A kind of hydrochloric acid lysozyme band-aid and its preparation method and application
A technology of lysozyme hydrochloride and band-aid, which is applied in the field of medicine, can solve the problems of undescribed aseptic preparation process, large local irritation, and deposition in the human body, so as to promote wound healing, proliferation, and connective tissue fiber formation. Effect
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preparation example Construction
[0039] A preparation method of lysozyme hydrochloride band-aid, comprising the following steps:
[0040] (1) Weigh polyoxyl 40 stearate, polysorbate 80, poloxamer 188, sodium dihydrogen phosphate, ethylparaben, and purified water in an operation tank according to the proportion, and extinguish it at 131°C. Bacteria for 30min~60min, cool down to 30~40℃, stir evenly;
[0041] (2) Weigh hydrochloric acid lysozyme according to the proportion, add purified water to dissolve hydrochloric acid lysozyme, pass through a 0.22 μm microporous filter plate to sterilize, stir and add to step (1), the temperature is controlled between 30~40°C, as water box;
[0042] (3) Weigh light liquid paraffin, cetyl alcohol, stearyl alcohol, white petrolatum, and glyceryl monostearate according to the proportion and place them in an operation tank, sterilize at 135°C for 30min to 60min, stir evenly, and ~40℃ heat preservation, as the oil phase;
[0043] (4) Slowly add the oil phase prepared in step (...
experiment example 1
[0076] Experimental example 1. Stability experiment before prescription design of lysozyme hydrochloride band-aid
[0077] This experiment mainly studies the physical stability and biological activity of lysozyme hydrochloride solution under different conditions, and provides a basis for the research and development of dosage forms of lysozyme hydrochloride, related experimental research, and industrial production.
[0078] 1. Reagent and instrument: drug: lysozyme hydrochloride; instrument: ultraviolet spectrophotometer;
[0079] (1) The influence of the pH value: the influence of the pH value of the solution on the stability of lysozyme hydrochloride.
[0080] Experimental scheme: Prepare lysozyme hydrochloride solutions with different compositions, and put them under certain conditions for regular sampling. The experimental conditions of each solution are shown in Table 1. Each sample was sampled at 0, 0.25, 1, 2, 3, 5, and 7 days, and the titer of lysozyme hydrochloride w...
experiment example 2
[0095] Experimental example 2, the high-temperature sterilization experiment of the oil phase ointment in hydrochloric acid lysozyme band-aid
[0096] The comparison of different high temperature sterilization temperatures and times on the high temperature sterilization effect of excipients is shown in Table 4:
[0097] Table 4 Comparison of high temperature sterilization effects of excipients
[0098]
[0099] It can be analyzed from Table 2 that:
[0100] 1. Under the condition of high temperature sterilization temperature of 121℃~131℃ and time of 15min~60min, the sterility test does not meet the requirements;
[0101] 2. High-temperature sterilization at 135°C for 15 minutes, sterility inspection, does not meet the requirements;
[0102] 3. The high temperature sterilization temperature is 135°C, the time is 30min to 60min, and the sterility inspection meets the regulations.
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