What Is Terbutaline Sulfate?

A drug term, also known as hydroxyshuchuanling, tertidine, is mainly used for the treatment of bronchospasm in bronchial asthma, asthmatic bronchitis and chronic obstructive pulmonary disease.

Terbutaline sulfate

A drug term, also known as oxyshuchuanling, tertidine, mainly used in the bronchus

Take about 1mg of this product, put in a test tube, add 1ml of water to dissolve, add buffer solution (pH9.5) (take 36.3g of dimethylolaminomethane, dissolve and dilute to 1000ml with water, adjust the pH value with 1mol / L hydrochloric acid (To 9.5) 5 ml, add 0.5 ml of freshly prepared 2% 4-aminoantipyrine solution and 2 drops of freshly prepared potassium ferricyanide solution (2 25), mix, heat in a water bath, and the solution is purple. Take this product, add 0.1 mol / L hydrochloric acid solution to make a solution containing 0.1 mg per 1 ml, and determine it by spectrophotometry (Appendix IV A). It has a maximum absorption at a wavelength of 276 nm. (3) The infrared absorption spectrum of the product should be consistent with that of the reference product (Appendix IV C). If not, take an appropriate amount of the product, dissolve it in formaldehyde-free methanol, and evaporate it in a water bath to measure. The identification reaction of the aqueous solution of sulfate of this product (Appendix III).

Acidity: Take 0.2g of this product, add 10ml of water to dissolve, use potentiometric method to indicate the end point (Appendix A), titrate with sodium hydroxide titration solution (0.02mol / L) to pH 6, and consume sodium hydroxide titration solution (0.02mol / L) Do not exceed 0.50ml. Clarity and color of the solution: Take 0.20g of the product. After dissolving in 10ml of water, the solution should be clear and colorless; if color is developed, check according to law (Appendix A second method), put in a 2cm absorption cell and measure at a wavelength of 400nm. Absorbance should not be greater than 0.11. 3,5-dihydroxy--tert-butylaminoacetophenone sulfate. Take this product and add 0.01mol / L hydrochloric acid solution to make a solution containing 20mg per 1ml. Spectrophotometric method ( Appendix IV A), the absorbance measured at a wavelength of 330nm shall not be greater than 0.47. Related substances are protected from light. Take 0.25g of this product, add 1ml of water to dissolve, add ethanol to make a solution containing 25mg per 1ml as the test solution; take a precise amount and dilute with ethanol to a solution containing 0.125mg per 1ml as a control solution. . According to the thin layer chromatography (Appendix VB) test, draw 20 l of each of the two solutions, and point them on the same silica gel G thin layer plate, using the aldehyde-free methanol-water-concentrated ammonia solution (90: 10: 1.5) as the developing agent. After being unfolded, air-dry and spray with potassium permanganate test solution to make the color develop. The test solution such as impurity spots should not be deeper than the main spot of the control solution (0.5%). Take the product after losing weight and dry it at 105 to constant weight, and the weight loss should not exceed 0.5% (Appendix L). The ignition residue shall not exceed 0.2% (Appendix N). The heavy metal shall be taken as the residue left under the burning residue and shall be inspected in accordance with the law (Appendix H). The content of heavy metal shall not exceed 20 parts per million.

Take about 0.3g of this product, accurately weigh, add 30ml of glacial acetic acid, heat to dissolve, let cool, add 30ml of acetonitrile, potentiometric titration method (Appendix A), titrate with perchloric acid titrant (0.1mol / L) And correct the titration results with a blank test. Each 1ml of perchloric acid titration solution (0.1mol / L) is equivalent to 54.87mg of (C12H19NO3) 2.H2SO4.

Method name:

Terbutaline sulfate-determination of terbutaline sulfate-potentiometric titration

Application:

This method uses potentiometric titration to determine the content of terbutaline sulfate ((C12H19NO4) 2 · H2SO4).

This method is suitable for determination of terbutaline sulfate.

Method principle:

Take an appropriate amount of this product, add glacial acetic acid, heat to dissolve, let cool, add acetonitrile, titrate with perchloric acid titration solution (0.1mol / L) according to the potentiometric titration method, and correct the result of the titration with a blank test. Each 1mL of perchloric acid titration solution (0.1 mol / L) is equivalent to 54.87mg of (C12H19NO4) 2 · H2SO4.

