More work on the R&D of Dispersible Pseudoephedrine Hydrochloride Compound Tablets

Interaction between main drug and excipient

Due to the small amount of newly added colorant and aromatic agent, we adopt the main drug: excipient =20: (the main drug is acetaminophen, pseudoephedrine hydrochloride, chlorpheniramine maleate mixed in the prescribed proportion, the auxiliary material is colorant, aromatic agent mixed in proportion), take a certain amount, according to the experimental method of influencing factors in the guiding principles of drug stability test, The drug was placed in high light (4500±500LX), high temperature (60℃) and high humidity (90±5% relative humidity) for 10 days. HPLC was used to check the content and the changes of related substances before and after placing, and observe the changes of appearance and color and other drug properties.In addition, we conducted parallel control experiments with pure raw materials to distinguish between the change of raw materials themselves and the influence of auxiliary materials.Main drug: excipients = 20:1 Chromatogram: 0 days, strong light 10 days, high temperature 10 days, high humidity 10 days and raw materials: 0 days, strong light 10 days, high temperature 10 days, high humidity 10 days altogether 8 chromatogram.

Humidity: saturated NaCl solution (15.5 ~ 60℃, relative humidity 75±1%)

KNO3Saturated solution (25℃, relative humidity 92.5%)

NaNO2Saturated solution (25 ~ 40℃, relative humidity 64 ~ 61.5%)

1. Quality study related to substance inspection

   1. Methods HPLC was used

   2. System suitability test and content determination

   3. Destructive experiment

This experiment has been investigated in the original quality research work, and it has been proved that the degradation products and components of the three main drugs can be effectively separated and the separation degree is good after being destroyed by strong light (because the influence factor test shows that the drug is not stable to strong light).

1. Minimum detection

Because the amount of acetaminophen in the main drug component of this drug is larger than that of the other two main drugs, we chose acetaminophen as the evaluation index.

Precise weighing of acetaminophen reference products were made into each 1mL containing 0.8mg (impurity limit 0.025%), 0.4mg (impurity limit 0.0125%), 0.2mg (impurity limit 0.00625%), 0.02mg (impurity limit 0.000625%) solution, as the test liquid.5mL of each test solution was measured and injected into the liquid chromatograph, and the chromatogram was recorded.At that concentration, the peak height of the main component of the product was observed to be 3 times the baseline noise, and the concentration multiplied by 5ml was the minimum detection limit.(With 1 photo)

1. Determination method

Take this product, grind it, weigh it accurately and take appropriate amount of fine powder (approximately equivalent to 80mg paracetamol), place it in 25ml measuring bottle, add mobile phase and appropriate amount of shaking to dissolve, dilute to scale, shake well and filter, and take filtrate as test solution.Inject 5μ L of each solution into the liquid chromatograph with precision, and record the total area of impurity peaks in the solution of the test sample compared with the area of each peak, which should not be greater than 2% of the total area of the main drug peak and impurity peak.

In addition, the stability test still needs to provide 22 maps (note that the peak area with a retention time of about 2 minutes should be printed out).