CN101352440B - Guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release preparation and preparation method thereof - Google Patents
Guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a compound preparation which can be slowly released in the body, maintain stable blood concentration, has the advantages of high efficiency and safety, is conveniently taken and is used for treating cold. The compound preparation adopts unique slow release technique and preparation technique, utilizes polymer material with different viscosities for water absorption and expansion to form a gradient slope gel layer, and sustained release tablets which are taken for once every 12 hours, so that the detention time of the medicine in the body is deferred, and long residual action exists, thereby reducing the times for taking medicine as well as toxicity and side effects. The compound preparation has simple medical prescription and mature technique, and is easy to realize industrial production.
Description
Technical field
The invention belongs to technical field of medicine, relate to particularly a kind of dosage form composition of guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release preparation and the preparation technology of said preparation thereof.
Background technology
The upper respiratory diseases such as cold, flu, cough are a kind of modal multiple diseases.Flu is divided into upper respiratory tract infection (upper sense) and influenza (influenza), and the latter's infectiousness is strong, propagates rapidly.Influenza is the actute infection of the upper respiratory tract mucosa that caused by a lot of dissimilar viruses.The morbidity of flu is more anxious, and General Symptoms often has heating, headache, fear of cold, fatigue and weak etc.; Shed tears often with watery nasal discharge in the part, sneeze, nose, laryngopharynx swelling and pain, hoarseness and cough, excessive phlegm.There is no at present the practicable method of preventing and treating for flu (comprising influenza).Mainly to remove nasal congestion, reduce nasal discharge, alleviate the symptom such as fever and headache to the treatment of flu.At present, also do not have a kind of folk prescription medicine can solve all these symptoms.Therefore, just had many take antipyretic analgesic, alleviate nasal congestion medicine, cough medicine, expectorant and antihistaminic as the compound preparation of the most frequently used constituent.Have in the compound sustained-released tablet recipe of the applicant's development: nasal mucosa vasoconstrictor-pseudoephedrine hydrochloride, central antitussive-dextromethorphan hydrobromide, expectorant-guaifenesin.
By drug effect, toxicological test finds that these three kinds of medicine prescriptions have no obvious antagonism and synergism on interacting, and its toxicity has no obvious enhancing and weakens.And the drug effect aspect, various pharmacological actions are each other also without significantly strengthening and antagonism.Show separately distinctive effect, each other without significantly impact, and each prescription used time effect is more simple, and compound preparation can make its range of application more extensive, is conducive to improve expectorant, coughs, and usually the symptom such as breathes heavily and the respiratory tract disease of depositing.
It is as follows that the product identical with this compound preparation composition researched and developed situation both at home and abroad: " beautiful pearl coughs pleasure " (Dextromethorphan Hydrobromide Compound Tablets) that have LiZhu Medicine Group Co., Ltd to produce of domestic present listing, the each 1-2 sheet of oral adult, every day 3 times; " the Lei Dengtai oral liquid " that Xinan Pharmaceutical Co., Ltd. produces (the more husky fragrant oral liquid of fiber crops) becomes the each 10ml of human oral, every day 3-4 time.At present, China there is no the compound slow release preparation listing of these three kinds of ingredients, for improving curative effect of medication, reduce day medication number of times and a gastrointestinal side effect, facilitating clinical application, has developed the guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet.
Summary of the invention
the invention provides a kind of guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release tablet, this slow releasing tablet is take the solubility of hypromellose and/or ethyl cellulose and/or polyacrylic resin class and/or polycarboxy ethene and/or alginic acid/insoluble salt as slow-release material, these slow-release materials can be that hypromellose for example includes the extensive stock of hypromellose (HPMC) such as U.S. many elegant (Methocel) of all size, ethyl cellulose for example includes the extensive stock of ethyl cellulose (EC), the polyacrylic resin class for example includes polyacrylic resin II, the acrylic resin of III class or analog such as all size (Eudragit).Other adjuvant is binding agent (solid content 0.5%～1.5%): can adopt polyvinylpyrrolidone, hypromellose, starch slurry, syrup, dextrin, rubber cement or their mixture; Diluent (consumption is generally by total formulation weight amount 1.2%～2.2%): can adopt lactose, starch, sucrose, pregelatinized Starch, microcrystalline Cellulose, dextrin, mannitol, sorbitol, calcium sulfate or their mixture; Lubricant (consumption is generally by total formulation weight amount 0.3%～1.0%): can adopt magnesium stearate, calcium stearate, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, Stepanol MG, sodium lauryl sulphate or their mixture; Fluidizer (consumption is generally by total formulation weight amount 0.5%～2.0%): can adopt micropowder silica gel, Pulvis Talci; Wetting agent (consumption is generally by total formulation weight amount 15%～30%): can adopt ethanol, ethanol water, water; Coating materials (weightening finish 2%～4%): can adopt hypromellose, Pulvis Talci, titanium dioxide, Polyethylene Glycol, propylene glycol, ethanol water or their mixture.Eutectic phenomenon when preparation technology adopts granulation respectively or isolation feeding method to avoid particle drying.
