CN104906035A - Cefmenoxime hydrochloride and low-sodium carrier drug composition for children - Google Patents
Cefmenoxime hydrochloride and low-sodium carrier drug composition for children Download PDFInfo
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- CN104906035A CN104906035A CN201510281825.XA CN201510281825A CN104906035A CN 104906035 A CN104906035 A CN 104906035A CN 201510281825 A CN201510281825 A CN 201510281825A CN 104906035 A CN104906035 A CN 104906035A
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Abstract
The invention relates to a cefmenoxime hydrochloride drug composition for children, namely, a drug composition preparation of cefmenoxime hydrochloride and a low-sodium carrier infusion solution, in particular to a composition application package. The composition comprises the cefmenoxime hydrochloride and the low-sodium carrier infusion solution for injection. The low-sodium carrier infusion solution comprises a dextrose and sodium chloride injection (15-200:1), a glucose, sodium chloride and potassium chloride injection (15-200:1:0-1) and the like. Relative to the compatible and mixed use of the cefmenoxime hydrochloride and the low-sodium carrier infusion solution, clinical application steps are simplified. The clinical risks caused due to the fact that the kidneys of the children are not mature and are incapable of metabolizing too much sodium existing in blood are reduced. The clinical application quality and safety of child drugs are improved.
Description
Technical field
The present invention relates to a kind of child form Abbott 50192 and low sodium carrier pharmaceutical composition, belong to medicinal chemistry art.
Background technology
Abbott 50192 chemical name is (6R, 7R)-7-[2-(2-amino-4-thiazolyl) (methoxyimino) acetamido]-3-[[(1-methyl isophthalic acid H-tetrazolium-5-base)-sulfur]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid hydrochloride, also known as Cefmenoxime, Bestcall, be third generation cephalo, all have antibacterial action to Gram-negative and positive aerobe and anaerobe.In gram negative bacteria, slightly stronger than cefotiam to the antibacterial action of escherichia coli, pneumobacillus, obviously be better than the cefazolin sodium of the first generation, to influenza bite blood bacillus, Bacillus proteus, serratia marcesens, Citrobacter, Enterobacter antibacterial action also stronger, also have very strong antibacterial action to Bacteroides.In gram positive bacteria, also stronger to micrococcus scarlatinae, pneumococcal antibacterial action.Also powerful antibacterial action is had to Peptococcus, Peptostreptococcus.Beta lactamase is stablized.This product is applicable to responsive microbial septicemia, meningitis, respiratory tract infection, empyema, liver and gallbladder infection, peritonitis, urinary tract infection, genital system infection and burn and surgical wound infection etc.
The preparation of prior art Abbott 50192 is generally taked: in cefmenoxime acid, add water formulated suspension, add sodium carbonate stirring and dissolving, aseptic filtration after activated carbon decolorizing, filtrate added drop-wise hydrochloric acid, and stirred crystallization, filters after washing.This preparation method is simple to operate, and the Abbott 50192 prepared also can meet Chinese Pharmacopoeia standard.But, because Abbott 50192 dissolves difficulty, and cephalo-type product poor stability in the solution, in dissolving, overlong time can cause cefmenoxime to be degraded, and impurity increases.Children's torso each side is still in growth stage, and the side effect that Drug-related causes can show particularly evident, controls Drug-related content in pediatric pharmaceuticals, seems particularly important.How improving children's by Abbott 50192 purity is current problem demanding prompt solution, has great Social benefit and economic benefit.
Because child's kidney is not reached maturity, there is no sodium too much in ability metabolism blood.If hypernatremia, be difficult to recover to the injury of child, and the age is less, and to receive injury larger, particularly neonate.Neonate and infant kidney are poor to acid, alkali and water metabolism regulating power, and the filtration rate of glomerule is only adult's 1/4 ~ 1/2.
For the physiological characteristics of child, reduce the clinical risk that cefmenoxime is in use possible, invent and a kind ofly can meet the child form Abbott 50192 of child's stage physiological characteristics and low sodium carrier pharmaceutical composition, namely the carrier transfusion of low sodium is packed with cefmenoxime Combination application.
