Overall Status of National Engineering Laboratory Projects
National Engineering Laboratory for Quality Control of Traditional Chinese Medicine, a base for incubating proprietary Chinese medicines. Located within the newly constructed Xiuzheng Pharmaceutical Beijing Medical Park, adjacent to Wendu Water City and the new Anzhen Hospital district.
1New Incubation Base Experimental Building
New Construction Area6000Large building covering multiple square meters. Funding investment completed.4100Ten thousand yuan. Of which, civil engineering investment1500Ten thousand yuan for water, electricity, and gas capacity expansion supporting infrastructure investment200Laboratory decoration and renovation project investment: 10,000 yuan1600Ten thousand yuan, equipment and instrument investment80010,000 yuan.
Construction started (early 2009) | In progress
Renovation complete
2Build and retrofit pilot and production lines
Complete5000Expansion and renovation of a pilot workshop to enhance the pilot-scale production line2lines, including liquid oral dosage lines (with aseptic filling) and comprehensive solid dosage form lines (including tablets, hard capsules, and granules), which have been put into operation.
Pilot Plant Exterior
Pilot line for oral liquid production
Pilot Line for Solid Dosage Form Production
Overall Status of National Engineering Laboratory Projects
National Engineering Laboratory for Quality Control of Traditional Chinese Medicine: Decoction Piece R&D Platform and Incubation Base, established atChina Traditional Chinese Medicine CompanyThe process control technology development platform for traditional Chinese medicine decoction pieces is located in the Daxing Research and Comprehensive Building of China Traditional Chinese Medicine Company, featuring a toxic decoction piece production line.2Two lines, established at the Beijing Huamiao TCM Engineering Technology Development Center and Sichuan Jiangyou Zhongba Aconite Science & Technology Development Co., Ltd. respectively.
1. Toxic Decoction Production Line:AtBeijing Huamiao TCM Engineering Technology Development Center, transformtoxic medicinal ingredient production lineRenovation area: approximately1500square meters. Currently equipped with production processes including frying, soaking, steaming, boiling, and drying; primarily processes toxic varieties such as Aconitum carmichaelii. Located in Beijing.FDADesignate a manufacturing enterprise.
2. Aconite Slice Production Line:AtFourChuanjiang Oil Zhongba Aconite Technology Development Co., Ltd.Modified oneAconitum Production LineEquipped with production processes such as soaking, steaming, boiling, stir-frying, and drying, capable of producing over a dozen types of processed Aconite products, with an annual fresh Aconite processing capacity.1100Yutong is a professional manufacturer specializing in deep processing of Aconitum.
3、TCM Decoction Piece Process Control Technology R&D Platform：Laboratory area
Overall Status of National Engineering Laboratory Projects
National Engineering Laboratory for Quality Control of Traditional Chinese Medicine, located at the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences. Renovation and reconstruction completed.4The laboratory area on each floor is approximately3000square meters, a pilot production base for traditional Chinese medicine preparations, and a safety evaluation center for traditional Chinese medicine.
1, Renovate Lab
（1) The first floor has been renovated into a large-scale laboratory, including areas for common analytical testing instruments andHPLC-MSRegion andNMRrooms, etc.
（2The five-level laboratory underwent a comprehensive renovation. Walk-in fume hoods were installed in the experimental area, all workbenches were updated, a new exhaust system was installed, electrical capacity was increased, and a new liquid chromatography system was added.-Mass spectrometry room and cell culture room.
（3Experiments were conducted on the 8th and 9th floors, involving test bench upgrades, drain pipe replacements, and electrical capacity increases.
2、Chinese Medicine Pilot Production Base
PressGMPA workshop has been established for preclinical pilot studies of new common traditional Chinese medicines.210square meters), establishing a pilot production line for extraction, concentration, drying, and granule/tablet formation that meets routine R&D requirements.
2013Year4Last month, the Beijing Municipal Medical Products Administration's Drug Evaluation Center passed and approved an on-site assessment for a new drug pilot production.
3、Traditional Chinese Medicine Safety Evaluation Center
OwnSPFAnimal facilities and various instruments. We have a professional team dedicated to preclinical safety evaluation of drugs, adverse drug reactions, and their mechanisms. A comprehensive system has been established.Standard Operating ProcedureConduct new traditional Chinese medicine safety evaluation research in strict accordance with all relevant regulations and national technical specifications. Has undertaken the National "863Programs, supporting initiatives, and national key special projects such as the National Major New Drug Innovation Program.
