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CN1586486A - Cefpodoxime proxetil soft capsule preparation and its preparing method - Google Patents

Cefpodoxime proxetil soft capsule preparation and its preparing method Download PDF

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Publication number
CN1586486A
CN1586486A CN 200410068904 CN200410068904A CN1586486A CN 1586486 A CN1586486 A CN 1586486A CN 200410068904 CN200410068904 CN 200410068904 CN 200410068904 A CN200410068904 A CN 200410068904A CN 1586486 A CN1586486 A CN 1586486A
Authority
CN
China
Prior art keywords
soft capsule
cefpodoxime proxetil
capsule
cefpodoxime
proxetil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 200410068904
Other languages
Chinese (zh)
Inventor
庄大伟
孙丽红
王卓睿
王嘉瑜
张志宏
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BEIJING RUIYIREN TECHNOLOGY DEVELOPMENT Co Ltd
Original Assignee
BEIJING RUIYIREN TECHNOLOGY DEVELOPMENT Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BEIJING RUIYIREN TECHNOLOGY DEVELOPMENT Co Ltd filed Critical BEIJING RUIYIREN TECHNOLOGY DEVELOPMENT Co Ltd
Priority to CN 200410068904 priority Critical patent/CN1586486A/en
Publication of CN1586486A publication Critical patent/CN1586486A/en
Pending legal-status Critical Current

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Abstract

The present invention discloses one kind of soft cefpodoxime proxetil capsule and its preparation process. The medicine consists of medicine liquid and capsule shell, the medicine liquid contains cefpodoxime proxetil, matrix and stabilizer, and the capsule shell contains gelatin, glycerin, water, preservative and light screening agent. Compared with available cefpodoxime proxetil preparations, the present invention is even suitable for children and other people incapable of taking care of himself to take and has the advantages of high bioavailability, high stability, accurate content, etc.