Can access desirable release profiles after the compositions tabletting of three kinds of medicines and selected adjuvant, make in three kinds of medicine bodies, the dependency of outer release is good.Thereby can the interior situation about discharging of enough release in vitro curve prediction bodies.The compositions of best adjuvant forms and needs preferably to obtain by orthogonal test or even test.The consumption of concrete slow-release material is: hypromellose 15000 centipoise consumptions are by total formulation weight amount 16%～25%; Hypromellose 4000 centipoise consumptions are by total formulation weight amount 18%～28%; The ethyl cellulose consumption is by total formulation weight amount 15%～20%; Hypromellose 4000 centipoises and hypromellose 50 centipoise ratios can change between 10:1, preferably are selected in 6:1 (hypromellose 4000 centipoises and hypromellose 50 centipoise total amounts are by total formulation weight amount 14%～22%).
According to " Chinese Pharmacopoeia 2005 version appendix XIX D slow release, controlled release and slowbreak preparation guideline are determined the limit of release in vitro, and whether namely first sample point is used for investigating medicine prominent releasing; Second point is middle sample point, is used for determining drug release feature; Whether last sample point is used for investigating release substantially complete.These 3 can be used for characterizing external slow releasing preparation drug release rate.The rate of release of this preparation is: 1 hour: the release of pseudoephedrine hydrochloride is between 20%～50%; The release of dextromethorphan hydrobromide is between 15%～40%; The release of guaifenesin is between 15%～40%.3 hours: the release of pseudoephedrine hydrochloride was between 50%～80%; The release of dextromethorphan hydrobromide is between 40%～60%; The release of guaifenesin is between 40%～60%.8 hours: the release of pseudoephedrine hydrochloride was greater than 80%; The release of dextromethorphan hydrobromide is greater than 75%; The release of guaifenesin is greater than 75%.
The preparation method of the oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet of the present invention comprises crosses 80-100 mesh sieves with raw material and excipient, and mixing is standby; By the prescription proportioning with guaifenesin with by the excipient of total formulation weight amount 70%, by adding suitable amount of adhesive after the abundant mixing of equivalent incremental method, make soft material 1 with 24 mesh sieves; Pseudoephedrine hydrochloride and dextromethorphan hydrobromide and by the excipient of total formulation weight amount 30% by adding suitable amount of adhesive after the abundant mixing of equivalent incremental method, are made soft material 2 with 24 mesh sieves; With soft material 1 and soft material 2, obtained respectively granule 1 and granule 2 in 2-4 hours in 45 ℃ of dryings; With with granule 1 and granule 2 use equivalent incremental method mix homogeneously, with 20 mesh sieve granulate, add lubricant, mixing, compress tablet coating.
The present invention compared with prior art has following advantage: adopt unique slow release method, utilize the hypromellose imbibition of different viscosities to form the release that the gradient gel layer is controlled medicine, make the vitro release of pseudoephedrine hydrochloride within 2 hours less than 50%, guaifenesin and dextromethorphan hydrobromide are external at 0-12 hours synchronizes release; If this compound preparation uses common wet granulation and drying process, can not obtain dry granule, thus can not tabletting, the present invention adopts and granulates respectively or the eutectic phenomenon of isolation feeding method when avoiding particle drying, and tabletting can be carried out smoothly; Make every slow releasing tablet of taking once in 12 hours, not only overcome the shortcoming of blood concentration fluctuation in the gastrointestinal side effect of the oral rear generation of ordinary preparation and body but also can delay the medicine holdup time in vivo, have more long-lasting, thereby reduced number of times and the toxic and side effects of medication.In addition, this compound preparation prescription is simple, and technical maturity is easy to realize suitability for industrialized production.
Description of drawings
Fig. 1 a is the release profiles of pseudoephedrine hydrochloride in embodiment 1.
Fig. 1 b is the release profiles of dextromethorphan hydrobromide in embodiment 1.
Fig. 1 c is the release profiles of guaifenesin in embodiment 1.
