Preparation, Standardization and Anti-plasmodial Efficacy of Novel Malaria Nosodes.

BACKGROUND: Resistance to artemisinin and its partner drugs has threatened the sustainability of continuing the global efforts to curb malaria, which urges the need to look for newer therapies to control the disease without any adverse side effects. In the present study, novel homeopathic nosodes were prepared from Plasmodium falciparum and also assessed for their in vitro and in vivo anti-plasmodial activity. METHODS: Three nosodes were prepared from P. falciparum (chloroquine [CQ]-sensitive [3D7] and CQ-resistant [RKL-9] strains) as per the Homeopathic Pharmacopoeia of India, viz. cell-free parasite nosode, infected RBCs nosode, mixture nosode. In vitro anti-malarial activity was assessed by schizont maturation inhibition assay. The in vitro cytotoxicity was evaluated by MTT assay. Knight and Peter's method was used to determine in vivo suppressive activity. Mice were inoculated with P. berghei-infected erythrocytes on day 1 and treatment was initiated on the same day. Biochemical, cytokine and histopathological analyses were carried out using standard methods. RESULTS: In vitro: the nosodes exhibited considerable activity against P. falciparum with maximum 71.42% (3D7) and 68.57% (RKL-9) inhibition by mixture nosode followed by cell-free parasite nosode (62.85% 3D7 and 60% RKL-9) and infected RBCs nosode (60.61% 3D7 and 57.14% RKL-9). The nosodes were non-toxic to RAW macrophage cell line with >70% cell viability. In vivo: Considerable suppressive efficacy was observed in mixture nosode-treated mice, with 0.005 ± 0.001% parasitemia on day 35. Levels of liver and kidney function biomarkers were within the normal range in the mixture nosode-treated groups. Cytokine analysis revealed increased levels of IL-4 and IL-10, whilst a decline in IL-17 and IFN-γ was evident in the mixture nosode-treated mice. CONCLUSION: The mixture nosode exhibited promising anti-malarial activity against P. falciparum and P. berghei. Biochemical and histopathological studies also highlighted the safety of the nosode for the rodent host. The study provides valuable insight into a novel medicament that has potential for use in the treatment of malaria.

Homeopathic Treatment in Patients with Polycystic Ovarian Syndrome: A Case Series.

BACKGROUND AND OBJECTIVES: Polycystic ovary syndrome (PCOS) is a common heterogeneous endocrine disorder in women of reproductive age. It is characterized by various clinical presentations such as ovulatory dysfunction, polycystic ovaries, and hyperandrogenism. Considering the side effects associated with conventional treatment and the patients who fail to respond to these measures, there is a demand for a complementary therapy that would alleviate symptoms of PCOS without side effects. Homeopathy is a complementary system of medicine that has been successfully used in different disease conditions, including PCOS. A case series of PCOS is hereby presented, to demonstrate some positive results of individualized homeopathic treatment. METHODS: Seven cases of young women with PCOS were treated with individualized homeopathic medicines. Each case was followed up with clinical and ultrasonographic evidence and was reported according to the criteria set out in the HOM-CASE guidelines. The assessment of causal attribution of homeopathic treatment effect was carried out using the Modified Naranjo Criteria. RESULTS: Marked improvement was observed in all seven cases of PCOS. The irregular menstrual cycles and other associated symptoms became normal, along with a resolution of cysts in ovaries as evidenced by ultrasonography. All cases improved within 4 to 12 months of treatment. The Modified Naranjo Criteria total score was +9/13 for each case, which indicates a positive causal attribution of homeopathy in relieving the symptoms of PCOS. CONCLUSION: This case series suggests a significant role of individualized homeopathic medicines in PCOS by regularizing the menstrual cycle along with the resolution of cysts and associated symptoms.

Homeopathic Treatment of a Lower Leg Edema-A Case Report.

BACKGROUND: Homeopathy is frequently and successfully used in daily clinical practice, so there is a need for well-documented case reports that illustrate its effectiveness. For this reason, we present a case in which homeopathy was used to treat an ankle and lower leg for spontaneous acute swelling and redness. CASE REPORT: A 54-year-old man presented with recurrence of a swollen left ankle and lower leg, which had previously been treated by conventional medicine. After case taking, a homeopathic treatment with Apis mellifica 200c led to a fast improvement. The patient was free of symptoms within 24 hours and has remained so for 3 years. CONCLUSION: Homeopathic treatment with Apis mellifica led to a fast and long-lasting improvement of an acute ankle swelling and reddening that had recurred after conventional medical therapy of similar symptoms.

