CN103622916A - Cefixime dry suspension and preparation method thereof - Google Patents
Cefixime dry suspension and preparation method thereof Download PDFInfo
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- CN103622916A CN103622916A CN201310698188.7A CN201310698188A CN103622916A CN 103622916 A CN103622916 A CN 103622916A CN 201310698188 A CN201310698188 A CN 201310698188A CN 103622916 A CN103622916 A CN 103622916A
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Abstract
The invention relates to a cefixime dry suspension and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The cefixime dry suspension contains 40-60 parts by weight of cefixime crystal form, wherein the X-ray powder diffraction pattern of the cefixime crystal form has characteristic absorption peaks at reflection angles 2theta of 11.14 degrees, 11.50 degrees, 14.14 degrees, 16.60 degrees, 16.90 degrees, 17.18 degrees, 20.50 degrees, 21.40 degrees, 22.20 degrees, 22.80 degrees, 22.94 degrees and 28.54 degrees. As the cefixime crystal form is used by the cefixime dry suspension, absorption of the cefixime dry suspension in human bodies is accelerated and the bioavailability is improved, thus the curative effects are improved. The cefixime dry suspension has better stability and dissolution effect and improves the use efficiency of unit dose.
Description
Technical field
The present invention relates to a kind of medicinal dry mixed suspension preparation and preparation method thereof, relate in particular to dry mixed suspension preparation of a kind of cefixime and preparation method thereof, belong to technical field of medicine.
Background technology
Cefixime is oral third generation cephalosporin, has a broad antifungal spectrum, part gram positive bacteria and negative bacterium are all had to antibacterial activity, particularly to the streptococcus in gram positive bacteria (except enterococcus), streptococcus pneumoniae, gonococcus in gram negative bacteria, Branhamella catarrhalis, escherichia coli, Cray Bai Shi belongs to, husky Lei Shi belongs to, Proteus, hemophilus influenzas etc. have stronger antibacterial action, its mechanism of action is for stoping the synthetic of bacteria cell wall, its application point because of the kind of antibacterial different, with PBP1 (1a in penicillin-binding protein (PBP), 1b, 1c) and PBP3 have compared with high-affinity.Cefixime has stronger stability to various bacteriogenic beta-lactamases.Cefixime is to Streptococcus (except enterococcus), streptococcus pneumoniae pouring, coccus, mucositis Blanc diplococcus, escherichia coli, Klebsiella, Serratia, Proteus, responsive microbial following the infection effectively of cefixime in hemophilus influenza: acute episode of chronic bronchitis, the concurrent antibacterial infection of acute bronchitis, concurrent infection of bronchiectasis, pneumonia; Pyelonephritis, cystitis, gonococcal urethritis; Acute biliary tract system bacterial infection (cholecystitis, cholangitis); Scarlet fever; Otitis media, sinusitis.
Domestic kind of producing is the earliest the Cefspan that Baiyunshan Pharmaceutical General Factory produces, and is capsule (specification is 100mg) and granule (specification is 50mg).Existing State Food and Drug Administration approved many manufacturer production, dosage form is mainly: capsule, tablet, dispersible tablet, chewable tablet, granule, dry suspension etc.
At present, it is more that the cefixime using on market is dry mixed outstanding preparation variety, and there is some difference for the drug quality of different manufacturers, to selection of clinical, brings certain difficulty.
Summary of the invention
Technical problem to be solved by this invention is that the defect that overcomes prior art provides a kind of cefixime dry mixed suspension preparation, and this dry mixed suspension preparation has the features such as stability is strong, for Hospital Drugs preferentially and clinical application good product is provided.In addition the present invention further provides, the preparation method of this dry mixed suspension preparation.
Technical problem of the present invention is realized by following technical scheme.
