CN102743390A - cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof - Google Patents
cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof Download PDFInfo
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- CN102743390A CN102743390A CN2012102338634A CN201210233863A CN102743390A CN 102743390 A CN102743390 A CN 102743390A CN 2012102338634 A CN2012102338634 A CN 2012102338634A CN 201210233863 A CN201210233863 A CN 201210233863A CN 102743390 A CN102743390 A CN 102743390A
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Abstract
The invention relates to a cefepime hydrochloride medicine composition, a powder-injection thereof and a preparation method thereof. The medicine composition comprises the following ingredients: cefepime hydrochloride, L-arginine and hydroxypropyl-beta-cyclodextrin, wherein the weight of the L-arginine is 40% of that of the cefepime hydrochloride, and the weight of the hydroxypropyl-beta-cyclodextrin is 10% of that of the cefepime hydrochloride. The medicine composition is good in mixing uniformity, has small pH value change in subpackaging and transportation processes, is small in gastrointestinal tract side effect, and greatly improves the stability and safety of the medicine.
Description
Technical field
The invention belongs to the drug invention field, relate in particular to a kind of cefepime hydrochloride pharmaceutical composition, its injectable powder and preparation method thereof.
Background technology
Cefepime (cefepime; BMY-28142; CFPM) be by 100 o'clock Mei-Shi Guibao company (Bristol-Myerssquibb) develop the 4th generation cephalosporin for injections class antibiotic, in 1993 in Sweden's Initial Public Offering, got into Chinese market in 1998.
Cefepime hydrochloride, and chemical name: 1-(6R, 7R)-7-2-(2-amino-4-thiazolyl)-glyoxyl amido-2-carboxyl-8-oxygen-5-thia-1-azabicyclic 4.2.0 oct-2-ene-3-ylmethyl-1-methylpyrrole inner salt.The water that contains a part in the cefepime hydrochloride that uses at present.Its chemical structural formula is following:
Cefepime hydrochloride be the 4th generation cephalosporins.Compare with third generation cephalosporin class antibiotic, antimicrobial spectrum is wider, and antibacterial activity is stronger, and is more stable to bacteriogenic beta-lactamase.When keeping the third generation cephalosporin characteristic, strengthen G bacterium antimicrbial power, because they contain a quaternary nitrogen positive charge on 3; Can form amphion, and molecular structure is bullet-shaped, can passes the albumen bypass rapidly; Make its adventitia transmitance improve 5-7 doubly; Reduce significantly with the affinity of the chromosome beta-lactamase of enterobacter cloacae etc., improve enzyme stability, so enterobacter cloacae and bacillus pyocyaneus etc. is had stronger antibacterial activity.Because cefepime hydrochloride is efficient, low toxicity, advantages such as wide spectrum are used clinically in a large number, determined curative effect.
Cefepime hydrochloride adopts the injection form administration at present, and the pH value of its raw material cefepime hydrochloride is about 1.6-2.1, be used for the pH value that human body must be adjusted this medicine.Regulate pH value according to all adding an amount of L-arginine in bibliographical information and imported product (Maxipime injectable powder) prescription, can make the pH value of hydrochloride for injection cefepime maintain 4.0-6.0.
US5095011 discloses a kind of injection cefepime injectable powder, i.e. Maxipime (Maxipime) injectable powder, and by 375mg arginine and 4.45ml water for injection and 500mg cefepime hydrochloride mixed preparing, pH value is 3-7.
WO2006106529 discloses a kind of injection cefepime injectable powder, is made up of cefepime hydrochloride and L-arginine, water, and pH value is 3-7.
CN200810001184.8 discloses a kind of cefepime hydrochloride powder injection, is made up of cefepime hydrochloride and L-arginine, and wherein the arginic content of L-is 83.5% of cefepime.The pH value of this cefepime hydrochloride powder injection under storage condition is about 4.5.
" stability study of hydrochloride for injection cefepime " (referring to the stability study of the hydrochloride for injection cefepime of Wang Haiyang etc., drug identification, 2005 the 14th the 12nd phases of volume) studied the stability of hydrochloride for injection cefepime; From this research, can see; Commercially available hydrochloride for injection cefepime in accelerated test, an only time sampling check in month, the content of its related substance is just greater than 1%; Change more obvious; And investigate in the test keeping sample for a long time, the variation of its related substances also clearly, visible its stability and bad.
