Catalog 1 Pinyin 2 English Reference 3 National Essential Drugs 4 Norfloxacin Pharmacopoeia Standard 4.1 Name 4.1.1 Chinese Name 4.1.2 Chinese Pinyin 4.1.3 English Name 4.2 Structural Formula 4.3 Molecular Formula and Molecular Weight 4.4 Source (Name), Content (Potency) 4.5 Properties 4.5.1 Melting Point 4.6 Identification 4.7 Examination 4.7.1 Clarification of Solution 4.7.2 4.7.2 Related substances 4.7.3 Loss of weight on drying 4.7.4 Residue from incineration 4.7.5 Heavy metals 4.8 Determination of content 4.8.1 Chromatographic conditions and system suitability tests 4.8.2 Assay 4.9 Classes 4.10 Storage 4.11 Formulations 4.12 Appendices: 4.13 Versions 5 NORFLOXACIN DIRECTIONAL INSTRUCTIONS 5.1 Alias for Norfloxacin 5.2 Names of the foreign languages 5.3 Indications for norfloxacin 5.4 Dosage and administration Dosage and Administration of Norfloxacin 5.5 Precautions 5.6 Specifications Attachment: * Other versions of Norfloxacin-related drug inserts 1 Pinyin

nuò fú shā xīng

2 English Reference

Norfloxacin

3 National Essential Drugs

Information on the retail guideline price of National Essential Drugs related to Norfloxacin

Serial number Essential Drugs

Catalog No. Drug Name Formulation Specification Unit Retail Guide Price

Guide Price Category Remarks 203 18 Norfloxacin Capsules 100mg*20 Box (Bottle) 3 Chemical Drugs and Biological Products Section * 204 18 Norfloxacin Capsules 100mg*6 Box (Bottle) 0.94 Chemical Drugs and Biological Products Section 205 18 Norfloxacin Capsules 100mg*10 Box (Bottle) 1.5 Chemicals and Biologicals Section 206 18 Norfloxacin Capsules 100mg*12 Boxes (Bottles) 1.8 Chemicals and Biologicals Section 207 18 Norfloxacin Capsules 100mg*24 Boxes (Bottles) 3.6 Chemicals and Biologicals Section 208 18 Norfloxacin Capsules 100mg*30 Boxes (Bottles) 4.4 Chemicals and Biologicals Section 209 18 Norfloxacin Capsules 100mg*30 Boxes (Bottles) 4.4 Chemicals and Biologicals Section 209 18 Norfloxacin Capsules 100mg*6 Boxes (Bottles) Norfloxacin Capsules 100mg*40 Boxes (Vials) 5.9 Chemicals and Biologicals Section 210 18 Norfloxacin Capsules 100mg*48 Boxes (Vials) 7 Chemicals and Biologicals Section 211 18 Norfloxacin Capsules 100mg*50 Boxes (Vials) 7.3 Chemicals and Biologicals Section 212 18 Norfloxacin Capsules 100mg*60 Boxes (Vials) 8.6 Chemicals and Biologicals Section 213 18 Norfloxacin Capsules 100mg*60 Boxes (Vials) 8.6 Chemical Drugs and Biologicals Section 213 18 Norfloxacin Capsules 100mg*100 Boxes (Bottles) 14.1 Chemical Drugs and Biologicals Section 214 18 Norfloxacin Tablets 100mg*10 Boxes (Bottles) 1.3 Chemical Drugs and Biologicals Section 215 18 Norfloxacin Tablets 100mg*24 Boxes (Bottles) 3.1 Chemical Drugs and Biologicals Section

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1.

1. The products marked with "*" in the Remarks column of the table are representative products.

2, the table on behalf of the dosage form specifications in the Remarks column with "△", the representative dosage form specifications and its clear differential price relationship with the price of the relevant specifications for the interim price.

4 Norfloxacin Pharmacopoeia standard 4.1 Name 4.1.1 Chinese name

Norfloxacin

4.1.2 Chinese pinyin

Nuofushaxing

4.1.3 English name

Norfloxacin

4.2 Structural formula 4.3 Molecular formula and molecular weight

C16H18FN3O3 319.24

4.4 Source (name), content (potency)

This product is 1 ethyl 6-fluoro 1,4 dihydro 4-oxo 7 (1 piperazinyl) 3 quinoline carboxylic acid. Calculated according to the dry product, containing C16H18FN3O3 should be 98.5% to 102.0%.

4.5 Properties

This product is off-white to light yellow crystalline powder; odorless, slightly bitter taste; moisture-inducing.

