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The influence of packaging on the weight and appearance of ointment preparations for external use in hospitals (Part 1)

according to the industrial standard of biodegradable plastic packaging products (hj/t209 ⑵ 005) issued in November 2005, Abstract: the influence of packaging on the weight, appearance properties and content of active ingredients of ointment preparations for external use in hospitals was investigated. Methods: six kinds of hospital preparations were examined according to the "minimum loading test method" in Chinese Pharmacopoeia and the corresponding content determination method, and their appearance properties were observed at the same time. Results: there was no significant change in the sealed packaging samples, while the changes of the ordinary packaging samples were different. Conclusion: it is suggested to improve the packaging of hospital ointment; The original expiration date can be applied to the ointment in sealed packaging

key words: packaging; Weight; appearance; Content

the period of validity of ointment preparations for external use in hospitals is generally tentatively determined as 1y due to its small output and fast use. Most of its packaging uses ordinary plastic boxes, and the seams between the box cover and the box body are sleeved, without threads, inner covers and gaskets. At present, there is no literature report on whether this kind of packaging has an impact on the quality of drugs. Therefore, the author notes: width, thickness, sample length, 10% modulus, 20% modulus, 40% modulus, tensile strength (RM), elongation from the preparation weight, appearance properties and content of active ingredients, the following observation and determination were carried out for 1 year on 6 hospital preparations, including 15% urea fat, 0.5% neomycin fat, kangzha fat, 5% sulfur yellow cream, 2% miconazole cream, Fusuo cream, It is expected to provide reference for improving packaging and formulating expiration date

1 materials and methods

1.1 instruments

uv-2201 UV spectrophotometer (Shimadzu company, Japan); Bl150 balance (Germany saidoris company)

1.2 test drug

urea reference substance (Shaanxi Weihe fertilizer plant, batch No.: 011028); Neomycin sulfate reference substance (Shanghai Xianfeng pharmaceutical factory, potency: 685iu/mg, batch number: 020224); Miconazole nitrate reference substance ("through cooperation with a company with a long history in material development and manufacturing, Shanghai integrated pharmaceutical factory, batch number: 020109); 15% urea fat (30g/box), 0.5% neomycin fat (30g/box), Kang crack fat (30g/box), 5% sulfur yellow cream (30g/box), 2% miconazole cream (20g/box) and Fusuo cream (20g/box) (self-made by the external preparation room of Huashan Hospital Affiliated to Fudan University) ； All reagents used in the test are analytical pure

1.3 methods

take three batches of samples of each preparation, and divide them into ordinary and sealed packaging. Ordinary packaging is a commonly used plastic box. The seam between the box cover and the box body is sleeved, without thread, inner cover and gasket; Sealed packaging is to seal and apply a layer of wax outside the joint of ordinary plastic box. All test samples were placed under constant conditions (temperature 18 ℃ ~ 25 ℃, humidity 45% ~ 65%) for 1y, and the weight (n=5) was measured every 3Mo × 3 batches of long glass fiber reinforced polypropylene composites and modified nylon materials for accelerator pedal of Julong Technology) and content (n=5 × 3 batches), and the appearance properties were observed at the same time. The weight is checked according to the method recorded in Chinese Pharmacopoeia [1]; The content of 15% urea fat was determined according to the Chinese hospital preparation specifications [2], 0.5% neomycin fat according to the Shanghai hospital preparation manual [3], 5% sulfur yellow cream according to the Chinese Pharmacopoeia [1], Kang crack fat, 2% miconazole cream and Fu Suo cream according to the methods recorded in the Shanghai Drug Standards [4], and the results were compared with those before storage

2 results

2.1 weight

the weight changes of the six preparations after storage for different times under different packaging conditions are shown in Table 1

2.2 appearance properties

the changes of appearance properties of the six preparations after storage for different times under different packaging conditions are shown in Table 2

note: "-" indicates that there is no change in appearance properties, "+", "+ +" and "+ +" indicate the degree of change in appearance properties

note: "-" standsfornochange; "+", "+ +" and "+ +" indicatethedegreeofchanges

(to be continued)