CN101642439A - Rifaximin dry suspension agent and production method thereof - Google Patents
Rifaximin dry suspension agent and production method thereof Download PDFInfo
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- CN101642439A CN101642439A CN200910034012A CN200910034012A CN101642439A CN 101642439 A CN101642439 A CN 101642439A CN 200910034012 A CN200910034012 A CN 200910034012A CN 200910034012 A CN200910034012 A CN 200910034012A CN 101642439 A CN101642439 A CN 101642439A
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- rifaximin
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Abstract
The invention relates to a rifaximin dry suspension agent and a production method thereof, relating to the technical field of medicines, in particular to a rifaximin dry suspension agent for enteric infection and a production method thereof. The rifaximin dry suspension agent comprises the following components by weight percent: 1-40 percent of rifaximin, 20-60 percent of carboxymethylcellulose sodium-microcrystalline cellulose, 10-50 percent of dextrin, 1-10 percent of polyvidone K30 and 20-60 percent of flavouring agent. The rifaximin dry suspension agent has high stability, quickly forms anevenly distributed suspension after water is added, has fragrant and sweet flavor, is not absorbed by a human body almost after being taken, has higher concentration in the enteric canal, low incidence rate of adverse reaction and slight adverse reaction and can overcome the defect that tablets, capsules, and the like are not easy to swallow, thereby being especially suitable for children and gerontal patients.
Description
Technical field
The present invention relates to medical technical field, particularly a kind of Rifaximin dry suspension agent and production method thereof that is used for intestinal infection.
Technical background
The toxicity of the present equal various degrees of other treatment diarrheal gastrointestinal tract medication.As: neomycin, streptomycin and other aminoglycosides antibiotics have the damage auditory function, cause disadvantages such as stomach functional defect.Tetracycline has certain curative effect for infectious diarrhea, can cause deficiencies such as permanent tooth xanthochromia, dentium nitor dysplasia and osteogenesis inhibition but the juvenile uses tetracycline and similar medicine such as oxytetracycline, doxycycline, minocycline etc.; Norfloxacin has curative effect preferably to the gastrointestinal tract bacillary dysentery, but this medicine and similar medicine have the possibility that causes osseous lesion, and medicinal charcoal can adsorb and cause suffering from diarrhoea and the multiple poisonous or nontoxic stimulus object of abdominal discomfort.Thereby play anti-diarrhea effect, yet because this medicine adsorption is strong and non-selectivity, all influential to the biological activity of digestive enzyme such as pepsin, pancreatin, prolonged application there is the possibility that causes infantile malnutrition; This product has overcome the deficiency of said medicine, and the normal parasitic flora of intestinal can be settled in intestinal very soon, avoids repeated infection, and the intestinal mucosa inflammation can be tending towards disappearing.
Some is clinical to be used for the treatment of the diarrheal medicine with the passing of service time, produced certain drug resistance, and side effect is restricted the range of application of these medicines.Seek the target that efficient, wide spectrum, the low medicine of the side effect person that always is the drug research constantly explores.
Rifaximin is by the research and development of Italian Alfa Wassermann company, rifaximin is first non-aminoglycosides enterally administer, its antibacterial action is strong, and has a broad antifungal spectrum suppresses the synthetic of bacteria RNA by the beta subunit irreversible fixation with DNA of bacteria-dependenc RNA polymerase.Compare with aminoglycosides, this product has high activity to clostridium difficile, staphylococcus epidermidis and streptococcus faecalis, the Bacteroides etc. in gram aerobe, the gram anaerobe, and aminoglycosides antibiotics is to the basic non-activity of above Pseudomonas.In addition, this product also has good activity or high activity to Salmonella, escherichia coli, shigella, yersinia enterocolitica etc.The one big characteristics of this product are to be difficult in vivo being absorbed, and keep high concentration in intestinal, and do not exist in other organs, so its toxic and side effects is minimum.This product is applicable to that Grain-positive and negative bacterium, aerobic and anaerobic bacteria cause acute and chronic intestinal infection, diarrhoea due to diarrhoea syndrome, intestinal microbial population change, hyperammonemia, diseases such as portal encephalopathy and hepatic coma also can be used as before the art or the prophylactic of postoperative intestinal.This product is used in enterally administer, neither needs the intestinal spasmolytic during use, does not also need the intestinal adsorbent.This product effect is rapid, both no longer suffers from diarrhoea all very fast disappearances of symptom such as abdominal cramps pain, headache and nausea and vomiting after general 2 days.
But rifaximin has only dosage form tablet, capsule at present, can't use for the patient of dysphagia.
Summary of the invention
The present invention seeks in order to comply with the demand of dysphagia patients, increase the space that the patient selects different dosage form, expand a kind of application of rifaximin and the Rifaximin dry suspension agent invented.
The present invention includes rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, 30 POVIDONE K 30 BP/USP 30 and correctives, described rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, 30 POVIDONE K 30 BP/USP 30 and correctives account for 1～40%, 20～60%, 10～50%, 1～10%, 20～60% of dry suspension gross weight respectively.
The present invention is a suspending agent with the sodium carboxymethyl cellulose microcrystalline Cellulose, is filler with the dextrin, is binding agent with 30 POVIDONE K 30 BP/USP 30, and the product stability of formation is good.After product adds water, form the suspension that is evenly distributed rapidly, product has fragrant and sweet abnormal smells from the patient, and after taking, human body absorbs hardly, only at intestinal higher concentration is arranged, and adverse reaction rate is low, and slight.Overcome the defective that inconvenience such as tablet, capsule are swallowed, be particularly suitable for child and gerontal patient and use.
Another purpose of the present invention is to provide a kind of production method for above Rifaximin dry suspension agent.