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts.

BACKGROUND: Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. METHODS: A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. RESULTS: Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes-both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. CONCLUSION: As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. TRIAL REGISTRATION: CTRI/2019/10/021659; UTN: U1111-1241-7340.

Effects of Homeopathic Preparations of Mercurius corrosivus on the Growth Rate of Moderately Mercury-Stressed Duckweed Lemna gibba L.

BACKGROUND: A bioassay with severely mercury-stressed duckweed (Lemna gibba L.) had revealed growth-inhibiting effects of homeopathically potentised mercury(II) chloride (Mercurius corrosivus, Merc-c.). We hypothesised that effects of potentised preparations are dependent on the stress level of the organisms used in the bioassay. The aim of the present investigation was to examine the response of duckweed to potentised Merc-c. at a lower stress level. METHODS: Duckweed was moderately stressed with 2.5 mg/L mercury(II) chloride for 48 hours. Afterwards plants grew in either Merc-c. (seven different potency levels, 24x-30x) or water controls (unsuccussed or succussed water) for 7 days. Growth rates of the frond (leaf) area were determined using a computerised image-analysis system for day 0-3 and 3-7. Three independent experiments with potentised Merc-c. and three systematic negative control experiments were performed. All experiments were randomised and blinded. RESULTS: Unsuccussed and succussed water did not significantly differ in their effects on duckweed growth rate. The systematic negative control experiments did not yield any significant effects, thus providing evidence for the stability of the experimental system. Data from the two control groups and the seven treatment groups (Merc-c. 24x-30x) were each pooled to increase statistical power. Duckweed growth rates for day 3-7 were enhanced (p < 0.05) after application of Merc-c. compared with the controls. Growth rates for day 0-3 were not influenced by the homeopathic preparations. CONCLUSIONS: Moderately mercury-stressed Lemna gibba L. yielded evidence of growth-enhancing specific effects of Merc-c. 24x-30x in the second observation period (day 3-7). This observation is complementary to previous experiments with severely mercury-stressed duckweed, in which a decrease in growth was observed in the first observation period (day 0-3). We hypothesise that the differing results are associated with the level of stress intensity (moderate vs. severe).

Use of Homeopathy in Integrative Oncology in Strasbourg, France: Multi-center Cross-Sectional Descriptive Study of Patients Undergoing Cancer Treatment.

CONTEXT: The use of homeopathy in oncological supportive care seems to be progressing. The first French prevalence study, performed in 2005 in Strasbourg, showed that only 17% of the subjects were using it. What is the situation 12 years later? MATERIALS AND METHODS: This is a descriptive study, using a questionnaire identical to that used in 2005, on 633 patients undergoing treatment in three anti-cancer centers in Strasbourg. The results of the "homeopathy" sub-group were extracted and studied. RESULTS: Of the 535 patients included, 164 used homeopathy: that is 30.7%. The main purpose of its use was to reduce the side effects of cancer treatments (75%). Among the users, 82.6% were "somewhat" or "very" satisfied, against "quite" satisfied for 15.5%, and "not at all" satisfied for 1.9%. The homeopathic treatment was prescribed by a doctor in 75.6% of the cases; the general practitioner was kept informed in 87% of the cases and the oncologist in 82%. Fatigue, pain, nausea, anxiety, sadness and diarrhea were improved in 80% of the cases. However, alopecia, weight disorders and loss of libido were the least improved symptoms. The use of homeopathy was significantly associated with the female sex. CONCLUSION: With a prevalence of 30.7%, homeopathy is the most used complementary medicine in integrative oncology in Strasbourg. Over 12 years, we have witnessed an increase of 83% in its use in the same city. Almost all respondents declare themselves satisfied and tell their doctors more readily than in 2005.

Impact of Homeopathic Treatment on the Quality of Life of Women with Chronic Diseases: A Randomized Controlled Pragmatic Trial.

BACKGROUND: Despite the increasing demand for complementary and integrative medicine, only a few studies have evaluated the effect of these types of treatments on the quality of life (QoL) of patients with chronic diseases. The objective of this study was to evaluate the QoL of women treated with homeopathy within the Public Health System of Belo Horizonte, Brazil. METHODS: This is a prospective randomized controlled pragmatic trial. The patients were divided into two independent groups, one group underwent homeopathic treatment in the first 6-month period and the other did not receive any homeopathic treatment. In both randomized groups, patients maintained their conventional medical treatment when necessary. The World Health Organization Quality of Life abbreviated questionnaire (WHOQOL-BREF) was used for QoL analysis prior to treatment and 6 months later. RESULTS: Randomization afforded similar baseline results in three domains of QoL analysis for both groups. After 6 months' treatment, there was a statistically significant difference between groups in the physical domain of WHOQOL-BREF: the average score improved to 63.6 ± (SD) 15.8 in the homeopathy group, compared with 53.1 ± (SD) 16.7 in the control group. CONCLUSIONS: Homeopathic treatment showed a positive impact at 6 months on the QoL of women with chronic diseases. Further studies should be performed to determine the long-term effects of homeopathic treatment on QoL and its determinant factors.

