CN1650868A - Compound medicinal preparation for treating pneumonia infection disease and its preparation method - Google Patents
Compound medicinal preparation for treating pneumonia infection disease and its preparation methodDownload PDFInfo
- Publication number
- CN1650868A CN1650868ACN 200410081382CN200410081382ACN1650868ACN 1650868 ACN1650868 ACN 1650868ACN 200410081382CN200410081382CN 200410081382CN 200410081382 ACN200410081382 ACN 200410081382ACN 1650868 ACN1650868 ACN 1650868A
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- CN
- China
- Prior art keywords
- compound medicinal
- hydrochloride
- cefixime
- medicinal formulation
- preparation
- Prior art date
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Links
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- Medicinal Preparation (AREA)
Abstract
Description
Technical field:
The present invention relates to a kind of anti-infective compound medicinal formulation and preparation method thereof, concrete, the present invention relates to a kind of compound medicinal formulation for the treatment of pneumonia infection disease and preparation method thereof.
Background technology:
Pneumonia infection disease is one of common respiratory tract infection illness.Because characteristics such as cephalo-type antibiotics are stable to beta-lactamase, has has a broad antifungal spectrum, and bactericidal action is strong, therefore be usually used in treatment, the especially third generation cephalo-type antibiotics of respiratory tract infection illness clinically, as cefixime (Cefixime C16H15N5O7S23H2O), Ro 15-8074/001 (Cefetamet SodiumC14H14N5NaO5S2), Cefetamet Pivoxil Hydrochloride (Cefetamet Pivoxil HydrochlorideC14H15N5O7S2HCL) etc.But the sensitivity of microorganism to it is not only depended in the success of antibacterial therapy, but also closely related with the drug level of infection site.
So far as is known, ambroxol hydrochloride (Ambroxol Hydrochloride) is the phlegm dissolving agent of a new generation, it not only can increase the secretion of respiratory mucosa serous gland, reduce the mucous gland secretion, thereby reduce sputum viscosity, but also can promote the secretion of pulmonary surfactant, and increase the bronchus ciliary movement, make sputum be easy to expectoration.On this basis, discover through us, phlegm dissolving agent ambroxol hydrochloride can also increase the penetrance of cephalosporins such as cefixime, Ro 15-8074/001 and Cefetamet Pivoxil Hydrochloride to lung tissue, thereby improved the concentration of antibiotics greatly, but simultaneously the drug level in the blood plasma has not been had influence at infection sites such as lungs.
Current, be that cephalo-type preparation and ambroxol hydrochloride preparation are used as two kinds of compatibility of drugss clinically, because dose is big, dosage is not accurate enough, thereby causes its therapeutic effect to be affected.
Summary of the invention:
The object of the present invention is to provide a kind of compound medicinal formulation for the treatment of pneumonia infection disease.Said preparation not only can strengthen the antibacterial activity of infected pulmonary greatly, strengthens therapeutic effect, has also simultaneously that clinical practice is more convenient, taking dose is less relatively and characteristic of accurate.
Another object of the present invention is to provide the preparation method of this compound medicinal formulation.
The objective of the invention is that following technical scheme realizes by implementing.
A kind of compound medicinal formulation for the treatment of pneumonia infection disease is characterized in that it mainly is to be made by 1: 1～20 weight proportion by ambroxol hydrochloride and cephalo-type antibiotics active component.
The chemical structural formula of described ambroxol hydrochloride is as follows:
Ambroxol hydrochloride (Ambroxol Hydrochloride)
Described cephalo-type antibiotics is selected cefixime, Ro 15-8074/001 or Cefetamet Pivoxil Hydrochloride for use, and its chemical structural formula is as follows respectively:
Cefixime (Cefixime)
Ro 15-8074/001 (Cefetamet Sodium)
Cefetamet Pivoxil Hydrochloride (Cefetamet Pivoxil Hydrochloride)
The preferred weight proportioning of described ambroxol hydrochloride and Cefetamet Pivoxil Hydrochloride is 1: 1～8.
The preferred weight proportioning of described ambroxol hydrochloride and Ro 15-8074/001 is 1: 1～5.
Described compound medicinal formulation comprises peroral dosage forms such as tablet, dispersible tablet, chewable tablet, capsule, granule, oral liquid, dry suspension, and various injection, injectable sterile powder, freeze-dried powder etc.
Described compound medicinal formulation comprises adjuvant necessary on the galenic pharmacy, and the adjuvant of described necessity comprises the diluent of tablet, binding agent, disintegrating agent, lubricant, correctives, aromatic; The solvent of oral liquid, stabilizing agent, acid-base modifier; The cosolvent of injection, antioxidant, acid-base modifier.
