As precious Chinese medicinal materials， Moschus and Bovis Calculus are often used in the treatment of acute and severe patients. However， due to their scarce sources and high prices， wild animal resources are in urgent need of protection， natural Moschus and Bovis Calculus can no longer meet the needs of preparation production. The use of substitutes such as Moschus Artifactus， Bovis Calculus Artifactus and Bovis Calculus Sativus has alleviated the shortage of original medicinal materials to some extent， and has been widely used in the production and use of traditional Chinese medicine （TCM） preparations. According to statistics， the 2020 edition of Chinese Pharmacopoeia contains 75 TCM preparations containing Moschus and 95 preparations containing Bovis Calculus， but in the quality standards of these 134 TCM preparations， the difference between natural medicinal materials and their substitutes is not very obvious， and some quality control projects are relatively simple. Based on this， the author intends to sort out the quality standards of TCM preparations containing Moschus or Bovis Calculus in the 2020 edition of Chinese Pharmacopoeia （volume Ⅰ）， including the type， drug form， prescription dosage， maximum daily （time） dosage and the quality control items of Moschus and Bovis Calculus in the preparation， in order to explore the rationality of the quality standard of TCM preparations containing Moschus or Bovis Calculus， and to give some suggestions on standardizing the use types of Moschus and Bovis Calculus， improving the quality control items of Moschus and Bovis Calculus in TCM preparations combining modern research achievements and advanced technology.

As a rare Chinese medicinal material， Paridis Rhizoma is mainly distributed in Yunnan， Guangxi， and Guizhou in southwestern China， with the effect of clearing heat and detoxifying， alleviating edema and relieving pain， cooling liver and tranquilizing mind. It is particularly effective for injuries from falls， fractures， contusions and strains， snake bites， cold wind-induced convulsion， and other diseases， which has been used for more than 2 000 years. According to modern research， polyphyllin Ⅱ， one of the main active components of Paridis Rhizoma， belongs to diosgenin in structure. It has the anti-tumor， anti-inflammatory， antiviral， antibacterial， immune-regulating， antioxidant， and multidrug resistance-reversing activities， showing good application prospect. Especially， the anti-tumor effect of polyphyllin Ⅱ has attracted wide attention， and the mechanism is inhibiting proliferation， migration， and invasion of tumor cells， inducing cell cycle arrest， apoptosis， and autophagy， suppressing angiogenesis， and modulating tumor microenvironment. However， the pharmacokinetic results show that polyphyllin Ⅱ has low bioavailability in vivo due to the low solubility， poor absorption， unsatisfactory distribution， and slow metabolism， which limit the clinical application. In recent years， there has been an explosion of research on the adverse reactions of polyphyllin Ⅱ， such as the strong hemolytic activity and obvious cytotoxicity to liver， kidney， myocardium and cardiovascular cells. Thus， papers were retrieved from "CNKI"， "VIP"， "Wanfang Data"， "PubMed"， "Web of Science"， and "Elsevier SD" with "Paris saponin Ⅱ"， "Polyphyllin Ⅱ" as the main keywords， and the pharmacological activities and mechanisms， pharmacokinetics， and adverse reactions were summarized. The findings are expected to serve as a reference for the in-depth research， development， and utilization of polyphyllin Ⅱ.