Ciprofloxacin Hydrochloride

E-mail: lilyoo@bbcapharma.com

For urogenital system infections caused by sensitive bacteria, including simple, complex urinary tract infections, bacterial prostatitis, gonorrhea neisseria urinary tractitis or cervicitis (including those caused by enzyme strains). Respiratory infections, including acute episodes of bronchial infections caused by sensitive gram-negative bacteria and lung infections. Gastrointestinal infections, caused by shiga, salmonella, enterotoxin e. Coli, hydrophilic monocytobacteria, parahemolytic vibrio, etc. It can also treat typhoid bone and joint infections, skin soft tissue infections, sepsis and other systemic infections.

Instructions

Hydrochloric acid ring acrylic star pinyin name: yansuan huanbingshaxing

English name: ciprofloxacin hydrochloride

English alias: 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acidicide

Chinese name: hydrochloric acid cyanide

Chinese alias: cyclopropylity hydrochloride; 1-cyclopropyl-6-fluorine-1, 4-dihydro-4-oxygen-7-(1-pyridine-based)-3-cyclic hydrochloric acid

Page number: 2010 edition ii-722

C17h18fn3o3. Hcl.H2o 385.82

The product is 1-cprogyl-6-fluorine-1, 4-dihydro-4-oxygen-7-(1-pyridine-3-hydrochloric acid hydrate. Calculated as waterless, including

C17h18fn3o3.Hcl) shall not be less than 98.5%.

Cas no. 86393-32-0

Contraindications are banned in patients who are allergic to this product and quinolones.

Product specifications: 0.25g (by csa).

Usage usage: 1 common adults: 0.5 to 1.5g per day; (2) bone and joint infections: 1 to 1.5g a day, 2-3 times, course 4 to 6 weeks or more. (3) pneumonia and skin soft tissue infection: l to 1.5g a day, divided into 2 to 3 times, course 7 to 14 days. (4) intestinal infection: 1g a day, 2 times, course 5 to 7 days. (5) typhoid fever: 1.5g a day, divided into 2-3 times, treatment 10-14 days. (6) urinary tract infection: acute simple urinary tract infection, 0.5g a day, divided into 2 sessions, course 5 to 7 days; complex urinary tract infection, lg, divided into 2 times, course 7 to 14 days. (7) simple gonorrhea: 0.5g per oral session.

Storage method: blackout, sealed storage.

E-mail: lilyoo@bbcapharma.com

Drug Traits

The product is white or slightly yellow crystalline powder;

The product dissolves in water, slightly in methanol, slightly in ethanol, almost insoluble in chloroform, soluble in sodium hydroxide test fluid.

Product Performance

Used for urological system infections, respiratory infections, gastrointestinal infections, typhoid fever, bone and joint infections, skin soft tissue infections, sepsis and other systemic infections.

Efficacy is the Main Treatment

For sensitive bacteria caused by

1. Urological infections, including simple, complex urinary tract infections, bacterial prostatitis, gonorrhea neisseria urinary tractitis or cervicitis (including those caused by enzyme strains).

2. Respiratory infections, including acute episodes of bronchial infections caused by sensitive gram-negative bacteria and lung infections.

3. Gastrointestinal infections, caused by shiga, salmonella, enterotoxin e. Coli, hydrophilic monocytobacteria, parahemolytic vibrio, etc.

4. Typhoid fever.

5. Bone and joint infections.

6. Skin soft tissue infection.

7. Sepsis and other systemic infections. Chemical composition: hydrochloric acid ring propylene sand star. Its chemical name is: l-cpropyl-6-fluorine-1, 4.Dihydro.4. Oxygen generation-7-(1-pyridine-3-hydrochloric acid molecular formula: C17H18FN3O3 HCl· H2O

E-mail: lilyoo@bbcapharma.com

Pharmacological Effects

The product has a broad-spectrum antibacterial effect, especially on the need for oxygen gram-negative bacteria antibacterial activity is high, the following bacteria in vitro have a good antibacterial effect: e. Coli most bacteria, including e. Coli genus, culvert, e. Coli, e. Coli, creeb bacteria genus, deformation bacillus genus, salmonella genus, shiga genus , vibrio genus, yersinia, etc. Often on multi-drug-resistant bacteria also have antibacterial activity. Gonorrhea, haemophilus influenzae and mora, which are resistant to penicillin, are highly antibacterial. Most strains of the pseudomonas genus, such as copper-green pseudomonas, have antibacterial effects. The product is sensitive to methicillin staphylococcus has antibacterial activity, and only moderate antibacterial activity for streptococcus pneumoniae, hemolytic streptococcus and fecal enterococci. It also has good effect on trachea chlamydia, mycoplasma and legionella, and also has antibacterial activity on mycobacterium tuberculosis and sars-type mycobacteria. Poor antibacterial activity against anaerobic bacteria. Cyclopaedia is a fungicide that inhibits the synthesis and replication of dna by acting on a subunits of bacterial dna helix enzymes, resulting in bacterial death.

Drug Utility

1.Urinary alkalinization drugs can reduce the solubility of the product in the urine, resulting in crystalline urine and renal toxicity.

