The instruments and equipment required for TCM preparation R&D can be divided into four categories according to the R&D process: pretreatment, extraction and purification, formulation, and quality control, covering the entire workflow from material feeding and process validation to finished product testing.
I. Pretreatment Stage Equipment
(I) Crushing and Sieving Equipment
Universal grinder: used for coarse and medium crushing of common medicinal materials, meeting the particle size requirements before feeding.
Jet mill: used for ultrafine grinding of medicinal materials, with particle size controlled below 10 μm, improving the dissolution rate of active components.
Vibrating sieve: used together with crushing equipment to control particle size distribution and remove oversized impurities.
(II) Impurity Removal and Cleaning Equipment
Air separator and magnetic separator: remove light impurities such as mud and weeds, as well as metal foreign matter.
Drum-type herb washing machine / ultrasonic herb washing machine: clean mud and sand from herb surfaces; in some scenarios, dedicated cleaning agents can be used to remove some pesticide residues.
II. Extraction and Purification Stage Equipment
(I) Extraction Equipment
Multifunctional extraction tank: can perform water decoction, alcohol extraction, reflux extraction, and other processes; it is a general small-scale equipment for TCM extraction.
Microwave extraction equipment: suitable for rapid extraction of heat-sensitive TCM components; extraction time can be reduced by more than 70% compared with traditional processes.
Supercritical CO₂ extraction equipment: used for efficient extraction of high-value fat-soluble components such as volatile oils, with no solvent residue. As high-pressure special equipment, it must be operated by certified personnel and have safety accessories calibrated regularly according to special equipment management requirements.
(II) Purification and Concentration Equipment
Vacuum concentration tank: concentrates the extract under reduced pressure to avoid high-temperature degradation of active components.
Spray dryer: rapidly dries the concentrated liquid into powder, suitable for subsequent solid dosage form processing.
Membrane separation system (ultrafiltration/nanofiltration): used for clarification, impurity removal, and classification of active components in extracts; it can replace traditional alcohol precipitation and reduce solvent use.
Column chromatography system: used for separation and purification of single TCM components, meeting the needs of reference standard preparation or quality standard research in new drug development.
III. Formulation Stage Equipment
(I) Solid Dosage Form Equipment
Wet granulator: mixes powder with binder to produce granules, used in the early preparation of granules, tablets, and capsules.
High-efficiency coating machine: used for coating tablets and pills, improving appearance and controlling dissolution rate.
Rotary tablet press: compresses granules into tablets, suitable for small-batch production in the R&D stage.
Capsule filling machine: completes the filling of hard capsules with powder or granules.
(II) Liquid Dosage Form Equipment
Liquid preparation tank: prepares the liquid according to the formulation ratio, with stirring and temperature control functions.
High-pressure homogenizer: evenly disperses suspended components in the liquid to avoid stratification and sedimentation.
Filling machine: completes quantitative filling and sealing of liquid preparations.
(III) Special Dosage Form Equipment
Emulsifying tank: used for base preparation and mixing of ointments and creams.
Freeze dryer: used for the formation of freeze-dried powder injections, preserving the biological activity of heat-sensitive active components.
Clean bench: used for aseptic preparation, liquid filling, and other clean operation steps.
IV. Quality Control and Stability Research Equipment
(I) Basic Physicochemical Testing Equipment
Electronic analytical balance: accurately weighs samples; in R&D scenarios, precision should reach 0.0001 g.
pH meter: measures the pH of medicinal liquids and extracts.
Electric blast drying oven: determines moisture content and residue on ignition.
Muffle furnace: used for determination of ash content and acid-insoluble ash in medicinal materials.
(II) Chromatographic Analysis Equipment
High-performance liquid chromatograph (HPLC): the core testing equipment for quality standards of TCM preparations, used for content determination of active components and fingerprint construction.
Gas chromatograph (GC): used for detection of volatile components and residual solvents.
Thin-layer chromatography scanner: used for rapid qualitative identification of characteristic components in herbs and preparations.
(III) Spectroscopic and Structural Identification Equipment
UV-Vis spectrophotometer: used for rapid quantitative detection of common active components.
Infrared spectrometer: used for qualitative identification of herbs and preparations.
LC-MS / GC-MS: used for structural identification of complex components and detection of trace impurities.
(IV) Microbial Testing Equipment
Autoclave: sterilizes experimental utensils and culture media. It is a pressure vessel and requires regular calibration of safety accessories, with operation following high-pressure equipment procedures.
Constant temperature incubator: used for microbial culture.
Microbial limit tester: quickly detects microbial contamination in preparations.
(V) Stability Test Equipment
Constant temperature and humidity chamber: simulates long-term storage conditions to investigate preparation stability.
Strong light exposure test chamber: used for photostability testing of preparations.
Accelerated stability test chamber: shortens the stability testing period and quickly predicts shelf life.
For non-standard tank interfaces, screens, stirring shafts, and seals involved in equipment selection and setup, we can provide single-piece or small-batch machining according to customer drawings.