The dry mixed suspension preparation of cefixime, the Fructus Citri tangerinae taste powdered flavor of the cefixime crystal formation that contains 40～60 weight portions in this dry mixed suspension preparation, the hydroxypropyl cellulose of 10～20 weight portions, the xanthan gum of 10～30 weight portions, the anhydrous citric acid of the xylitol of 800～1000 weight portions, 7.3～7.4 weight portions, 0.4～0.6 weight portion, the lemon yellow pigment of 0.05～0.15 weight portion; Wherein, its X-ray powder diffraction pattern of described cefixime crystal formation is 11.14 °, 11.50 °, 14.14 °, 16.60 °, 16.90 °, 17.18 °, 20.50 °, 21.40 °, 22.20 °, 22.80 °, 22.94 ° and 28.54 ° at angle of reflection 2 θ and has located characteristic absorption peak.
The dry mixed suspension preparation of above-mentioned cefixime, the infrared absorption spectroscopy of described cefixime crystal formation is at 3203cm
-1, 3085cm
-1, 2568cm
-1, 1679cm
-1, 1665cm
-1, 1523cm
-1, 1486cm
-1, 1346cm
-1, 1237cm
-1there is absworption peak at place.
The dry mixed suspension preparation of above-mentioned cefixime, its fusing point of differential scanning spectrum analysis of described cefixime crystal formation is 170～175 ℃.
A method of preparing the dry mixed suspension preparation of above-mentioned cefixime, comprises the steps:
A. prepare cefixime crystal formation: cefixime is dissolved in to dioxane and is warmed to 50～55 ℃, with behind 20% hydrochloric acid solution adjust pH to 2.0～3.0, in 5 minutes, add normal butane, solution is kept 20 minutes at 50～55 ℃, add oxolane cooling crystallization, filter, 50～55 ℃ dry, obtains cefixime crystal formation;
B. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
C. mix: step b gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
The above-mentioned method of preparing the dry mixed suspension preparation of cefixime, the w/v of the consumption of described cefixime and dioxane consumption is 1g: 5～10ml.
The above-mentioned method of preparing the dry mixed suspension preparation of cefixime, the volume ratio of the consumption of described normal butane and dioxane consumption is 0.01～0.03: 1.
The above-mentioned method of preparing the dry mixed suspension preparation of cefixime, the volume ratio of the consumption of described oxolane and dioxane consumption is 2～4: 1.
The above-mentioned method of preparing the dry mixed suspension preparation of cefixime is cooled to-5～-10 ℃ of crystallizes after adding oxolane.
The invention provides a kind of dry mixed suspension preparation of cefixime that is different from prior art, the cefixime crystal formation impurity in this dry mixed suspension preparation is few, and purity is high, can reach more than 99.7%, and particle diameter is large compared with little, specific surface area, good fluidity, stability are high; Under simulation listing terms of packing, at 40 ℃ ± 2 ℃ of temperature, relative humidity, be to place after 6 months under 75% ± 5% condition, every quality detecting index is without significant change, illustrate that this crystal formation has better quality stability and stable crystal form than the crystal formation of previous literature report, illustrate further cefixime crystal formation of the present invention and be more conducive to ensure the efficacy and saferry of its pharmaceutical preparation in clinical practice, be more suitable for using as crude drug.In addition, the dry mixed suspension preparation of cefixime of the present invention, owing to using cefixime crystal formation to accelerate the absorption in human body, has improved bioavailability, thereby has improved curative effect; Stable better, result of extraction is better, has improved the service efficiency of unit dose, for Hospital Drugs preferentially and clinical application good selection is provided, there is very high economy and social meaning.
Accompanying drawing explanation
The diffracting spectrum of the powder X-ray line diffraction of Fig. 1 cefixime crystal formation of the present invention.
The powder infrared spectrum collection of illustrative plates of Fig. 2 cefixime crystal formation of the present invention.
The powder thermogravimetric analysis collection of illustrative plates of Fig. 3 cefixime crystal formation of the present invention.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described in further details.