Fig. 2 a is the release profiles of pseudoephedrine hydrochloride in embodiment 2.
Fig. 2 b is the release profiles of dextromethorphan hydrobromide in embodiment 2.
Fig. 2 c is the release profiles of guaifenesin in embodiment 2.
Fig. 3 a is the release profiles of pseudoephedrine hydrochloride in embodiment 3.
Fig. 3 b is the release profiles of dextromethorphan hydrobromide in embodiment 3.
Fig. 3 c is the release profiles of guaifenesin in embodiment 3.
Fig. 4 a is the release profiles of pseudoephedrine hydrochloride in embodiment 4.
Fig. 4 b is the release profiles of dextromethorphan hydrobromide in embodiment 4.
Fig. 4 c is the release profiles of guaifenesin in embodiment 4.
Fig. 5 a is the release profiles of pseudoephedrine hydrochloride in embodiment 5.
Fig. 5 b is the release profiles of dextromethorphan hydrobromide in embodiment 5.
Fig. 5 c is the release profiles of guaifenesin in embodiment 5.
Fig. 6 a is the release profiles of pseudoephedrine hydrochloride in embodiment 6.
Fig. 6 b is the release profiles of dextromethorphan hydrobromide in embodiment 6.
Fig. 6 c is the release profiles of guaifenesin in embodiment 6.
Fig. 7 a is the release profiles of pseudoephedrine hydrochloride in embodiment 7.
Fig. 7 b is the release profiles of dextromethorphan hydrobromide in embodiment 7.
Fig. 7 c is the release profiles of guaifenesin in embodiment 7.
Fig. 8 a is the release profiles of pseudoephedrine hydrochloride in embodiment 8.
Fig. 8 b is the release profiles of dextromethorphan hydrobromide in embodiment 8.
Fig. 8 c is the release profiles of guaifenesin in embodiment 8.
Fig. 9 a is the release profiles of pseudoephedrine hydrochloride in embodiment 9.
Fig. 9 b is the release profiles of dextromethorphan hydrobromide in embodiment 9.
Fig. 9 c is the release profiles of guaifenesin in embodiment 9.
Figure 10 a is the release profiles of pseudoephedrine hydrochloride in embodiment 10.
Figure 10 b is the release profiles of dextromethorphan hydrobromide in embodiment 10.
Figure 10 c is the release profiles of guaifenesin in embodiment 10.
Figure 11 a is the release profiles of pseudoephedrine hydrochloride in embodiment 11.
Figure 11 b is the release profiles of dextromethorphan hydrobromide in embodiment 11.
Figure 11 c is the release profiles of guaifenesin in embodiment 11.
Curve when Figure 12 a is the medicine of zoopery pseudoephedrine hydrochloride in embodiment 2.
Figure 12 b is curve during the nor-right U.S. husky medicine of zoopery oxygen in embodiment 2.
Curve when Figure 12 c is the medicine of zoopery guaifenesin in embodiment 2.
The specific embodiment
Be described in further detail the present invention below with reference to embodiment, described embodiment only is used for purpose of the present invention is described, and does not limit the present invention in any way.Should be appreciated that, all improvement of the present invention, change, variant, modification and equivalent are all within the scope of the present invention.
Embodiment 1
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hypromellose 60RT4000130g, hypromellose 60RT5013g, diluent: pregelatinized Starch 8.0g, microcrystalline Cellulose 8.0g, binding agent: 4% hypromellose 60RT550% alcoholic solution 230g, fluidizer or lubricant: magnesium stearate 7g, Pulvis Talci 7g.The release profiles of medicine is seen Fig. 1 a, Fig. 1 b, Fig. 1 c.
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hypromellose 60RT4000120g, hypromellose 60RT5020g, diluent: pregelatinized Starch 7.5g, microcrystalline Cellulose 7.5g, binding agent: 4% hypromellose 60RT550% alcoholic solution 225g, fluidizer or lubricant: magnesium stearate 7g, Pulvis Talci 7g.The release profiles of medicine is seen Fig. 2 a, Fig. 2 b, Fig. 2 c.Releases phenomenon without prominent after the guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet of the oral embodiment 2 of Beagle Canis familiaris L., the peak time of three kinds of medicines is respectively: dextrophan is that 3.57 ± 0.99 hours, guaifenesin are that 2.39 ± 0.24 hours, pseudoephedrine hydrochloride are 2.59 ± 0.24 hours.
