Reproducibility of the effects of homeopathically potentised Argentum nitricum on the growth of Lemna gibba L. in a randomised and blinded bioassay.

BACKGROUND: A previous study reported a significant statistical interaction between experiment date and treatment effect of Argentum nitricum 14x-30x on the growth rate of duckweed (Lemna gibba L.). The aim of the present study was to investigate the stability of the test system and intra-laboratory reproducibility of the effects found. METHODS: Duckweed was treated with A. nitricum potencies (14x-30x) as well as succussed and unsuccussed water controls. The outcome parameter area-related growth rate for day 0-7 was determined by a computerised image analysis system in two series of independent randomised and blinded experiments. Systematic negative control (SNC) experiments were carried out to investigate test system stability. Statistical analysis was performed with full two-way analysis of variance (ANOVA) and protected Fisher's Least Significant Difference (LSD) test. RESULTS: In the first repetition series we found a significant treatment effect (p = 0.016), while in the second series no effect was observed. The negative control experiments showed that the experimental system was stable. An a posteriori subgroup analysis concerning gibbosity revealed the importance of this growth state of L. gibba for successful reproduction of the statistically significant interaction in the original study; flat: no interaction (p = 0.762); slight gibbosity: no interaction (p = 0.356); medium gibbosity: significant interaction (p = 0.031), high gibbosity: highly significant interaction (p = 0.005). CONCLUSIONS: With the original study design (disregarding gibbosity status of L. gibba) results of the original study could not be reproduced sensu stricto. We conclude that the growth state gibbosity is crucial for successful reproduction of the original study. Different physiological states of the test organisms used for bioassays for homeopathic basic research must carefully be considered.

[Effect of multicomponent environment on intestinal permeability of puerarin in biopharmaceutics classification system of Chinese materia medica].

The evaluation of permeability in biopharmaceutics classification system of Chinese materia medica (CMMBCS) requires multicomponent as a whole in order to conduct research, even in the study of a specific component, should also be put in the multicomponent environment. Based on this principle, the high content components in Gegen Qinlian decoction were used as multicomponent environmental impact factors in the experiment, and the relevant parameters of intestinal permeability about puerarin were measured with using in situ single-pass intestinal perfusion model, to investigate and evaluate the intestinal permeability of puerarin with other high content components. The experimental results showed that different proportions of baicalin, glycyrrhizic acid and berberine had certain influence on intestinal permeability of puerarin, and glycyrrhizic acid could significantly inhibit the intestinal absorption of puerarin, moreover, high concentration of berberine could promote the absorption of puerarin. The research results indicated that the important research ideas of permeability evaluation in biopharmaceutics classification system of Chinese materia medica with fully considering the effects of other ingredients in multicomponent environment.

[In vitro study on gastrointestinal absorption of FITC labeled pilose antler protein extraction].

An in vitro detection method of the gastrointestinal absorption of Pilose Antler protein was established for mixed protein activity. Five bands of protein with molecular weight of 17.8-160 kD derived from the Pilose Antler were extracted and sufficiently labeled with FITC (FITC-PE). The stability and variation of FITC-PE in gastrointestinal circumstances were detected by native polyacrylamide gel electrophoresis and confocal laser scanning microscope. Results showed that the main component of FITC-PE kept invariant after being reacted with artificial gastric fluid and artificial intestinal fluid. The fluorescence signal was detected 20 min after administration in the valgus intestinal purse experiment, and three kinds of protein, with molecular weight of 45, 25, and 17.8 kD, were detected in the mixture of absorbent protein. The research laid the foundation for the further in vivo study of Pilose Antler protein. Meanwhile, it would be an in vitro screening method for the absorption, distribution and metabolism of mixed protein from traditional Chinese medicine.

Deviating from clinical practice: Pharmacokinetics of Chinese materia medica faces a substantial challenge.

The pharmacokinetics of Chinese materia medica (PCMM) has made a great contribution to investigations of the in vivo process of various components in Chinese materia medica (CMM), intending to provide useful information for clinical guidance related to CMM. However, some issues are worthy of further consideration, and current PCMM studies face a substantial challenge. First, high-dosage administration is prevalent in PCMM studies, and the obtained results might be meaningless and inappropriate for guiding the clinical application of CMM, as they deviate from clinical practice. Improvements in instrument sensitivity have not reduced the prevalence of high-dosage administration. In addition, the selection of components for detection in PCMM studies is usually uncertain, lacking sufficient scientific support, especially for components without clarified bioactivities. Therefore, the scientific value of current PCMM studies is limited. We believe that these abnormalities can be attributed to the poor recognition of the characteristics of CMM and the improper application of research approaches from Western medicines. Currently, the more pressing key scientific issues for CMM should be clinical effectiveness, quality control and bioactivity discovery, which are closely related to its own characteristics and are beneficial to its modern developments.

A feasible biocompatible hydrogel film embedding Periplaneta americana extract for acute wound healing.

The wound healing effects of pharmaceutic preparations of Periplaneta americana, Kangfuxin liquid, have been widely utilized in clinics. However, its wound repair efficacy is limited due to short retention capability on cutaneous wound location. Herein, Periplaneta americana extract (PAE), which showed pro-fibrogenic and pro-angiogeneic effects, was embedded into hydrogel film (PAE/Film) by solution cast method by blending polyvinyl alcohol, hydroxypropyl chitosan and carbomer at the weight ratio of 78/6/3, with glycerol as plasticizer. PAE/Film exhibited smooth, flexible, and excellent swelling ability (WVTR of 2464 ±â€¯31.5 g/m2/day), characterized by scanning electron microscopy, Fourier transform infrared spectroscopy, and differential scanning calorimetry, meting the condition of ideal wound dressing. The superior wound healing capacity of PAE/Film was demonstrated that it significantly accelerated wound healing process in vivo in both full-thickness skin defect and scald wounded models. Compared to saline, blank vehicle (drug-free) and free PAE group, PAE/Film could accelerate wound healed, promote re-epithelialization and collagen deposition by means of TGF-ß/Smad signal pathway activation. Taken together, this novel hydrogel film-loading PAE would be a useful pharmaceutic candidate for acute cutaneous wound health care.

