What Is Ciprofloxacin Hydrochloride?

Ciprofloxacin hydrochloride is a prescription drug. For genitourinary system infections caused by sensitive bacteria, including simple, complex urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis, or cervicitis (including those caused by enzyme-producing strains). Respiratory tract infections, including acute attacks of bronchial infections and lung infections caused by sensitive Gram-negative bacilli. Gastrointestinal infections are caused by Shigella, Salmonella, Enterotoxigenic Escherichia coli, Hydrophila Aeromonas, and Vibrio parahaemolyticus. It can also treat systemic infections such as typhoid bone and joint infections, skin and soft tissue infections, and sepsis.

Ciprofloxacin Hydrochloride

Ciprofloxacin hydrochloride is a prescription drug. For urogenital infections caused by sensitive bacteria, including simple,

Ciprofloxacin Hydrochloride

The product is a white or slightly yellow crystalline powder; almost odorless and bitter.

The product is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol,

For urogenital infections, respiratory infections caused by sensitive bacteria,

1. For urogenital infections caused by sensitive bacteria, including simple, complex urinary tract infections, bacterial prostatitis,

This product has a broad-spectrum antibacterial effect, especially for

1Urine alkalizing drug can reduce the solubility of the product in urine, resulting in

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

1 Because Escherichia coli is more resistant to fluoroquinolone drugs, urine culture specimens should be retained before administration, and the drug should be adjusted with reference to the bacterial drug sensitivity results.

2 This product should be taken on an empty stomach, although food can delay its absorption, but its total absorption (bioavailability) has not decreased, so it can also be taken after a meal to reduce gastrointestinal reactions; 250ml of water should be taken at the same time.

3 Crystallized urine can occur when the product is used in large doses or when the urine pH is above 7. In order to avoid the occurrence of crystallized urine, it is advisable to drink plenty of water and keep the urine output above 1200ml for 24 hours.

Pinyin name

: Yansuan Huanbingshaxing Diyanye

English name: Ciprofloxacin Hydrochloride Eye Drops

Page number: 2000 edition two -624

This product contains ciprofloxacin (C17H18FN3O3) should be 90.0% to 110.0% of the labeled amount.

Ciprofloxacin Hydrochloride Properties

This product is colorless or slightly yellow clear liquid.

Identification of Ciprofloxacin Hydrochloride

Take an appropriate amount of this product and the reference product of ciprofloxacin hydrochloride, add water to make a solution containing 3mg of ciprofloxacin per 1ml, as

Test solution and reference solution. According to the thin layer chromatography (Appendix V B) test, draw 1 l of each of the two solutions, and point them on the same silica gel G.

The thin layer plate was put into ammonia gas for about 15 minutes, taken out, and using methylene chloride-methanol-concentrated ammonia solution-acetonitrile (4: 4: 2: 1) as a developing agent.

Allow to dry and inspect under UV light (254nm). The color and position of the main spots displayed by the test solution should be the same as the main spots of the reference solution.

In the chromatogram recorded under the content determination item, the retention time of the main peak of ciprofloxacin hydrochloride in the test product should be the retention time of the reference peak

Consistent.

(3) This product shows the identification reaction of chloride (Appendix III).

Ciprofloxacin hydrochloride inspection

The pH should be between 4.0 and 5.0 (Appendix VI H).

Others should comply with the relevant provisions under eye drops (Appendix I J).

Determination of Ciprofloxacin Hydrochloride

According to high performance liquid chromatography (Appendix VD).

Chromatographic conditions and system suitability test using octadecylsilane bonded silica as a filler; 0.05mol / L citric acid solution-acetonitrile (82:

18) Use triethylamine to adjust the pH to 3.5 as the mobile phase; the detection wavelength is 277nm. The number of theoretical plates should be not less than the peak of ciprofloxacin hydrochloride.

In 2000, the resolution of the ciprofloxacin hydrochloride peak and the adjacent impurity peaks should meet the requirements.