Description

Cefpodoxime proxetil soft capsule preparation and preparation method thereof
Technical field
The present invention relates to soft capsule preparation of Cefpodoxime Proxetil and preparation method thereof, belong to the technical field of medicine and preparation thereof.
Technical background
Cefpodoxime Proxetil (Cefpodoxime proxetil) is that Japan three common (Sankyo) Co., Ltd. succeeded in developing and produced the oral efficient third generation cephalosporin of listing in 1989.Cefpodoxime Proxetil is the precursor of cefpodoxime (Cefpodoxime), demonstrates good antibacterial activity after the absorption, and its antibacterial activity is that it suppresses the synthetic of bacteria cell wall, and is highly stable to beta-lactamase.Has a broad antifungal spectrum comprises traditional pathogenic bacteria of drug-resistant, multiple gram positive bacteria and gram negative bacteria all there is very strong antibacterial activity, especially staphylococcus, Streptococcus etc. there is high activity, the significant advantage that is better than other third generation cephalosporin is provided.Also has Synergistic biocidal effect with the organism infection defensive enginery.Since Cefpodoxime Proxetil have broad-spectrum antiseptic, anti-enzyme, oral effectively, long half time and take the few advantage of number of times, not only solved the problem of bacterial resistance preferably, and kept the excellent safety of Beta-lactam medicine, be fit to very much the child and use.But mostly be the dosage form that suitable adult such as Cefpodoxime Proxetil sheet, Cefpodoxime Proxetil capsule, Cefpodoxime proxetil suspension uses at present clinically, do not have the children special-purpose dosage form.And the child has a lot of particularitys at physiology with comparing with the adult psychologically, each phylogeny of health is unsound, swallow is poor, that takes care of oneself is indifferent, poor to drug compliance, originally should be different to some extent in the medication, therefore press for the dosage form of a kind of suitable children taking of exploitation, make child's clinical application safer, convenient, economical.Same for the relatively poor patient of similar self care ability with the child, gerontal patient for example, special populations such as dementia patient also are badly in need of a kind of suitable pharmaceutical dosage form clinically.
Summary of the invention
Purpose of the present invention is exactly that dosage form at existing Cefpodoxime Proxetil is applicable to that the adult takes more, provides a kind of child and the patient that can't take care of oneself takes safety, Cefpodoxime proxetil soft capsule dosage form and preparation technology thereof easily.The present invention easily packs, transports, preserves, compares with tablet, without compression process, so disintegrate and rate of dispersion are fast, the higher advantage of bioavailability is arranged, content accurately, good uniformity, good looking appearance, taste and abnormal smells from the patient zest are not strong, easily be accepted, especially make special-shaped soft capsule and also can be called the capsule-type drop, splash in the mouth after can puncturing, it is very convenient to take, the patient's use that very is fit to the child and can't take care of oneself.
The present invention is made of medicinal liquid and softgel shell two large divisions, medicinal liquid by weight every contain the 10-160mg Cefpodoxime Proxetil and contain substrate 40-600mg, stabilizing agent 0.4-500mg, the gelatin that contains 10 parts of weight in the softgel shell, the glycerol of 3-6 part weight, the water of 10 parts of weight and antiseptic, lucifuge agent.
The present invention can contain in liquid polyethylene glycol, glycerol and the vegetable oil one or more as substrate; Contain in ethyl cellulose, PEG6000, Cera Flava, hydroxypropyl cellulose, single-stearic acid aluminum, lecithin, the Arlacel-80 one or more as stabilizing agent; Contain in ethyl hydroxybenzoate, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate one or more as antiseptic; In ferrum oxide, curcumin, lemon yellow, the titanium dioxide one or more are as the lucifuge agent.Can also add any pharmaceutically useful adjuvant in the soft capsule of the present invention, as long as the adjuvant safety, the avirulence that add, do not destroy effect of the present invention on the contrary.
The present invention is an oral administered dosage form; in this dosage form; Cefpodoxime Proxetil is in the suspension state; can overcome the shortcoming of existing dosage form; bioavailability significantly improves, and has added the lucifuge agent in the capsule material of soft capsule, can block the influence of daylight to medicine; thereby the protection Cefpodoxime Proxetil is not subjected to photodissociation, has improved the stability of this product greatly.And satisfy such dosage form and rationalize standard aspect stable at outward appearance, hardness, disintegration etc.Said preparation guaranteeing under the suitable prerequisite of principal agent dosage, by selecting adjuvant and formulation method for use, Cefpodoxime Proxetil made suspension be wrapped in and make soft capsule in the rubber, help medicine oral, absorb, reach high bioavailability.Clinical a kind of renewal, the better dosage form selection of providing also is provided simultaneously.
The present invention is owing to be soft capsule, and medicine is hedged off from the outer world in the shell, can be moistureproof, anti-oxidation, lucifuge, medicine stability be good.Done following accelerated test for proving these characteristics.
Accelerated test
Time (moon) Character Related substance (%) Content % Disintegration (minute)
????0 Bright and clean crack-free content does not have precipitation ????0.23 ????100 ????10.5
????1 Bright and clean crack-free content does not have precipitation ????0.31 ????99.4 ????10.3
????2 Bright and clean crack-free content does not have precipitation ????0.52 ????98.9 ????10.9
????3 Bright and clean crack-free content does not have precipitation ????0.56 ????98.7 ????11.1
????6 Bright and clean crack-free content does not have precipitation ????0.52 ????99.0 ????11.2
Specific embodiments
The detailed component of the present invention is provided by the following example, but protection scope of the present invention is not limited to this.
Embodiment 1
In 1kg gelatin, 350g glycerol, 1kg water, an amount of pigment, putting of 2.5g ethyl hydroxybenzoate glue jar, again with about this mixture heated to 70~80 ℃, mix homogeneously, evacuation, filtration, insulation is left standstill, and is stand-by.Get the PEG6000 of 3g and the PEG400 of 257g, heat fused, the Cefpodoxime Proxetil that adds 40g more fully mixes in blender, measures content, and is stand-by.In the soft capsule maker, after the compacting, drop put in the forming machine finalize the design.After the washing, drop about 30 ℃ dry 12 hours.
According to the technology of embodiment 1, below can change detailed component.
Embodiment 2
Group component (g)
Cefpodoxime Proxetil 40
Hydroxypropyl cellulose 15
Vegetable oil 245
Embodiment 3
Group component (g)
Cefpodoxime Proxetil 40
Cera Flava 9
Vegetable oil 251
Embodiment 4
Group component (g)
Cefpodoxime Proxetil 45
Aluminum monostearate 6
Arlacel-80 30
Vegetable oil 219
Although described the present invention by specific embodiment, some is revised and equivalence is obvious for the technical staff who is proficient in this field, and these variations are believed to comprise within the scope of the present invention.

