CN103054813A - Azithromycin oral sustained-release dry suspension and preparation method thereof - Google Patents
Azithromycin oral sustained-release dry suspension and preparation method thereof Download PDFInfo
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Abstract
The invention provides an azithromycin oral sustained-release dry suspension and a preparation method thereof. The preparation can overcome the shortcoming of strong bitter taste of an azithromycin oral preparation, continuously and slowly release a medicament for 5-7 days and realize a treatment effect within 7 days after the preparation is taken once. A sustained-release micropill of azithromycin is of the micropill containing the azithromycin, a layer for alleviating taste and a sustained-release layer are further wrapped for preparation, the layer for alleviating the bitter taste is selected from pharmaceutical polymer materials, namely hydroxypropyl methylcellulose, hydroxypropyl cellulose, acrylic acid polymer, polyvidone, polyethylene glycol 4000, citric acid ethyl ester and the like; and the sustained-release layer is selected from the pharmaceutical polymer materials, namely glyceryl behenate, the citric acid ethyl ester, ethyl cellulose, the acrylic acid polymer, the polyvidone, the polyethylene glycol 4000 and the like. The preparation method disclosed by the invention has the advantages of adoption of conventional equipment, original creation of formula process, sweet taste and long sustained-release time. Compared with the ordinary preparation, the medicament has the advantages of long acting time, sweet taste and lasting efficacy, and is particularly suitable for children and easy to accept by patients.
Description
Technical field
The present invention relates to a kind of oral sustained-release dry suspendible technology of azithromycin, be used for the oral medication antibacterial and infect, belong to medical technical field.
Background technology
Azithromycin is the azalides antibiotic, is white or off-white color crystalline powder, odorless, and bitter in the mouth, its mechanism of action is by being combined with the ribosomal subunit of the 50s of sensitive microbial, thereby disturbs synthetic (not the affecting the synthetic of nucleic acid) of its albumen.Mechanism is by being combined with the ribosomal subunit of the 50s of sensitive microbial, thereby disturbs the synthetic of its protein, and nucleic acid is synthetic unaffected.Azithromycin concentrates in epithelial cell, fibroblast, macrophage, mononuclear cell and neutrophil cell.In vitro study shows, behind the hatching 1h in the cell/and the ratio of EC＞30.Studies show that, concentrated in vivo macrophage and leukocyte may cause inflammatory drug to distribute.Azithromycin has good pharmaco-kinetic properties, and blood and tissue concentration are high, and declines the phase long (12～14 hours), administration number of times few (every day 1～2 time), and untoward reaction is few.Thereby reduced the untoward reaction of medicine, further improved the drug level in the tissue, and drug half-life has been longer.
Therefore, elimination long half time according to azithromycin, tissue distribution is wide, contain the leucocyte migration of medicine to pharmacokinetics characteristics such as infection sites, we can adopt the slow release method of the heavy dose of single dose administration of azithromycin, can make the drug level of infection site higher during treatment, better efficacy is used for treating respiratory tract infection, skin soft-tissue infection and urogenital infections only need administration every day 1 time, continuous 3～5d, accumulated dose 1～5g only needs single-dose 1.0g for sexually transmitted disease (STD), has to use conveniently, short treating period, the advantages such as curative effect is sure, possessed desirable antibiotic condition, penicillin anaphylaxis and pediatric patients have been had more practical significance.Can obtain to be equivalent to existing drug administration produce an effect more than 7 days, the high dose Antibiotic use that time slack discharges can improve patient compliance, reduces to greatest extent the generation of drug resistance.
The ordinary preparation that goes on the market at present such as sheet, capsule, oral liquid, dispersible tablet etc., the preparation oral taste is bitter, the child is difficult for accepting, and gastrointestinal side effect arranged, in order to make the patient be easy to accept, developed the azithromycin oral slow-release dry suspension, specification is for containing azithromycin 2.0g/ bag, this dosage form is comprised of sustained-release microparticle, alkalizing agent, correctives, thickening agent etc., by preparation technique medicine is slowly discharged in upper gastro-intestinal tract, when covering the bitterness of azithromycin, avoided the generation of gastrointestinal side effect.
Summary of the invention
The purpose of this invention is to provide a kind of obvious compliance and convenience of improving administration, compare with ordinary preparation that mouthfeel is fragrant and sweet, long without bitterness, suspendible time, the azithromycin oral slow-release dry suspension of lasting medicine, and provide this release oral to be dry mixed original creation formulation and technology and the preparation method of outstanding preparation.