Preparation method of the present invention is that active component and adjuvant are made various dosage forms by the universal method on the galenic pharmacy.
The invention has the advantages that:
1, ambroxol hydrochloride can increase the concentration of cephalosporin in pulmonary, thereby has brought into play the antibacterial action of cephalosporin to greatest extent.
2, after antibiotics such as ambroxol hydrochloride and cefixime, Ro 15-8074/001, Cefetamet Pivoxil Hydrochloride share, the action intensity of antibiotics was significantly improved, thereby has significantly improved the therapeutic effect to pneumonia infection disease.
3, compound medicinal formulation clinical practice of the present invention is convenient, taking dose is less relatively and accurate.
The specific embodiment:
Embodiment 1: the preparation of cefixime ambroxol sheet
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Starch 25g
Microcrystalline Cellulose 50g
The low hydroxypropyl cellulose 12.5g that gets
10% starch slurry 30ml
Magnesium stearate 2.5g
Make 1000
Preparation technology: take by weighing cefixime, ambroxol hydrochloride, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add magnesium stearate and cross 18 mesh sieve granulate, tabletting, every heavily about 0.25g.
Embodiment 2: the preparation of cefixime ambroxol dispersible tablet
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Lactose 37.5g
Microcrystalline Cellulose 36g
Crospolyvinylpyrrolidone 15g
10% polyvinylpyrrolidonesolution solution 30ml
Sodium lauryl sulphate 1.5g
Make 1000
Preparation technology: take by weighing cefixime, ambroxol hydrochloride, lactose, microcrystalline Cellulose, crospolyvinylpyrrolidone respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% polyvinylpyrrolidonesolution solution system soft material, the wet grain of the 30 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add sodium lauryl sulphate and cross 20 mesh sieve granulate, the heavily about 0.25g of tabletting, sheet.
Embodiment 3: the capsular preparation of cefixime ambroxol
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Starch 25g
Microcrystalline Cellulose 50g
The low hydroxypropyl cellulose 12.5g that gets
10% starch slurry 25ml
Magnesium stearate 2.5g
Make 1000
Preparation technology: take by weighing cefixime, ambroxol hydrochloride, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add magnesium stearate and cross 18 mesh sieve granulate, the heavily about 0.25g of filled capsules, capsule.
Embodiment 4: the preparation of cefixime ambroxol granule
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Sucrose 525g
Carboxymethyl starch sodium 495g
10% starch slurry 30ml
Essence 2ml
Make 1000 bags
Preparation technology: take by weighing cefixime, ambroxol hydrochloride, sucrose, carboxymethyl starch sodium respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously adds 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours, cross 18 mesh sieve granulate, spray into essence, mix homogeneously, packing, every bag of about 1.2g.
Embodiment 5: the preparation of cefixime ambroxol chewable tablet
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Sucrose 122g
Micropowder silica gel 15g
10% starch slurry 40ml
Essence 2ml
Magnesium stearate 3g
Make 1000
Preparation technology: take by weighing cefixime, ambroxol hydrochloride, sucrose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously adds 10% starch slurry system soft material, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃ of dryings 3 hours, add micropowder silica gel, magnesium stearate is crossed 18 mesh sieve granulate, sprays into essence, mix homogeneously, the heavily about 0.3g of tabletting, sheet.
Embodiment 6: the preparation of Ro-15-8075 ambroxol sheet
Prescription:
Cefetamet Pivoxil Hydrochloride 100g
Ambroxol hydrochloride 60g
Starch 25g
Microcrystalline Cellulose 50g
The low hydroxypropyl cellulose 12.5g that gets
10% starch slurry 30ml
Magnesium stearate 2.5g
Make 1000
Preparation technology: take by weighing Cefetamet Pivoxil Hydrochloride, ambroxol hydrochloride, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add magnesium stearate and cross 18 mesh sieve granulate, tabletting, every heavily about 0.25g.
Embodiment 7: the preparation of Ro-15-8075 ambroxol dispersible tablet
Prescription:
Cefetamet Pivoxil Hydrochloride 100g
Ambroxol hydrochloride 60g
Lactose 37g
Microcrystalline Cellulose 36g
Crospolyvinylpyrrolidone 15g
10% polyvinylpyrrolidonesolution solution 35ml
Sodium lauryl sulphate 1.5g
Make 1000
Preparation technology: take by weighing Cefetamet Pivoxil Hydrochloride, ambroxol hydrochloride, lactose, microcrystalline Cellulose, crospolyvinylpyrrolidone respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% polyvinylpyrrolidonesolution solution system soft material, the wet grain of the 30 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add sodium lauryl sulphate and cross 20 mesh sieve granulate, the heavily about 0.25g of tabletting, sheet.
