol PEG4000, polyethylene glycol 6000, PVP, sucrose is chosen any one kind of them in the mannitol or more than one mixture.
5, Ondansetron Hydrochloride slow-release micro-pill as claimed in claim 1 is characterized in that antiplastering aid can be Pulvis Talci, Kaolin, magnesium stearate, silicon dioxide, in the titanium dioxide any one.
6, slow-release micro-pill as claimed in claim 1 is characterized in that sustained-release coating layer is made up of following component:
Acrylic resin 50%-90%
Porogen 5%-25%
Antiplastering aid 5%-25%
7, slow-release micro-pill as claimed in claim 1 is characterized in that not pastille confining bed, and the seal-coat layer is made up of following component:
Hydroxypropyl emthylcellulose 55%-90%
Antiplastering aid 10%-45%
8, a kind of method for preparing the described slow-release micro-pill of claim 1: it is characterized in that suspension spray coating, exsiccant method in ebullated bed are not adopted in the preparation of pastille confining bed, the preparation of sustained-release coating layer can be adopted sustained release coating liquid spray coating or with sustained release coating liquid coating in centrifugal granulating coating machine in the ebullated bed machine, the seal-coat layer prepare the method that adopts suspension spray coating in the ebullated bed machine.
9, preparation method as claimed in claim 8, oneself crosses 200 mesh sieves to it is characterized in that antiplastering aid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031197639A CN1530104A (en) | 2003-03-11 | 2003-03-11 | Sustained releasing talbets for radioactive and chemical therpay and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031197639A CN1530104A (en) | 2003-03-11 | 2003-03-11 | Sustained releasing talbets for radioactive and chemical therpay and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1530104A true CN1530104A (en) | 2004-09-22 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031197639A Pending CN1530104A (en) | 2003-03-11 | 2003-03-11 | Sustained releasing talbets for radioactive and chemical therpay and preparation thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100423779C (en) * | 2006-09-27 | 2008-10-08 | 中国药科大学 | Medicinal composition comprising active components of 5-HT 3 receptor antagonist and H2 receptor antagonist and use thereof |
| US8512751B2 (en) | 2004-12-20 | 2013-08-20 | Collegium Pharmaceutical, Inc. | Pharmaceutical compositions for sleep disorders |
| CN107625740A (en) * | 2016-07-18 | 2018-01-26 | 北京科信必成医药科技发展有限公司 | A kind of Ondansetron is anhydrous to swallow particle |
-
2003
- 2003-03-11 CN CNA031197639A patent/CN1530104A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8512751B2 (en) | 2004-12-20 | 2013-08-20 | Collegium Pharmaceutical, Inc. | Pharmaceutical compositions for sleep disorders |
| CN100423779C (en) * | 2006-09-27 | 2008-10-08 | 中国药科大学 | Medicinal composition comprising active components of 5-HT 3 receptor antagonist and H2 receptor antagonist and use thereof |
| CN107625740A (en) * | 2016-07-18 | 2018-01-26 | 北京科信必成医药科技发展有限公司 | A kind of Ondansetron is anhydrous to swallow particle |
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