Used principal agent is azithromycin, and English name Azithromycin comprises anhydrous azithromycin and azithromycin hydrate (such as azithromycin-hydrate, azithromycin dihydrate, azithromycin trihydrate etc.).Molecular formula is C
38H
72N
2O
12NH
2O (n=0～10), chemical structural formula:
Reach a kind of technical scheme of the object of the invention as follows: be prepared from by the slow-release micro-pill that is loaded with azithromycin and the adjuvant (thickening agent, correctives, basifier) of pharmaceutically commonly using; The described slow-release micro-pill that is loaded with azithromycin is by azithromycin and Blank Pellets and cover the bitterness layer and slow release layer forms; Describedly cover the bitterness layer and slow release layer is pharmaceutical polymers.
The pharmaceutical polymers of covering the bitterness layer and being by one or more mixes: hydroxypropyl methylcellulose, hydroxypropyl cellulose, acrylate copolymer, polyvidone, Macrogol 4000, ETHYL CTTRATE etc.
Slow release layer is mixed by one or more pharmaceutical polymers: Glyceryl Behenate, ETHYL CTTRATE, ethyl cellulose, acrylate copolymer, polyvidone, Macrogol 4000 etc.
Be loaded with in the slow-release micro-pill of azithromycin, the weight ratio of azithromycin and Blank Pellets is 5: 1 to 1: 5; Be preferably 2: 1 to 1: 2.
Be loaded with in the slow-release micro-pill of azithromycin medicine carrying, all standby forming of employing end spray legal system in fluid bed of covering bitterness layer and slow release layer.
The present invention also provides the preparation method of this azithromycin oral slow-release dry suspension, and it may further comprise the steps:
1. take by weighing azithromycin and polyvidone, under stirring, join in 95% ethanol, stirring and dissolving must be carried azithromycin solution; 2. the Blank Pellets with recipe quantity places fluid bed, adopts end spray method, sprays into year azithromycin solution that 1. step obtains, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps dry up 10～20min after finishing in fluid bed, namely get azithromycin medicine carrying micropill; 3. the pharmaceutical polymers with one or more mixes, join in 75% ethanol, be stirred to fully dissolving, namely get and cover bitterness layer coating solution, adopt end spray method, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps, spray into and cover bitterness layer coating solution, in fluid bed, dry up 10～20min after finishing, namely get the Azithromycin micro-pill that bag is covered the bitterness layer; 4. one or more pharmaceutical polymers mixes, and joins in 95% ethanol, is stirred to fully dissolving, namely gets the slow release layer coating solution.Adopt end spray method, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps spray into the slow release layer coating solution, dry up 10～20min after finishing in fluid bed, namely get the slow-release micro-pill that is loaded with azithromycin; 5. will make the slow-release micro-pill that is loaded with azithromycin and measure content, after the calculating, add in proportion corresponding adjuvant, pack after mixing, and get final product.
The present invention is to provide the oral sustained-release dry suspension of azithromycin, specification is the 2.0g/ bag, compared to prior art, the present invention wraps the azithromycin of bitter in the mouth to cover bitterness layer and slow release layer in fluid bed, the adjuvants such as thickening agent, correctives, basifier are being mixed with it, namely make and only need take 1 time, namely get 7 days azithromycin oral slow-release dry suspensions curative effect, that taste is fragrant and sweet.
The present invention uses spraying equipment at the bottom of the fluid bed, and preparation technology's original creation, environmental protection are taken mouthfeel fragrant and sweet, constant product quality.Compare with common azithromycin oral preparation, this medicine onset is lasting, have good taste, be specially adapted to children's's usefulness, and avoided the generation of gastrointestinal side effect.For patient, provide a kind of new medicine, so the oral sustained-release dry suspension of development azithromycin has very important meaning to clinical application.
The present invention is with respect to prior art, and production cost is low, and bioavailability is high, and side effect is little, has obviously improved compliance and the convenience of administration, is a kind of preparation with clinical meaning.
