CN101455664A - Preparation method of ornidazole gastric floating tablets and use thereof - Google Patents
Preparation method of ornidazole gastric floating tablets and use thereof Download PDFInfo
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- CN101455664A CN101455664A CNA2007101795129A CN200710179512A CN101455664A CN 101455664 A CN101455664 A CN 101455664A CN A2007101795129 A CNA2007101795129 A CN A2007101795129A CN 200710179512 A CN200710179512 A CN 200710179512A CN 101455664 A CN101455664 A CN 101455664A
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- ornidazole
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
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- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention discloses a preparation method and applications of gastric floating tablets containing ornidazole, belonging to a novel technical field of medicament and relating to a novel medicament form of ornidazole. 1. The gastric floating tablets are used to treat a plurality of diseases caused by bacteroides fragilis, bacteroides distasonis, bacteroides oval window, etc.; (2) oral cavity infections: pericoronitis, periapical periodontitis, pericoronitis, acute ulcerouse gingivitis etc.; (3) gynae infections: endometritis, myometritis, oviduct or ovarian abscess, pelvic cavity soft tissue infection, haemophilis vaginitis etc.; (4) surgical infections: wound infection, abscess of epidermis, bedsore ulcerouse infection, cellulites, gas gangrene etc.; (5) brain infections: meningitis, brain abscess; (6) septicaemia and severe general infections etc. 2. The gastric floating tablets are used to prevent infections before an operation and treat anaerobic infections after an operation. 3. The gastric floating tablets are used to treat urogenital canal trichomonas and giardia lamblia infections, such as trichomoniasis etc. 4. The gastric floating tablets are used to treat alimentary system amebiasis, such as amebic dysentery, amoebic liver abscess etc. The new medicament form is characterized in that the surface thereof is hydrated into gel after contacting with gastric juice at body temperature so as to cause volume expansion because the gastric floating tablets contain a plurality of hydrophilic macromolecule materials. Weight of the tablets is less than floating force of the gastric juice, so the tablets float on the gastric juice so as to prolong time in a stomach.
Description
Technical field
The invention belongs to the medicine new technical field, a kind of novel form that relates to ornidazole is used for 1. treatments by bacteroides fragilis, bacteroides disiens, ovum garden bacteroid, bacteroides thetaiotaomicron, bacteroides vulgatus, clostridium, Eubacterium, dyspepsiacoccus and peptostreptococcus, helicobacter pylori, bacaeroides melaninogenicus, Fusobacterium, CO
2Bite the multiple disease that anaerobic infections such as knitting dimension bacterium, gingiva bacteroid causes, comprising: (1) abdominal infection: peritonitis, peritoneal abscess, liver abscess, peptic ulcer, necrotizing pneumonia, pulmonary abscess, empyema etc.; (2) oral cavity infection: periodontitis, periapical periodontitis, pericoronitis, acute ulcerative gingivitis etc.; (3) gynecological infection: endometritis, myometritis, fallopian tube or ovarian abscess, pelvic cavity soft tissue infection, haemophilis vaginitis etc.; (4) surgical infection: wound infection, epidermis abscess, decubitus ulcer infection, cellulitis, gas gangrene etc.; (5) brain infection: meningitis, brain abscess; (6) septicemia and serious systemic infection etc.2. the treatment of prevention infection and operation back anaerobic infection before being used to perform the operation.3. treatment men and women urogenital tract trichomonacide, giardia lamblia infect, as trichomonal vaginitis etc.4. treatment digestive system ameba parasitosis is as pharmaceutical preparation of amebic dysentery, amebic liver abscess etc. and preparation method thereof, a kind of preparation method of ornidazole gastric floating tablets and application thereof specifically.
Background technology
Anaerobe and protozoan infection are a kind of common clinicals, are perplexing human orthobiosis always, are threatening human beings'health, and particularly women's sickness rate is higher.
Bacterial vaginosis mainly is because the ecological balance of vagina normal flora gets muddled, the dominant microflora lactobacillus reduces or disappears, and microorganism undue growth such as vagina Gartner bacterium, anaerobe and cause to increase with fish raw meat sample gas flavor with vaginal secretions be the disease of feature.Ornidazole is the novel product of anaerobe resistant, is the 5-nitro imidazole derivatives, is the substitute products of tinidazole.
