Abstract:
OBJECTIVE To sort out and analyze the Chinese patent medicinal details of pregnancy and lactation period, which were included in Chinese Pharmacopoeia 2020 Edition, so as to provide reference for clinical drug consultation.
METHODS The description of pregnancy contraindications related to all proprietary Chinese patent medicines in Chinese Pharmacopoeia 2015 Edition and 2020 Edition were statistically, compared, classified and summarized to clarify the changes of Chinese patent medicines for pregnancy and lactation period included in Chinese Pharmacopoeia 2020 Edition.
RESULTS The Chinese Pharmacopoeia 2020 Edition added 54 Chinese patent medicines related to pregnancy contraindications compared with the Chinese Pharmacopoeia 2015 Edition, in gestation related new drugs, 14 species were administrated with caution for pregnant women, 13 species were defined to contraindication in pregnancy, and 20 species were divided into "forbidden in pregnancy" domain. Another more, 7 types were related to lactation contraindication additional. In the Chinese Pharmacopoeia 2020 Edition(Volume I), 134 kinds of Chinese patent medicines containing prohibited ingredients but without contraindications were included, and 22 kinds of prohibited ingredients were involved. There were 4 Chinese patent medicines involved in different pregnancy contraindications marked under the attention item of the same prescription and different dosage forms.
CONCLUSION Chinese patent medicines for pregnancy and lactation period in Chinese Pharmacopoeia 2020 Edition are more specific than those in the 2015 edition, but there are still different contraindications in decoction pieces, Chinese patent medicines and different dosage forms of Chinese patent medicines in the same prescription. It is suggested that the relevant departments should try their best to establish a unified contraindication standard for pregnancy and lactation period, so as to provide legal basis for the rational use of Chinese patent medicines.