Overall Status of National Engineering Laboratory Projects
Established a new quality control method: "One Test, Multiple Evaluations"
The multi-component nature of traditional Chinese medicine (TCM) means that multi-component quality control can comprehensively reflect TCM quality, while multi-indicator quality control faces challenges due to the lack of reference standards.awkwardconstraints such as high ground detection costs make it difficult to apply in production and supervision. To address this, we have at2006Established in {0}, the One-Test-Multiple-Assessment (QAMS) A new quality evaluation model that resolves the challenges of multi-component quality assessment.
QAMSThis method integrates the advantages of classical internal standard, correction factor, principal component self-reference, and UV percent absorptivity methods. It uses intrinsic components in traditional Chinese medicine as internal references to establish relative correction factors between these references and target analytes, enabling direct quantification of other components using these relative correction factors in practice.
Once this method is proposed,2007Received the first special award in the traditional Chinese medicine industryproject initiation support, including Coptis chinensis, Scutellaria baicalensis, Evodia rutaecarpa, Forsythia suspensa, and Salvia miltiorrhiza20For medicinal materials containing multiple types of compounds, we conductedQAMSA systematic study was conducted on technical applicability and implementation feasibility, including method validation, method robustness, system suitability, and a scientifically rational evaluation of the discrepancies between calculated and measured values. The study demonstrated the method's feasibility in practical applications and resulted in the publication of the "Technical Guidelines for Establishing the One-Method-Multiple-Assessments Approach."
QAMSapplied toAssay of Coptis Chinensis and its processed slices, for2010Included in the Chinese Pharmacopoeia, it has become2010Version of the Chinese PharmacopoeiaFourOne of the key highlights: The research work was honored with an award for "Advanced Unit" by the Pharmacopoeia Committee.QAMSAt2015The latest edition of the Chinese Pharmacopoeia has comprehensively promoted standards for crude drugs, processed slices, extracts, and proprietary Chinese medicines.
Key Supporting Projects:
①Research on multi-indicator evaluation methods and technologies for traditional Chinese medicine quality, tailored to TCM characteristics; a specialized research project in the TCM industry.2007-2010。
②2010Revision of Chinese Pharmacopoeia Varietal Standards—62Herbal medicines and decoction pieces, National Pharmacopoeia Commission2009-2010。
③ 2015Pharmacopoeia of China task.
④Traditional Chinese Medicine Production Technology and Process Control Standards Platform, 11th Five-Year Plan“Major New Drug Innovation”Special Project，2009-2011。
Publish related papers 19 piece, among whichSCISource Paper 2 Chapter.
Overall Status of National Engineering Laboratory Projects
Introduced a new method for selecting quality control indicators.—— SEMACFrench
Discovering and confirming the active substances in traditional Chinese medicine is an extremely complex process. How can we forge a "golden key" to unlock this treasure trove, or“Luoyang Spade”is the key and dream of developing traditional Chinese medicine.
The quality of Traditional Chinese Medicine (TCM) is evaluated against standards, and the scientific selection of quality control indicators is key to standard-setting. So, who should be selected for quality control? Naturally, it should be the active ingredients (or groups). How can quality analysts quickly identify the active ingredients (or groups) in TCM (or compound formulas) and apply them to establish quality standards?
We are based on "Only components that enter the bloodstream can be effective." and "Intrinsic component groups of traditional Chinese medicine>>Blood-derived components>EfficacyIngredient Groups ”The logical approach of using "blood-entry component groups" as a breakthrough point for identifying pharmacologically active components is flawed. Due to the laborious nature of studying in vivo absorption, interference from metabolic products and endogenous substances during detection, and other factors, this method is neither efficient nor suitable for widespread adoption among quality analysts and chemists.
To this end, we integrated an everted intestinal sac in vitro absorption model with high-performance liquid chromatography to20Conducted rapid discovery of active substance bases for various traditional Chinese medicines (single herbs, herb pairs, and formulas). Through comparative studies using in vitro and in vivo models, we confirmed the technical feasibility and reliability of the new method. Leveraging the method's characteristics and quality standard requirements, we further developed the instrumentation, finalized the methodology, and established technical guidelines.Methods and Principles for Selecting Quality Evaluation Indicators Based on Intestinal Absorption, China Journal of Chinese Materia Medica, 2011,36(6) 659-662), used for selecting quality evaluation indicators of traditional Chinese medicine. We refer to this as the "intestinal absorption-based method for selecting quality evaluation indicators."Selection of Evaluation Markers by Absorbed Components，SEMAC”。
This method has been successfully applied to rapidly identify the active substance basis and select quality evaluation indicators for Shaoyao (Red Peony Root), Baishao (White Peony Root), Plantago Seed, Plantago Herb, Gentian, Gastrodia, Atractylodes Macrocephala, Atractylodes Lancea, Yinqiao herb pairs, Wuzhuyu Tang herbal materials, herb pairs, and compound formulations. The compound types involved mainly include phenolic acids, iridoids, diterpenes, sesquiterpenes, saponins, and alkaloids.6Types.