Need in Clinical practice to buy use in conjunction respectively, the assembly packaging of the carrier flow of infusate combination preparation of Abbott 50192 and low sodium does not occur commercially with in medical institutions.
Summary of the invention
The object of this invention is to provide the medicine composition that a kind of child form Abbott 50192 pharmaceutical composition and Abbott 50192 and low sodium carrier are infused, especially Combination application packaging, with a kind of Abbott 50192 preparation method, it can solve above-mentioned shortcoming of the prior art.
For achieving the above object, the present invention is by the following technical solutions:
A kind of child form Abbott 50192 and low sodium carrier pharmaceutical composition are Abbott 50192 glucose sodium chloride potassium injection or Abbott 50192 Dextrose and Sodium Chloride Inj..
Preferably, this Abbott 50192 glucose sodium chloride potassium injection comprises each component of following quality:
Abbott 50192 0.25g-1.0g;
Glucose 5-9g;
Sodium chloride 0.1-0.2g;
Potassium chloride 0.1-0.2g;
Add water to 100mL.
This Abbott 50192 Dextrose and Sodium Chloride Inj. comprises each component of following quality:
Abbott 50192 0.25g-1.0g;
Glucose 5-9g;
Sodium chloride 0.1-0.2g;
Add water to 100mL.
Preferably, this pharmaceutical composition can be packed for Combination application.
Preferably, this Abbott 50192 is prepared by following steps:
(1) Abbott 50192 crude product adds water, and stirs and slowly drips sodium bicarbonate solution until clarification, add extractant, be transferred to and be full of in pressure vessel, sealing vibration after removal bubble, the freezing rear taking-up of temperature control;
(2) remove organic facies, solid adds active carbon after melting, and stirs decolouring, filters;
(3) filtrate is with salt acid for adjusting pH to 1.2-2.0, and growing the grain, filters, wash with water, 40 DEG C of vacuum dryings and get final product.
Preferably, in described step (1), Abbott 50192 solution concentration is no more than 0.3g/ml.
Preferably, described extractant is several mixing of ethyl acetate, chloroform, ether or more.
Preferably, in described step (1), the volume ratio of described extractant and described water is 1:100 ~ 200.
Preferably, described temperature control cryogenic temperature is greater than the fusing point of extractant.
Preferably, in described step (1), be refrigerated to aqueous portion and freeze rear taking-up.
Preferably, in described step (1), regulate pH to 1.5.
Technique scheme has following beneficial effect: in refrigerating process, aqueous solvent is frozen into ice, volumetric expansion increases, internal pressure in airtight pressure vessel is increased, thus the dissolubility of the organic impurities that improve in Abbott 50192 in extractant, reduce the impurity content in finished product; In the process of simultaneously water condensation Cheng Bing, because organic impurities is extruded in ice, further increase extraction efficiency, reduce impurity content; Compared with the Abbott 50192 that traditional handicraft is obtained, the Abbott 50192 impurity that the present invention obtains obviously is reduced, thus has good stability, purity advantages of higher.Meanwhile, have employed the carrier flow of infusate assembly packaging of Abbott 50192 and low sodium, used in combination relative to the compatibility of the two, simplify step, improve the safety of children; Decrease because child's kidney is not reached maturity, there is no the clinical risk that in ability metabolism blood, too much sodium brings, improve the clinical practice quality of children.
Detailed description of the invention
Set forth the specific embodiment of the present invention further below:
Embodiment 1
(1) take cefmenoxime crude product 100g, add water 1000ml, stirs and slowly drip 4% sodium bicarbonate solution until clarification, add 10ml ethyl acetate under stirring, be transferred in 1000ml pressure vessel, guarantee to be full of and bubble removal, sealed container, vibration, takes out after the freezing 3h of temperature control-18 DEG C;
(2) remove organic facies, after ice-out, add 10g active carbon, stir decolouring, filter;
(3) filtrate is transferred to crystallizer, temperature control 10 ~ 15 DEG C, regulates pH to 1.5 with dilute hydrochloric acid, and continue growing the grain 1h, sucking filtration, washes with water, 40 DEG C of vacuum dryings and get final product.Maximum list assorted 0.13%, always mixes 0.23%.
