Chinese Pharmacopoeia 2010 Pdf [UPDATED]

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The family Ganodermataceae describes polypore basidiomycetous fungi having a double-walled basidiospore (Donk 1964). In all, 219 species within the family have been assigned to the genus Ganoderma, of which G. lucidum (W. Curt.: Fr.) P. Karsten is the species type (Moncalvo 2000). Basidiocarps of this genus have a laccate (shiny) surface that is associated with the presence of thickwalled pilocystidia embedded in an extracellular melanin matrix (Moncalvo 2000). Ganoderma species are found all over the world, and different characteristics, such as shape and color (red, black, blue/green, white, yellow, and purple) of the fruit body, host specificity, and geographical origin, are used to identify individual members of the species (Zhao and Zhang 1994; Woo et al. 1999; Upton 2000). Unfortunately, the morphological characteristics are subject to variation resulting from, for example, differences in cultivation in different geographical locations under different climatic conditions and the natural genetic development (e.g., mutation, recombination) of individual species. Consequently, the use of macroscopic characteristics has resulted in a large number of synonyms and a confused, overlapping, and unclear taxonomy for this mushroom. Some taxonomists also consider macromorphological features to be of limited value in the identification of Ganoderma species due to its high phenotypic plasticity (Ryvarden 1994; Zhao and Zhang 1994). More reliable morphological characteristics for Ganoderma species are thought to include spore shape and size, context color and consistency, and the microanatomy of the pilear crust. Chlamydospore production and shape, enzymatic studies and, to a lesser extent, the range and optima of growth temperatures have also been used for differentiating morphologically similar species (Gottlieb, Saidman, and Wright 1998; Moncalvo 2000; Saltarelli et al. 2009). Biochemical, genetic, and molecular approaches have also been used in Ganoderma species taxonomy. Molecular-based methodologies adopted for identifying Ganoderma species include recombinant (rDNA) sequencing (Moncalvo et al. 1995; Gottlieb, Ferref, and Wright 2000), random amplified polymorphic DNA-PCR (RAPD; PCR stands for polymerase chain reaction), internal transcribed spacer (ITS) sequences (Hseu et al. 1996), sequence-related amplified polymorphism (SRAP; Sun et al. 2006), enterobacterial repetitive intergenic consensus (ERIC) elements, and amplified fragment length polymorphism (AFLP; Zheng et al. 2009). Other approaches to the problem of G. lucidum taxonomy include nondestructive nearinfrared (NIR) methods combined with chemometrics (Chen et al. 2008), nuclear magnetic resonance (NMR)-based metabolomics (Wen et al. 2010), and high-performance liquid chromatography (HPLC) for generating chemical fingerprints (Su et al. 2001; Chen et al. 2008; Shi, Zhang et al. 2008; Chen et al. 2010).

In G. lucidum, the chemical structure of the triterpenes is based on lanostane, which is a metabolite of lanosterol, the biosynthesis of which is based on cyclization of squalene (Haralampidis, Trojanowska, and Osbourn 2002). Extraction of triterpenes is usually done by means of methanol, ethanol, acetone, chloroform, ether, or a mixture of these solvents. The extracts can be further purified by various separation methods, including normal and reverse-phase HPLC (Chen et al. 1999; Su et al. 2001). The first triterpenes isolated from G. lucidum are the ganoderic acids A and B, which were identified by Kubota et al. (1982). Since then, more than 100 triterpenes with known chemical compositions and molecular configurations have been reported to occur in G. lucidum. Among them, more than 50 were found to be new and unique to this fungus. The vast majority are ganoderic and lucidenic acids, but other triterpenes such as ganoderals, ganoderiols, and ganodermic acids have also been identified (Nishitoba et al. 1984; Sato et al. 1986; Budavari 1989; Gonzalez et al. 1999; Ma et al. 2002; Akihisa et al. 2007; Zhou et al. 2007; Jiang et al. 2008; Chen et al. 2010). Examples of triterpenes are shown in Figure 9.3.