Ornidazole (ornidazde, ORN), chemistry 1-(3-chloro-2-hydroxypropyl) by name-2-methyl-5-nitro imidazoles is the third generation nitro imidazole derivatives after metronidazole, tinidazole, has good anaerobe resistant and anti-protoplasm (as infusorian etc.) infection effect.Ornidazole is to be listed a company by Switzerland Roche the seventies in 20th century, and trade name Tiberal records in Czech's pharmacopeia (version in 1991).China has ratified the production of ornidazole raw material and various preparations in succession since 2002, and the domestic existing preparation has tablet, capsule, dispersible tablet, vagina effervescence, injection, sodium chloride injection, glucose injection at present.Ornidazole tablet standard is become a full member, and records in become a full member the 47th of standard of new drug, standard No. WS
1-(X-445)-2003.
Ornidazole is mainly at liver metabolism, in vivo mainly with former medicine with cytotoxicity and intermediate supersession activated product with cytotoxicity, act on the DNA of anaerobe, ameba worm, giardia lamblia and trichomonacide cell, make the fracture of its helical structure or block it and transcribe and duplicate and cause its death and reach antibiotic anti-plasmic purpose.
Ornidazole tablets is behind metronidazole, tinidazole, a new generation's wide spectrum anaerobe resistant and protozoacide new drug, have antibiotic and parasiticidal active high, toxicity is low, long half time in the human body, characteristics such as tissue permeability is good, comparing with tinidazole with metronidazole that clinical efficacy is better, untoward reaction is slighter is the choice drug of anaerobe resistant nuclear antigen insect infection.Be widely used clinically, be mainly used in prevention and iatrotechnics postoperative infection and reproduction and infect.
A large amount of clinical trial proof ornidazoles are used for the treatment of the bacterial vaginosis good effect, short treating period, GI irritation is little, and the patient is acceptant, many data show that long-term oral tinidazole can cause peptic ulcer and infection again, and do not see document announcement as yet about ornidazole.Prove that through clinical observation ornidazole is wider than tinidazole anaerobe resistant spectrum when the treatment bacterial vaginosis, antimicrbial power is strong, long half time, and the cure rate height, untoward reaction waits clear superiority less, is worth being promoted in clinical.
The chemical structural formula of ornidazole is:
Molecular formula: C
7H
10ClN
3O
3
Molecular weight: 219.63
Pharmacological action and clinical practice
1. pharmacological toxicology
Ornidazole is a third generation nitro imidazole derivatives, its performance anti-microbial effect cutter reason really it be unclear that, and may be by the nitro in its molecule, is reduced into amino or the formation by free radical in oxygen-free environment, interact with cell component, thereby cause the death of microorganism.
2. pharmacokinetics
Domestic still do not have the detailed research of a this product report.According to " the big pharmacopeia of Martindale " the 31st edition (version in 1996), ornidazole The book of Changes gastrointestinal absorption, 1.5g the single oral dose medication just reached the maximal plasma concentration of about 30ug/ml in 2 hours, drop to 9ug/ml after 24 hours, dropped to 2.5ug/ml after 48 hours.Ornidazole also through per vaginam absorbing, it is reported, inserts behind the 500mg ornidazole vagina suppository 12 hours, and maximal plasma concentration is 5ug/ml.
It is 14 hours that the blood plasma of ornidazole is eliminated the half-life, with plasma protein binding rate less than 15%.Be distributed widely in tissue and the body fluid, comprise cerebrospinal fluid.
Ornidazole is metabolism in liver, mainly drains with conjugates and metabolite in urine, drains in feces in a small amount.Having reported that single oral dose amount of cancellation in 5 days is 85%, is 63% in the urine, is 22% in the feces.Bile excretion accounts for 4.1% in the elimination of ornidazole and metabolite thereof.