Prescription:
Preparation method:
A. prepare cefixime crystal formation: 100g cefixime is dissolved in to 800ml dioxane and is warmed to 53 ℃, with after 20% hydrochloric acid solution adjust pH to 2.5, in 5 minutes, add 16ml normal butane, solution is kept 20 minutes at 53 ℃, add 2400ml oxolane to be cooled to-7 ℃ of crystallizes, filter, 53 ℃ dry, obtain 96.4g cefixime crystal formation, yield 96.4%, it is 99.57% that HPLC measures purity;
B. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
C. mix: step b gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
Data monitoring:
The diffracting spectrum of the powder X-ray line diffraction of gained cefixime crystal formation is as Fig. 1.
The powder thermogravimetric analysis collection of illustrative plates of gained cefixime crystal formation is as Fig. 2.
The powder infrared spectrum collection of illustrative plates of gained cefixime crystal formation is as Fig. 3.
Prescription:
Preparation method:
A. prepare cefixime crystal formation: 100g cefixime is dissolved in to 500ml dioxane and is warmed to 50 ℃, with after 20% hydrochloric acid solution adjust pH to 2.0, in 5 minutes, add 5ml normal butane, solution is kept 20 minutes at 50 ℃, add 1000ml oxolane to be cooled to-5 ℃ of crystallizes, filter, 50 ℃ dry, obtain 95.8g cefixime crystal formation, yield 95.8%, it is 99.38% that HPLC measures purity;
B. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
C. mix: step b gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
Embodiment 3 prepares the dry mixed suspension preparation of cefixime
Prescription:
Preparation method:
A. prepare cefixime crystal formation: 100g cefixime is dissolved in to 1000ml dioxane and is warmed to 55 ℃, with after 20% hydrochloric acid solution adjust pH to 3.0, in 5 minutes, add 30ml normal butane, solution is kept 20 minutes at 55 ℃, add 4000ml oxolane to be cooled to-10 ℃ of crystallizes, filter, 55 ℃ dry, obtain 95.4g cefixime crystal formation, yield 95.4%, it is 99.33% that HPLC measures purity;
B. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
C. mix: step b gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
Comparative example 1 prepares the dry mixed suspension preparation of cefixime
Prescription:
Preparation method:
A. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
B. mix: step a gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
The study on the stability contrast test of comparative experimental example 1 cefixime crystal formation of the present invention
Get the commercially available cefixime raw material using in comparative example 1 as a comparison sample.
According to (two appendix XIX C of Chinese Pharmacopoeia version in 2010) relevant regulations, cefixime crystal formation of the present invention and comparative sample have been carried out to accelerated test.Get respectively each embodiment 1～3 and comparative sample appropriate, simulation listing packing, at 40 ℃ ± 2 ℃ of temperature, relative humidity, be to place 6 months under 75% ± 5% condition, respectively at sampling respectively the 0th, 1,2,3,6 the end of month, sample property, clarity of solution, loss on drying, related substance, content equistability are investigated index and measured and record, and concrete data see the following form 1:
The accelerated test result table of table 1 embodiment 1-3 and comparative sample
Above result of the test shows: under simulation listing terms of packing, embodiment 1～3 and comparative sample are to place after 6 months under 75% ± 5% condition at 40 ℃ ± 2 ℃ of temperature, relative humidity, every detection index has no significant change, all, in prescribed limit, illustrate that above-mentioned sample all has good stability.But related substance and changes of contents amplitude that embodiment 1～3 sample is placed after 6 months with respect to comparative sample are less, illustrate aspect stability, and cefixime crystal formation of the present invention more has superiority.In addition, from upper table data, also can find out, the related substance of cefixime crystal formation of the present invention (comprising single maximum contaminant and total impurities) is lower than comparative sample, content is higher than comparative sample, cefixime crystal formation impurity content of the present invention is described still less, purity is higher, more can ensure the efficacy and saferry of its pharmaceutical preparation in clinical practice.
The mobility comparison of comparative experimental example 2 cefixime crystal formation of the present invention
Be the easiest method of check powder fluidity quality angle of repose, and angle of repose is less, illustrates that frictional force is less, and mobility is better.This test adopts injection method (fixed funnel method) to measure the angle of repose of the commercially available cefixime raw material using in embodiment 1～3 and comparative example 1.Pour testing sample into funnel, make it fall into disc centre lightly, equably, form a cone, when material stops feeding in raw material when freely falling disk border from powder body hypotenuse, with protractor, measure angle of repose, measurement result is in Table 2.