Embodiment 2
(1) take cefmenoxime crude product 100g, add water 1000ml, stirs and slowly drip 4% sodium bicarbonate solution until clarification, add 10ml chloroform under stirring, be transferred in 1000ml pressure vessel, guarantee to be full of and bubble removal, sealed container, vibration, takes out after the freezing 3h of temperature control-18 DEG C;
(2) remove organic facies, after ice-out, add 10g active carbon, stir decolouring, filter;
(3) filtrate is transferred to crystallizer, temperature control 10 ~ 15 DEG C, regulates pH to 1.7 with dilute hydrochloric acid, and continue growing the grain 1h, sucking filtration, washes with water, 40 DEG C of vacuum dryings and get final product.Maximum list assorted 0.19%, always mixes 0.29%.
Embodiment 3
(1) take cefmenoxime crude product 100g, add water 1000ml, stirs and slowly drip 4% sodium bicarbonate solution until clarification, add 7ml ethyl acetate under stirring, be transferred in 1000ml pressure vessel, guarantee to be full of and bubble removal, sealed container, vibration, takes out after the freezing 3h of temperature control-18 DEG C;
(2) remove organic facies, after ice-out, add 10g active carbon, stir decolouring, filter;
(3) filtrate is transferred to crystallizer, temperature control 10 ~ 15 DEG C, regulates pH to 1.5 with dilute hydrochloric acid, and continue growing the grain 1h, sucking filtration, washes with water, 40 DEG C of vacuum dryings and get final product.Maximum list assorted 0.17%, always mixes 0.24%.
Embodiment 4 (comparative example)
Take cefmenoxime crude product 100g, add water 1000ml, stirs and slowly drip 4% sodium bicarbonate solution until clarification, add 10g active carbon, stirs decolouring, filters; Filtrate is transferred to crystallizer, temperature control 10 ~ 15 DEG C, regulates pH to 1.5 with dilute hydrochloric acid, and continue growing the grain 1h, sucking filtration, washes with water, 40 DEG C of vacuum dryings and get final product.Maximum list assorted 0.25%, always mixes 0.53%.
Embodiment 5
The preparation of glucose sodium chloride potassium injection:
Configuration 1: glucose 8g, sodium chloride 0.18g, potassium chloride 0.15g, inject water to 100mL, with 0.22 μm of microporous filter membrane aseptic filtration.
Configuration 2: glucose 5g, sodium chloride 0.11g, potassium chloride 0.1g, inject water to 100mL, with 0.22 μm of microporous filter membrane aseptic filtration.
Embodiment 6
The preparation of Dextrose and Sodium Chloride Inj.:
Configuration 3: glucose 8g, sodium chloride 0.18g, inject water to 100mL, with 0.22 μm of microporous filter membrane aseptic filtration.
Configuration 4: glucose 5g, sodium chloride 0.11g, inject water to 100mL, with 0.22 μm of microporous filter membrane aseptic filtration.
Embodiment 7
The preparation of assembly packaging medicine:
The child form Abbott 50192 of embodiment 1-3 and the glucose sodium chloride potassium injection of embodiment 5-6 or Dextrose and Sodium Chloride Inj. are carried out assembly packaging according to 0.25g:100ml, 0.5g:100ml, 0.75g:100ml, 1.0g:100ml respectively.
More than describe preferred embodiment of the present invention in detail.Should be appreciated that those of ordinary skill in the art just design according to the present invention can make many modifications and variations without the need to creative work.Therefore, all technical staff in the art, all should by the determined protection domain of claims under this invention's idea on the basis of existing technology by the available technical scheme of logical analysis, reasoning, or a limited experiment.
