[Study on botanical pesticides and its application in production of traditional Chinese medicine].

The issues including excessive pesticide residues and heavy metal contamination have become the bottle-neck in the development of Chinese herbal medicines. Compared with traditional chemical pesticides, biological pesticides, especially botanical pesticides, are more safe and environment-friendly, which were beneficial to the quality improvement Chinese medicinal materials. Though there exists a weak basic research and it is hard for promotion and regulation, the policy of good and the desire for botanical pesticides will accelerate its development, and replace traditional chemical pesticides gradually. This paper reviews the current situation of botanical pesticides, and gives some pertinence suggestions according to the existing problems and challenges. Research on botanical pesticides will become the key point to solve the problem of excessive pesticides residues and heavy metal contamination, and promote the healthy development of Chinese materia medica.

[Inheritance and innovation of traditional Chinese medicinal authentication].

Chinese medicinal authentication is fundamental for the standardization and globalization of Chinese medicine. The discipline of authentication addresses difficult issues that have remained unresolved for thousands of years, and is essential for preserving safety. Chinese medicinal authentication has both scientific and traditional cultural connotations; the use of scientific methods to elucidate traditional experience-based differentiation carries the legacy of Chinese medicine forward, and offers immediate practical significance and long-term scientific value. In this paper, a path of inheritance and innovation is explored through the scientific exposition of Chinese medicinal authentication, featuring a review of specialized publications, the establishment of a Chinese medicine specimen center and Chinese medicinal image databases, the expansion of authentication technologies, and the formation of a cultural project dedicated to the Compedium of Materia Medica.

An outbreak of cutaneous infection due to Mycobacterium abscessus associated to mesotherapy.

INTRODUCTION: In February 2009 an outbreak of subcutaneous abscesses due to Mycobacterium abscessus was detected in Spain which affected healthy women who had undergone mesotherapy procedures in an aesthetic clinic. METHODS: Epidemiological research, health inspection and microbiological studies were conducted. The patients were given antibiotic treatment (according to susceptibility testing) with clarithromycin, and in some cases, combined with amikacin. RESULTS: Seventeen out of 77 patients treated in the clinic were affected. The products used for the injections were homeopathic drugs in multi-dose vials. The environmental samples were negative. The sterile injection equipment and the clinical procedures were evaluated as correct. The storage conditions for the drugs were also correct, and all the samples tested negative for Mycobacteria. However Paenibacillus provencensis was isolated from samples of unused multi-dose vials and the withdrawal of the product from distribution was ordered. Deficiencies were detected in the sterile products process of at the homeopathic drug factory, so the production line was suspended. CONCLUSIONS: The results of environmental investigation suggest the most likely cause of the outbreak could have been the contamination of the products in the factory, although there was no laboratory confirmation. The widespread use of homeopathic products in invasive procedures requires extreme control during the manufacturing, handling and packaging process. It is important to consider mesotherapy and parenteral use of homeopathic medicines as potential sources of infection and therefore the same precautions in the procedures and quality assurance of products should be applied as with any other drug or medical activity.

The in vitro evidence for an effect of high homeopathic potencies--a systematic review of the literature.

OBJECTIVE: Systematic assessment of the in vitro research on high potency effects. METHOD: Publications of experiments were collected through databases, experts, previous reviews, citation tracking. INCLUSION CRITERIA: stepwise agitated dilutions <10(-23); cells or molecules from human or animal. Experiments were assessed with the modified SAPEH score. RESULTS: From 75 publications, 67 experiments (1/3 of them replications) were evaluated. Nearly 3/4 of them found a high potency effect, and 2/3 of those 18 that scored 6 points or more and controlled contamination. Nearly 3/4 of all replications were positive. Design and experimental models of the reviewed experiments were inhomogenous, most were performed on basophiles. CONCLUSIONS: Even experiments with a high methodological standard could demonstrate an effect of high potencies. No positive result was stable enough to be reproduced by all investigators. A general adoption of succussed controls, randomization and blinding would strengthen the evidence of future experiments.

[Analysis of 5 pyrethroid pesticide residues in Hirudo and Hippocampus].

