What Is Diphenhydramine HCL?

Diphenhydramine Hydrochloride English name Diphenhydramine Hydrochloride, molecular formula is C17H22ClNO, alias Benazin, Ketamine; chemical name is N, N-dimethyl-2- (diphenylmethoxy) ethylamine hydrochloride. Can eliminate allergic symptoms.

Diphenhydramine hydrochloride

Diphenhydramine Hydrochloride English name Diphenhydramine Hydrochloride, molecular formula is C17H22ClNO, alias

Can eliminate allergic symptoms. its

Method name: Determination of Diphenhydramine Hydrochloride-Neutralization Titration

Application range: This method uses the titration method to determine the content of diphenhydramine hydrochloride.

This method is applicable to diphenhydramine hydrochloride.

Principle of the method: After the test product is dissolved with glacial acetic acid and acetic anhydride, mercury acetate test solution and crystal violet indicator solution are added, and the solution is titrated with perchloric acid titration solution (0.1mol / L) until the solution is blue-green. The amount of fluid used is calculated.

Reagent: 1. Water (new boiling to room temperature)

2. Perchloric acid titrant (0.1mol / L)

3. Crystal violet indicator liquid

Acetic anhydride

5. Glacial acetic acid

6. Mercury acetate test solution

7. Reference Potassium Phthalate

Sample preparation: 1. Perchloric acid titration solution (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.

Crystal violet indicator liquid

Take 0.5g of crystal violet, add 100mL of glacial acetic acid to dissolve, and get.

Operation steps: Accurately weigh 0.2g of the test sample, add 20mL of glacial acetic acid and 4mL of acetic anhydride, add 4mL of mercury acetate test solution and 1 drop of crystal violet indicator solution, and titrate with perchloric acid titrant (0.1mol / L) The solution was blue-green, and the titration result was 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 29.18 mg of benzyl hydrochloride Lamin (C17H21NO · HCl), that is.

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

References: Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 edition, Part Two, p.528.

Common central inhibitory effects, such as drowsiness, dizziness, headache, dry mouth, nausea, vomiting, and discomfort in the upper abdomen. Rare side effects include shortness of breath, chest tightness, cough, and dystonia. It has been reported that closed teeth and laryngospasm can occur after administration. The elderly are prone to stagnation or dizziness for a long time after medication.

Oral: 12.5 mg per adult, 2 to 3 times daily. Children 2 to 3 times a day, 2.5 to 5 mg for children under 1 year old; 5 to 7.5 mg for children 1 to 3 years old; 7.5 to 10 mg for children 4 to 6 years old; and 10 to 12.5 mg for children over 7 years old.

When used to prevent motion sickness, it should be taken 1 to 2 hours before travelling, and at least 30 minutes before taking.

Overdose may cause confusion, convulsions, tremors, dyspnea, and hypotension. Overdose in infants and children can cause agitation, hallucinations, convulsions, and even death. If you take a toxic amount, you can use gastric lavage and catharsis. Diazepam can be controlled while convulsing. Hypotension can be treated symptomatically with vasoconstrictors. Others include oxygen and intravenous fluids and supportive care.

Pregnancy class B, pregnant women and lactating women should be used with caution, newborns and premature infants are contraindicated. In renal failure, the interval between dosing should be extended. Myasthenia gravis,

