ABSTRACT
Objective To prepare a sustained-release membrane with longer adhesion time and dissolution time, and compare it with the commercially available oral ulcer membrane. Method Adhesion strength, adhesion time, swelling coefficient, dissolution time, etc. were used as the inspection indicators, and a combination of single factor inspection and analytic hierarchy process were used to screen the membrane -forming materials. The dispersion method of clotrimazole, ornidazole and borneol were investigated to prevent the drug from seed out. The method of combining orthogonal experiment and analytic hierarchy process were used to optimize the dosage of CMC-Na, PVA-1788 and glycerin; and the commercial products were compared. Results Through single-factor investigation and orthogonal experiment, the optimal ratio of excipients was selected as CMC-Na∶PVA-1788∶glycerol (3∶1∶0.08). The water-insoluble component clotrimazole, ornidazole and borneol were treated by precipitation in liquid with good effect. The best method was used to prepare the membrane. The adhesion strength was 102 g. The adhesion time was 55 min. The swelling coefficient was 1 939.52. The average dissolution time was 110 min. The appearance was white and the surface was free of bubbles, soft and elastic. The membrane forming time at 60 ℃ was 300 min and the demolding effect was better which could be completely peeled off with moderate thickness. Conclusion The oral ulcer membrane developed in this method has good appearance, comfortable use, strong adhesion, long adhesion time and dissolution time, and could stay on the ulcer surface for a long time to form physical isolation, and slowly release the drug during the dissolution process, which could play the role of long-term pain relief, antibacterial, anti-inflammatory and promote healing effects on oral ulcers.
ABSTRACT
Objective To analyze the quality of the hospital preparation magnesium sulfate oral solution by using capability sixpack. Methods By using the capability sixpack of Minitab, the content of magnesium sulfate in the magnesium sulfate oral solution was used as an indicator to determine whether the magnesium sulfate composition reached a controlled state during the production process and whether the production process of magnesium sulfate oral solution was stable. Results The content of magnesium sulfate and the production process of magnesium sulfate oral solution was under control, but there were potential disadvantages. Based on the concept of risk management philosophy, The failure model and effect analysis (FMEA) were applied to the prospective management of potential risks. Conclusion The application of the capability sixpack in the quality analysis of the hospital preparation of magnesium sulfate oral solution is helpful for us to discover the potential risks under the controlled state of the production process, which is beneficial to the improvement of the preparation production process and the assurance of the quality of the preparation.