The prescription that present commercially available cefepime hydrochloride mixes powder and formulation products is cefepime hydrochloride and L-arginine; Cefepime hydrochloride mixes there is packing difference in powder in packing problem; Cause cefepime hydrochloride and L-arginine after the packing to change than regular meeting; And pH is unstable in the branch process of assembling, influences stability of drug products.
In addition, cefepime hydrochloride mixes powder and in transportation, occurs lamination easily, and uniformity is destroyed easily, causes pH value to change, and influences drug quality.
The applicant has found cefepime hydrochloride pharmaceutical composition of the present invention on the basis of existing cefepime hydrochloride/L-arginine mixed powder having been carried out big quantity research; For the research of hydrochloride for injection cefepime provides new prescription; Solved the problem that exists in the prior art, special proposition the present invention.
Summary of the invention
For pH stability in the branch process of assembling that overcomes hydrochloride for injection cefepime of the prior art, packing is inhomogeneous and transportation in the pH stability problem, the invention provides in a kind of minute process of assembling pH good stability in pH good stability, packing good uniformity, the transportation, cefepime hydrochloride pharmaceutical composition that gastrointestinal side effect is little.
The objective of the invention is to realize through following technical proposals:
A kind of cefepime hydrochloride pharmaceutical composition; Form by cefepime hydrochloride, L-arginine and HP-; The arginic weight of described L-is 40% of cefepime hydrochloride weight; The weight of described HP-is the 8%-12% of cefepime hydrochloride weight, preferred 10%.
Because cefepime hydrochloride is different with L-arginine Electrostatic Absorption amount; Cefepime hydrochloride is higher than the L-arginine at glass or stainless steel surfaces adsorbance; In packing early stage and later stage cefepime hydrochloride and the arginic ratio of L-are changed, thereby cause that the mixed powder packing of cefepime hydrochloride is inhomogeneous, pH value changes and do not meet the pharmacopeia requirement.Equally, occur lamination in the transportation of cefepime hydrochloride easily, the uniformity balance is destroyed easily, causes pH value to change, and influences drug quality.The applicant is through a large amount of experimentatioies; The unexpected discovery: when adding a certain amount of HP-(weight of HP-is the 8%-12% of cefepime hydrochloride weight); The pH value of cefepime hydrochloride pharmaceutical composition of the present invention in minute process of assembling changes in ± 0.3 scope; And commercially available cefepime hydrochloride mixes the pH value variation (being 12 times that cefepime hydrochloride pharmaceutical composition pH value of the present invention changes) in ± 3.6 scope of powder; Reduce the pH unstability of packing greatly, shown packing uniformity preferably.In transportation pH stability test; When adding a certain amount of HP-(weight of HP-is the 8%-12% of cefepime hydrochloride weight); The pH value of pharmaceutical composition of the present invention in transportation changes in ± 0.17 scope; And the pH value of commercially available cefepime hydrochloride formulation products changes in ± 1.88 scope (being about 10 times that cefepime hydrochloride pharmaceutical composition pH value of the present invention changes); Reduce the pH unstability that transportation brings widely, the weight that makes cefepime hydrochloride is homogeneous all the time.
Particularly when the weight of the HP-that adds be cefepime hydrochloride weight 10% the time, pH stability is better in transit for cefepime hydrochloride pharmaceutical composition of the present invention, pH change be controlled at ± 0.1 scope in.
The L-arginine uses as a kind of nutritional supplement as a kind of non essential amino acid at present, but uses the kidney to patients with renal failure can cause extra burden in a large number.The arginic weight of L-in the cefepime hydrochloride pharmaceutical composition of the present invention is 40% of cefepime hydrochloride weight, has significantly reduced the arginic use amount of L-, is fit to comprise the various patients' of renal failure treatment.
Behind big quantity research; The applicant has obtained cefepime hydrochloride pharmaceutical composition of the present invention; About the pH value of this cefepime hydrochloride pharmaceutical composition in the process of packing, transportation all is stabilized in 4.5, the packing good uniformity, guaranteed that well medicine is from producing the quality of each links such as packing, transportation.
Another object of the present invention is to provide a kind of cefepime hydrochloride preparation of drug combination method; This method comprises the steps: cefepime hydrochloride and L-arginine pulverize separately are sieved; Proportionally take by weighing cefepime hydrochloride and L-arginine, mix homogeneously joins in the coating machine; HP-is dissolved in ethanol or concentration expressed in percentage by volume is the ethanol water of 50-70%, and the particle layer that the solution after the dissolving all is ejected into equably cefepime hydrochloride and the arginine mixed compound of L-is surperficial; Drying obtains the cefepime hydrochloride pharmaceutical composition.