Toxicity data from literature and journals

Numbering	Toxicity type	testing method	Test object	Dosage used	Toxic effect
1	Acute toxicity	oral	child	12500 ug / kg	1. Behavioral toxicityconvulsions or seizure thresholds affected 2. Cardiotoxicityarrhythmia 3. Reproductive toxicityincreased mortality after implantation
2	Acute toxicity	oral	Adult male	10714 ug / kg	1. Autonomic neurotoxicity-affects parasympathetic nerves 2. Behavioral toxicity-hallucinations and perceptual distortions 3. Vascular toxicity-blood pressure height without autonomic ganglia
3	Acute toxicity	oral	Adult woman	83 mg / kg	1. Behavioral toxicityconvulsions or seizure thresholds affected 2. Behavioral toxicitycoma 3. Cardiotoxicityarrhythmia
4	Acute toxicity	Skin surface	child	60 mg / kg / 6H-I	1. Eye toxicity-not reported 2. Behavioral toxicity-Appearing hallucinations and perceptual distortion 3. Behavioral toxicity-Ataxia
5	Acute toxicity	oral	Rat	500 mg / kg	Detailed effects are not reported other than lethal dose
6	Acute toxicity	Intraperitoneal injection	Rat	82 mg / kg	Detailed effects are not reported other than lethal dose
7	Acute toxicity	Subcutaneous injection	Rat	201 mg / kg	Detailed effects are not reported other than lethal dose
8	Acute toxicity	Intravenous injection	Rat	35 mg / kg	1. Behavioral toxicity-changes in sleep time (including changes in righting reflex) 2. Behavioral toxicity-convulsions or seizure thresholds affected 3. Lung, chest or respiratory toxicity-dyspnea
9	Acute toxicity	oral	Mouse	164 mg / kg	Detailed effects are not reported other than lethal dose
10	Acute toxicity	Intraperitoneal injection	Mouse	56 mg / kg	1. Behavioral Toxicity-Convulsions or Seizure Thresholds Affected 2. Behavioral Toxicity-Excitement
11	Acute toxicity	Subcutaneous injection	Mouse	99200 ug / kg	1. Behavioral toxicity-lethargy 2. Behavioral toxicity-convulsions or seizure thresholds affected 3. Skin and accessory toxicity-changes in hair
12	Acute toxicity	Intravenous injection	Mouse	20 mg / kg	1. Behavioral toxicityconvulsions or seizure thresholds are affected 2. Behavioral toxicitychanges in exercise behavior (specific analysis) 3. Behavioral toxicity-ataxia
13	Acute toxicity	Intravenous injection	dog	24 mg / kg	1. Behavioral toxicity-lethargy 2. Behavioral toxicity-affected by convulsions or seizure thresholds 3. Behavioral toxicity-excitement
14	Acute toxicity	Intravenous injection	rabbit	10 mg / kg	1. Behavioral toxicity-convulsions or seizure thresholds are affected 2. Behavioral toxicity-excitement 3. Lung, chest or respiratory toxicity-difficulty breathing
15	Acute toxicity	oral	Guinea Pig	280 mg / kg	Detailed effects are not reported other than lethal dose
16	Acute toxicity	Intraperitoneal injection	Guinea Pig	75 mg / kg	Detailed effects are not reported other than lethal dose
17	Acute toxicity	Subcutaneous injection	Guinea Pig	40 mg / kg	1. Behavioral toxicity-tremor 2. Behavioral toxicity-convulsions or seizure thresholds affected 3. Behavioral toxicity-muscle contraction or spasm
18	Acute toxicity	Intravenous injection	Hamster	18 mg / kg	1. Behavioral toxicity-tremor 2. Behavioral toxicity-convulsions or seizure thresholds affected 3. Behavioral toxicity-excitement
19	Acute toxicity	Intramuscular injection	pigeon	63 mg / kg	1. Gastrointestinal toxicity-nausea, vomiting
20	Acute toxicity	Intraperitoneal injection	mammal	80 mg / kg	Detailed effects are not reported other than lethal dose
twenty one	Chronic toxicity	oral	Rat	1750 mg / kg / 14D-C	1. Chronic disease-related toxicity-death
twenty two	Chronic toxicity	oral	Rat	5687 mg / kg / 13W-C	1. Hepatotoxicity-hepatolenticular degeneration
twenty three	Chronic toxicity	Subcutaneous injection	Rat	6796 ug / kg / 14D-I	1. Nutrition and metabolic system toxicity-weight loss or weight loss rate reduction 2. Chronic disease related toxicity-changes in ovarian weight 3. Chronic disease related toxicity-changes in uterine weight
twenty four	Chronic toxicity	oral	Mouse	3706 mg / kg / 14D-C	1. Chronic disease-related toxicity-death
25	Chronic toxicity	oral	Mouse	3418 mg / kg / 13W-C	1. Chronic disease-related toxicity-death
26	Chronic toxicity	oral	dog	1440 mg / kg / 5W-I	1. Behavioral Toxicity-Excitement 2. Behavioral Toxicity-Ataxia
27	Mutation toxicity		Rat liver	100 umol / L
28	Mutation toxicity		Hamster lung	200 mg / L
29	Mutation toxicity		Hamster Ovary	100 mg / L
30	Carcinogenicity	oral	Rat	27037 mg / kg / 2Y-C	1. Carcinogenicity-may be carcinogenic (according to RTECS standards) 2. Brain toxicity-tumor
31	Reproductive toxicity	oral	Rat	1 mg / kg, 6-15 days after conception	1. Reproductive toxicity-fetal toxicity (such as fetal dysplasia but not death) 2. Reproductive toxicity-abnormal development of the urinary system
32	Reproductive toxicity	oral	Rat	39 mg / kg, 6-15 days after conception	1. Reproductive toxicity-increased mortality after implantation
33	Reproductive toxicity	Parenteral	Rat	12 mg / kg, 10 days after conception	1. Reproductive toxicity-abnormal skull and facial development (including nose / tongue) 2. Reproductive toxicity-abnormal development of musculoskeletal system 3. Reproductive toxicity-abnormal development of urinary system
34	Reproductive toxicity	Parenteral	Rat	48 mg / kg, 13-16 days after conception	1. Reproductive toxicity-other changes
35	Reproductive toxicity	Parenteral	Rat	12 mg / kg, 5 days after conception	1. Reproductive toxicity-increased mortality after implantation
36	Reproductive toxicity	oral	Mouse	420 mg / kg, 1 to 21 days after conception	1. Reproductive toxicity-stillbirth of the newborn 2. Reproductive toxicity-affects the vitality index of the newborn (if alive on the 4th day of birth)
37	Reproductive toxicity	oral	Mouse	4200 mg / kg, 1 to 21 days after conception	1. Reproductive toxicity-other changes
38	Reproductive toxicity	oral	Mouse	320 mg / kg, 11-14 days after conception	1. Reproductive toxicity-fetal toxicity (such as fetal dysplasia but not death)
39	Reproductive toxicity	oral	Mouse	800 mg / kg, 8-12 days after conception	1. Reproductive toxicity-reduced weight gain in newborns
40	Reproductive toxicity	Subcutaneous injection	Mouse	50 mg / kg, 8 days after female conception	1. Reproductive toxicity-fetal toxicity (such as fetal dysplasia but not death)
41	Reproductive toxicity	Subcutaneous injection	Mouse	100 mg / kg, 8 days after conception	1. Reproductive toxicity-abnormal development of the urinary system
42	Reproductive toxicity	Not reported	Mouse	1600 mg / kg, 6-15 days after conception	1. Reproductive toxicity-fetal toxicity (such as fetal dysplasia but not death)

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