Considerations of Traditional Chinese Medicine (TCM)
| Key Aspect | Considerations | Risk Control Measures |
| Pre-treatment of Herbs | Moisture content, fiber/oil content | Control moisture (typically ≤10%); pre-crush fibrous or oily herbs if necessary |
| Equipment Selection | Herb properties (hardness, viscosity, etc.) | Use hammer mills for brittle herbs, shear or turbo mills for fibrous herbs |
| Temperature Control | Heat generation leading to loss of active compounds | Low-temperature crushing (e.g., water cooling), intermittent operation; cryogenic grinding (liquid nitrogen) for heat-sensitive herbs |
| Fineness Requirements | Particle size standards for different uses (e.g., pills, powders, extracts) | Adjust sieve mesh (typically 80–200 mesh) based on process needs; avoid over-crushing affecting efficacy |
| Dust & Explosion Prevention | Flammable/explosive risks (e.g., starch, volatile oils) | Use explosion-proof motors, inert gas protection, dust removal, and anti-static measures |
| Microbial Contamination | Microorganisms from herbs or environment | Operate in clean areas; apply irradiation or sterilization if needed |
| Metal Contamination Control | Metal shavings from equipment wear | Magnetic separation, regular inspection of sieves/blades; prioritize stainless steel equipment |
| Component Uniformity | Layering due to density differences in mixed herbs | Multi-stage crushing + blending, or use composite homogenization technology |
| Cross-Contamination | Residual traces between different herbs | Strict cleaning protocols, color-coding, or dedicated production lines |
| Preservation of Volatile Compounds | Aromatic herbs (e.g., mint, borneol) | Sealed crushing, low-temperature rapid processing to minimize exposure |
Key Process Control Points during production of Sodium deoxycholate
|
Step |
Control Parameters |
Risk Mitigation |
| Hydrolysis | NaOH concentration, temperature, time | Avoid over-hydrolysis to prevent impurity generation |
| Acid precipitation | pH (strictly 3-4), cooling rate | Prevent emulsification or impurity entrapment in precipitates |
| Deoxygenation | Catalyst activity, H₂ pressure/reducing agent dosage | Monitor reaction endpoint (TLC/HPLC) |
| Recrystallization | Solvent ratio, decolorization temperature | Use pharmaceutical-grade activated carbon to avoid heavy metal residues |
| Salt formation | Precise pH control (8-9) | Prevent local over-alkalization leading to degradation |
| Drying | Temperature ≤60℃, vacuum level | Avoid decomposition or clumping of heat-sensitive components |
We remain firmly committed to a dual-driven approach that combines GMP and ISO management systems, integrating safety, environmental protection and innovation as our fundamental principles. This represents our scientific pathway to enhance core competitiveness and achieve sustainable development.
Partial Production Equipment List:
Extraction tank, extraction column, centrifuge, concentrator, counter-current extraction system, homogenizer, UHT sterilizer, spray dryer, microwave dryer, mixer, etc.
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