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超细粉碎机技术对药物制剂质量和工艺制作要求

中药制剂质量
Quality of Traditional Chinese Medicine Preparations
关于固体制剂的质量控制,重量差别、混合平均度、片剂的强度等多与粉体操作有关,而崩解时限、溶出度和生物应用度则与药物处方中各种物料的粉体性质有关。由于中药超细粉体的特性,在超细粉碎机技术过程还存在诸多影响要素,同一设备、同一粉碎工艺要到达同一细度超细粉体的请求还有难度。事实上,并非一切药物都是粒度越小越好,应经过实验肯定单味药材和复方制剂的最佳粒径。
As for the quality control of solid preparations, weight difference, mixing average and tablet strength are related to powder operation, while disintegration time, dissolution and bioavailability are related to powder properties of various materials in drug prescriptions. Due to the characteristics of ultra-fine powder of traditional Chinese medicine, there are still many influencing factors in the technical process of ultra-fine grinder. It is difficult for the same equipment and the same grinding process to reach the request of the same ultra-fine powder. In fact, not all drugs are the smaller the particle size, the better, we should confirm the best particle size of single herbs and compound preparations through experiments.
工艺过程
Process
由于粉末直接压片工艺具有显著的技术优点和宏大的经济潜力,目前已成为制药企业,特别是国外大型制药企业改造消费线的重点和趋向。限制粉末直接压片工艺普遍应用的最大障碍,还是来自于原辅料本身的粉体学控制、消费效率和消费线应用率等。药材微粉化后会给制药作业带来一些不利要素,如粉尘的飞扬、粉体的聚会和活动性问题等。
Due to its remarkable technical advantages and huge economic potential, powder direct tableting technology has become the focus and trend of pharmaceutical enterprises, especially large foreign pharmaceutical enterprises, in reforming their consumption line. The biggest obstacle to the universal application of powder direct pressing technology is the powder control, consumption efficiency and the application rate of consumption line of raw materials and accessories themselves. After micronization of medicinal materials, some unfavorable factors will be brought to pharmaceutical operations, such as dust flying, powder gathering and activity problems.
超细粉碎中药并非越细越好,要依据客户或工艺的请求控制好粉体的物理指标,诸如粒度大小和散布、粒子的比外表积、松装密度和敲严密度、活动性、崩解性等。
Ultrafine crushing of traditional Chinese medicine is not the finer the better. It is necessary to control the physical indexes of powder according to the requirements of customers or processes, such as particle size and dispersion, specific surface area of particles, loose density and knock density, activity, disintegration and so on.
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超细粉碎机技术特性及设备
Technical Characteristics and Equipment of Ultrafine Crusher
实践工业消费中,常先用传统办法将药材停止粗粉碎预处置,经筛分后,再进一步超细粉碎,到达请求的粒度规格(分级)。中药超细粉碎机技术的应用,带来了中药传统剂型的改造和开展,拓宽以生药入药的剂型。
In the practice of industrial consumption, traditional methods are often used to stop crushing and pretreatment of medicinal materials. After screening, the medicinal materials are further superfine crushed to reach the required size specifications (grading). The application of ultra-fine crusher technology of traditional Chinese medicine has brought about the transformation and development of traditional Chinese medicine dosage forms and broadened the dosage forms of crude drugs.
超细粉碎过程的关键,是依据生药的物理特性判别适宜的粉碎力场,从而选择最有效的超细粉碎设备。目前,中药的超细粉碎办法主要有机械粉碎、振动粉碎和气流粉碎,已有多种国产超微粉碎消费工业设备销售,包括振动磨粉碎机、机械剪切式粉碎机、低温粉碎机、气流粉碎机,以后两者在制药工业上的应用较普遍,而气流粉碎机中又以流化床式气流超微粉碎机应用最广。
The key to the ultra-fine grinding process is to determine the appropriate grinding force field according to the physical characteristics of the crude drug, so as to select the most effective ultra-fine grinding equipment. At present, the main methods of ultra-fine crushing of traditional Chinese medicine are mechanical crushing, vibration crushing and airflow crushing. There are many kinds of domestic ultra-fine crushing consuming industrial equipment sales, including vibration crusher, mechanical shear crusher, cryogenic crusher and airflow crusher. Later, they are widely used in pharmaceutical industry, while airflow crusher uses fluidized bed airflow ultrafine crusher. The most widely used.
机械法超细粉碎又可分为干法粉碎和湿法粉碎,依据粉碎过程中产生粉碎力的原理不同,干法粉碎有气流式、高频振动式、旋转球(棒)磨式、锤击式和自磨式等几种方式,湿法粉碎主要是胶体磨和均质机。
Mechanical ultra-fine comminution can be divided into dry comminution and wet comminution. According to the different principles of the comminution force, dry comminution can be divided into airflow, high frequency vibration, rotating ball (rod) grinding, hammering and self-grinding. The main wet comminution methods are colloid mill and homogenizer.
现代超细粉碎机技术是对药物停止微观组合,充沛应用微粉化、复合化、精细化、外表改性及粒子设计技术使药物到达最高程度,在这方面可研讨应用的技术空间非常宽广。该技术的深化研讨及应用,对中药来说将是新的技术增长点及新的经济增长点。国外在微粒和纳米粒方面的停顿非常疾速,控释药的呈现就是其中的典型超细粉碎技术的应用,能够拓宽以生药入药的剂型,也可促进先进制剂技术在这此“生药”剂型中的应用。总之,超细粉碎机技术在中药制剂中的应用将使中药的开展进入新的阶段。
Modern ultra-fine grinder technology is to stop the micro-combination of drugs, and make full use of micro-grinding, compounding, refinement, surface modification and particle design technology to achieve the highest level of drugs. In this regard, the technology space for discussion and application is very broad. Deepening research and application of this technology will be a new technological growth point and a new economic growth point for TCM. The pause in the field of particles and nanoparticles in foreign countries is very rapid. The appearance of controlled-release drugs is the typical application of ultra-fine grinding technology, which can broaden the dosage forms of crude drugs and promote the application of advanced preparations technology in this "crude drugs" dosage form. In a word, the application of ultra-fine grinder technology in traditional Chinese medicine preparation will make the development of traditional Chinese medicine enter a new stage.

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