Described drying can be drum-type drying, box-type drying, vacuum drying, fluid bed drying, spray drying, lyophilization, infrared drying, the preferred fluid bed drying of the present invention.
Cefepime hydrochloride pharmaceutical composition of the present invention can also obtain through direct blended mode: with sieving behind cefepime hydrochloride, L-arginine, the HP-pulverize separately, take by weighing above-mentioned prescription then in proportion, mix homogeneously promptly gets.
Above-mentioned cefepime hydrochloride pharmaceutical composition can further be sub-packed in the cillin bottle, tamponade, rolls lid, lamp inspection, is up to the standards, and labeling, packing promptly get its injectable powder.
The preparation of aforementioned pharmaceutical compositions and injectable powder thereof is all carried out under the condition that Chinese GMP (2010) requires.
The cefepime hydrochloride pharmaceutical composition is used for the purposes of the medicine of mammal (comprising the people) bacterial infection in preparation.
The prescription that commercially available cefepime hydrochloride described in the present invention mixes powder and formulation products thereof is cefepime hydrochloride and L-arginine, does not contain other pharmaceutic adjuvants, and formulation products obtains through cefepime hydrochloride and the mixing of L-arginine, packing.
Packing of the present invention is meant in earlier stage from the start of antibiotic screw rod racking machine and connects the process of powder to the beginning packing; The described packing later stage is meant from the powder position of storing up the material powder in the powder cover to be the process that finished to packing of storage powder cover height at 1/2 o'clock.Described antibiotic screw rod racking machine is a KFG series antibiotic screw type sub packaging machine.
Compared with prior art, cefepime hydrochloride pharmaceutical composition of the present invention has following outstanding advantage and beneficial effect:
1, cefepime hydrochloride pharmaceutical composition of the present invention and powder injection formulation thereof pH value good stability before and after packing, packing good uniformity, formulation products quality homogeneous.
2, the good uniformity of cefepime hydrochloride pharmaceutical composition of the present invention and powder injection formulation product in transportation thereof, the pH value good stability has guaranteed the product quality in the transportation.
3, cefepime hydrochloride pharmaceutical composition of the present invention and powder injection formulation thereof have reduced the gastrointestinal side effect of cefepime hydrochloride.
4, the L-arginine content in cefepime hydrochloride pharmaceutical composition of the present invention and the powder injection formulation thereof is lower, goes for the antibacterial drug therapy of patients with renal failure.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail, but the working of an invention mode is not limited thereto.
Embodiment 1: the prescription of cefepime hydrochloride pharmaceutical composition and technology
Cefepime hydrochloride 100kg
L-arginine 40kg
HP-10kg
Method for preparing: respectively 28 mesh sieves are pulverized, crossed to cefepime hydrochloride, L-arginine and HP-; Take by weighing cefepime hydrochloride 100kg, L-arginine 40kg, HP-10kg after sieving, mix homogeneously promptly gets the cefepime hydrochloride pharmaceutical composition.
Embodiment 2: the prescription of cefepime hydrochloride pharmaceutical composition and technology
Cefepime hydrochloride 100kg
L-arginine 40kg
HP-8kg
Method for preparing: 1) supplementary material is removed outer package, with crossing 28 mesh sieves behind hydrochloric acid cephalo pyrrole and the L-arginine pulverize separately; 2) get hydrochloric acid cephalo pyrrole 100kg and L-arginine 40kg after sieving respectively, join behind the mix homogeneously in the coating machine; 3) the 8kg HP-is dissolved in an amount of ethanol, gained solution is mist all evenly is ejected into the arginic mixture particle layer of hydrochloric acid cephalo pyrrole and L-surface, promptly get hydrochloric acid cephalo pyrrole pharmaceutical composition through fluid bed drying.
Embodiment 3: the prescription of cefepime hydrochloride pharmaceutical composition
Cefepime hydrochloride 100kg
L-arginine 40kg
HP-12kg
Method for preparing is following: 1) supplementary material is removed outer package, with crossing 28 mesh sieves behind hydrochloric acid cephalo pyrrole and the L-arginine pulverize separately; 2) get hydrochloric acid cephalo pyrrole 100kg and L-arginine 40kg after sieving respectively, join behind the mix homogeneously in the coating machine; 3) the 12kg HP-is dissolved in an amount of ethanol, gained solution is mist all evenly is ejected into the arginic mixture particle layer of hydrochloric acid cephalo pyrrole and L-surface, promptly get hydrochloric acid cephalo pyrrole pharmaceutical composition through fluid bed drying.