Features and development trends in international standardization of Chinese materia medica in ISO/TC 249.

Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.

Homeopathic Rhus toxicodendron Induces Cell Adhesions in the Mouse Pre-osteoblast Cell Line MC3T3-e1.

BACKGROUND: Rhus toxicodendron (R. tox) has been used as a homeopathic remedy for the treatment of inflammatory conditions. Previously, we reported that R. tox modulated inflammation in the mouse chondrocyte and pre-osteoblastic MC3T3-e1 cell line. During the inflammatory process, cells adhere to the extracellular matrix (ECM) and then migrate to the inflammation site. We examine here the process of cell adhesion in MC3T3-e1 cells after their stimulation with homeopathic R. tox. METHODS: For the cell-substrate adhesion assay, the cultured MC3T3-e1 cells were trypsinized, starved for 1 h in serum-free media, and plated onto culture plates coated with fibronectin (FN), 30c R. tox or gelatin, respectively. The cells were allowed to adhere for 20 min incubation and unattached cells were washed out. Adherent cells were measured using the water-soluble tetrazolium salt-8 assay. The intracellular signals after stimulation of R. tox were examined by analyzing the tyrosine phosphorylation of focal adhesion kinase (FAK), Src kinase, and Paxillin using immunoblot assay. Formation of focal adhesion (FA, an integrin-containing multi-protein structure that forms between intracellular actin bundles and the ECM) was analyzed by immunocytochemistry using NIH ImageJ software. RESULTS: Cell adhesion increased after stimulation with R. tox (FN, 20.50%; R. tox, 44.80%; and gelatin, 17.11% vs. uncoated cells [control]). Tyrosine phosphorylation of FAK, Paxillin, and Src increased compared with that of gelatin when stimulated with R. tox. Additionally, R. tox-stimulated cells formed many FAs (number of FAs per cell, 35.82 ± 7.68) compared with gelatin-stimulated cells (number of FAs per cell, 19.80 ± 7.18) and exhibited extensive formation of actin stress fibers anchored by FAs formed at the cell periphery. CONCLUSION: Homeopathic R. tox promotes the formation of cell adhesions in vitro.

Prevalence and Likelihood Ratio of Six Objective Signs among Good Responders to Natrum muriaticum: Multi-centre Observational Assessment.

BACKGROUND: The reliability of homeopathic prescriptions may increase through resource to objective signs and guiding symptoms with significant positive likelihood ratio (LR). We estimated LR for six objective signs attributed to the homeopathic medicine Natrum muriaticum (Nat-m). METHODS: In this multi-centre observational assessment, we investigated the prevalence of six signs in the general patient population and among good responders to Nat-m in daily homeopathic practice. Next, we calculated LR for these six signs. RESULTS: Data from 36 good responders to Nat-m and 836 general population patients were compared. We found statistically significant positive LR (95% confidence interval) for signs such as lip cracks (1.94; 1.15 to 3.24), recurrent herpes (2.29; 1.20 to 4.37), hairline eruptions (2.07; 1.03 to 4.18), and dry hands (2.13; 1.23 to 3.69). CONCLUSIONS: Objective signs with significant positive LR might increase the reliability of homeopathic prescriptions. Further studies are warranted to confirm the validity of this approach.

Material Risks of Homeopathic Medicinal Products: Regulatory Frameworks, Results of Preclinical Toxicology, and Clinical Meta-Analyses and Their Implications.