Embodiment 3
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hypromellose 60RT4000100g, hypromellose 60RT5050g, diluent: pregelatinized Starch 7.5g, microcrystalline Cellulose 7.5g, binding agent: 4% hypromellose 60RT550% alcoholic solution 220g, fluidizer or lubricant: magnesium stearate 7g, Pulvis Talci 7g.The release profiles of medicine is seen Fig. 3 a, Fig. 3 b, Fig. 3 c.
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: ethyl cellulose 60RT400090g, hypromellose 60RT5050g, diluent: lactose 15g, binding agent: 5% polyvinylpyrrolidone 50% alcoholic solution 218g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 5g.The release profiles of medicine is seen Fig. 4 a, Fig. 4 b, Fig. 4 c.
Embodiment 5
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: sodium alginate 210g, calcium alginate 60g, diluent: lactose 10g, binding agent: 5% polyvinylpyrrolidone 50% alcoholic solution 216g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 5g.The release profiles of medicine is seen Fig. 5 a, Fig. 5 b, Fig. 5 c.
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hydroxypropyl methylcellulose 60RT15000145g, diluent: microcrystalline Cellulose 15g, pregelatinized Starch 30g, binding agent: 4% hypromellose 60RT550% alcoholic solution 230g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 5g.The release profiles of medicine is seen Fig. 6 a, Fig. 6 b, Fig. 6 c.
Embodiment 7
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hydroxypropyl methylcellulose 60RT15000250g, diluent: microcrystalline Cellulose 15g, pregelatinized Starch 20g, binding agent: 4% hypromellose 60RT550% alcoholic solution 258g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 10g.The release profiles of medicine is seen Fig. 7 a, Fig. 7 b, Fig. 7 c.
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hydroxypropyl methylcellulose 60RT4000162g, diluent: microcrystalline Cellulose 10g, pregelatinized Starch 30g, binding agent: 3% ethyl cellulose 80% alcoholic solution 245g, fluidizer or lubricant: magnesium stearate 7g, Pulvis Talci 7g.The release profiles of medicine is seen Fig. 8 a, Fig. 8 b, Fig. 8 c.
Embodiment 9
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: hydroxypropyl methylcellulose 60RT4000280g, diluent: microcrystalline Cellulose 7.5g, pregelatinized Starch 7.5g, binding agent: 4% hydroxypropyl methylcellulose 60RT550% alcoholic solution 262g, fluidizer or lubricant: magnesium stearate 7g, Pulvis Talci 7g.The release profiles of medicine is seen Fig. 9 a, Fig. 9 b, Fig. 9 c.
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: ethyl cellulose 132g, diluent: microcrystalline Cellulose 10g, pregelatinized Starch 30g, binding agent: 3% ethyl cellulose 80% alcoholic solution 216g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 5g.The release profiles of medicine is seen Figure 10 a, Figure 10 b, Figure 10 c.
Embodiment 11
A kind of oral guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet, its formula is every 1000 and contains following material: crude drug: guaifenesin 600mg, pseudoephedrine hydrochloride 60mg, dextromethorphan hydrobromide 30mg, excipient has: slow-release material: ethyl cellulose 175g, diluent: microcrystalline Cellulose 7.5g, pregelatinized Starch 7.5g, binding agent: 4% hydroxypropyl methylcellulose 60RT550% alcoholic solution 210g, fluidizer or lubricant: magnesium stearate 5g, Pulvis Talci 5g.The release profiles of medicine is seen Figure 11 a, Figure 11 b, Figure 11 c.
The assay method of slow releasing tablet
Get the slow releasing tablet of above-described embodiment 1～11 preparation according to drug release determination method (Chinese Pharmacopoeia version appendix XD in 2000), adopt dissolution method (Chinese Pharmacopoeia version appendix XC in 2000), take 1000mL water as release medium, rotating speed is per minute 100 to turn, and temperature is 37 ± 0.5 ℃, in accordance with the law operation, respectively get solution 4mL through 1h, 2h, 4h, 6h, 8h, 12h, and timely supplementing water 4mL in process container, sample liquid filters, and measures with high performance liquid chromatography.
Zoopery
6 of healthy Beagle Canis familiaris L.s, body weight 9.5～10.5kg,
3,
3, overnight fasting gives 2 of guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheets, and dosage is: DP6mg/kg, GF120mg/kg, PSE12mg/kg.Respectively at after administration 0.5,1.0,1.5,2,3,4,6,8,12 and 24h venous blood sampling 4.0ml, separation of serum is got supernatant and is measured.For example, to the guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release sheet of the oral embodiment 2 of Beagle Canis familiaris L., during the medicine of three kinds of medicines, curve is seen Figure 12 a, Figure 12 b, Figure 12 c.As can be seen from the figure three kinds of medicines slowly discharge in Beagle Canis familiaris L. body, without the prominent phenomenon of releasing.
