Proprietary Chinese medicines
Proprietary Chinese medicines are medicinal powder materials formulated under the guidance of traditional Chinese medicine theories, manufactured from Chinese medicinal herbs (including rhizome and root types, liana and woody types, flower and leaf types, animal types, etc.) through processes such as extraction, purification, crushing and mixing. They serve as the core raw materials for various preparations including traditional Chinese medicine formula granules, tablets, capsules, pills and external powders.Different types of Chinese medicinal herbs exhibit remarkable differences in physical properties: oily or volatile oil-containing materials (such as Angelica sinensis, Ligusticum chuanxiong and Mentha haplocalyx) are rich in heat-sensitive active ingredients, which are prone to volatilization under heat and oil precipitation; fibrous materials (such as Astragalus membranaceus, Bupleurum chinense and Glycyrrhiza uralensis) feature high toughness and long fibers, making them difficult to crush by conventional processing methods. Multi-component formulas often contain trace active ingredients or auxiliary materials, which impose stringent requirements on ingredient stability, particle size uniformity and mixing uniformity during the processing process, and directly affect the efficacy consistency and medication safety of the final pharmaceutical products.
Powders of traditional Chinese patent medicines are widely used in multiple core production links of the traditional Chinese medicine industry, and different scenarios have differentiated requirements for powder processing technologies.
Traditional Chinese Medicine Formula Granules: It is necessary to achieve uniform particle size of powder and stable dissolution rate to ensure the consistency of medicinal efficacy of formulas in different batches. Meanwhile, the powder is required to have good fluidity to adapt to automatic packaging equipment;
Oral Solid Preparations: The powder raw materials for tablets and capsules need to possess good moldability and compressibility, avoiding problems such as difficulty in granulation and delayed tablet disintegration caused by fibrous materials;
External Preparations: The powder for powders and ointments needs to reach an ultrafine particle size to enhance skin permeability and user experience. In addition, the powder is required to be impurity-free and compliant with microbial indicators;
Deep Processing of Traditional Chinese Medicine Extracts: The crushing and mixing process of extract powder shall ensure no degradation of active ingredients and uniform content among batches, so as to meet the processing requirements of subsequent preparations or health products.
Process
In the processing of traditional Chinese medicine powder, the industry is generally faced with two core challenges that restrict the improvement of product quality and production efficiency:
It is difficult to crush oily and fibrous materials, and active ingredients are prone to loss.
For oily or volatile oil-containing materials, heat generated by equipment friction during conventional crushing easily causes oil precipitation and volatilization of volatile oil components. This not only leads to the loss of active ingredients, but also causes problems such as material adhesion to the wall and material blockage, greatly reducing crushing efficiency and increasing equipment cleaning and maintenance costs.
High-toughness fibrous materials are hard to be fully crushed by conventional impact equipment, and are prone to fiber winding and insufficient crushing. The finished powder has a wide particle size distribution with a large number of uncrushed fibers, failing to meet the requirements of subsequent preparation for fluidity and moldability, and even affecting the dissolution rate and bioavailability of pharmaceuticals.
Low mixing efficiency and poor uniformity of multi-component/trace element materials
Traditional Chinese medicine formulas often contain a variety of raw materials with significantly different physical properties (e.g., large differences in powder density, particle size and fluidity). The content of some active ingredients or excipients is extremely low, ranging from one ten-thousandth to one thousandth. Traditional mixing equipment such as V-type mixers and double-cone mixers feature long mixing time and low efficiency, and are prone to material segregation and stratification.
Trace components can hardly be uniformly dispersed in multi-component systems, resulting in large content deviations of products between batches. This fails to meet the quality consistency requirements for pharmaceutical production, increases the cost of subsequent quality inspection and rework, and even brings compliance risks.
In addition, the industry is faced with additional challenges including GMP compliance renovation, cross-contamination prevention and control in multi-variety production, and dust explosion protection safety. Traditional processing equipment can hardly balance efficiency, quality and compliance requirements simultaneously.
