Medicinal materials may be contaminated with a broad variety of fungi, which are represented by Aspergillus spp, Penlicillium spp, Fusarium spp, Rhizopus spp, Mucor spp et al. This fact limits the utilization of medicinal materials, besides, medicinal materials may also be contaminated with mycotoxins produced by these fungi, and bring harm to human health. Several mycotoxins have been detected in medicinal materials, such as AFTs, OTA, FBs, et al. The contamination may originate from the conditions in which the medicinal plants are cultivated, stored and in the finished product manufacturing stages. Some methods have been used for detoxifcation and disinfection for medicinal materials, but they have limited effects. Taking into consideration the background situation, it is important for medicinal materials to be protected from contamination of fungi at every stage of production. The present study intends to give a review of contamination of medicinal materials by moulds and mycotoxins and discuss the factors influencing this situation, expecting to contribute to the knowledge for reducing the contamination.
Drug Contamination ; prevention & control ; Fungi ; isolation & purification ; Mycotoxins ; analysis

During the storage process, Chinese medicinal materials are susceptible to insect infestation due to their own nature and external storage factors. Infestation by insects can have varying impacts on the materials. In mild cases, it affects the appearance and reduces consumer purchasing power, while in severe cases, it affects the quality, reduces medicinal value, and introduces impurities such as insect bodies, excrement, and secretions, resulting in significant contamination of the medicinal materials. This study reviewed the rele-vant factors influencing insect infestation in Chinese medicinal materials and the compositional changes that occur after infestation and summarized maintenance measures for preventing insect infestation. Additionally, it provided an overview of detection techniques applicable to identifying insect infestation during the storage of Chinese medicinal materials. During the storage process, insect infestation is the result of the combined effects of biological factors(source, species, and population density of insects), intrinsic factors(moisture, chemical composition, and metabolism), and environmental factors(temperature, relative humidity, and oxygen content). After infestation, there are significant changes in the content of constituents in the medicinal materials. By implementing strict pre-storage inspections, regular maintenance after storage, and appropriate storage and maintenance methods, the occurrence of insect infestation can be reduced, and the preservation rate of Chinese medicinal materials can be improved. The storage and maintenance of Chinese medicinal materials are critical for ensuring their quality. Through scientifically standardized storage and strict adherence to operational management standards, the risk of insect infestation can be minimized, thus guaranteeing the quality of Chinese medicinal materials.
Animals ; Drug Contamination/prevention & control* ; Insecta ; Preservation, Biological ; Temperature

OBJECTIVETo develop a headspace gas chromatography method for determining dimethyl sulphate residual in granisetron hydrochloride.

METHODSAn Angilent INNOWAX capillary column with nitrogen gas as carrier and FID as detector was applied in this study. Dimethyl sulphate was tested under a constant column temperature.

RESULTDimethyl sulphate had different retention time from other organic solvents such as alcohol,acetoacetate, isopropanol, dichlormethane and chloroform, which might exist in granisetron hydrochloride. The detection limit of dimethyl sulphate;s was 0.0016%.

CONCLUSIONThe method can be used for the determination of dimethyl sulphate residual in granisetron hydrochloride.

Chromatography, Gas ; methods ; Drug Contamination ; prevention & control ; Granisetron ; analysis ; Pharmaceutical Preparations ; analysis ; Sulfuric Acid Esters ; analysis

In our study, 198 types of pesticides in 120 types 333 lots of traditional Chinese medicine (TCM), which were reasonably classified according to its matrix property, were determined by using the pretreatment platform and gas chromatography-mass spectrometry method. As a result, 158 were contaminated with pesticides. However, the content of pesticides in most TCM was very low. In addition, types of pesticides were different in different part of materia medica. In conclusion, the current status of pesticide residues pollutants in TCM was summarized, and the result can provide proof for the formulation of maximum residue limit. The new species of herbs and the new detecting index should be electively monitored in Chinese Pharmacopeia.
China ; Drug Contamination ; prevention & control ; Pesticide Residues ; analysis ; Plants, Medicinal ; chemistry ; Quality Control

OBJECTIVETo determine the pesticide residues in Shengmaiyin.

METHODThe residues were simultaneously identified and quantified by capillary gas chromatography. The capillary column was OV-1701(0. 32 mm x 30 m, 0.5 microm), splitless injection and Agilent 63Ni electron capture detector ECD were adopted. The carrier gas were high-pure nitrogen, the flow rate were 60 mL x min(-1), the injector temperature was 260 degrees C, and the detector temperature was 300 degrees C.