Embodiment 8: the capsular preparation of Ro-15-8075 ambroxol
Prescription:
Cefetamet Pivoxil Hydrochloride 100g
Ambroxol hydrochloride 60g
Starch 25g
Microcrystalline Cellulose 50g
The low hydroxypropyl cellulose 12.5g that gets
10% starch slurry 30ml
Magnesium stearate 2.5g
Make 1000
Preparation technology: take by weighing Cefetamet Pivoxil Hydrochloride, ambroxol hydrochloride, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously, add 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours add magnesium stearate and cross 18 mesh sieve granulate, the heavily about 0.25g of filled capsules, capsule.
Embodiment 9: Ro-15-8075 ambroxol granule
Prescription:
Cefetamet Pivoxil Hydrochloride 100g
Ambroxol hydrochloride 60g
Sucrose 525g
Carboxymethyl starch sodium 495g
10% starch slurry 35ml
Essence 2ml
Make 1000 bags
Preparation technology: take by weighing Cefetamet Pivoxil Hydrochloride, ambroxol hydrochloride, sucrose, carboxymethyl starch sodium respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously adds 10% starch slurry system soft material, the wet grain of the 20 eye mesh screen systems of crossing, 50 ℃ of dryings 3 hours, cross 18 mesh sieve granulate, spray into essence, mix homogeneously, packing, every bag of about 1.2g.
Embodiment 10: Ro-15-8075 ambroxol chewable tablet
Prescription:
Cefetamet Pivoxil Hydrochloride 100g
Ambroxol hydrochloride 60g
Sucrose 122g
Micropowder silica gel 15g
10% starch slurry 30ml
Essence 2ml
Magnesium stearate 3g
Make 1000
Preparation technology: take by weighing Cefetamet Pivoxil Hydrochloride, ambroxol hydrochloride, sucrose respectively by above-mentioned prescription, pulverize the back and cross 80 eye mesh screens, mix homogeneously adds 10% starch slurry system soft material, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃ of dryings 3 hours, add micropowder silica gel, magnesium stearate is crossed 18 mesh sieve granulate, sprays into essence, mix homogeneously, the heavily about 0.3g of tabletting, sheet.
Embodiment 11: the preparation of cefixime Ambroxol Hydrochloride Oral Solution
Prescription:
Cefixime 100g
Ambroxol hydrochloride 60g
Glycerol 300g
Water for injection adds to 1000ml
Make 1000ml altogether
Preparation technology: take by weighing each supplementary material respectively by above-mentioned prescription, ambroxol hydrochloride is dissolved in the 350ml water for injection, the dissolving back adds cefixime, stirring makes suspendible, adds glycerol again, adds the injection water after stirring evenly to 1000ml, be sub-packed in the plastic bottle every bottle of 50ml.
Embodiment 12: the preparation of cefixime ambroxol dry suspension
Prescription:
Cefixime 100.0g
Ambroxol hydrochloride 60.0g
Sucrose 840.0g
Make 1000g altogether
Preparation technology: take by weighing cefixime, ambroxol hydrochloride and sucrose by above-mentioned prescription, pulverize separately is crossed mix homogeneously behind 60 mesh sieves, is sub-packed in the packaging bag every bag of 1g.
Embodiment 13: the preparation of Ro 15-8074/001 ambroxol injection
Prescription:
Ro 15-8074/001 60g
Ambroxol hydrochloride 60g
Make 1000
Preparation technology: under the gnotobasis, (refining methanol is through the aseptic washing of 95% ethanol with the Ro 15-8074/001 aseptic powder by above-mentioned prescription, dry gained) and the fully mixing in aseptic Aluminum Drum of ambroxol hydrochloride aseptic powder, be distributed into 1000, every 0.12g seals with butyl rubber bung.
Embodiment 14: the preparation of Ro 15-8074/001 ambroxol freeze-dried powder
Prescription:
Ro 15-8074/001 60g
Ambroxol hydrochloride 60g
Make 1000
Preparation technology: by above-mentioned prescription Ro 15-8074/001, ambroxol hydrochloride are added injection water 1000ml dissolving, through aseptic filtration, be sub-packed in the 5ml cillin bottle, every dress 1ml put in the freeze drying box lyophilizing 26 hours, and tamponade under the vacuum is taken out and added a cover aluminium lid, promptly.Said preparation can be made intravenous injection, and intravenous drip or intramuscular injection are used.
