What Is Buprenorphine Hydrochloride?

Medicines, analgesics, used for various post-operative pain, chronic cancer pain, post-burn pain, limb pain caused by vasculitis, and angina and other visceral pain.

Buprenorphine hydrochloride

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Medicines, analgesics, used for various post-operative pain, chronic cancer pain, post-burn pain, limb pain caused by vasculitis, angina pectoris and others

Buprenorphine hydrochloride

Phonetic name: Yansuan Dingbingnuofei

English name: Buprenorphine Hydrochloride

Page number: 2000 edition two -541

C29H41NO4.HCl 504.11

The product is 21-cyclopropyl-7 [(S) -1-

Identification of buprenorphine hydrochloride

Take about 2mg of this product, add 5ml of water to dissolve, add a few drops of bromine test solution, and a yellow precipitate is formed.

Take an appropriate amount of this product, add water to make a solution containing 0.16mg per 1ml, and determine it by spectrophotometry (Appendix IV A), at 286nm ± 2nm

There is maximum absorption at the wavelength of.

(3) The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 633).

The identification of chlorides in aqueous solution of this product (Appendix III).

Buprenorphine hydrochloride test

For acidity, take 8mg of this product, add 25ml of water to dissolve it, and then measure it according to law (Appendix VI H). The pH of the solution should be 5.0 7.0.

The clarity of the solution is about 8 mg of the product. After dissolving in 25 ml of water, the solution should be clear.

Take this product and add ethanol to make a solution containing 10mg per 1ml as the test solution; take a precise amount and add ethanol

A solution containing 0.01 mg per 1 ml was used as a control solution. According to the thin layer chromatography (Appendix V B) test, pipette 10 l of each of the above two solutions, respectively

Point on the same silica gel G thin-layer plate prepared with a 0.1mol / L sodium hydroxide solution, and use chloroform-methanol (15: 1) as the developing agent.

Saturated with saturated iodine vapor, except for the main spots, the spots of impurities should not be deeper than 0.1%.

Take the product after losing weight and dry it in a phosphorus pentoxide dryer under reduced pressure for 4 hours. The weight loss should not exceed 0.5% (Appendix L).

Determination of buprenorphine hydrochloride

Take about 0.12g of this product, weigh it accurately, add 30ml of glacial acetic acid and 2ml of mercury acetate test solution to dissolve, then add crystal violet indicator liquid 1

Drop, titrate with perchloric acid titration solution (0.02mol / L) until the solution becomes blue, and correct the titration result with a blank test. Titration per 1ml of perchloric acid

Liquid (0.02mol / L) is equivalent to 10.00mg of C29H41NO4.HCl.

[Category] Analgesics.

[Storage] shading and sealed.

[Preparation] buprenorphine hydrochloride sublingual tablet buprenorphine hydrochloride injection

Method for determination of buprenorphine hydrochloride

Method name:

Determination of buprenorphine hydrochloride-neutralization titration method

Application:

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

This method is applicable to buprenorphine hydrochloride.

Method principle:

After adding test solution of glacial acetic acid and mercury acetate, and adding crystal violet indicator solution, titrate the solution with perchloric acid titration solution (0.02mol / L) until the solution turns blue. Record the amount of perchloric acid titration solution and calculate That's it.

Reagent:

Water (newly boiled to room temperature)

Perchloric acid titrant (0.02mol / L)

Crystal violet indicator liquid

Acetic anhydride

Glacial acetic acid

Mercury acetate test solution

Reference potassium hydrogen phthalate

equipment:

Sample preparation:

Perchloric acid titrant (0.02mol / 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.

The above perchloric acid titration solution is 0.1 mol / L, an appropriate amount is precisely measured, and diluted 5 times with glacial acetic acid to obtain 0.02 mol / L of perchloric acid titration solution, and the concentration is used after calibration.

Crystal violet indicator liquid

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

Steps:

Accurately weigh 0.12g of the test product, add 30mL of glacial acetic acid and 2mL of mercury acetate test solution, add 1 drop of crystal violet indicator solution, and titrate the solution with perchloric acid titration solution (0.02mol / L) to show a blue color. The results were corrected with a blank test, and the volume of perchloric acid titrant consumed (mL) was recorded. Each 1 mL of perchloric acid titrant (0.02 mol / L) was equivalent to 10.08 mg of buprenorphine hydrochloride (C29H41NO4 · HCl) That's it.

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.

references:

Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 edition, Part Two, p.459.