3. clinical practice
The treatment bacterial vaginosis
Data and method: in July, 2004～2005 example in year July 60 is the prescription on individual diagnosis patient of Shouguang City, Shandong health center for women and children, gets rid of trimester of pregnancy and women breast-feeding their children, 17～56 years old age, average 29.4 years old.All the patient all has typical clinical symptoms, and as pruritus vulvae, leucorrhoea grow in quantity has fish off-flavors etc.The visible secretions amount of gynecologial examination is many, thin, yellow skin, vaginal secretions pH value〉5.0, smear is through the lab testing cell that all picks up scent.Therapeutic Method: 60 examples are organized in treatment, ornidazole capsule 0.5g, every day 2 times, totally 7 days.Matched group 48 examples, tinidazole sheet 400mg, every day 3 times, and place 200mg, shared 7 days in intravaginal every night.Two groups of married patients all require husband's oral medication simultaneously, and dosage is all the same the course of treatment.Efficacy evaluation: treatment ends at 3～5 people check of the clean back of next menstruation, totally 3 times.1. recovery from illness: the symptom and sign complete obiteration, 3 times lab testing is all negative; 2. take a turn for the better: symptom and sign has clear improvement, and the lab testing feminine gender is arranged 2 times; 3. invalid: symptom and sign does not have obvious improvement, maximum 1 lab testing feminine gender.The result: the result of two kinds of method treatment bacterial vaginosis compares: 60 examples are organized in treatment, 54 examples of fully recovering, 5 examples that take a turn for the better, invalid 1 example, total effective rate 98.33%; Matched group 48 examples, 35 examples of fully recovering, 5 examples that take a turn for the better, invalid 8 examples, total effective rate 88.33%.Untoward reaction: treatment is organized 1 routine patient and slight gastrointestinal reaction occurred, gastrointestinal reactions such as significantly feeling sick appears in matched group 9 routine patients, vomiting.Discuss: bacterial vaginosis mainly is because the ecological balance of vagina normal flora gets muddled, the dominant microflora lactobacillus reduces or disappears, and microorganism undue growth such as vagina Gartner bacterium, anaerobe and cause to increase with fish raw meat sample gas flavor with vaginal secretions be the disease of feature.Ornidazole is the novel product of anaerobe resistant, be the 5-nitro imidazole derivatives, substitute products for tinidazole, we are used for the treatment of the bacterial vaginosis good effect, short treating period, GI irritation is little, and the patient is acceptant, many data show that long-term oral tinidazole can cause peptic ulcer and infection again, and do not see document announcement as yet about ornidazole.Prove that through clinical observation ornidazole is wider than tinidazole anaerobe resistant spectrum when the treatment bacterial vaginosis, antimicrbial power is strong, long half time, and the cure rate height, untoward reaction waits clear superiority less, is worth being promoted in clinical.
Treatment trichomonal vaginitis
Physical data: case inclusion criteria: the married woman of non-menstrual phase, clinical diagnosis is diagnosed as trichomonal vaginitis, and the vaginal secretions microscopy finds infusorian, does not obey other anti-trichomonal medicines in nearly 1 week or uses the vagina cleaning agent.Exclusion standard: serious liver, kidney, heart, hemopoietic system and patient with nervous system disease, serious systemic infection, nitroimidazoles medicine there are allergies, trimester of pregnancy and age of sucking the patient, once obeyed other anti-anaerobic agents or antitrichomonal drug in nearly 1 week, can not adhere to test, dropped by the wayside because of a variety of causes, not by research approach (as delivery time, dosage etc.) medication person, the patient requires to add with other anti-anaerobism medicine persons in the therapeutic process; Serious adverse reaction takes place in the therapeutic process, can not continue medication person's (by untoward reaction record statistics).Selected qualified case 80 examples at 22～45 years old age, by the numbering successively of going to a doctor, are included two groups in according to table of random number, i.e. each 40 example of treatment group and matched group at random.Two groups of ages, infect physical data contrast differences such as disease type (acute chronic urgency is sent out), the course of treatment and do not have significance, have comparability.Adopt double blinding, dual analog parallel check experiment method research at random.Therapeutic Method: the treatment group is taken ornidazole 500mg (trade name: deep and clear right, Xi'an Bo Hua drugmaker produces, authentication code: the accurate word H20020715 of traditional Chinese medicines, every 250mg) reaches 1 of the comfort medicine consistent with tinidazole sheet outward appearance, matched group take tinidazole sheet 500mg (by the Hunan just too pharmaceutcal corporation, Ltd produce every 500mg is provided) and 2 of outward appearance comfort medicines consistent with ornidazole.All take to take medicine every day 2 times for two groups, each 3, be 5 days the course of treatment.Reach have a blood test after the end course of treatment routine, platelet count, hepatic and renal function, routine urinalysis etc. before the treatment, if treatment back is checked unusual person and should be followed up a case by regular visits to normally, clinical symptoms, sign variation, untoward reaction and the degree thereof of observation every day and record patient during the treatment, fill in item by item by observing form, comprise concrete manifestation, persistent period, treatment measures and lapse to etc.Get vaginal secretions smear for microscopic examination infusorian before the treatment and after finishing the course of treatment.Result: treatment group cure rate 97.5% (39/40), matched group cure rate 82.5% (33/40), χ
2=1.1660, P＜0.05; Two groups of effective percentage are 100.0%, and difference does not have significance.The untoward reaction situation: treatment group generation untoward reaction 4 examples (6 examples are inferior), 3 examples of wherein feeling sick are vomitted 2 examples, dizzy 1 example; Matched group generation untoward reaction 7 examples (10 example time), wherein dizzy 5 examples, frequent micturition 2 examples are felt sick, xerostomia, each 1 example of dysurea.A situation arises that difference does not have significance (χ for two groups of untoward reaction
2=0.9486, P〉0.05) to organize 4 routine untoward reaction person's symptoms all low weight in treatment, do not deal with, and symptom all disappears after the drug withdrawal; Matched group frequent micturition, dysurea do not take a turn for the better, and urinalysis is not seen the infection evidence.Lab testing: check result shows, treatment group and matched group routine blood test, routine urinalysis and hepatic and renal function all fluctuate in normal range, do not have a clinical meaning, and have no significant change before and after the treatment of most of index, illustrate that ornidazole is very little to the influence of These parameters, short application use is safe.