Reagent:

Water (newly boiled to room temperature)

Glacial acetic acid

Acetonitrile

Perchloric acid titrant (0.1mol / L)

Reference potassium hydrogen phthalate

Anhydrous glacial acetic acid

Crystal violet indicator liquid

equipment:

Sample preparation:

Perchloric acid titrant (0.1mol / L)

Preparation: Take 750mL of anhydrous glacial acetic acid (calculated with water content, add 5.22mL of acetic anhydride per 1g of water), add 8.5mL of perchloric acid (70 ~ 72%), shake well, let cool, add an appropriate amount of anhydrous glacial acetic acid 1000mL, shake well and leave for 24 hours. If the test sample is easily acetylated, the water content of the solution must be determined by the moisture measurement method, and then the water content of the solution is 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 slowly titrate with this solution to Blue, and the titration results 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.

Crystal violet indicator liquid

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

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

Steps:

Take about 0.3g of this product, accurately weigh, add 30mL of glacial acetic acid, heat to dissolve, let cool, add 30mL of acetonitrile, according to potentiometric titration method, titrate with perchloric acid titrant (0.1mol / L), and titrate the The results were corrected with a blank test.

Note 1: "Precise weighing" means that the weighed weight should be accurate to one thousandth of the weighed weight. "Precision weighing" means that the accuracy of the measured volume should conform to the national standard for the volume of the pipette. Precision requirements.

Note 2: "Determination of moisture" uses the drying method, taking 2 to 5 g of the test sample, and spreading it in a flat weighing bottle that is dry to constant weight, the thickness does not exceed 5 mm, and the loose test sample does not exceed 10 mm. Open the bottle cap and dry at 100 ~ 105 ° C for 5 hours. Place the cap on the dryer, cool it for 30 minutes, and weigh it precisely. Then dry it at the above temperature for 1 hour, cool, and weigh until two times in a row. The difference in weighing does not exceed 5 mg. Calculate the moisture content (%) in the test product based on the weight lost.

references:

Pharmacopoeia of the People's Republic of China, edited by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 Edition Two, p.749.

[Pharmacology and Toxicology] This product is an adrenergic agonist. It can selectively activate 2-receptors, relax bronchial smooth muscle, inhibit the release of endogenous spastic substances and edema caused by endogenous mediators, improve the ability of bronchial mucosal ciliary epithelium to clear, and relax uterine smooth muscle.

[Pharmacokinetics] It takes effect within 30 minutes after oral administration, and reaches the maximum effect in 2 to 4 hours. It can last for 5 to 8 hours. Subcutaneous injection can maintain 1.5 to 4 hours. The effect of aerosol inhalation takes 5 to 15 minutes, and the maximum effect occurs in 0.5 to 1 hour. Lasts about 4h. The oral bioavailability was 15 ± 6%, and the asthma effect appeared in about 30 minutes. The effective blood concentration is 3 g / ml, and the plasma protein binding rate is 25%. The effect reaches a peak in 2-4 hours, lasting 4-7 hours. Vd is 1.4 ± 0.4L / kg.

[Indications] For bronchial asthma, asthma-type bronchitis

Drug appearance And bronchospasm in chronic obstructive pulmonary disease. Continuous intravenous drip of this product can stimulate uterine smooth muscle 2 receptor, inhibit spontaneous uterine contraction and uterine contraction caused by oxytocin, and prevent premature birth. The same principle can be applied to fetal asphyxia.

[Usage and dosage] Subcutaneous injection, 0.25mg / time, if there is no obvious clinical improvement in 15-30 minutes, the injection can be repeated once, but the total amount cannot exceed 0.5mg in 4 hours.

[Adverse reactions] A few cases have finger tremor, headache, palpitations and gastrointestinal disorders.

[Contraindication] Those who are allergic to this product are prohibited. Pregnancy class B. Use with caution in patients with hypertension, coronary heart disease, hyperthyroidism, diabetes, and pregnancy.

[Precautions] 1. A few cases have finger tremor, headache, palpitations and gastrointestinal disorders. When 5mg orally, the incidence of finger tremor can reach 20% -33%.

Use with caution in patients with hyperthyroidism, coronary heart disease, hypertension, and diabetes.

High-dose application can cause ketoacidosis in patients with a history of epilepsy.

Long-term application can form drug resistance and reduce efficacy.