Claims (9)
1. child form Abbott 50192 and a low sodium carrier pharmaceutical composition, is characterized in that, described pharmaceutical composition is Abbott 50192 glucose sodium chloride potassium injection or Abbott 50192 Dextrose and Sodium Chloride Inj.; Described Abbott 50192 glucose sodium chloride potassium injection comprises each component of following quality:
Abbott 50192 0.25g-1.0g;
Glucose 5-9g;
Sodium chloride 0.1-0.2g;
Potassium chloride 0.1-0.2g;
Add water to 100mL.
Described Abbott 50192 Dextrose and Sodium Chloride Inj. comprises each component of following quality:
Abbott 50192 0.25g-1.0g;
Glucose 5-9g;
Sodium chloride 0.1-0.2g;
Add water to 100mL.
2. child form cefmenoxime sodium as claimed in claim 1 and low sodium carrier pharmaceutical composition, it is characterized in that, described pharmaceutical composition can be packed for Combination application.
3. child form Abbott 50192 as claimed in claim 1 and low sodium carrier pharmaceutical composition, it is characterized in that, described cefmenoxime hydrochloride compound is prepared by following steps:
(1) Abbott 50192 crude product adds water, and stirs and slowly drips sodium bicarbonate solution until clarification, add extractant, be transferred to and be full of in pressure vessel, sealing vibration after removal bubble, the freezing rear taking-up of temperature control;
(2) remove organic facies, solid adds active carbon after melting, and stirs decolouring, filters;
(3) filtrate is with salt acid for adjusting pH to 1.2-2.0, and growing the grain, filters, wash with water, 40 DEG C of vacuum dryings and get final product.
4. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, it is characterized in that, in described step (1), Abbott 50192 solution concentration is no more than 0.3g/ml.
5. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, it is characterized in that, described extractant is several mixing of ethyl acetate, chloroform, ether or more.
6. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, it is characterized in that, in described step (1), the volume ratio of described extractant and described water is 1:100 ~ 200.
7. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, it is characterized in that, described temperature control cryogenic temperature is greater than the fusing point of extractant.
8. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, is characterized in that, in described step (1), be refrigerated to aqueous portion and freeze rear taking-up.
9. child form Abbott 50192 as claimed in claim 3 and low sodium carrier pharmaceutical composition, is characterized in that, in described step (1), regulates pH to 1.5.
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| CN201510281825.XA CN104906035A (en) | 2015-05-28 | 2015-05-28 | Cefmenoxime hydrochloride and low-sodium carrier drug composition for children |
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| CN201510281825.XA CN104906035A (en) | 2015-05-28 | 2015-05-28 | Cefmenoxime hydrochloride and low-sodium carrier drug composition for children |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101569628A (en) * | 2009-06-19 | 2009-11-04 | 山东罗欣药业股份有限公司 | Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof |
| CN101697961A (en) * | 2009-10-24 | 2010-04-28 | 徐斌 | New cefmenoxime hydrochloride preparation for drug administration by injection and preparation method thereof |
| CN102179063A (en) * | 2011-03-23 | 2011-09-14 | 苏州汇通色谱分离纯化有限公司 | High pressure liquid-liquid extraction method |
| CN103554136A (en) * | 2013-10-31 | 2014-02-05 | 哈药集团制药总厂 | Preparation method of cefmenoxine hydrochloride dry powder |
-
2015
- 2015-05-28 CN CN201510281825.XA patent/CN104906035A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101569628A (en) * | 2009-06-19 | 2009-11-04 | 山东罗欣药业股份有限公司 | Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof |
| CN101697961A (en) * | 2009-10-24 | 2010-04-28 | 徐斌 | New cefmenoxime hydrochloride preparation for drug administration by injection and preparation method thereof |
| CN102179063A (en) * | 2011-03-23 | 2011-09-14 | 苏州汇通色谱分离纯化有限公司 | High pressure liquid-liquid extraction method |
| CN103554136A (en) * | 2013-10-31 | 2014-02-05 | 哈药集团制药总厂 | Preparation method of cefmenoxine hydrochloride dry powder |
Non-Patent Citations (2)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典2010年版第一增补本》", 31 August 2012 * |
| 迟延青等: "《最新临床用药必备》", 31 January 2011 * |
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Application publication date: 20150916 |