Li Yue, Yu Qiong-Xi, Yau Lee-Fong, Huang Guo-Kai, Lu Jing-Guang, Liu Xiao-Xiao, Jiang Zhi-Hong, Wang Jing-Rong
State Key Laboratory of Quality Research in Chinese Medicines, Macau Institute for Applied Research in Medicine and Health, Macau University of Science and Technology, Taipa, 999078, Macao, China.
Guangdong Institute for Drug Control, Guangzhou, 510663, China.
Chin Med. 2023 Jun 2;18(1):65. doi: 10.1186/s13020-023-00777-x.
Baphicacanthis Cusiae Rhizoma et Radix, commonly known as Nan-Ban-Lan-Gen (NBLG), is an essential traditional Chinese medicine that possesses diverse bioactivities, particularly noteworthy for its antiviral properties. Although NBLG has been listed in the Chinese Pharmacopoeia as an independent Chinese medicine, the establishment of a comprehensive quality standard for NBLG remains elusive. The absence of assay for marker compound in its quality standards has led to the lack of corresponding quality control measures for NBLG-containing preparations, and its discrimination from adulterant species in the market which thereby can significantly impact the efficacy and safety of NBLG-containing products.
Ultra-high performance liquid chromatography (UHPLC) coupled with quadrupole-time-of-flight mass spectrometry (Q-TOF-MS) was employed for comprehensive profiling of the chemical constituents of NBLG, the stem of Baphicacanthus cusia (Nees) Bremek (NBLJ), and the roots of Isatis indigotica Fort. (Bei-Ban-Lan-Gen, BBLG). Additionally, multivariate analysis was conducted to compare the chemical components of NBLG with those of NBLJ and BBLG. Furthermore, we established an optimized and validated HPLC method to obtain the fingerprint of NBLG and quantify the content of 2-benzoxazolinone and acteoside in the samples.
A total of 73 compounds belonging to six classes were assigned in NBLG, with alkaloids being the most abundant and diverse species. High compositional similarities with significant differences in content were observed between NBLG and NBLJ. Moreover, the chemical profile of BBLG markedly differed from that of NBLG. An informative high performance liquid chromatography (HPLC) fingerprint of NBLG comprising seven characteristic peaks that can be used for quality assessment was established. Notably, we propose a quality control standard for NBLG, stipulating that the limit of content in dry weight for both 2-benzoxazolinone and acteoside should not be less than 0.010%.
This study provides the most comprehensive chemical information to date on NBLG, offering valuable insights into its authentication and quality control. Our findings highlight the importance of comprehensive chemical profiling to differentiate potential substitutions and adulterations of herbal medicines, particularly when the original source is scarce or unavailable. These results can aid in the development of quality control measures for NBLG-containing preparations, ensuring their safety and efficacy.
马蓝根茎及根，习称南板蓝根（NBLG），是一种重要的传统中药，具有多种生物活性，其抗病毒特性尤为显著。尽管NBLG已被列入《中国药典》作为独立的中药，但建立全面的NBLG质量标准仍难以实现。其质量标准中缺乏对指标性成分的测定，导致含NBLG制剂缺乏相应的质量控制措施，且难以与市场上的掺伪品种区分开来，从而可能显著影响含NBLG产品的疗效和安全性。
采用超高效液相色谱（UHPLC）与四极杆-飞行时间质谱（Q-TOF-MS）联用技术对NBLG、马蓝（Nees）Bremek的茎（NBLJ）和菘蓝的根（北板蓝根，BBLG）的化学成分进行全面分析。此外，进行多变量分析以比较NBLG与NBLJ和BBLG的化学成分。此外，我们建立了一种优化并验证的HPLC方法，以获得NBLG的指纹图谱并定量样品中2-苯并恶唑啉酮和毛蕊花糖苷的含量。
在NBLG中总共鉴定出属于六类的73种化合物，其中生物碱是含量最丰富且种类最多的。NBLG与NBLJ之间观察到高成分相似性但含量存在显著差异。此外，BBLG的化学图谱与NBLG明显不同。建立了一个包含七个特征峰的信息丰富的NBLG高效液相色谱（HPLC）指纹图谱，可用于质量评估。值得注意的是，我们提出了NBLG的质量控制标准，规定2-苯并恶唑啉酮和毛蕊花糖苷的干重含量限度均不应低于0.010%。
本研究提供了迄今为止关于NBLG最全面的化学信息，为其鉴别和质量控制提供了有价值的见解。我们的研究结果强调了全面化学分析对于区分草药潜在替代物和掺伪物的重要性，特别是当原始来源稀缺或无法获得时。这些结果有助于制定含NBLG制剂的质量控制措施，确保其安全性和有效性。