Claims (1)
1. a compound sustained-released oral drug preparation, is characterized in that, said preparation contains guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and slow-release auxiliary material; Described slow-release auxiliary material is that consumption is hypromellose 15000 centipoises by total formulation weight amount 16% ~ 25%; Consumption is hypromellose 4000 centipoises by total formulation weight amount 18% ~ 28%; Consumption is the ethyl cellulose by total formulation weight amount 15% ~ 20%; Consumption is hypromellose 4000 centipoises and hypromellose 50 centipoises of 10:1 or 6:1 for the ratio by total formulation weight amount 14% ~ 22%; With the rate of release of this slow releasing preparation be:
1 hour: the release of pseudoephedrine hydrochloride was between 20% ~ 50%; The release of dextromethorphan hydrobromide is between 15% ~ 40%; The release of guaifenesin is between 15% ~ 40%;
3 hours: the release of pseudoephedrine hydrochloride was between 50% ~ 80%; The release of dextromethorphan hydrobromide is between 40% ~ 60%; The release of guaifenesin is between 40% ~ 60%;
8 hours: the release of pseudoephedrine hydrochloride was greater than 80%; The release of dextromethorphan hydrobromide is greater than 75%; The release of guaifenesin is greater than 75%.
2, compound sustained-released oral drug preparation as claimed in claim 1, wherein said pharmaceutical preparation also comprises other adjuvant: the binding agent of solid content 0.5% ~ 1.5%, consumption are wetting agent by total formulation weight amount 15% ~ 30%, the coating materials of weightening finish 2% ~ 4% for lubricant, the consumption by total formulation weight amount 0.3% ~ 1.0% for fluidizer, consumption by total formulation weight amount 0.5% ~ 2.0% for diluent, the consumption by total formulation weight amount 1.2% ~ 2.2%.
3, compound sustained-released oral drug preparation as claimed in claim 2, wherein said binding agent are polyvinylpyrrolidone, hypromellose, starch slurry, syrup, dextrin, rubber cement or their mixture.
4, compound sustained-released oral drug preparation as claimed in claim 2, wherein said diluent are lactose, starch, sucrose, microcrystalline Cellulose, dextrin, mannitol, sorbitol, calcium sulfate or their mixture.
5, compound sustained-released oral drug preparation as claimed in claim 4, wherein said starch is pregelatinized Starch.
6, compound sustained-released oral drug preparation as claimed in claim 2, wherein said lubricant are magnesium stearate, calcium stearate, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, Stepanol MG, sodium lauryl sulphate or their mixture.
7, compound sustained-released oral drug preparation as claimed in claim 2, wherein said fluidizer are micropowder silica gel, Pulvis Talci or their mixture.
8, compound sustained-released oral drug preparation as claimed in claim 2, wherein said wetting agent are ethanol, ethanol water, water or their mixture.
9, the preparation method of the described compound sustained-released oral drug preparation of any one in claim 1-8, is characterized in that, prepares with granulating respectively or isolating feeding method.
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| CN106727561A (en) * | 2015-11-19 | 2017-05-31 | 哈尔滨圣吉药业股份有限公司 | A kind of Yumei sustained-release tablet and preparation method thereof |
| CN106913572B (en) * | 2017-04-06 | 2019-09-20 | 地奥集团成都药业股份有限公司 | A kind of Compound theophylline-ketofen tablet and preparation method thereof |
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|---|---|---|---|---|
| CN1768751A (en) * | 2005-10-14 | 2006-05-10 | 四川泰华堂制药有限公司 | Method for preparing 'Fen Ma Mei Yu' dispersible tablet |
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| CN1768751A (en) * | 2005-10-14 | 2006-05-10 | 四川泰华堂制药有限公司 | Method for preparing 'Fen Ma Mei Yu' dispersible tablet |
Non-Patent Citations (4)
| Title |
|---|
| 国家药品标准新药转正标准第54册.人民卫生出版社,2006,130. * |
| 平其能.现代药剂学.中国医药科技出版社,1998,483-491. * |
| 张静等.国产与进口羟丙基甲基纤维素的性质对比.辽宁药物与临床4 1.2001,4(1),26. |
| 张静等.国产与进口羟丙基甲基纤维素的性质对比.辽宁药物与临床4 1.2001,4(1),26. * |
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