Embodiment 4: hydrochloride for injection cefepime pharmaceutical composition injectable powder
Get the cefepime hydrochloride pharmaceutical composition 1000g of embodiment 1 or embodiment 2 or embodiment 3 preparation gained, survey content and be sub-packed in 1000 cillin bottles after qualified, tamponade, roll lid, lamp inspection, be up to the standards, labeling, pack and promptly get.
Embodiment 5: cefepime hydrochloride mixes stable comparison of packing pH of powder in cefepime hydrochloride pharmaceutical composition of the present invention and the prior art
Get embodiment 1 mix powder (20110514) with two batches of pharmaceutical compositions of the present invention (being numbered 20110512S, 20110514S respectively) that embodiment 2 prepares with commercially available cefepime hydrochloride, according to the mixed powder (20110512) of the cefepime hydrochloride of patent CN200810001184.8 embodiment 1 preparation; Carry out the investigation of branch process of assembling pH simultaneously, to investigate its mixing uniformity.Married operation is a purpose with constituent composition uniformity, in the total formulation production process, has consequence.For the cefepime hydrochloride pharmaceutical composition, whether the most reliable method of mix homogeneously is to judge through the pH value of measuring mixture.The sampling of a plurality of several times continuously sites records the pH unanimity mixture mix homogeneously then is described.
Get above-mentioned four lot sample article, with reference to the pH value assay method of two appendix VI of Pharmacopoeia of the People's Republic of China version in 2010 H, measure pH, the result is following:
Cefepime hydrochloride mixes the packing pH study on the stability result of powder in table 1 pharmaceutical composition of the present invention and the prior art
Can find out from table 1 data: cefepime hydrochloride of the prior art mixes the pH value of powder (20110514,20110512) in packing early stage and packing later stage to be changed greatly; Changing value is in ± 3.6 scopes; Cause the product pH in packing early stage and later stage defective; And the pH value of cefepime hydrochloride pharmaceutical composition of the present invention (20110512S, 20110514S) in minute process of assembling changes less; Changing value shows that the packing pH of cefepime hydrochloride pharmaceutical composition of the present invention has good stability in ± 0.3 scope.Simultaneously, the pH value of cefepime hydrochloride pharmaceutical composition of the present invention changes little, mix homogeneously, and packing is even.
Embodiment 6: the investigation of the transportation pH stability of cefepime hydrochloride pharmaceutical composition of the present invention and commercially available cefepime hydrochloride formulation products
Present embodiment carries out plane shaking table experiment to cefepime hydrochloride pharmaceutical composition of the present invention and commercially available cefepime hydrochloride formulation products; Come the simulate situation, investigate through taking a sample whether transportation causes that product separates again and inhomogeneous from four different loci of ABCD.
Get cefepime hydrochloride pharmaceutical composition and commercially available cefepime hydrochloride formulation products that embodiment 2 prepares, with reference to the pH value assay method of two appendix VI of Pharmacopoeia of the People's Republic of China version in 2010 H, measure pH value, the result is following:
The transportation pH study on the stability result of table 2 cefepime hydrochloride pharmaceutical composition of the present invention and commercially available cefepime hydrochloride formulation products
Can find out from table 2 data; The pH value of commercially available cefepime hydrochloride formulation products in the traffic condition simulation experiment changes greatly; Excursion is ± 1.88, explains that commercially available cefepime hydrochloride formulation products mixing uniformity in transportation changes, and can cause the cefepime hydrochloride degraded to be accelerated; Drug product stability goes wrong, and drug quality is unstable.And the pH value variation of product of the present invention in experiment is very little, and excursion is ± 0.17.Cefepime hydrochloride pharmaceutical composition of the present invention has well guaranteed its stability in transportation, and drug quality consistently.
Embodiment 7: the investigation of transportation pH stability and the HP-relation of cefepime pharmaceutical composition of the present invention
Present embodiment carries out plane shaking table experiment to the product of the present invention of different HP-content, comes the simulate situation, investigates through taking a sample from three different loci of ABCD whether transportation causes that product separates again and inhomogeneous.