Measurement result angle of repose of table 2 cefixime crystal formation
| Sample | Outward appearance | Angle of |
| Embodiment | ||
| 1 | White crystalline powder | 28.8 |
| |
White crystalline powder | 31.5 |
| Embodiment 3 | White crystalline powder | 32.1 |
| Comparative example 1 | White crystalline adhesion powder | 41.6 |
Result of the test by upper table 2 can be found out: embodiment 1～3, also be cefixime crystal formation of the present invention, be less than 35 degree the angle of repose of its crystal particle, shows good fluidity, the need for liquidity in production process be can meet, production pharmaceutical preparation and storage transportation are applicable to being applied to; And being greater than 40 degree the angle of repose of the commercially available cefixime raw material that comparative example 1 uses, mobility is poor, cannot meet Production requirement, is not suitable for useful in preparing drug formulations; Therefore cefixime crystal formation of the present invention is compared with commercially available cefixime raw material, its mobility of particle is better, more can meet Production requirement.3 spore of the present invention ground Buddhist nuns of comparative experimental example are dry mixed outstanding preparation stability test
(1) accelerated test
Get the embodiment dry mixed suspension preparation of 1～3 gained cefixime and the dry mixed suspension preparation of comparative example's 1 gained cefixime, under simulation listing terms of packing, be placed in the hermetic container of relative humidity RH75% ± 5%, in 40 ℃ ± 2 ℃, place 6 months, respectively at the 1st, 2,3,6 samplings at the end of month once, by investigation project, detect, result of the test is in Table 3.
The dry mixed suspension preparation accelerated test of table 3 cefixime data
(2) long term test
Get the embodiment dry mixed suspension preparation of 1 gained cefixime and the dry mixed suspension preparation of comparative example's 1 gained cefixime, in cool dark place (lucifuge is also no more than 20 ℃), under relative humidity 60% ± 10% condition, place 24 months, respectively at the 3rd, sampling in June, by above-mentioned investigation project, detect, result of the test sees the following form 4.
The dry mixed suspension preparation long term test of table 4 cefixime data
(3) from table 3, table 4 data can be found out, embodiment of the present invention 1-31 and the dry mixed suspension preparation of the prepared cefixime of comparative example 1 are investigated through the accelerated test of 6 months and the long term test of 6 months, comparative example 1 the dry mixed suspension preparation of cefixime is in acidity, polymer, single contaminant, the aspects such as total impurities all change compared with the dry mixed suspension preparation of the prepared cefixime of the embodiment of the present invention 1, exceed a lot, assay, dissolution has approached lower limit even, the dry mixed suspension preparation of visible cefixime of the present invention has more superiority aspect stability, show that cefixime of the present invention is dry mixed the outstanding quality of the pharmaceutical preparations and more stablizes controlled, clinical use is safer and more effective.
Above-described embodiment is only explanation technical conceive of the present invention and advantage; the present invention also can have other variation; as well known to the skilled person; above-described embodiment only plays the exemplary role in foregoing invention protection domain; for those of ordinary skills; in the protection domain limiting in the present invention, also have a lot of conventional distortion and other embodiment, these distortion and embodiment are by within the protection domain awaiting the reply in the present invention.
Claims (8)
1. the dry mixed suspension preparation of cefixime, it is characterized in that the Fructus Citri tangerinae taste powdered flavor of the cefixime crystal formation that contains 40～60 weight portions in this dry mixed suspension preparation, the hydroxypropyl cellulose of 10～20 weight portions, the xanthan gum of 10～30 weight portions, the anhydrous citric acid of the xylitol of 800～1000 weight portions, 7.3～7.4 weight portions, 0.4～0.6 weight portion, the lemon yellow pigment of 0.05～0.15 weight portion; Wherein, its X-ray powder diffraction pattern of described cefixime crystal formation is 11.14 °, 11.50 °, 14.14 °, 16.60 °, 16.90 °, 17.18 °, 20.50 °, 21.40 °, 22.20 °, 22.80 °, 22.94 ° and 28.54 ° at angle of reflection 2 θ and has located characteristic absorption peak.
