What aspects does the dissolution test of oral liquid bottles include

Oral liquid bottles are commonly used packaging for various traditional Chinese medicine oral liquids and syrups. An important indicator for judging this kind of packaging is the dissolution test. Through this test, it can be judged whether the packaged raw materials contain ingredients that endanger drug safety. The dissolution test includes the following items:

PET amber bottle

28mm child resistant  cap for liquid medicine

5ml oral dosing pipette

Clarity: Take water for the test solution and check it according to the law (Chinese Pharmacopoeia 2015 Edition General Principles 0902). The solution should be clear; if it is turbid, it should not be more concentrated than the No. 2 turbidity standard solution.

pH change value: Take 20ml each of the water test solution and the water blank solution, add 1ml of potassium chloride solution (1 → 1000) respectively, and measure according to the law (Chinese Pharmacopoeia 2015 Edition General Chapter 0631). The difference in pH value between the two should not exceed 1.0.

Absorbance: Take an appropriate amount of water for the test solution and measure it according to UV-visible spectrophotometry (Chinese Pharmacopoeia 2015 Edition General Chapter 0401). The maximum absorbance in the wavelength range of 220 ~ 360nm shall not exceed 0.10.

Easy to oxidize: Precisely measure 20ml of water for test solution, accurately add 20ml of potassium permanganate titrant (0.002mol/L) and 1ml of dilute sulfuric acid, boil for 3 minutes, cool quickly, add 0.1g of sodium carbonate, and place in a dark place 5 minutes, titrate with sodium thiosulfate titration solution (0.01 mol/L). When the titration reaches the end point, add 5 drops of starch indicator solution and continue titration until colorless. Take another water blank solution and operate in the same way. Both consume thiosulfate. The difference between uranium sulfate titrant (0.0lmol/L) shall not exceed 1.5 ml.

Non-volatile matter: Precisely measure 50ml each of water, 65% ethanol, n-hexane and blank solution, place them in evaporating dishes with constant weight, evaporate to dryness in a water bath, dry at 105°C for 2 hours, cool and weigh accurately. The difference between the water non-volatile residue and its blank liquid residue shall not exceed 12.0 mg; the difference between the 65% ethanol non-volatile residue and its blank liquid residue shall not exceed 50.0 mg; the difference between the n-hexane non-volatile residue and its blank liquid residue shall not exceed 75.0 mg .

Heavy metals: Precisely measure 20 ml of water for the test solution, add 2 ml of acetate buffer (pH 3.5), and measure according to the law (Chinese Pharmacopoeia 2015 Edition General Chapter 0821 Method}). The heavy metal content should not exceed one part per million.

The above are the requirements for dissolution testing in the national quality standard for oral liquid bottles "Pharmaceutical Polyester Bottles for Oral Liquids" YBB00102002-2015. This test mainly tests the quality of raw materials, which is also an important basis for judging packaging quality.