2.Acid-making drugs containing aluminum or magnesium can reduce the oral absorption of the product, it is recommended to avoid joint use. It should not be avoided 2 hours before taking the product, or 6 hours after taking the medicine.

3. This product and the tea-alkali class may be combined with the cytomelet p450 binding site competitive inhibition, resulting in a significant reduction in the liver elimination of the phenyl group, blood elimination half-life (t1/2 beta) extension, increased concentration of blood drugs, the appearance of symptoms of phenyl poisoning, such as nausea, vomiting, tremors, restlessness, agitation, convulsions, palpitations, etc., So the concentration and adjustment dose of the hemp-alkali blood drugs should be determined.

4.When cyclosporine is used in combination with this product, the concentration of the drug increases, and the concentration of cyclosporine blood must be monitored and the dose adjusted.

5.This product and anticoagulant warfarin can enhance the latter's anticoagulant effect, when combined with the patient's clotting enzyme time should be closely monitored.

6.Propylene sulfonshu can reduce the secretion of the product from the renal tube about 50%, when combined with the blood concentration of the product can be increased toxicity.

7.This product interferes with the metabolism of caffeine, resulting in reduced caffeine elimination, prolonged blood elimination half-life (t1/2 beta) and possible central nervous system toxicity.

8.Dehydroxymusine (DDI) drugs can reduce the oral absorption of the product, because its preparation contains aluminum and magnesium, can be chelated with the product, so it is not suitable for use.

E-mail: lilyoo@bbcapharma.com

Drug Reaction

1.Gastrointestinal reactions are more common and can manifest themses as abdominal discomfort or pain, diarrhea, nausea, or vomiting.

2.Central nervous system reactions can be dizziness, headache, drowsiness or insomnia.

3.Allergic reactions: rash, itching of the skin, occasional oozing polymorphic erythema and vascular neuroedema. A small number of patients have photosensitive reactions.

4.Even can happen:

(1) seizures, mental abnormalities, irritability, confusion, hallucinations, tremors.

(2) hematuria, fever, rash and other interstitial nephritis performance.

(3) crystalline urine, most commonly found in high-dose applications.

(4) joint pain.

5.A small number of patients can occur serum amino transferase elevation, hematurozorea nitrogen increase and surrounding blood elephant white blood cells decreased, mostly mild, and showed a one-over sex.

Pay Attention to Matters

1.As e. Coli is more resistant to fluoroquinolones, urine culture specimens should be left before administration, with reference to bacterial drug sensitivity results to adjust medication.

2.This product should be taken on an empty stomach, although the food can delay its absorption, but its total absorption (bioavailability) has not been reduced, it can also be taken after meals to reduce gastrointestinal reactions;

3.Crystallized urine can occur when the product is applied in large doses or when the ph of urine is above 7. In order to avoid the occurrence of crystalline urine, it is advisable to drink more water, to maintain 24-hour urination in more than 1200 ml.

4.Renal function is reduced, the dose of administration should be adjusted according to kidney function.

5.The application of fluoroquinolones can occur in moderate and severe photosensitive reactions. The product should be used to avoid excessive exposure to sunlight, such as photosensitivity reactions need to stop the drug.

6.When liver function is reduced, such as severe (liver cirrhosis ascites water) can reduce drug removal, blood concentration increased, liver and kidney function are particularly obvious, all need to weigh the pros and cons of application, and adjust the dose.

7.Patients with pre-existing central nervous system disorders, such as epilepsy and epilepsy history should avoid application, there are indications need to carefully weigh the pros and cons of application.

E-mail: lilyoo@bbcapharma.com

Eye Drops

Pinyin name

:yansuan huanbingshaxing diyanye

English name: ciprofloxacin hydrochloride eye drops

Page number: 2000 edition ii-624

This product contains c17h18fn3o3) should be 90.0% to 110.0% of the indicated amount.

Characters

The product is a clear liquid without color or slight yellow.

Differential

(1)take the product and hydrochloric acid cpropylene control products in the appropriate amount, respectively, add water to each 1 ml containing cyclopropylity 3 mg solution, as

The test solution and the control solution. In the thin layer chromatography (appendix v.B) test, the two solutions were absorbed by 1 μl each, pointing at the same silicone g

On a thin plate, place in ammonia for about 15 minutes, remove, expand with dichloromethane-methanol-concentrated ammonia solution-acetylene (4:4:2:1), and expand,

Dry and check under uv light (254nm). The color and position of the main speck shown in the test solution should be the same as the main spot of the control solution.

(2) in the chromatography recorded under content determination, the retention time of the main peak of the cycloprostar hydrochloric acid in the test subjects shall be the retention time of the control peak

Unanimous.

(3) the identification reaction of the chloride (appendix iii).

Examine

The PH should be 4.0 to 5.0 (appendix vi. H).

Others shall comply with the relevant provisions under eye drops  (APPENDIX I. J).

Content Determination

Photo high-efficiency liquid chromatography (appendix v. D) is measured.