Homeopathy is widely used and broadly accepted by health care professionals and the general public but less in academic circles. To assess possible material health risks of homeopathic medicinal products, it is necessary to identify, select, and synthesize the findings of recent reviews of controlled homeopathic clinical trials. Matching these findings with experimental data from toxicological studies helps to clarify what is known and not known about the material risks of homeopathic medicines. Rules for toxicological risk assessment and management need to be applied independently of individual attitudes towards specific therapeutic options. European regulatory bodies have developed special protocols and decision trees to assure the safety of nonindividualized homeopathic remedies. This narrative review leads to suggestions that could ease and improve toxicological decision making. No homeopathy-specific type or pattern of side effects could be extracted from the meta-analysis data. No differences in the frequency of adverse reactions between homeopathic treatment and placebo treatment could be seen, no matter whether adverse events were reported in a quantitative or a qualitative manner. Some patterns of side effects show that adverse reactions do not necessarily correlate with treatment but with the condition of the patient. Overall, the controlled clinical data available for the material risk assessment of homeopathic remedies support the statement that, if a risk exists, it must be so small that it has not yet been established. To make our risk findings useful for personal decisions regarding homeopathy, we provide a thought experiment based on four different health situations and ask the question: is homeopathy as a monotherapy or as an add-on treatment an option or should it be rejected?

Effect of Homeopathic Preparations on Lettuce, Parasitized or Not by Meloidogyne enterolobii.

BACKGROUND: There are relatively few scientific works on the use of homeopathy to manage plant pathogens, particularly nematodes. A handful of studies focused on Meloidogyne spp. parasitizing vegetables have brought contradictory results on nematode control and enhancement of plant tolerance to parasitism. OBJECTIVE: Our goal was to assess the effect of Cina-a well-known anti-nematode ingredient-on Meloidogyne enterolobii parasitizing lettuce. METHODS: Cina was applied daily on nematode-inoculated plants, from the seedling stage until harvest. We tested an evenly spaced range of Hahnemannian concentrations (c), which were applied though irrigation with a constant dose of the ingredient. Several absolute and relative controls were employed to allow the assessment of the effect of Cina on nematode reproduction and lettuce growth. RESULTS: Cina affected growth of non-parasitized plants, both positively and negatively; this effect was modulated by the c applied and the thermal stress suffered by the plants in one of the assays. The effect of Cina on the growth of nematode-parasitized plants was neutral or negative. Cina reduced nematode reproduction by 25-36%. CONCLUSION: Based on the moderate negative effect of Cina on M. enterolobii reproduction, it seems this ingredient may be useful as a complementary strategy for Meloidogyne control. But Cina did not enhance the tolerance of lettuce to Meloidogyne spp.

Homeopathic Treatment of Pododermatitis in Magellanic Penguins (Spheniscus magellanicus).

BACKGROUND: Problems with the feet are common in penguins, with a particular predisposition to pododermatitis. This condition usually occurs due to the changes in normal activity that result from being held captive, but its precise pathogenesis is still undetermined. METHODS/PATIENTS: This veterinary case study reports the use of oral homeopathic treatment on acute and chronic pododermatitis in five Magellanic penguins in a zoological park setting. During treatment, the patients remained in the penguins' living area, and the effect of the treatment on the progression of their lesions was assessed visually once weekly. The treatment consisted of a combination of Arnica montana and Calcarea carbonica. RESULTS: After treatment, the appearance of the lesions had noticeably improved: in the majority of penguins there was no longer evidence of infection or edema in the feet. The rate of recovery depended on the initial severity of the lesion. Those penguins that still showed signs of infection nevertheless exhibited a clear diminution of the size and thickness of the lesions. Homeopathic treatment did not cause any side effects. CONCLUSION: Homeopathy offers a useful treatment option for pododermatitis in captive penguins, with easy administration and without side effects.

Preparation and Standardization of Escherichia coli Nosodes Sourced from Select E. coli Strains.

BACKGROUND: The nosodes are well-known preparations in homeopathy that are sourced from organisms and diseased materials. More than 40 known nosodes have been used in homeopathic practice for over a century. Having identified the need for scientifically developed new nosodes sourced from organisms that are currently prevalent, the preparation of Escherichia coli nosodes from different strains of the bacterium is presented in this article. MATERIALS AND METHODS: Escherichia coli strains (E. coli ATCC 11775E, ATCC 25922, and ATCC 8739) were identified, cultured, and tested for purity, and 20 billion cells were processed following the nosode preparation method given in the Homoeopathic Pharmacopoeia of India, group N1. Serial dilution and potentization for liquid potency were done up to 30c potency. Nosodes were prepared by two methods: from cell-free extract (endotoxin) and from entire-cell extract. RESULT: Six nosodes were developed in total. Three univalent nosodes were prepared using individual endotoxins, one from each of the three E. coli strains; those three univalent nosodes were also combined as "Trivalent nosode-I". "Trivalent nosode-II" was prepared by mixing entire cells of the three E. coli strains. A mix of both Trivalent nosode-I and Trivalent nosode-II was labeled "EC-Polynosode". The safety profile of the potentized nosodes was documented by the non-detectability of traces of source material (absence of contamination, live organisms, or DNA material) through a culture test, sterility test, and molecular testing (polymerase chain reaction). CONCLUSION: Different variants of E. coli nosodes were systematically and scientifically prepared and standardized using the cultures. Homeopathic pathogenetic trials, in-vitro efficacy studies, and clinical evaluation of E. coli nosodes (single, trivalent, or polyvalent nosodes) will be required in future.