[Medication for pregnant women and lactating women] As this product can relax uterine smooth muscles, it can inhibit the uterine mobility and delivery of pregnant women, so it should be used with caution.

[Children's medication] The dosage for children under 12 years old and children has not been established.

[Drug interactions] 1. Combined use of other adrenergic receptor agonists can increase efficacy, but adverse reactions may also worsen. 2. Concomitant use of theophylline drugs can increase the efficacy, but palpitations and other adverse reactions may also worsen. 3. Non-selective beta blockers can partially or completely inhibit the effects of the drug.

[Storage] Keep tightly closed in a cool and dry place.

[Validity] 12 months tentative

Terbutaline sulfate atomizing solution

[Chinese name] Terbutaline sulfate spray

[Product English name] Terbutaline Sulphate Solution for Nebulization

[Indications] Bronchial asthma, chronic asthmatic bronchitis, obstructive emphysema, and other lung diseases with bronchospasm.

chemical composition

This product contains terbutaline sulfate.

[Pharmacological action]

Terbutaline can selectively stimulate 2 adrenergic receptors and relax bronchial smooth muscle.

medicine interactions

1 Concomitant use of other adrenergic receptor agonists can increase efficacy, but adverse reactions may also worsen. 2 Concomitant use of theophylline drugs can increase efficacy, but palpitations and other adverse reactions may also worsen. 3 Non-selective -blockers can partially or completely inhibit the effects of the drug.

Adverse reactions

A few patients have mild adverse reactions, mainly manifested as dry mouth, stuffy nose, mild chest tightness, lethargy, palpitations, and hand tremor.

Contraindications

Those who are allergic to this product and other adrenergic receptor agonists are contraindicated.

[Product Specifications]

2ml: 5mg

Dosage

Adults: 1.25 mg (half tablet) each time for 1-2 weeks, 2-3 times a day. It can be added to 2.5 mg (one tablet) each time, 3 times a day. Children: 0.065 to 0.075 mg per kg of body weight, 3 times a day.

storage

Keep away from light and keep tightly closed.

Precautions

1 Use with caution in patients with uncontrolled hyperthyroidism and diabetes.

2 Do not use in combination with non-selective beta blockers.

3 The pressure-resistant container plugged with this product must not damage the valve, avoid direct sunlight and high temperature above 40 .

4 The aerosol plastic case should be cleaned regularly in warm water, and the aerosol aluminum bottle should be put in after it is completely dry.

5 For those who are sensitive to adrenergic receptor agonists, start with a small amount. If the general dose is not effective, please consult your doctor.

Terbutaline sulfate tablets

Drug Name: Terbutaline Sulfate Tablets

English name: Terbutaline Sulfate Tablets

Phonetic script ( Hanyu Pinyin): Liusuan Tebutalin Pian

Main ingredient: Terbutaline sulfate

Traits: white tablets.

Pharmacological effects: selective 2 receptor agonists. It relaxes the bronchial smooth muscle and relieves the bronchial smooth muscle spasm. Less exciting to the heart.

Pharmacokinetics: Terbutaline sulfate is rapidly absorbed through the intestine after oral administration. The peak time of plasma drug concentration is 1 to 4 hours, and the average in vivo residence time is 9 hours. Excreted by bile or urine after metabolism.

Indications: Bronchial asthma, chronic asthmatic bronchitis, obstructive emphysema, and other lung diseases with bronchospasm.

Usage and dosage: oral. 2.5mg (1 tablet), 3 times a day or as directed by your doctor.

Adverse reactions: mainly dry mouth, finger tremor, palpitations, dizziness, headache, stomach upset, etc., but it does not affect the treatment. Symptoms can be weakened or disappeared after continued taking.

Contraindications:

Note: 1 Use with caution for pregnant women and infants.

2 Use with caution in patients with hyperthyroidism, hypertension, heart disease, and diabetes.

3 Collaboration with other sympathomimetics can aggravate side effects.

4 Should not be combined with -adrenergic blockers.

Specifications: 2.5mg.

Storage: shading and sealed.

Validity period: Tentative 2 years.

Prescription drugs: Yes

side effect

Occasionally tremor, tonic spasm, and palpitations, the degree of adverse reactions depend on the dose and route of administration.

Increasing from small doses to therapeutic doses can reduce adverse reactions.