Chromatography conditions and system suitability test using eighteen alkyl silane bonding silicones as fillers;

18) the ph was adjusted to 3.5 as the flow phase with triethylamine, and the detection wavelength was 277nm. The number of theoretical plates should be calculated according to the peak of epoxacine hydrochloric acid

2000, the separation degree of the hydrochloric acid ring propylene star peak and the adjacent impurity peak should be in accordance with the regulations.

Measurement method precision measure of the product 2 ml (about equivalent to cyclopropylene 6mg), placed in a 50 ml volume bottle, water diluted to the scale, shake well, precision amount

Take 5 ml, place 50 ml bottle, add water diluted to the scale, shake well, as a solution for the test. Another precision is called a hydrochloric acid ring that is dried to a constant weight at 105 degrees c

The appropriate amount of cesar control products (about equivalent to 20 mg of csar), placed in a 50 ml volume bottle, add the right amount of water to dissolve, and dilute to the scale, shake well, precision

Take 2 ml, place 50 ml bottle, add water diluted to the scale, shake well, as a control solution. The test solution and the control solution were taken separately at 10 μl each

Inject liquid chromatography, record chromatography, and calculate the peak area according to the outer scale method.

E-mail: lilyoo@bbcapharma.com

The Method of Measurement

Method name: determination of hydrochloric acid ring propylene sand star - high-efficiency liquid chromatography

Application range: this method uses high-efficiency liquid chromatography to determine the hydrochloric acid ring propylene sand star (c17h18fn3o3) hcl) content.

This method is suitable for hydrochloric acid cycloprosaccharides.

Methods principle: the test product is made into a flow phase solution, entered into the high-efficiency liquid chromatography chromatograph for chromatography separation, with ultraviolet absorption detector, at wavelength 277nm to detect the absorption value of hydrochloric acid ring propylene sand star, calculate its content.

Reagents:

1. 0.05mol/l sacid solution

2. Acetylene

3. Triethylamine

Instruments: 1. Instrument

1.1 high-efficiency liquid chromatograph

1.2 column

Eighteen alkane silicone bonding silicone as a filler, the theoretical number of towers according to the ring propylene star peak calculation is not less than 2000, the separation between the ephemera star peak and the adjacent impurity peak should meet the requirements.

1.3 uv absorption detector

2. Chromatographic conditions

2.1 flow phase: 0.05mol/l acetic acid solution acetylene , 82 18, with triethylamine to regulate ph to 3.5.

2.2 detection wavelength: 277nm

2.3 column temperature: 30 degrees c

Sample preparation: 1. Call it a test

Precision to take the right amount of the product.

E-mail: lilyoo@bbcapharma.com

2. Preparation of the control solution

Precision weighing the appropriate amount, plus the flow phase solution dissolved and made each 1ml containing 0.5 mg of solution, shake well, that is.

3. Preparation of the solution for the test

The test product plus the liquid phase solution dissolved and quantitatively diluted into a solution containing 0.5 mg per 1ml, shake well, that is, get.

Note: "precision weighing" refers to the allegation that the weight should be accurate to one thousandth of the weight taken. "Precision quantity extraction" means that the accuracy of volume extraction should meet the accuracy requirements of the volume pipette in the national standard.

Operation steps: respectively, the precision absorption of the above-mentioned control solution and the test solution each 10 μl into the high-efficiency liquid chromatography, with ultraviolet absorption detector, at the wavelength 277nm to determine the absorption value of the cyclopropylosa star, calculate its content.

References: pharmacopoeia of the people's republic of china, editor of the national pharmacopeia commission, chemical industry press, 2005 edition, part ii, p.526.

E-mail: lilyoo@bbcapharma.com

Category

Antibacterial drugs.

Storage

Shade, seal, and keep in the dark.

Pharmacokotics

This product is a local drug, only a small amount of absorption.

Indications

For external eye infections caused by sensitive bacteria (e.G. Conjunctivitis, etc.).

Usage Usage

Drops in the eyelids, 1 to 2 drops at a time, 3 to 6 times a day, the course of treatment is 6 to 14 days.

Adverse Reactions

Occasional localized sexual stimulation symptoms. Local burns and foreign body sensations can occur. In addition, eyelid edema, tears, fear of light, vision loss, allergic reactions and so on are rare.

Taboo

Banned in patients who are allergic to this product and quinolones.

E-mail: lilyoo@bbcapharma.com

Precautions

1. Only for eye drops.

2. If allergic symptoms such as rash or other serious adverse reactions occur during use, the medicine should be discontinued immediately.

Women's medication

Animal experiments have not confirmed the teratogenic effects of quinolones, but there is no clear conclusion in the study of drug use in pregnant women. In view of the fact that this medicine can cause joint lesions in minor animals, pregnant women and lactating women should use it with caution.

Children's medicine

This product is generally not used in infants and young children.

The Effect of the Drug

Long-term heavy use by local absorption, can produce the same drug interaction with systemic drugs, such as can make the carbapenems, cyclosporine, propylene sulfonazy and other drugs blood concentration increased, enhance the anticoagulant anticoagulant drug warfarin, interfere with the metabolism of caffeine.

E-mail: lilyoo@bbcapharma.com

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