Analysis on the current quality standards of Chinese materia Medica used in COVID-19 prevention and treatment.

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.

Real-time process quality control of ramulus cinnamomi by critical quality attribute using microscale thermophoresis and on-line NIR.

Real-time process quality control of ramulus cinnamomi (cassia twig) is still a challenge in pharmaceutical industry. Rapid critical quality attribute (CQA) determination of ramulus cinnamomi is essential for quality control. Microscale thermophoresis (MST) was used to investigate the CQA of ramulus cinnamomi by the interaction with biomacromolecule. There was a good affinity between cinnamaldehyde and human serum albumin (HSA) with Ka as 2.1722×103mol/L. It was an excellent combination of similarity to ibuprofen with same binding force as discovered as hydrogen bond and van der Waals force. Furthermore, regarding cinnamaldehyde as CQA, on-line near-infrared was used to monitor pilot extraction process of ramulus cinnamomi combined with high performance liquid chromatography (HPLC). Quantitative model was established with Rpre2 as 0.9798 and RMSECV as 0.0993, suggesting the NIR model was so robust and accurate for pilot process quality control. This method provided a perfect guideline for rapid CQA determination and real-time process quality control of Chinese materia medica (CMM) based on a vital CQA.

[Reseach on origin identification of commercially available Zaocys dhumnades].

Through market investigation, the adulteration of Zaocys dhumnades on markets was found out, and samples of authentic and adulterated Z. dhumnades on markets were collected. The origin and properties of the adulterated Z. dhumnades were studied in order to provide reference for the identification of Z. dhumnades. The counterfeit Z. dhumnades sold on markets were as follows: Ptyas korros, P. mucosus, Najanaja atra, Sinonatrix annularis, Dinodon septentrionalis, etc. It is found that there existed a obvious difference between the traits of the Z. dhumnades and counterfeits. Genuine Z. dhumnades with "sword ridge" "iron tail", strongly ribbed scales and other features, is the key point to identify the difference from adulterants.

[Current situation and research strategy of quality control of health food containing Chinese materia medica].

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.

[Present situation and analysis of deer industry standardization at home and abroad].

Deer is valuable all over the body,which is rich in nutritional value and medicinal value. Deer breeding and processing are very advanced in North America and New Zealand where many related standards have been published. The development of Chinese deer industry lack standard and normal management,neither standards' number nor coverage area formed complete frame structure. The international standards like Panax ginseng and P. notoginseng were more lacked. This paper makes a classification statistics on standardization organizations at home and abroad,foreign standards,Chinese national standards,industry standards,local standards and enterprise standards. The classes,contents,ages,implementation and promotion and demonstration area construction of standards were compared and analyzed. We found Chinese deer industry standards were deficient in coverage,uniformity,innovation,repeatability and support. And we give advises for the construction of industry quality standard system,organizational mobility and ideology of consumers,hoping to boost the standard construction and promote international competitiveness of Chinese deer industry.

[Bio-characteristic profiling related to clinic:thought and practice on quality evaluation of Chinese materia medica].

The quality evaluation of Chinese materia medica(CMM) is an important and difficult topic research in traditional Chinese medicine, due to its inherent complexity, and incompatibility of evaluation patterns and their key techniques. To solve the issue, it is necessary to break the limit of conventional evaluation, and establish the evaluation pattern and its key techniques about CMM quality related to clinic. Hence, with the strategy- "originating from clinic, validating by experiments and returning to clinic", a novel academic concept is proposed which is termed as "bio-characteristic profiling related to clinic of CMM". A series of key techniques should be established including living-cell dynamic monitoring, enzyme bioactivity dynamic monitoring, electric chemistry dynamic monitoring and isothermal titration dynamic monitoring, etc. Besides, the quality fluctuation of CMM(products) which is hard to control and assess could be evaluated when associated with clinical efficacy and safety(exemplified by Chinese herbal injection, animal medicine and joint use of drugs in clinic). It is expected to form the novel evaluation system for CMM quality based on bio-characteristic profiling related to clinic and its key techniques, which provides novel ideas and techniques for improving quality and clinical efficacy, and promotes the modernization and internationalization of CMM.