2. the dry mixed suspension preparation of cefixime according to claim 1, is characterized in that, the infrared absorption spectroscopy of described cefixime crystal formation is at 3203cm
-1, 3085cm
-1, 2568cm
-1, 1679cm
-1, 1665cm
-1, 1523cm
-1, 1486cm
-1, 1346cm
-1, 1237cm
-1there is absworption peak at place.
3. the dry mixed suspension preparation of cefixime according to claim 1, is characterized in that, its fusing point of differential scanning spectrum analysis of described cefixime crystal formation is 170～175 ℃.
4. a method of preparing the dry mixed suspension preparation of cefixime as described in claim as arbitrary in claims 1 to 3, is characterized in that, comprises the steps:
A. prepare cefixime crystal formation: cefixime is dissolved in to dioxane and is warmed to 50～55 ℃, with behind 20% hydrochloric acid solution adjust pH to 2.0～3.0, in 5 minutes, add normal butane, solution is kept 20 minutes at 50～55 ℃, add oxolane cooling crystallization, filter, 50～55 ℃ dry, obtains cefixime crystal formation;
B. get the raw materials ready: cefixime crystal formation raw material is crossed 60 mesh sieves, and adjuvant is crossed 80 mesh sieves, by recipe quantity, takes;
C. mix: step b gained material all adds in mixer, fully mix, after checking that semi-finished product are qualified, by recipe quantity, be sub-packed in aluminum-plastic composite membrane bag, and heat-sealing.
5. the method for preparing the dry mixed suspension preparation of cefixime according to claim 4, is characterized in that, the w/v of the consumption of described cefixime and dioxane consumption is 1g: 5～10ml.
6. the method for preparing the dry mixed suspension preparation of cefixime according to claim 5, is characterized in that, the volume ratio of the consumption of described normal butane and dioxane consumption is 0.01～0.03: 1.
7. the method for preparing the dry mixed suspension preparation of cefixime according to claim 5, is characterized in that, the volume ratio of the consumption of described oxolane and dioxane consumption is 2～4: 1.
8. the method for preparing the dry mixed suspension preparation of cefixime according to claim 6, is characterized in that, is cooled to-5～-10 ℃ of crystallizes after adding oxolane.
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Cited By (3)
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| CN105496984A (en) * | 2015-12-18 | 2016-04-20 | 石药集团欧意药业有限公司 | Cefixime capsule stable in quality and preparation method thereof |
| CN106902084A (en) * | 2017-03-15 | 2017-06-30 | 深圳立健药业有限公司 | A kind of dry mix suspension grain of Cefixime |
| CN107970215A (en) * | 2017-11-14 | 2018-05-01 | 海南葫芦娃药业集团股份有限公司 | A kind of Sugarless type Cefixime granule and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105496984A (en) * | 2015-12-18 | 2016-04-20 | 石药集团欧意药业有限公司 | Cefixime capsule stable in quality and preparation method thereof |
| CN105496984B (en) * | 2015-12-18 | 2019-01-11 | 石药集团欧意药业有限公司 | A kind of Cefixime Capsules and preparation method thereof that quality is stable |
| CN106902084A (en) * | 2017-03-15 | 2017-06-30 | 深圳立健药业有限公司 | A kind of dry mix suspension grain of Cefixime |
| CN107970215A (en) * | 2017-11-14 | 2018-05-01 | 海南葫芦娃药业集团股份有限公司 | A kind of Sugarless type Cefixime granule and preparation method thereof |
| CN107970215B (en) * | 2017-11-14 | 2019-08-02 | 海南葫芦娃药业集团股份有限公司 | A kind of Sugarless type Cefixime granule and preparation method thereof |
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| CN103622916B (en) | 2015-04-08 |
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