The product is slightly soluble in dimethylformamide, very slightly soluble in water or ethanol; soluble in acetic acid, hydrochloric acid or sodium hydroxide solution.

4.5.1 Melting point

The melting point of this product is 218-224 ℃ (2010 version of the Pharmacopoeia II Appendix VI C).

4.6 Identification

(1) take the product and norfloxacin control appropriate amount, respectively, add trichloromethane - methanol (1:1) to make a solution containing 2.5 mg per 1 ml, as a test solution and the control solution, according to the thin-layer chromatography (2010 version of the Pharmacopoeia, Part II, Appendix V B) test, take 10 μl of each of the above two solutions, respectively, spot on the same silica gel G thin-layer plate. The same silica gel G thin layer plate, trichloromethane-methanol-concentrated ammonia solution (15:10:3) as the unfolding agent, unfolding, drying, placed in the ultraviolet light (365nm) under the examination. The position and fluorescence of the main spot of the test solution should be the same as that of the main spot of the control solution.

(2) In the chromatogram recorded under content determination, the retention time of the main peak of the test solution should be the same as that of the main peak of the control solution.

The above (1) and (2) can be one of the two optional.

4.7 Check 4.7.1 Clarification of the solution

Take 5 copies of the product, each 0.5 g, respectively, add sodium hydroxide test solution 10 ml dissolved, the solution should be clarified; such as turbidity, and the No. 2 turbidity standard solution (2010 version of the Pharmacopoeia, Appendix IX B of the second part of the second appendix), are not more concentrated.

4.7.2 Related substances

Take the appropriate amount of this product, precision weighing, add 0.1mol / L hydrochloric acid solution appropriate amount (each 12.5mg of norfloxacin plus 0.1mol / L hydrochloric acid solution 1ml) to make soluble, with the quantitative dilution of the mobile phase A made of about 0.15mg of each 1ml of the solution, as a test solution; precision measurement of the appropriate amount of the solution, with the mobile phase A quantitative dilution made of 0.75mg of each 1ml, with the mobile phase A, as a test solution. The solution containing 0.75 μg in 1 ml was used as the control solution. Also weigh about 15mg of impurity A control product, put it in 200ml measuring flask, add acetonitrile to dissolve and dilute it to the scale, shake well, take an appropriate amount of it in precise measurements, and dilute it quantitatively with mobile phase A to make a solution containing about 0.3μg per 1ml, as impurity A control solution. Determined by high performance liquid chromatography (2010 version of Pharmacopoeia II Appendix V D), using octadecylsilane-bonded silica gel as filler; 0.025 mol/L phosphoric acid solution (with triethylamine to adjust the pH value to 3.0 ± 0.1) - acetonitrile (87:13) as mobile phase A, acetonitrile as mobile phase B; according to the table below the elution of a linear gradient. Weigh the appropriate amount of norfloxacin control, ciprofloxacin control and enrofloxacin control, add 0.1 mol/L hydrochloric acid solution to make it dissolved, dilute with mobile phase A to make a mixed solution containing 0.15 mg of norfloxacin, 3 μg of ciprofloxacin and 3 μg of each enrofloxacin per 1 ml, and inject 20 μl into the liquid chromatograph to record chromatograms with detection wavelength of 278 nm, and the retention time of the norfloxacin peak was about 9 min. The retention time of the norfloxacin peak was about 9 min. The separation of norfloxacin peak and ciprofloxacin peak and norfloxacin peak and enrofloxacin peak should be greater than 2.0. 20 μl of the control solution was injected into the liquid chromatograph with 278 nm as the detection wavelength, and the detection sensitivity was adjusted, so that the peak height of the peak of the main ingredient chromatography peak was about 25% of the full scale. Precisely measure 20 μl each of the test solution, control solution and impurity A control solution, respectively, injected into the liquid chromatograph, with 278 nm and 262 nm as the detection wavelength, and record the chromatogram. If there is an impurity peak in the chromatogram of the test solution, the impurity A (262nm detection) was calculated by peak area according to the external standard method, which should not exceed 0.2%. Other single impurity (278nm detection) peak area shall not be greater than the main peak area of the control solution (0.5%); the sum of the peak area of other impurities (278nm detection) shall not be greater than two times the main peak area of the control solution (1.0%). Any peak in the chromatogram of the test solution that is less than 0.1 times the area of the main peak of the control solution is negligible.