This product has following characteristics: this product is an intra-gastric floating tablet, and this intra-gastric floating tablet is owing to contain multiple hydrophilic high molecular material, and behind body temperature contact gastric juice, surface water changes into gel, and makes volumetric expansion.The weight of tablet floats on the gastric juice tablet less than the buoyancy of gastric juice at this moment, is prolonged gastric transit time.
Summary of the invention
The object of the invention be to provide a kind of good stability, quality height, evident in efficacy, untoward reaction is little is tablet of making of principal agent and preparation method thereof with the ornidazole, use the ornidazole gastric floating tablets that this method makes and it is characterized in that this intra-gastric floating tablet owing to contain multiple hydrophilic high molecular material, behind body temperature contact gastric juice, surface water changes into gel, and makes volumetric expansion.The weight of tablet floats on the gastric juice tablet less than the buoyancy of gastric juice at this moment, is prolonged gastric transit time.
A kind of intra-gastric floating tablet that contains ornidazole of the present invention is made up of following component:
250 parts of ornidazoles
100 parts of hydroxypropyl celluloses
120 parts of hydroxyethyl-celluloses
500 parts of acroleic acid resins
100 parts of sodium bicarbonate
1 part of micropowder silica gel
0.5 part of dodecyl sodium sulfate
A kind of intra-gastric floating tablet that contains ornidazole of the present invention is achieved through the following technical solutions:
With the ornidazole of recipe quantity, hydroxypropyl cellulose, hydroxyethyl-cellulose, acroleic acid resin, sodium bicarbonate, behind the mix homogeneously, 80 mesh sieve mixings add micropowder silica gel and dodecyl sodium sulfate, with the supplementary material mix homogeneously, direct compression, product inspection, packing.
A kind of intra-gastric floating tablet that contains ornidazole that the present invention obtains has that method is simple, good stability, characteristics that quality is high.
Following examples explanation the present invention, but do not limit the present invention in any way.
Embodiment 1: 1000 of specifications
Prescription:
250 parts of ornidazoles
100 parts of hydroxypropyl celluloses
120 parts of hydroxyethyl-celluloses
500 parts of acroleic acid resins
100 parts of sodium bicarbonate
1 part of micropowder silica gel
0.5 part of dodecyl sodium sulfate
Method for making:
With the ornidazole of recipe quantity, hydroxypropyl cellulose, hydroxyethyl-cellulose, acroleic acid resin, sodium bicarbonate, behind the mix homogeneously, 80 mesh sieve mixings add micropowder silica gel and dodecyl sodium sulfate, with the supplementary material mix homogeneously, direct compression, product inspection, packing.
Embodiment 2: 10000 of specifications
Prescription:
Ornidazole 2500g
Hydroxypropyl cellulose 1000g
Hydroxyethyl-cellulose 1200g
Acroleic acid resin 5000g
Sodium bicarbonate 1000g
Micropowder silica gel 10g
Dodecyl sodium sulfate 5g
Method for making:
With the ornidazole of recipe quantity, hydroxypropyl cellulose, hydroxyethyl-cellulose, acroleic acid resin, sodium bicarbonate, behind the mix homogeneously, 80 mesh sieve mixings add micropowder silica gel and dodecyl sodium sulfate, with the supplementary material mix homogeneously, direct compression, product inspection, packing.
Claims (6)
1. the preparation method of ornidazole gastric floating tablets and application thereof, it is characterized in that this intra-gastric floating tablet is is the tablet that principal agent is made with the ornidazole, this intra-gastric floating tablet is owing to containing multiple hydrophilic high molecular material, behind body temperature contact gastric juice, surface water changes into gel, and makes volumetric expansion.The weight of tablet floats on the gastric juice tablet less than the buoyancy of gastric juice at this moment, is prolonged gastric transit time.