Targeting the core pain points in the processing of traditional Chinese patent medicines, Hosokawa Micron leverages its century-long accumulation of powder processing technology to launch an integrated solution suitable for oily, fibrous and multi-component formulas. Through customized equipment combinations, it addresses the key challenges in the crushing and mixing processes:
Targeted crushing process, adapted to the characteristics of oily and fibrous materials
UPZ/CW fine Impact Mill + Liquid Nitrogen Low-temperature Pulverization Process: For oily or volatile oil-containing materials, liquid nitrogen is used to cool the materials to the embrittlement temperature, which greatly reduces the viscosity and toughness of the materials and prevents oil precipitation, wall adhesion and material blockage during pulverization. Meanwhile, the low-temperature environment can effectively inhibit the degradation of volatile oil and heat-sensitive components, fully retain the active ingredients in raw materials. The pulverized powder features controllable particle size and good fluidity, suitable for subsequent preparation processing.
Alpine Microburst AMB Ultra-fine Pulverization Process: For high-toughness fibrous materials, it adopts the high-speed airflow impact pulverization principle. Long fibers are cut off by the shearing and impact force of airflow to realize ultra-fine pulverization. The finished powder has a narrow particle size distribution and no fiber residue, meeting the high fineness requirements for formula granules, external preparations and other products. In addition, the equipment has no moving parts, avoiding the risk of material contamination.
Selection of High-Efficiency Mixing Equipment to Solve the Mixing Challenges of Multi-Component Materials
For the mixing requirements of multi-component and trace element materials, Hosokawa Micron series mixing equipment (such as Nauta conical mixers) can be selected according to material characteristics, mixing scale and process requirements. Adopting the low-shear gentle mixing principle, the equipment avoids material stratification and damage to active ingredients, greatly shortens mixing time, realizes uniform dispersion of trace components, and ensures the uniformity of product content between batches. Meanwhile, the equipment supports CIP/SIP cleaning design, adapts to multi-variety production scenarios, reduces the risk of cross-contamination, and fully complies with GMP production specifications.
The Hosokawa Micron proprietary Chinese medicine processing solution is tailor-made for the complex physical properties and production demands of traditional Chinese medicine powders, featuring six core advantages:
Full-scenario material adaption: The combined process of low-temperature pulverization and jet milling solves the pulverization difficulties of oily/fibrous materials simultaneously. It adapts to the processing needs of most Chinese medicinal materials, covers multiple material types without replacing multiple sets of equipment, and reduces production line configuration costs.
High retention rate of active ingredients: The liquid nitrogen low-temperature process prevents the loss of volatile oils and heat-sensitive components, maximizes the medicinal value of raw materials, resolves material wall adhesion and blockage issues, improves pulverization efficiency and raw material utilization rate, and reduces material waste.
Precise particle size control and stable finished product quality: Both low-temperature pulverization and jet milling processes enable precise regulation of powder particle size with a narrow particle size distribution and no large particles or fiber residues. It meets the requirements of different preparations for powder fluidity and moldability, ensuring the stability of subsequent production.
Dual improvement of mixing efficiency and uniformity: Specialized mixing equipment significantly shortens the mixing time of multi-component materials and achieves uniform dispersion of trace components. It solves the problems of uneven mixing and large batch differences in traditional processes, guarantees consistent product quality, and lowers the rework rate.
Compliance and safety guarantee: The equipment design complies with GMP specifications for pharmaceutical production and supports CIP/SIP cleaning and disinfection to eliminate cleaning dead corners and adapt to multi-variety production scenarios. It can also be equipped with nitrogen protection and explosion-proof systems to meet the safety production requirements of traditional Chinese medicine dust processing and avoid compliance risks.
Flexible industrial adaptability: A full range of equipment options are available from lab trial, pilot test to large-scale industrial production. Custom production line solutions can be provided according to enterprise capacity demands, and modular expansion of production lines is supported to adapt to the upgrading needs of intelligent traditional Chinese medicine manufacturing, helping enterprises achieve efficient, compliant and large-scale production.
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