The characteristics of azithromycin oral slow-release dry suspension provided by the invention are that production technology is simple and easy to control, favorable reproducibility, and the adjuvant source is easy to get, and is fit to industrialized great production.The specific embodiment is as follows:
Fig. 1: 3 batches of products (Tt) and commercially available (Rt) dissolution similar factors result
Fig. 2: the plasma concentration-time graph of azithromycin behind 8 Beagle dog oral test preparations
Fig. 3: the plasma concentration-time graph of azithromycin behind 8 oral reference preparations of Beagle dog
Fig. 4: 8 Beagle dogs are curve during the average medicine of azithromycin behind oral test preparation and the reference preparation respectively
The specific embodiment
Further understand the present invention by following examples, but following examples are not construed as limiting the invention.
Prescription (1000 bags of dosage)
Preparation technology has following steps:
1. take by weighing azithromycin and polyvidone, under stirring, join in 95% ethanol, stirring and dissolving must be carried azithromycin solution.2. the Blank Pellets with recipe quantity places fluid bed, adopts end spray method, sprays into year azithromycin solution that 1. step obtains, 60 ℃ of inlet temperature, and 30 ℃ of leaving air temps dry up 10min after finishing in fluid bed, namely get azithromycin medicine carrying micropill.3. polyoxyethylene sorbitan monoleate and hydroxypropyl methylcellulose are added in 75% ethanol, be stirred to fully dissolving, namely get and cover bitterness layer coating solution, adopt end spray method, 30 ℃ of inlet temperature, 20 ℃ of leaving air temps spray into and cover bitterness layer coating solution, in fluid bed, dry up 10min after finishing, namely get the Azithromycin micro-pill that bag is covered the bitterness layer.4. under stirring, ethyl cellulose, polyvidone and Macrogol 4000 joined and be stirred to fully dissolving in 95% ethanol, namely get the slow release layer coating solution.Adopt end spray method, 60 ℃ of inlet temperature, 50 ℃ of leaving air temps spray into the slow release layer coating solution, dry up 10min after finishing in fluid bed, namely get the slow-release micro-pill that is loaded with azithromycin.5. will make the slow-release micro-pill that is loaded with azithromycin and measure content, after the calculating, add in proportion sodium phosphate, sucrose, sodium carboxymethyl cellulose, pack after mixing, and get final product.
Prescription (1000 bags of dosage)
Preparation technology has following steps:
1. take by weighing azithromycin and polyvidone, under stirring, join in 95% ethanol, stirring and dissolving must be carried azithromycin solution.2. the Blank Pellets with recipe quantity places fluid bed, adopts end spray method, sprays into year azithromycin solution that 1. step obtains, 40 ℃ of inlet temperature, and 20 ℃ of leaving air temps dry up 10min after finishing in fluid bed, namely get azithromycin medicine carrying micropill.3. polyoxyethylene sorbitan monoleate and hydroxypropyl cellulose are added in 75% ethanol, be stirred to fully dissolving, namely get and cover bitterness layer coating solution, adopt end spray method, 40 ℃ of inlet temperature, 20 ℃ of leaving air temps spray into and cover bitterness layer coating solution, in fluid bed, dry up 10min after finishing, namely get the Azithromycin micro-pill that bag is covered the bitterness layer.4. under stirring, ethyl cellulose, polyvidone and ETHYL CTTRATE joined and be stirred to fully dissolving in 95% ethanol, namely get the slow release layer coating solution.Adopt end spray method, 40 ℃ of inlet temperature, 20 ℃ of leaving air temps spray into the slow release layer coating solution, dry up 10min after finishing in fluid bed, namely get the slow-release micro-pill that is loaded with azithromycin.5. will make the slow-release micro-pill that is loaded with azithromycin and measure content, after the calculating, add in proportion sodium phosphate, sucrose, xanthan gum, pack after mixing, and get final product.
Embodiment 3
Prescription (1000 bags of dosage)
Preparation technology has following steps:
1. take by weighing azithromycin and polyvidone, under stirring, join in 95% ethanol, stirring and dissolving must be carried azithromycin solution.2. the Blank Pellets with recipe quantity places fluid bed, adopts end spray method, sprays into year azithromycin solution that 1. step obtains, 60 ℃ of inlet temperature, and 30 ℃ of leaving air temps dry up 10min after finishing in fluid bed, namely get azithromycin medicine carrying micropill.3. Macrogol 4000 and acrylate copolymer are added in 75% ethanol, be stirred to fully dissolving, namely get and cover bitterness layer coating solution, adopt end spray method, 60 ℃ of inlet temperature, 50 ℃ of leaving air temps spray into and cover bitterness layer coating solution, in fluid bed, dry up 10min after finishing, namely get the Azithromycin micro-pill that bag is covered the bitterness layer.4. under stirring, ethyl cellulose, polyvidone and Glyceryl Behenate joined and be stirred to fully dissolving in 95% ethanol, namely get the slow release layer coating solution.Adopt end spray method, 50 ℃ of inlet temperature, 20 ℃ of leaving air temps spray into the slow release layer coating solution, dry up 10min after finishing in fluid bed, namely get the slow-release micro-pill that is loaded with azithromycin.5. will make the slow-release micro-pill that is loaded with azithromycin and measure content, after the calculating, add in proportion sodium phosphate, sucrose, arabic gum, tragakanta, pack after mixing, and get final product.
