In order to control the product quality of loratadine(1)orodispersible films and provide references for the establishment of specification for similar dosage forms,a quality standard for 1 orodispersible films had been established based on the guidance principles issued by ICH and NMPA,and referring to the pharmacopoeia standards of 1 oral solid dosage forms and the quality information on orodispersible films marketed abroad,in combina-tion with the characteristics of 1 orodispersible films.Quality inspection and stability investigation of three batches of 1 orodispersible films were carried out.The results showed that the appearance,identification,related substances,disso-lution,disintegration time,content,content uniformity and microbial limits of the self-made 1 orodispersible films were in compliance with the quality standard,indicating that the self-made product had good stability.In conclusion,the quality standard provided could adequately control the product quality of 1 orodispersible films.
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