Embodiment 15: contrast test
Experimental technique: select respiratory tract disease inpatient 20 examples to be divided into two groups randomly, matched group 8 examples, experimental group 12 examples.The every routine patient of matched group all oral cefixime sheet (containing cefixime 0.1g) every day 2 times before inspection, experimental group is taken cefixime ambroxol sheet (containing cefixime 0.1g, ambroxol hydrochloride 0.06g) every day 2 times.Collect after 3 days and middle cefixime of measurement bronchoalveolar lavage fluid (BALF) and proteic concentration, calculate both ratios.
Experimental result: (0.037 ± 0.014mg/L) than matched group (0.022 ± 0.011mg/L) high (P＜0.05) for the content of cefixime among the experimental group BALF; Cefixime content and protein content ratio 0.10 also are higher than 0.04 of matched group among the experimental group BALF, P＜0.05.And protein content there was no significant difference (P＜0.05) among two groups cefixime plasma concentration and the BALF.
Conclusion: use the experimental group and the matched group that uses the cefixime sheet of cefixime ambroxol sheet, the former cefixime concentration in lung more helps the treatment of pulmonary infection apparently higher than the latter.
Claims (8)
1, a kind of compound medicinal formulation for the treatment of pneumonia infection disease is characterized in that it mainly is to be made by 1: 1～20 weight proportion by ambroxol hydrochloride and cephalo-type antibiotics active component.
2, compound medicinal formulation according to claim 1 is characterized in that described cephalo-type antibiotics selects cefixime, Ro 15-8074/001 or Cefetamet Pivoxil Hydrochloride for use.
3, compound medicinal formulation according to claim 1, the weight proportion that it is characterized in that described ambroxol hydrochloride and cefixime is 1: 1～10.
4, compound medicinal formulation according to claim 1, the weight proportion that it is characterized in that described ambroxol hydrochloride and Ro 15-8074/001 is 1: 1～5.
5, compound medicinal formulation according to claim 1, the weight proportion that it is characterized in that described ambroxol hydrochloride and Cefetamet Pivoxil Hydrochloride is 1: 1～8.
6, according to claim 1,3,4,5 each described compound medicinal formulations, it is characterized in that described compound medicinal formulation comprises peroral dosage forms such as tablet, dispersible tablet, chewable tablet, capsule, granule, oral liquid, dry suspension, and various injection, injectable sterile powder, freeze-dried powder etc.
7, compound medicinal formulation according to claim 6 is characterized in that described preparation comprises adjuvant necessary on the galenic pharmacy, and the adjuvant of described necessity comprises the diluent of tablet, binding agent, disintegrating agent, lubricant, correctives, aromatic; The solvent of oral liquid, stabilizing agent, acid-base modifier; The cosolvent of injection, antioxidant, acid-base modifier.
8, a kind of compound medicinal formulation for the treatment of pneumonia infection disease is characterized in that it is that active component and adjuvant are made various dosage forms by the universal method on the galenic pharmacy.
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| CN 200410081382CN1650868A (en) | 2004-12-02 | 2004-12-02 | Compound medicinal preparation for treating pneumonia infection disease and its preparation method |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD4093B1 (en)* | 2004-05-03 | 2011-02-28 | Boehringer Ingelheim International Gmbh | Use of topical pharmaceutical composition containing ambroxol |
| WO2011139255A2 (en) | 2010-05-04 | 2011-11-10 | Mahmut Bilgic | Pharmaceutical compositions comprising cefetamet |
| CN101491501B (en)* | 2008-01-24 | 2012-09-26 | 沈阳华泰药物研究有限公司 | Preparation method of ambroxol for injection |
| CN104606166A (en)* | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Compound cefalexin capsule and preparation method thereof |
| CN110302202A (en)* | 2016-09-30 | 2019-10-08 | 华北制药河北华民药业有限责任公司 | The method for preparing cefamandole nafate for injection powder injection formulation |
- 2004
- 2004-12-02CNCN 200410081382patent/CN1650868A/enactivePending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD4093B1 (en)* | 2004-05-03 | 2011-02-28 | Boehringer Ingelheim International Gmbh | Use of topical pharmaceutical composition containing ambroxol |
| CN101491501B (en)* | 2008-01-24 | 2012-09-26 | 沈阳华泰药物研究有限公司 | Preparation method of ambroxol for injection |
| WO2011139255A2 (en) | 2010-05-04 | 2011-11-10 | Mahmut Bilgic | Pharmaceutical compositions comprising cefetamet |
| CN104606166A (en)* | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Compound cefalexin capsule and preparation method thereof |
| CN110302202A (en)* | 2016-09-30 | 2019-10-08 | 华北制药河北华民药业有限责任公司 | The method for preparing cefamandole nafate for injection powder injection formulation |
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