RESULTIt showed a good linear relationship between peak area and pesticide concentration for 11 kinds of pesticides in the detection concentration range. All correlation coefficients were higher than 0.996 2. The average recovery was 83.1% -114.7%.

CONCLUSIONA simple and efficient monitoring method of pesticide residues is established which provides the foundation for the safe use and analysis of Shengmaiyin.

Chromatography, Gas ; methods ; Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; chemistry ; Pesticide Residues ; analysis ; Reproducibility of Results

To improve the impurity control of extrinsic residues in Chinese crude drugs and ensure the quality of crude drugs, relative suggestions should be provided. The present situation of extrinsic residues control in crude drugs was reviewed, and relative problems existed were analyzed. To develop the impurity control of extrinsic residues in Chinese crude drugs, more effort focus on strengthening basic research, improving analytical methods and optimizing the pattern of administration should be made.
Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; analysis ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control

OBJECTIVETo identify Tongren Dahuoluo pills and Tongren Niuhuangqingxin pills respectively by analysis of IR fingerprint.

METHODBoth drugs were extracted with hexane, ethylether and butanone respectively and then the obtained extracts were measured with the ET-IR spectrometer.

RESULTBy analyzing IR fingerprint of 25 batches of Tongren Dahuoluo pills and 27 batches of Tongren Niuhuangqingxin pills, we found that different batches of the same drug hadstabile and repeatable fingerprint.

CONCLUSIONBy using IR fingerprint, either Tongren Dahuoluo pills or Tongren Niuhuangqingxin pills can be exactly identified. It provides a rapid method for drug identification and quality control.

Drug Combinations ; Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Plants, Medicinal ; chemistry ; Quality Control ; Spectrophotometry, Infrared

If the presence of residual solvents in pharmaceuticals exceeds tolerance limits as suggested by safety data, they may be harmful to the human body or the environment. It is because of this that the determination of residual solvents receives a great deal of attention. This paper reviews in detail the changes in the regulations on residual solvents in pharmaceuticals in leading pharmacopoeias, and the advances in the techniques involved, especially, the recent advances in the analytical techniques are summarized. At the end, the authors introduce the prospect of the expert system for determining residual solvents in pharmaceuticals based on the studies of their research group.
Capillary Electrochromatography ; Chromatography, Gas ; Drug Contamination ; prevention & control ; Drug and Narcotic Control ; Pharmaceutical Preparations ; chemistry ; Quality Control ; Solvents ; analysis

All kinds of traditional Chinese medicines (TCMs) differed from each other with different chemical components and properties. Owing to poor conditions and technologies, and the lack of scientific preservation, most TCMs will easily become mouldy during the processes of growth, harvest, handling, translation and especially storage, which will not only influence the quality, safety and efficacy of TCMs, but also cause serious waste and economic losses, and even do great harm to human health. The process of storage is closely related to the qualities of TCMs with many interference factors. Therefore, scientific preservation of TCM during storage is crucial to prevent them from being mouldy. This review analyzed the important harm of mouldy TCMs, summarized the internal and external factors of resulting in TCMs to become mouldy. Based on the above discussion, together with the characteristics and limitations of current TCM preservation techniques, we prospect novel, scientific and reasonable preservation techniques, expecting to provide references for scientific preservation of TCMs to avoid becoming mouldy and guarantee their qualities.
Drug Contamination ; prevention & control ; Drug Storage ; methods ; Drugs, Chinese Herbal ; chemistry ; Fungi ; growth & development ; isolation & purification ; Plants, Medicinal ; chemistry ; microbiology

In order to effectively remove the invalid impurities in Tongan injection, optimize the optimal parameters of the impurity removal technology of liquid mixing process, in this paper, taking Tongan injection as the research object, with the contents of celandine alkali, and sinomenine, solids reduction efficiency, and related substances inspection as the evaluation indexes, the removal of impurities and related substances by the combined process of refrigeration, coction and activated carbon adsorption were investigated, the feasibility of the impurity removal method was definited and the process parameters were optimized. The optimized process parameters were as follows: refrigerated for 36 h, boiled for 15 min, activated carbon dosage of 0.3%, temperature 100 degrees C, adsorption time 10 min. It can effectively remove the tannin, and other impurities, thus ensure the quality and safety of products.
Adsorption ; Charcoal ; chemistry ; Drug Compounding ; instrumentation ; methods ; Drug Contamination ; prevention & control ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Quality Control