Claims (9)

1, a kind of Cefpodoxime proxetil soft capsule preparation, Cefpodoxime Proxetil is to be sealed in the soft capsule with the suspension state, it is characterized in that medicinal liquid by weight every contain 10-160mg and contain substrate 40-600mg, stabilizing agent 0.4-50mg, the gelatin that contains 10 parts of weight in the softgel shell, the glycerol of 3-6 part weight, the water of 10 parts of weight and antiseptic, pigment.
2,, it is characterized in that can be made into two kinds of forms of common soft capsule and capsule-type drop as the said Cefpodoxime proxetil soft capsule of claim 1.
3,, it is characterized in that the capsule-type drop can be made into Pear-Shaped, special-shaped soft capsule such as ellipse as the said Cefpodoxime proxetil soft capsule of claim 2.
4,, it is characterized in that substrate is one or more in liquid polyethylene glycol, glycerol and the vegetable oil as the said Cefpodoxime proxetil soft capsule of claim 1;
5,, it is characterized in that stabilizing agent is one or more in hydroxypropyl cellulose, ethyl cellulose, single-stearic acid aluminum, PEG6000, Cera Flava, lecithin, the Arlacel-80 as the said Cefpodoxime proxetil soft capsule of claim 1.
6,, it is characterized in that antiseptic is one or more in ethyl hydroxybenzoate, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the butyl p-hydroxybenzoate as the said Cefpodoxime proxetil soft capsule of claim 1;
7,, it is characterized in that the lucifuge agent is one or more in ferrum oxide, curcumin, lemon yellow, the titanium dioxide as the said Cefpodoxime proxetil soft capsule of claim 1.
8, as the said Cefpodoxime proxetil soft capsule of claim 1, the preparation technology who it is characterized in that it may further comprise the steps: in gelatin, glycerol, water, antiseptic, putting of lucifuge agent glue jar, again with about this mixture heated to 70~80 ℃, mix homogeneously, evacuation, filter, insulation is left standstill, and is stand-by; Get substrate, the stabilizing agent of recipe quantity, heat fused, the Cefpodoxime Proxetil that adds recipe quantity more fully mixes in blender, and degassing back is put drop in the forming machine and to be finalized the design, after the washing drying, promptly in the soft capsule maker after the compacting.
9, as the said Cefpodoxime proxetil soft capsule of claim 1, the clinical infection that is widely used in responsive microbial department of otorhinolaryngology infection, respiratory system infection, urinary system infection, skin soft tissue etc.
CN 200410068904 2004-07-12 2004-07-12 Cefpodoxime proxetil soft capsule preparation and its preparing method Pending CN1586486A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200410068904 CN1586486A (en) 2004-07-12 2004-07-12 Cefpodoxime proxetil soft capsule preparation and its preparing method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200410068904 CN1586486A (en) 2004-07-12 2004-07-12 Cefpodoxime proxetil soft capsule preparation and its preparing method

Publications (1)

Publication Number Publication Date
CN1586486A true CN1586486A (en) 2005-03-02

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Family Applications (1)

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CN 200410068904 Pending CN1586486A (en) 2004-07-12 2004-07-12 Cefpodoxime proxetil soft capsule preparation and its preparing method

Country Status (1)

Country Link
CN (1) CN1586486A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100441173C (en) * 2005-11-25 2008-12-10 石药集团欧意药业有限公司 Agastachel patchoule summer heat dispelling soft capsule and its preparation method
CN100544707C (en) * 2005-12-14 2009-09-30 王殿华 panacea grass soft capsule and production method thereof
CN103263399A (en) * 2013-06-06 2013-08-28 南京正宽医药科技有限公司 Cefradine capsules and preparation method thereof
CN103462928A (en) * 2013-09-04 2013-12-25 南京正亮医药科技有限公司 Cefalexin capsules and preparation method thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100441173C (en) * 2005-11-25 2008-12-10 石药集团欧意药业有限公司 Agastachel patchoule summer heat dispelling soft capsule and its preparation method
CN100544707C (en) * 2005-12-14 2009-09-30 王殿华 panacea grass soft capsule and production method thereof
CN103263399A (en) * 2013-06-06 2013-08-28 南京正宽医药科技有限公司 Cefradine capsules and preparation method thereof
CN103263399B (en) * 2013-06-06 2015-07-22 南京正宽医药科技有限公司 Cefradine capsules and preparation method thereof
CN103462928A (en) * 2013-09-04 2013-12-25 南京正亮医药科技有限公司 Cefalexin capsules and preparation method thereof

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