OBJECTIVE: To investigate the levels of 5 pyrethroid pesticide residues in two kinds of Chinese traditional medicines, i.e. Hirudo, Hippocampus. METHODS: 11 samples of Hirudo and 5 samples of Hippocampus were collected and identified. The 5 pyrethroid pesticide residues in samples were extracted by solid-phase extraction to remove the interferences of co-extractives, and then were analyzed by gas chromatorgraph (GC) equipped with an electron capture detector, qualified by the chromatographic peak's retention time and quantified by the external standard method. RESULTS: The 5 pyrethroid pesticied residues were not detected in 5 samples of Hippocampus. Among 11 samples of Hirudo, the Cypermethrin were detected in all samples, and Fenvalerate were detected in 4 samples without exceeding the limit. CONCLUSION: The result suggest that the Hippocampus are not contaminated by the residues of 5 pyrethroid pesticides. The precaution procedure should be taken to control pyrethroid pesticide residues in Hirudo.

[The possible use of a ready-to-us film system for microbiological control in drug preparation]. / Possibilità di utilizzo di un sistema a film reidratabile nel controllo microbiologico di preparati farmaceutici.

Aim of this work was to verify the possibility of using a ready-to-use plate-count method to detect the microbial and fungal contamination on pharmaceutical products. The system consists of a flexible polypropylene film, supporting a suitable dehydrated medium, a second support containing guar, and an indicator on the internal surface. 33 raw materials, 11 natural origin materials, 20 medicinal product of official formula and 18 homeopathic products were analysed. As reference we chose the Italian Pharmacopoeia method. The two methods were comparable, showing no statistical differences, but for one case. This method, if our date will be further confirmed, could be used by the pharmacies and by the homeopathic industries.

[Cause and measure of short of quality control on Chinese medicine herbs].

Chinese medicine is short of quality control for three reasons. Firstly, near 90 percent Chinese medicine herbs are lack of quality standards and hard to be evaluated. Secondly, basal study falls behind relatively, which limites development speed of quality control and quality standard. Finally, Chinese medicine herbs haven't uniform refine operating norm. We must strengthen basal study, constitute the inspection norm of Chinese medicine herbs quality and establish perfect technical supervise system as fast as possible.

Study of the risk of heavy metal transfer to homoeopathic mother tinctures.

To assess the risk of heavy metal contamination of homoeopathic mother tinctures, 9 plant species and 1 fungus used in the manufacture of homoeopathic medicaments were investigated. Mother tinctures were prepared according to the manufacturing procedures described in the European Pharmacopoeia. The original herbal drug and the material processed during production were analysed for their cadmium (Cd), lead (Pb) and mercury (Hg) content. The plant components were harvested from 2 sites contaminated by different heavy metal exposure pathways and compared with reference material from Deutsche Homöopathie-Union (DHU). It was confirmed that in all cases a significant depletion of all heavy metals studied occurred during manufacture of the mother tincture, regardless of the starting material used. In all cases, most of the heavy metal content was retained in the press cake; low levels only were detected in the mother tincture. None of the mother tinctures of plant origin exceeded the required limits, not even those of plant starting materials originating from highly contaminated sites. Substantial heavy metal concentrations could only be detected in the mother tincture of the fungus Amanita muscaria, calculated from the dry weight of the starting material. According to the results obtained, a risk-based approach to heavy metal assessment is suggested where permanent control is focused on the heavy metals accumulating in organisms such as fungi.

Viral safety in homoeopathic medicinal products.

To guarantee the safety of medicinal products as regards infectious agents, numerous national guidelines and recommendations have in recent years been included in the pharmacopoeia general monographs and have influenced the content of the substance monographs. Although the stipulations of the European Pharmacopoeia set out objectives, there is still a certain scope in how the requirements are implemented. This is reflected in the very different responses in Europe to the problems of safety from infection. Different traditions in the use of homoeopathic and anthroposophic therapy and varying levels of expertise among the regulatory authorities within the European Union have resulted in varying standard of assessment. The aim of this publication is to present a standard form of assessment for medicinal products in these therapeutic systems. Demonstrated hereunder is an approach that can be adopted to ensure that the high safety standard required is met for homoeopathic and anthroposophic medicinal products.