Weigh 2ml (approximately 6mg of ciprofloxacin) into the 50ml volumetric flask, dilute to the mark with water, shake, and accurately measure

Take 5ml, place it in a 50ml measuring flask, add water to dilute to the mark, shake well, and use it as the test solution. Another precise weighed hydrochloric acid ring dried to constant weight at 105 ° C

Properfloxacin reference substance (approximately 20mg of ciprofloxacin), put in a 50ml measuring bottle, add an appropriate amount of water to dissolve, and dilute to the mark, shake well, precision

Measure 2ml, place it in a 50ml measuring flask, add water to dilute to the mark, shake well, and use it as a reference solution. Take 10l each of the test solution and the reference solution

Inject the liquid chromatograph, record the chromatogram, and calculate the peak area according to the external standard method.

Method for determination of ciprofloxacin hydrochloride

Method name: Determination of Ciprofloxacin Hydrochloride-High Performance Liquid Chromatography

Application: This method uses high performance liquid chromatography to determine the content of ciprofloxacin hydrochloride (C17H18FN3O3 · HCl).

This method is applicable to ciprofloxacin hydrochloride.

Principle of the method: The test product is made into a mobile phase solution, which is subjected to chromatographic separation by high-performance liquid chromatography. The absorption value of ciprofloxacin hydrochloride is measured at a wavelength of 277 nm using an ultraviolet absorption detector, and the content is calculated.

Reagent: 1. 0.05mol / L citric acid solution

Acetonitrile

Triethylamine

Equipment: 1. Instrument

1 HPLC

2 Column

Octadecylsilane-bonded silica gel is used as a filler. The number of theoretical plates calculated based on the ciprofloxacin peak is not less than 2000. The separation between the ciprofloxacin peak and the adjacent impurity peaks should meet the requirements.

3 UV absorption detector

Chromatographic conditions

1 Mobile phase: 0.05mol / L citric acid solution acetonitrile = 82 18, adjust the pH to 3.5 with triethylamine.

2 Detection wavelength: 277nm

3 Column temperature: 30

Sample preparation: 1. Weigh the test sample

Accurately weigh the appropriate amount of the product.

Preparation of reference solution

Accurately weigh the appropriate amount, add the mobile phase solution to dissolve and make a solution containing 0.5mg per 1mL, shake it to obtain.

Preparation of test solution

Dissolve and quantitatively dilute the test sample plus the mobile phase solution to make a solution containing 0.5 mg per 1 mL, and shake to obtain.

Note: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weight taken. "Precision measurement" means that the accuracy of measuring the volume should meet the accuracy requirements of the volume pipette in national standards.

Operation steps: Precisely draw 10 L each of the reference solution and the test solution into a high-performance liquid chromatograph, use an ultraviolet absorption detector to measure the absorption value of ciprofloxacin at a wavelength of 277 nm, and calculate its content.

References: Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 edition, Part Two, p.526.

Ciprofloxacin Hydrochloride Categories

Antibacterials.

Ciprofloxacin Hydrochloride Storage

Shaded, sealed, and stored in a cool and dark place.

Pharmacokinetics of Ciprofloxacin Hydrochloride

This product is topical and only absorbed in small amounts.

Ciprofloxacin hydrochloride indications

For external eye infections (such as conjunctivitis) caused by sensitive bacteria.

Ciprofloxacin hydrochloride dosage

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

Ciprofloxacin hydrochloride adverse reactions

Occasional transient transient irritation. Can cause local burns and foreign body sensations. In addition, eyelid edema, tearing, photophobia, decreased vision, and allergic reactions are rare.

Ciprofloxacin Hydrochloride Contraindications

Patients who are allergic to this product and quinolone drugs are contraindicated.

Precautions for Ciprofloxacin Hydrochloride

Only for eye drops. 2. If allergic symptoms such as rash or other serious adverse reactions occur during use, the drug should be stopped immediately.

Women medication

Animal experiments have not confirmed the teratogenic effects of quinolone drugs, but studies on pregnant women's use of drugs have not yet reached a clear conclusion. In view of the fact that this drug can cause joint disease in minor animals, pregnant women and lactating women should be used with caution.

Medication for children

This product is not generally used in infants.

Ciprofloxacin hydrochloride drug effect

After long-term extensive use after local absorption, it can produce the same drug interactions as systemic medications. For example, it can increase the blood concentration of theophylline, cyclosporine, probenecid and other drugs, and enhance the resistance of the anticoagulant warfarin. Coagulation, interfere with the metabolism of caffeine and so on.