MainSupporting Project（2009-2013）：
①“Research on Quality Control and Evaluation Methods for Traditional Chinese Medicine Compound Formulations——Wuzhuyu Tang”Project: National Support Program of the 11th Five-Year Plan.
②Fundamental Research on the Material Basis of Efficacy for the Yinqiao Herb Pair; National Natural Science Foundation of China.
③‘Key Technologies for Quality Evaluation of Traditional Chinese Medicine Based on Pharmacological Effects’——Key technologies for discovery and identification of active ingredient groups“11th Five-Year Plan”Special Program for Major New Drug Development.
Publish Paper：7piece, among whichSCI 2Chapter.
Overall Status of National Engineering Laboratory Projects
Integration of bioassays for quality evaluation of traditional Chinese medicine
The multi-component nature of traditional Chinese medicine means that using only1Evaluating quality based on one or a few components is limited, and the lack of clarity regarding active ingredients in many traditional Chinese medicines further complicates quality control. To address this, we explored the feasibility of establishing bioassays based on herb activity and clinical efficacy.
Key methods include:①DPPHlaw;②ABTSlaw;③FRAPlaw;④ORACMethods. Based on the correlation between components, total components, their proportional relationships, and biological activity, a method was constructed. Building upon a systematic evaluation of the methodology's feasibility, an analytical method was established and validated.Standard Operating Procedure。
Applying bioassays to evaluate the drug release kinetics of multi-component traditional Chinese medicine sustained and controlled release systems, resulting in a national award for...973Project initiation support, and2014Received unanimous expert endorsement during the verification conducted by the Ministry of Science and Technology.
MainSupporting Project（2009-2013）：
① Research on Evaluation Methods for Multi-Component Sustained and Controlled Release Drug Delivery Systems Based on Drug Release Kinetics, China973Plan.
② Platform for Systematic Evaluation Methods, Systems, and Technical Standards of Traditional Chinese Medicine Quality – Major Special Project on New Drug Creation during the 11th Five-Year Plan.
③ Research on the antioxidant activity and active components of Traditional Chinese Medicines for promoting blood circulation and removing blood stasis: A Ministry of Science and Technology International Cooperation Project.
④ Establishment of a technical system for efficacy and safety evaluation of antioxidant traditional Chinese medicines, an international cooperation project of the Ministry of Science and Technology.
Publish Paper： 7piece, among whichSCI 5Chapter.
[1] Antioxidant flavonoids from the seed ofOroxylum indicum. Phytotherapy, 2011，82（6）：841-848.
[2] In Vitro Antioxidant Activities of Maillard Reaction Products Formed During the Steaming of Polygonum multiflorum Root. Natural Product Communications, 2011,6(1):55-58.
[3] Study on the Effects of Sulfur Fumigation on Chemical Constituents and Antioxidant Activity ofChrysanthemumcv. Hang-ju，phytomedicine， 2014, 21(5): 773–779.
[4] Chemical Composition and Antimicrobial Activity of Three Essential Oils from Curcuma wenyujin, Natural Product Communications, 2013,8(4):523-526.
[5] Antioxidant Activity and Components of a Traditional Chinese Medicine Formula Containing Crataegus pinnatifida and Salvia miltiorrhiza. BMC Complementary & Alternative Medicine，2013,13:99.
[6] IgG_HepG2Cell-based study on allergen production potential of Compound Kushen Injection and its manufacturing process——Methodological exploration of using biotechnology for process monitoring of allergenicity. China Journal of Chinese Materia Medica, 2011，36（14）：1850-1854.
[7] Study on the Application of Bioassay in In Vitro Release Evaluation of Salvia Miltiorrhiza Hydrophilic Gel Matrix Tablets, China Journal of Chinese Materia Medica2013, 38(22): 3880-3887.