Production method of the present invention is:
1) respectively rifaximin being pulverized the back crosses 120 mesh sieves, sodium carboxymethyl cellulose microcrystalline Cellulose and pulverizes the back and cross 100 mesh sieves, dextrin and pulverize that 100 mesh sieves are crossed in the back, correctives is pulverized the back and crossed 100 mesh sieves;
2) with the rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin and the correctives that sieve with 1～40: 20～60: 10～50: 20～60 weight ratio is mixed;
3) with 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, 18 orders are granulated;
4) after 55 ± 5 ℃ of temperature environment oven dry, remove coarse granule with 16 mesh sieves, after adding essence mixes, packing.
This method technology is simple, is easy to suitability for industrialized production, and product percent of pass height, good stability make things convenient for the patient to take.
The specific embodiment
Example 1:
1, rifaximin is pulverized, crossed 120 mesh sieves then, get the rifaximin 100g that sieves, stand-by.
2, with sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, sucrose pulverize separately, distinguish 100 mesh sieves then, get sodium carboxymethyl cellulose microcrystalline Cellulose 400g, dextrin 200g, sucrose 500g respectively, stand-by.
3, be dissolved in the ethanol with 30 POVIDONE K 30 BP/USP 30, make the alcoholic solution of 5% (mass percent) 30 POVIDONE K 30 BP/USP 30.
4, with behind rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, sucrose, the mix homogeneously, 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, 18 orders are granulated.
5, after the semi-finished product that will make pellet place 55 ± 5 ℃ of temperature environments oven dry, remove coarse granule, add again after 5ml essence mixes, pack with 18 mesh sieves.
Example 2:
1, rifaximin is pulverized, crossed 120 mesh sieves then, get the rifaximin 200g that sieves, stand-by.
2, with sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, sucrose, stevioside pulverize separately, distinguish 100 mesh sieves then, get sodium carboxymethyl cellulose microcrystalline Cellulose 400g, dextrin 200g, sucrose 500g, stevioside 2.5g respectively, stand-by.
3, be dissolved in the ethanol with 30 POVIDONE K 30 BP/USP 30, make the alcoholic solution of 5% (mass percent) 30 POVIDONE K 30 BP/USP 30.
4, with behind rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, sucrose, the stevioside mix homogeneously, with 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, 18 orders are granulated.
5, after the semi-finished product that will make pellet place 55 ± 5 ℃ of temperature environments oven dry, remove coarse granule, add again after 5ml essence mixes, pack with 18 mesh sieves.
Above sodium carboxymethyl cellulose microcrystalline Cellulose is the import adjuvant, and Asahi Kasel Corporation produces, and its specification is RC-A-591NF.
Above correctives can adopt stevioside and essence, or stevioside, sucrose and essence.When stevioside, sucrose coupling, stevioside: sucrose=1: 200-300.
Claims (2)
1, Rifaximin dry suspension agent, it is characterized in that comprising rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, 5% 30 POVIDONE K 30 BP/USP 30 and correctives, described rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin, 5% 30 POVIDONE K 30 BP/USP 30 and correctives account for 1～40%, 20～60%, 10～50%, 1～10%, 20～60% of dry suspension gross weight respectively.
2, a kind of production method of Rifaximin dry suspension agent according to claim 1 is characterized in that may further comprise the steps:
1) respectively rifaximin being pulverized the back crosses 120 mesh sieves, sodium carboxymethyl cellulose microcrystalline Cellulose and pulverizes the back and cross 100 mesh sieves, dextrin and pulverize that 100 mesh sieves are crossed in the back, correctives is pulverized the back and crossed 100 mesh sieves;
2) with the rifaximin, sodium carboxymethyl cellulose microcrystalline Cellulose, dextrin and the correctives that sieve with 1～40: 20～60: 10～50: 20～60 weight ratio is mixed;
3) with 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution system soft materials, 18 orders are granulated;
4) after 55 ± 5 ℃ of temperature environment oven dry, remove coarse granule with 16 mesh sieves, after adding essence mixes, packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910034012A CN101642439A (en) | 2009-08-17 | 2009-08-17 | Rifaximin dry suspension agent and production method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910034012A CN101642439A (en) | 2009-08-17 | 2009-08-17 | Rifaximin dry suspension agent and production method thereof |
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| CN200910034012A Pending CN101642439A (en) | 2009-08-17 | 2009-08-17 | Rifaximin dry suspension agent and production method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836959A (en) * | 2010-05-20 | 2010-09-22 | 山东达因海洋生物制药股份有限公司 | Method for preparing almost bitterless rifaximin dry suspension |
| CN102218078A (en) * | 2011-04-19 | 2011-10-19 | 南京威泰珐玛兽药研究所有限公司 | Rifaximin suspension containing montmorillonite and preparation method thereof |
| CN110623929A (en) * | 2019-09-17 | 2019-12-31 | 南京臣功制药股份有限公司 | Rifaximin dry suspension and preparation method thereof |
-
2009
- 2009-08-17 CN CN200910034012A patent/CN101642439A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101836959A (en) * | 2010-05-20 | 2010-09-22 | 山东达因海洋生物制药股份有限公司 | Method for preparing almost bitterless rifaximin dry suspension |
| CN102218078A (en) * | 2011-04-19 | 2011-10-19 | 南京威泰珐玛兽药研究所有限公司 | Rifaximin suspension containing montmorillonite and preparation method thereof |
| CN102218078B (en) * | 2011-04-19 | 2012-10-10 | 南京威泰珐玛兽药研究所有限公司 | Rifaximin suspension containing montmorillonite and preparation method thereof |
| CN110623929A (en) * | 2019-09-17 | 2019-12-31 | 南京臣功制药股份有限公司 | Rifaximin dry suspension and preparation method thereof |
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Open date: 20100210 |