Tomasi et al. (2004) tested 58 basidiomycetes mushrooms, of which G. lucidum was shown to be the most effective in killing cancer cells. G. lucidum induced cell-cycle arrest and apoptosis in various human and rodent tumor cells, including murine lymphocytic leukemia L1210 and Lewis lung carcinoma (LLC; Min et al. 2000; Tomasi et al. 2004), mouse reticulocyte sarcoma L-II (Liu et al. 2002), murine sarcoma Meth-A (Min et al. 2000; Gao, Min et al. 2002) and S180 (Gao, Min et al. 2002; Liu et al. 2002), human leukemia HL-60 (Muller et al. 2006; Kim et al. 2007; Fukuzawa et al. 2008; Liu et al. 2009) and U937, K562, Blin-1, Nalm-6, RPMI8226 (Muller et al. 2006; Shang et al. 2009), human hepatoma PLC/PRF/5, KB (Lin et al. 2003), HepG2 (Liu et al. 2009; Weng et al. 2009), Hep3B (Chung et al. 2001), Huh-7 (Lin et al. 2003; Li, Chan et al. 2005), human liver tumor SMMC7721 (Tang et al. 2006), human breast cancer MDA-MB-123 (Jiang et al. 2008; Liu et al. 2009; Zhao et al. 2010), MCF-7 (Jiang, Slivova, and Sliva 2006; Liu et al. 2009; Shang et al. 2009), T-47D (Gao, Min et al. 2002) and MT-1 (Wu et al. 2006; Xie et al. 2009), human prostate cancer PC-3 (Jiang et al. 2004; Evans et al. 2009), human cervix uteri tumor Hela (Liu et al. 2002; Tang et al. 2006; Shang et al. 2009), human ovarian cancer SKOV4 (Shang et al. 2009), human colonic cancer HT-29 (Hong et al. 2004) and SW480 (Xie et al. 2006), human lung carcinoma PG (Cao and Lin 2006; Cao, Lin, and Wang 2007) and 95-D (Tang et al. 2006), human small-cell lung carcinoma NCI-H69 and multidrug-resistant strain VPA (Sadava et al. 2009), lowgrade bladder cancer MTC-11 (Lu et al. 2004), and human uroepithelial HUC-PC (Yuen, Gohel, and Au 2008) cells.

Polysaccharides extracted from G. lucidum and given orally to rats for 28 days were found to ameliorate cirrhosis induced by biliary ligation (Park et al. 1997). In addition, collagen (measured by hydroxyproline) content in the rat liver was lowered and improved liver morphology was found in comparison with control animals. The treatment significantly decreased ligation-induced increases in serum biochemical markers of liver damage (AST, ALT, ALP, and total bilirubin). Similar results were noticed in a study conducted by Wu, Fang, and Lin (2010) in which a decrease in hepatic hydroxyproline content and an improved liver histology were found in mice. In this study, liver fibrosis was induced by the administration of thioacetamide (TAA) for 12 weeks, which was followed by 4 weeks of treatment with G. lucidum extract (0.5 and 1.0 g/kg/day, per oral administration). The RT-QPCR analysis showed the extract treatment decreased mRNA expression of collagen (α1), smooth muscle α actin, and the enzymes metalloproteinase-1 and metalloproteinase-13. In addition, the TAA-induced decrease in total collagenase activity was reversed by the extract treatment, indicating that G. lucidum protection against injury may be related to the enhancement of collagenase activity.

Influenza strain A/Fort Monmouth/1/1947(H1N1) was purchased from the ATCC. Influenza strains A/Wuhan/359/1995(H3N2), BV/shenzhen/155/2005, clinical isolated A/Jinnan/15/2009(H1N1), and A/Zhuhui/1222/2010(H3N2), which are resistant to oseltamivir and amantadine, respectively, were kindly donated by the Institute for Viral Disease Control and Prevention, China Centers for Disease Control and Prevention, Yuelong Shu Professor. Viral stocks of these strains were prepared by passaging them in 10-day-old embryonated chicken eggs for 2 or 3 days.

Ingredients of TCMs, which are made often from multiple plants or other materials, are very complicated. Determining effective ingredients of TCMs is of great importance to clarify their antiviral mechanisms. These 10 medicines in our study are recorded in Chinese pharmacopoeia and their detailed components are shown in Supplementary Table 1. Scutellaria baicalensis or radix isatidis is common ingredient in 9 of the 10 TCMs. Previous reports show that extracts of Scutellaria baicalensis inhibit the neuraminidase activity of influenza A virus and the fusion of the virus with endosome/lysosome [27, 28]. In addition, radix isatidis inhibited influenza virus attachment on cells by cytoprotective activity [29, 30]. Therefore, Scutellaria baicalensis or radix isatidis may be the common effective ingredients in our 10 TCMs.

Therefore the objectives of this review is to summarize and discuss the differences between the TCM monographs in EP 10th edition (data updated to supplement 10.2, published in January, 2020) and ChP 2020 edition to emphasize the state of TCM monographs in the EP. Note that TCM in this review refer to the 73 herbal drugs considered as TCM in both pharmacopoeias in order to avoid confusions, other examples out of the 73 TCM are given as herbal drugs in general. Furthermore, some advanced analytical techniques for quality standard of herbal drugs and TCM are also discussed to show the progress of TCM quality control.

In addition, Latin synonyms in pharmacopoeias could be an issue for identification of botanical origins of TCM. An analysis showed that at least 16.13% Latin names of TCM in ChP (2010 edition) were not in accordance with Flora of China and the reasons of the issue may include: repeat naming of the same species; synonyms of the families; new definitions of species and families; as well as traditional use of old Latin names [16]. Among the 73 TCM reviewed, 24 entries have Latin synonyms stated in EP, and some other TCM without annotation may also have Latin synonyms. For example, botanical origins of Sinomenii Caulis in ChP include Sinomenium acutum (Thunb.) Rehd. et Wils. or Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils. But in fact, the latter is synonym of the former, and the former is the botanical origin stated in EP, thus the botanical origin of Sinomenii Caulis in both pharmacopoeias is actually the same. Therefore, when determining the botanical origins of TCM, Latin synonyms is still an issue that should be addressed. 2b1af7f3a8