Get the azithromycin oral slow-release dry suspension of embodiment 1, according to drug release determination method (two appendix XD of Chinese Pharmacopoeia version in 2010 first method), adopt dissolution method (two appendix XC the second methods of Chinese Pharmacopoeia version in 2010) device experiment.800ml is release medium with the phosphate buffer of 0.1mol/L pH6.0 (get disodium hydrogen phosphate,anhydrous 85.2 ± 0.3g, add water 6000ml and make dissolving, and take the salt acid for adjusting pH), and rotating speed is that per minute 50 turns.Get 6 bags, add respectively water 60ml, jolting made into suspension in 30 seconds, and be transferred to (timing from test sample contact release medium) in the stripping rotor, add respectively again release medium 40ml to the test sample bag, jolting, be transferred in the stripping rotor with method, sampling during respectively at 15,30,45,60,90,120,180 minutes is measured, and draws the dissolution rate curve.Three batch samples detect release by above-mentioned release method, calculating mean value, and Azithromycin slow-release agent (the azithromycin 2.0g/ bottle of producing with import Pfizer labs
) 15,30,60,120 minutes releases as reference.
Release the results are shown in Figure 1, the release that shows 3 batch samples with
Compare, similar factors proves prescription and the technique of Azithromycin slow-release dry suspension all greater than 50, can guarantee with
Has identical release in vitro behavior.
Bioavailability study in the embodiment 5 azithromycin oral slow-release dry suspension bodies
8 healthy Beagle dogs are subjects, adopt dog body pharmacokinetics method, take pharmacokinetic parameter as index, estimate Azithromycin slow-release agent (the azithromycin 2.0g/ bottle of azithromycin oral slow-release dry suspension agent (azithromycin 2.0g/ bag) with the import Pfizerlabs production of Guangdong Institute of Traditional Chinese Medicine's development
) bioequivalence.
Dosage regimen: the period 1, give the Beagle dog and be subjected to test preparation or reference preparation (agent of azithromycin oral slow-release dry suspension, 2.0g/ bag).2.0g (1 bag) preparation is put into the container of suitable volumes, add in 37 ℃ of deionized waters of 60ml, stir into the homogeneous suspension, fully give at once animal behind the suspendible, add again the deionized water at normal temperature of 40ml in the sack, slightly jolting, with residue mixing in the bag, also give the animal gavage.Second round, the intersection administration.The Beagle dog all needs fasting 12-16 hour before each test administration.The cleaning phase of each test period is 40 days, and test arrangement and relative bioavailability see Table 1-2.
Table 1 test arrangement
T: be subjected to test preparation (agent of azithromycin oral slow-release dry suspension), (dosage: a 2.0g/ animal)
R: reference preparation (agent of import Azithromycin slow-release), (dosage: a 2.0g/ animal)
The relative bioavailability of table 2 Azithromycin slow-release dry suspension
The results are shown in accompanying drawing 2-4, show that average bioavailability is 93.5% behind the animals administer, each main pharmacokinetic parameters is subjected to there was no significant difference between test preparation and reference preparation through to the variance analysis after the number conversion, also there was no significant difference between the test period; C
MaxWith the result of the two one-side t checks of AUC and the check of (1-2 α) confidence interval all within the scope of regulation, Tmax is subjected to there was no significant difference between test preparation and reference preparation through non parametric tests.Therefore, can think and be subjected to test preparation and reference preparation to have bioequivalence.
Claims (10)
1. an azithromycin oral slow-release dry suspension is characterized in that: be prepared from by the slow-release micro-pill that is loaded with azithromycin and the adjuvant of pharmaceutically commonly using; The described slow-release micro-pill that is loaded with azithromycin is the micropill that contains azithromycin, wraps to cover the bitterness layer and slow release layer is made again; Described adjuvant is pharmaceutical polymers.