? Time (min) ? Mobile phase A (%) ? Mobile phase B (%) 0 100 ?0 ?10 ?100 ?0 ?20 ?50 ?50 ?30 ?50 ?50 ?32 ?100 ?0 ?42 ?100 ?0 4.7.3 Loss of weight on drying

Take the product, dry it at 105 ℃ to a constant weight, and the loss of weight should not be more than 1.0% (2010 version of the Pharmacopoeia, Appendix VIII of the second part of L).

4.7.4 Residue of cauterization

Take 1.0g of the product, placed in a platinum crucible, according to the law check (2010 version of the Pharmacopoeia II Appendix VIII N), the residue should not be more than 0.1%.

4.7.5 Heavy metals

Take the residue left under the residue of incandescent cauterization, according to the law (2010 version of the Pharmacopoeia, Appendix VIII, Part II, H, the second method), containing no more than 15 parts per million of heavy metals.

4.8 Determination of content

Determined by high performance liquid chromatography (2010 version of the Pharmacopoeia II Appendix V D).

4.8.1 Chromatographic conditions and system suitability test

Octadecylsilane-bonded silica gel was used as filler; 0.025 mol/L phosphoric acid solution (pH adjusted to 3.0±0.1 with triethylamine) - acetonitrile (87:13) as mobile phase, detection wavelength of 278nm. Appropriate amount of Norfloxacin Control, Ciprofloxacin Control and Enrofloxacin Control was weighed, and 0.1 mol/L hydrochloric acid was added to dissolve the solution, and then diluted with the mobile phase to make a mixture containing 25 μg of Norfloxacin, 5 μg of Ciprofloxacin and Enrofloxacin each in 1 ml, 20 μl of which was injected into the liquid chromatograph, and the chromatograms were recorded, and the retention time of the peaks of Norfloxacin was about 9 minutes. The separation of the peak of norfloxacin and ciprofloxacin and the peak of norfloxacin and enrofloxacin should be more than 2.0.

4.8.2 Determination method

Take about 25mg of this product, weigh it accurately, put it into a 100ml vial, add 2ml of 0.1 mol/L hydrochloric acid solution to make it dissolved, dilute it with water to the scale, shake it well, measure 5ml accurately, put it into a 50ml vial and dilute it to the scale with mobile phase, shake it well and measure 5ml accurately, dilute it with mobile phase to the scale, shake it well. Scale, shake well, precise amount of 20μl injected into the liquid chromatograph, record the chromatogram; another Norfloxacin control, the same method of determination, according to the external standard method to the peak area, that is obtained.

4.9 Category

Quinolone antibacterial drugs.

4.10 Storage

Shielded from light, sealed, stored in a dry place.

4.11 Preparation

(1) Norfloxacin ointment? (2) Norfloxacin cream? (3) Norfloxacin capsule? (4) Norfloxacin eye drops

4.12 Attachment:

Impurity A: 1 ethyl 6 fluoro 7 chloro 4 oxo 1,4 dihydro quinoline 3 carboxylic acid

4.13 Version

The Chinese People's **** and the State Pharmacopoeia 2010 edition

5 Norfloxacin instructions 5.1 Norfloxacin aliases

Likeluo tablets; Gonocoxing; Norfloxacin; Likeluo; Haloperidol; Gonoxacin. ; Gonoxacin.

5.2 Synonyms

Norfloxacin, AM715, Brazan, Fulgram, Lexnor, MK0366, Uroxacin, Noroxin, Zoroxin

5.3 Indications for Norfloxacin

For infections of the urinary tract, the respiratory system, the intestinal tract, otorhinolaryngology, gynecology, surgery and dermatology. and other infectious diseases.

5.4 Dosage and Administration of Norfloxacin

Oral: Adults generally use 400 mg to 800 mg per day, divided into 3 to 4 times, typhoid fever or other Salmonella infections 800 to 1600 mg per day, divided into 4 times. The drug is better absorbed when taken on an empty stomach. The general course of treatment is 3 to 8 days, and in a few cases up to 3 weeks. For chronic urinary tract infections, the first general amount of 2 weeks, and then reduce the amount to 200mg per day, taken at bedtime, for several months.

5.5 Precautions

1. There may be epigastric discomfort at the beginning of the medication, usually without stopping the medication, and it can gradually subside on its own, but patients with a history of gastric ulcers should be used with caution.

2. A small number of patients may cause transaminase elevation, which can be normalized after stopping the drug.

3. A small number of patients can appear peripheral nerve *** symptoms, the skin of the limbs have a pins and needles feeling, or a slight burning sensation, plus vitamin B1 and B12 can be reduced.

4. Generally not used in young children.

5.6 Specifications