Get the product that embodiment 1 to embodiment 3 prepares (HP-weight be respectively cefepime hydrochloride weight 10%, 8%, 12%) respectively; PH value assay method with reference to two appendix VI of Pharmacopoeia of the People's Republic of China version in 2010 H; Measure pH value, the result is following:
The investigation result of transportation pH stability and the HP-relation of table 3 cefepime pharmaceutical composition of the present invention
Can find out from table 3 data, when HP-weight be cefepime hydrochloride weight 10% the time, the pH value of cefepime hydrochloride pharmaceutical composition of the present invention in transportation changes littler, be controlled at ± 0.1 in, stability is better.
The foregoing description is a preferred implementation of the present invention; But embodiment of the present invention is not restricted to the described embodiments; Other any do not deviate from change, the modification done under spirit of the present invention and the principle, substitutes, combination, simplify; All should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (7)
1. cefepime hydrochloride pharmaceutical composition; It is characterized in that: form by cefepime hydrochloride, L-arginine and HP-; The arginic weight of described L-is 40% of cefepime hydrochloride weight, and the weight of HP-is the 8%-12% of cefepime hydrochloride weight.
2. cefepime hydrochloride pharmaceutical composition as claimed in claim 1 is characterized in that: the weight of described HP-is 10% of cefepime hydrochloride weight.
3. cefepime hydrochloride pharmaceutical composition as claimed in claim 1 is characterized in that: the weight of each component is respectively in the pharmaceutical composition: cefepime hydrochloride 100kg
L-arginine 40kg
HP-10kg.
4. like each described cefepime hydrochloride preparation of drug combination method of claim 1-3; It is characterized in that this method may further comprise the steps: cefepime hydrochloride and L-arginine pulverize separately are sieved; Proportionally take by weighing cefepime hydrochloride and L-arginine; Mix homogeneously joins in the coating machine; HP-is dissolved in ethanol or concentration expressed in percentage by volume is the ethanol water of 50-70%, and the particle layer that the solution after the dissolving all is ejected into equably cefepime hydrochloride and the arginine mixed compound of L-is surperficial; Drying obtains the cefepime hydrochloride pharmaceutical composition.
5. like each described cefepime hydrochloride preparation of drug combination method of claim 1-3; It is characterized in that this method may further comprise the steps: with sieving behind cefepime hydrochloride, L-arginine, the HP-pulverize separately; Take by weighing above-mentioned prescription then in proportion, mix homogeneously promptly gets.
6. like each described cefepime hydrochloride pharmaceutical composition of claim 1-3, it is characterized in that: described preparation of pharmaceutical compositions becomes powder ampoule agent for injection.
7. the purposes that is used for the medicine of mammal bacterial infection like each described cefepime hydrochloride pharmaceutical composition of claim 1-3 in preparation.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111956597A (en) * | 2020-08-28 | 2020-11-20 | 上海欣峰制药有限公司 | Cefepime hydrochloride for injection and preparation method thereof |
| CN112094281A (en) * | 2020-08-11 | 2020-12-18 | 华北制药河北华民药业有限责任公司 | Preparation method of cefepime hydrochloride for injection |
-
2012
- 2012-07-06 CN CN 201210233863 patent/CN102743390B/en not_active Expired - Fee Related
Non-Patent Citations (6)
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| 《中国药业》 20071231 刘鄂湖，等 羟丙基--环糊精增溶难溶性药物研究进展 第26页右栏第2段 1-7 第16卷, 第8期 * |
| RACHEL F. EYLER, ET AL.: "antibiotic pharmacokinetic and pharmacodynamic considerations in patients with kidney disease", 《ADVANCES IN CHRONIC KIDNEY DISEASE》 * |
| 刘鄂湖，等: "羟丙基--环糊精增溶难溶性药物研究进展", 《中国药业》 * |
| 刘鄂湖，等: "羟丙基--环糊精增溶难溶性药物研究进展", 《中国药业》, vol. 16, no. 8, 31 December 2007 (2007-12-31), pages 26 - 2 * |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112094281A (en) * | 2020-08-11 | 2020-12-18 | 华北制药河北华民药业有限责任公司 | Preparation method of cefepime hydrochloride for injection |
| CN112094281B (en) * | 2020-08-11 | 2021-07-30 | 华北制药河北华民药业有限责任公司 | Preparation method of cefepime hydrochloride for injection |
| CN111956597A (en) * | 2020-08-28 | 2020-11-20 | 上海欣峰制药有限公司 | Cefepime hydrochloride for injection and preparation method thereof |
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