2. a kind of azithromycin oral slow-release dry suspension according to claim 1 is characterized in that: the described bitterness layer of covering is to be mixed by one or more pharmaceutical polymers: hydroxypropyl methylcellulose, hydroxypropyl cellulose, acrylate copolymer, polyvidone, Macrogol 4000, ETHYL CTTRATE etc.
3. a kind of azithromycin oral slow-release dry suspension according to claim 1 is characterized in that: described slow release layer is mixed by one or more pharmaceutical polymers: Glyceryl Behenate, ETHYL CTTRATE, ethyl cellulose, acrylate copolymer, polyvidone, Macrogol 4000 etc.
4. each described a kind of azithromycin oral slow-release dry suspension according to claim 1-3 is characterized in that: the slow-release micro-pill that is loaded with azithromycin is to adopt standby the forming of end spray legal system with fluid bed.
5. each described a kind of azithromycin oral slow-release dry suspension according to claim 1-3, it is characterized in that: the slow-release micro-pill that is loaded with azithromycin mixes with thickening agent, correctives, basifier.
6. a kind of azithromycin oral slow-release dry suspension according to claim 5, it is characterized in that: described thickening agent comprises sodium carboxymethyl cellulose, xanthan gum, arabic gum or tragakanta.
7. a kind of azithromycin oral slow-release dry suspension according to claim 5, it is characterized in that: described thickening agent is preferably xanthan gum.
8. each described a kind of azithromycin oral slow-release dry suspension according to claim 1-3, it is characterized in that: be loaded with in the slow-release micro-pill of azithromycin, the weight ratio of Blank Pellets and active medicine is 5: 1 to 1: 5.
9. preparation method such as each described azithromycin oral slow-release dry suspension of claim 1-3, comprise the steps: 1. to take by weighing azithromycin and polyvidone, under stirring, join in 95% ethanol, stirring and dissolving must be carried azithromycin solution; 2. the Blank Pellets with recipe quantity places fluid bed, adopts end spray method, sprays into year azithromycin solution that 1. step obtains, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps dry up 10～20min after finishing in fluid bed, namely get azithromycin medicine carrying micropill; 3. the pharmaceutical polymers with one or more mixes, join in 75% ethanol, be stirred to fully dissolving, namely get and cover bitterness layer coating solution, adopt end spray method, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps, spray into and cover bitterness layer coating solution, in fluid bed, dry up 10～20min after finishing, namely get the Azithromycin micro-pill that bag is covered the bitterness layer; 4. one or more pharmaceutical polymers mixes, and joins in 95% ethanol, is stirred to fully dissolving, namely gets the slow release layer coating solution.Adopt end spray method, inlet temperature 30-60 ℃, 20～50 ℃ of leaving air temps spray into the slow release layer coating solution, dry up 10～20min after finishing in fluid bed, namely get the slow-release micro-pill that is loaded with azithromycin; 5. will make the slow-release micro-pill that is loaded with azithromycin and measure content, after the calculating, add in proportion corresponding adjuvant, pack after mixing, and get final product.
10. the preparation method of a kind of azithromycin oral slow-release dry suspension according to claim 9 is characterized in that: the adjunct ingredient that adds in 5. in step comprises thickening agent, correctives, basifier.
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| CN107789336A (en) * | 2017-11-27 | 2018-03-13 | 武汉中钰钰民医药科技有限公司 | Azithromycin odor-masking pellet preparation and preparation method thereof |
| CN108740677A (en) * | 2018-06-22 | 2018-11-06 | 化州化橘红药材发展有限公司 | A kind of Exocarpium Citri Grandis slow-release solid beverage and preparation method thereof |
| CN111643455A (en) * | 2020-06-22 | 2020-09-11 | 健民药业集团股份有限公司 | Azithromycin sustained-release dry suspension and preparation method thereof |
| CN112843002A (en) * | 2021-04-06 | 2021-05-28 | 南京纽邦生物科技有限公司 | Gamma-aminobutyric acid oral sustained-release dry suspension and preparation method thereof |
| CN113262208A (en) * | 2015-01-29 | 2021-08-17 | 北京科信必成医药科技发展有限公司 | Azithromycin taste-masking dry suspension granule and preparation method thereof |
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Application publication date: 20130424 |