What Is Loperamide Hydrochloride?

Loperamide hydrochloride is a white or off-white crystalline powder. It can be used as an antidiarrheal medicine or a long-acting anti-diarrhea medicine. It is mostly used to treat acute and chronic dysentery. Toxic symptoms such as drowsiness, constipation, muscle tension, diminished pupils, and bradycardia may occur when overdose is taken. Naloxone can be used to detoxify and observe the patient for at least 48 hours in order to find the inhibitory effect of the central nervous system in time.

Loperamide hydrochloride

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Loperamide hydrochloride is a white or off-white crystalline powder. It can be used as an antidiarrheal medicine or a long-acting anti-diarrhea medicine. It is mostly used to treat acute and chronic dysentery. Toxic symptoms such as drowsiness, constipation, muscle tension, diminished pupils, and bradycardia may occur when overdose is taken. Naloxone can be used to detoxify and observe the patient for at least 48 hours in order to find the inhibitory effect of the central nervous system.

Chinese name

Loperamide hydrochloride

English name

loperamide hydrochloride

nickname

Loperamide hydrochloride; loperamide

Chemical formula

C29H34Cl2N2O2

Molecular weight

513.4985

CAS Registry Number

34552-83-5

EINECS registration number

252-082-4

Melting point

223-225 ° C

Density

1.1905

Exterior

Capsules containing white or yellow-white powder.

test methods

Determination of loperamide hydrochloride

Chinese name: Loperamide hydrochloride

Chinese alias: loperamide hydrochloride; loperamide

English name: loperamide hydrochloride

English alias: Loperamide hydrochloride [USAN: JAN]; Loperamide hydrochloride; 4- (4- (p-Chlorophenyl) -4-hydroxy-1-piperidyl) -N, N-dimethyl-2,2-diphenylbutyramide HCl; 4- ( p-Chlorophenyl) -4-hydroxy-N, N-dimethyl-alpha, alpha-diphenyl-1-piperidine butyramide HCl; 4- (p-Chlorophenyl) -4-hydroxy-N, N-dimethyl-alpha, alpha-diphenyl -1-piperidinebutyramide monohydrochloride; BLOX; BREK; Dissenten; Fortasec; Imodium; Imodium AD; Imodium AD EZ chews; Imosec; Lopemid; Lopemin; Loperamide HCl; Loperyl; Maalox Antidiarrheal; PJ185; R 18553; Suprasec; Tebloc; UNII-7735 ; Up and up anti diarrheal; 1-Piperidinebutanamide4- (4-chlorophenyl) -4-hydroxy-N, N-dimethyl-alpha, alpha-diphenyl-, hydrochloride; 1-Piperidinebutanamide, 4- (4-chlorophenyl) -4- hydroxy-NN-dimethyl-alpha, alpha-diphenyl-, monohydrochloride4- (4-Chlorophenyl) -4-hydroxy-N, N-dimethyl-alpha, alpha-diphenylpiperidine-1-butyramide monohydrochloride; 4- [4- (4- chlorophenyl) -4-hydroxypiperidin-1-yl] -N, N-dimethyl-2,2-diphenylbutanamide hydrochloride (1: 1)

CAS: 34552-83-5

EINECS: 252-082-4

Molecular formula: C29H34Cl2N2O2

Molecular weight: 513.4985

Active Ingredient: Loperamide Hydrochloride

Chemical name: N, N-dimethyl-, -diphenyl-4- (p-chlorophenyl) -4-hydroxy-1-loperamide hydrochloride

Capsules containing white or yellow-white powder.

Intestinal wall

Antidiarrheal. For various symptoms of acute and chronic diarrhea. For ileostomy patients, it can reduce the volume and frequency of defecation and increase the hardness of stool.

2mg / capsule

Suitable for adults and children over 5 years.

1. Acute diarrhea: The initial dose is 2 capsules for adults, 1 capsule for children over 5 years old, and 1 capsule for each subsequent unformed stool.

2. Chronic diarrhea: The starting dose is 2 capsules for adults and 1 capsule for children over 5 years of age. After that, the daily dose can be adjusted to maintain normal stool 1-2 times a day. The general maintenance dose is 1 to 6 capsules a day.