2. according to the preparation method and the application thereof of the described ornidazole gastric floating tablets of claim 1, it is characterized in that this intra-gastric floating tablet is to be used for 1. treatments by bacteroides fragilis, bacteroides disiens, ovum garden bacteroid, bacteroides thetaiotaomicron, bacteroides vulgatus, clostridium, Eubacterium, dyspepsiacoccus and peptostreptococcus, helicobacter pylori, bacaeroides melaninogenicus, Fusobacterium, CO
2Bite the multiple disease that anaerobic infections such as knitting dimension bacterium, gingiva bacteroid causes, comprising: (1) abdominal infection: peritonitis, peritoneal abscess, liver abscess, peptic ulcer, necrotizing pneumonia, pulmonary abscess, empyema etc.; (2) oral cavity infection: periodontitis, periapical periodontitis, pericoronitis, acute ulcerative gingivitis etc.; (3) gynecological infection: endometritis, myometritis, fallopian tube or ovarian abscess, pelvic cavity soft tissue infection, haemophilis vaginitis etc.; (4) surgical infection: wound infection, epidermis abscess, decubitus ulcer infection, cellulitis, gas gangrene etc.; (5) brain infection: meningitis, brain abscess; (6) septicemia and serious systemic infection etc.2. the treatment of prevention infection and operation back anaerobic infection before being used to perform the operation.3. treatment men and women urogenital tract trichomonacide, giardia lamblia infect, as trichomonal vaginitis etc.4. treat digestive system ameba parasitosis, as amebic dysentery, amebic liver abscess etc.
3. according to the preparation method and the application thereof of the described ornidazole gastric floating tablets of claim 1, it is characterized in that this floating tablets forms including but not limited to following component:
250 parts of ornidazoles
100 parts of hydroxypropyl celluloses
120 parts of hydroxyethyl-celluloses
500 parts of acroleic acid resins
100 parts of sodium bicarbonate
1 part of micropowder silica gel
0.5 part of dodecyl sodium sulfate
4. according to the preparation method and the application thereof of the described ornidazole gastric floating tablets of claim 3, it is characterized in that including but not limited to following pharmaceutically acceptable adjuvant: hydroxypropyl cellulose, hydroxyethyl-cellulose, acroleic acid resin series, sodium bicarbonate, micropowder silica gel, dodecyl sodium sulfate, cyclodextrin series, Polyethylene Glycol series, hexadecanol, stearic acid, magnesium stearate, Pulvis Talci, microcrystalline Cellulose etc.
5. according to the preparation method and the application thereof of claim 3,4 described ornidazole gastric floating tablets, one of prescription that it is characterized in that this floating tablets is:
Ornidazole 250g
Hydroxypropyl cellulose 100g
Hydroxyethyl-cellulose 120g
Acroleic acid resin 500g
Sodium bicarbonate 100g
Micropowder silica gel 1g
Dodecyl sodium sulfate 0.5g
6. the preparation method of ornidazole gastric floating tablets according to claim 5 and application thereof is characterized in that may further comprise the steps: with the ornidazole of recipe quantity, hydroxypropyl cellulose, hydroxyethyl-cellulose, acroleic acid resin, sodium bicarbonate is behind the mix homogeneously, 80 mesh sieve mixings, add micropowder silica gel and dodecyl sodium sulfate, with supplementary material mix homogeneously, direct compression, product inspection, packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101795129A CN101455664A (en) | 2007-12-14 | 2007-12-14 | Preparation method of ornidazole gastric floating tablets and use thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101795129A CN101455664A (en) | 2007-12-14 | 2007-12-14 | Preparation method of ornidazole gastric floating tablets and use thereof |
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| Publication Number | Publication Date |
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| CN101455664A true CN101455664A (en) | 2009-06-17 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104640451A (en) * | 2012-07-04 | 2015-05-20 | 雷蒙特亚特特拉维夫大学有限公司 | Ornidazole and related compounds for use as herbicides |
-
2007
- 2007-12-14 CN CNA2007101795129A patent/CN101455664A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104640451A (en) * | 2012-07-04 | 2015-05-20 | 雷蒙特亚特特拉维夫大学有限公司 | Ornidazole and related compounds for use as herbicides |
| US9237750B2 (en) * | 2012-07-04 | 2016-01-19 | Ramot At Tel-Aviv University Ltd. | Ornidazole and related compounds for use as herbicides |
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Open date: 20090617 |