3. Maximum daily dose: no more than 8 capsules for adults and no more than 3 capsules / 20kg body weight for children.

4. Those with other medical history should use it under the guidance of a doctor.

If strictly follow the recommended dosage and pay attention to contraindications, there will be no obvious adverse effects in long-term use. Allergic reactions (including rash), gastrointestinal upset, nausea and vomiting, bloating, loss of appetite, constipation, burnout, dizziness, headache, fatigue, dry mouth and other adverse reactions are reported, but it is usually not easy to distinguish from the symptoms associated with diarrhea.

Disabled for children under 2 years . Loperamide capsules are not suitable for children under 5 years of age.

For symptomatic drugs, treatment of the cause of diarrhea is still needed.

Cannot be used for basic treatment of acute bacterial dysentery with high fever and pus and blood.

It is contraindicated in patients with acute ulcerative colitis and pseudomembranous enteritis caused by broad-spectrum antibiotics.

1. Patients with diarrhea, especially children, often suffer from water and electrolyte loss. Supplementing water and electrolytes is the most important treatment. Children should use this product under the guidance of a doctor.

2. For acute diarrhea, if there is no improvement in clinical symptoms after taking this product for 48 hours, this product should be discontinued. It is recommended to consult a doctor.

3. Patients with liver dysfunction may cause a relative overdose of the drug. Pay attention to the symptoms of central nervous system poisoning.

Although loperamide has no teratogenic effects and embryo toxicity, pregnant women should still weigh the therapeutic effect and the potential harm, especially in the first three months of pregnancy.

Occasionally, loperamide is secreted in breast milk. Although its content in breast milk is low, breastfeeding women should also avoid using it.

Loperamide hydrochloride method name

Determination of loperamide hydrochloride-neutralization titration method

Application range of loperamide hydrochloride

This method uses a titration method to determine the content of loperamide hydrochloride.

This method is applicable to loperamide hydrochloride.

The principle of loperamide hydrochloride method

The test product was added with glacial acetic acid at a slight temperature to dissolve. After adding the mercury acetate test solution and the naphthol benzyl alcohol indicator solution, the solution was titrated with a perchloric acid titrant (0.1mol / L) until the solution became green. Measure, calculate, and get.

Reagent:

1. Water (newly boiled to room temperature)

2. Perchloric acid titration solution (0.1mol / L)

3. Naphthol benzyl alcohol indicator solution

4.glacial acetic acid

5, acetic anhydride

6, glacial acetic acid

7. Mercury acetate test solution

8.Basic potassium hydrogen phthalate

Loperamide hydrochloride equipment

Sample preparation

1. Perchloric acid titrant (0.1mol / L)

Preparation: Take 750mL of anhydrous glacial acetic acid (calculated with water content, add 5.22mL acetic anhydride per 1g of water), add 8.5mL perchloric acid (70% -72%), shake well, and slowly add acetic anhydride dropwise at room temperature. 23mL, shake while adding, shake evenly after adding, let cool, add an appropriate amount of anhydrous glacial acetic acid to 1000mL, shake well, and leave for 24 hours. If the test sample is easily acetylated, the water content on this page must be determined by moisture measurement, and then the water content of this solution should be adjusted to 0.01% -0.2% with water and acetic anhydride.

Calibration: Take about 0.16g of standard potassium hydrogen phthalate dried to constant weight at 105 , accurately weigh, add 20mL of anhydrous glacial acetic acid to dissolve, add 1 drop of crystal violet indicator solution, and titrate slowly with Blue, and the results of the titration are corrected with a blank test. Each 1mL of perchloric acid titration solution (0.1mol / L) is equivalent to 20.42mg of potassium hydrogen phthalate. Calculate the concentration of this solution based on the consumption of this solution and the amount of potassium hydrogen phthalate taken.

Storage: Place in a brown glass bottle and keep tightly closed.

2. Naphthol benzyl alcohol indicator solution

Take 0.5 g of naphthol benzyl alcohol, add 100 mL of glacial acetic acid to dissolve, and obtain.

Steps

Accurately weigh 0.3g of the test product, add 20mL of glacial acetic acid, add 10mL of mercury acetate test solution and 2 drops of naphthol benzyl alcohol indicator solution, titrate the solution with perchloric acid titration solution (0.1mol / L), and make the titration The results were corrected by a blank test. The volume of perchloric acid titrant consumed (mL) was recorded. Each 1 mL of perchloric acid titrant (0.1 mol / L) was equivalent to 51.35 mg of loperamide hydrochloride (C29H33ClN2O2 · HCl). That's it.

Note 1: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weight. Precision requirements.