[In vivo/in vitro evaluation of Kangfuxin colon targeting capsules].

OBJECTIVE: To evaluate the release in fixed position of pH-dependent and enzyme-dependent Kangfuxin colon targeting capsules in vivo and in vitro. METHOD: The dissolution was tested in vitro and X-ray radiography was used for the evaluation in vivo. RESULT: After two hours pH-dependent colon targeting in man-made colon fluid, medicine release in fixed position on the whole, colon loc-release. Add enzyme into man-made colon, when enzyme-dependent colon targeting in it, then medicine release quickly, mainly release in fixed position; The conveying time in vivo of pH-dependent and enzyme-dependent capsules have big individuality difference. In the experiment, disintegration is stabilize among individuales, between 2.0-3.5 hours. CONCLUSION: Kangfuxin colon targeting capsules of two principles all release in fixed position to achieve the goal.

[Optimization of formulation matrix proportion and preparation technology of realgar floating tablets for gastric retention by uniform design and correlation analysis].

OBJECTIVE: To optimize the different components proportions of the Realgar floating tablets for gastric retention by uniform design and correlation analysis. METHOD: With the different dosage of hydroxypropyl methyl cellulose (HPMC) as the tablets frame matrix, uniform design and correlation analysis were used to optimize the best component proportions of formula, and to measure the dissolution of the tablets in vitro. RESULT: Dissolution of the tablets in vitro was conformed to the expectation of experiment. The drug-release mechanism was by diffusion and corrosion at the same time. CONCLUSION: The Realgar floating tablets for gastric retention achieved the goal of design, which demand sustained release and safety.

[Studies on heart-protecting musk pH-dependent gradient-release pellets].

AIM: To prepare heart-protecting musk pH-dependent gradient-release pellets and investigate the drug release in vitro and in vivo. METHODS: The pH-dependent gradient-release pellet system was prepared by using HPMC, Eudragit L-30D-55 and Eudragit L100-Eudragit S100 (1:5) combinations as coater. The release of borneol and total ginsenoside from pH-dependent gradient-release pellets were determined according to the method of Pharmacopoeia of the People's Republic of China (2000) in the simulated gastrointestinal pH conditions. The gastrointestinal transit and disintegration of pellets was investigated by using gamma-scintigraphic trace in volunteers. The pharmacokinetics of borneol of heart-protecting musk pH-dependent gradient-release pellets was studied in 6 healthy volunteers by GC methods. RESULTS: The f2 value of release data of borneol and total ginsenoside of the heart-protecting musk pH-dependent gradient-release pellets was 79.6 in the simulated gastrointestinal pH conditions. The gamma-scintigraphic trace evaluation demonstrated that the pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations can disintegrate in stomach, duodenum and jejunum or ileum. The gastrointestinal transit time of pellets was about 5 hours in fasted state and about 6 hours in fed state. The concentration-time curves of borneol of heart-protecting musk pills fit in two-compartment model. The pharmacokinetics data showed that borneol had a short time of absorption and elimination. The mean residence time (MRT) of borneol of heart-protecting musk pills was 2.61 hours. The plasma concentration of borneol of heart-protecting musk sustained-release capsule which consisted of three kinds of pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations was steadier than those of heart-protecting musk pills, its Cmax was lower than and Tmax was near to those of heart-protecting musk pills, its MRT was 4.0 hours, and its relative bioavailability was 96%. CONCLUSION: The lipidsoluble borneol and watersoluble total ginsenoside of heart-protecting musk pH-dependent gradient-release pellets can release simultaneously while sustained-releasing in vitro. The heart-protecting musk pH-dependent gradient-release pellets had the characteristics of pH-dependent gradient-releasing and disintegration while transiting in gastrointestinal tract. A characteristic of gradient sustained-release was shown in the concentration-time curves of borneol of heart-protecting musk sustained-release capsule in volunteers.

[Absorption and distribution of mercury and arsenic from realgar and cinnabar of angong niuhuang pill in normal rats and rats with cerebral ischemia].

OBJECTIVE: To study comparatively the characteristics of absorption and distribution of mercury and arsenic from realgar and cinnabar of Angong Niuhuang Pill in normal rats and the rats with cerebral ischemia after oral administration. METHOD: The blood samples and homogenates of liver, kidney and brain were prepared at various intervals after the animals were treated with Angong Niuhuang pill ig. The levels of total mercury and total arsenic in the blood and the organ homogenates were measured with Microwava Accelerated Reaction System and AAs, respectively. RESULT: The blood concentrations of mercury and arseic reached the highest point in normal rats at one hour following single oral dosing of Angong Niuhuang pill. In normal rats, the mercury distribution was characterized by its higher level in blood and kidneys than in other organs, while a higher distribution of arsenic was found in blood than in organs. No difference in the distribution of mercury or arsenic was found between normal rats and rats with cerebral ischemia after the treatment with the pill. CONCLUSION: The highest level of mercury or arsenic in blood occurs at one hour after oral administration of the pill in normal rats. There is a higher distribution of mercury in blood and kidneys, while a higher distribution of the arsenic only in blood. There is no significant difference in the distribution of mercury or arsenic between the normal rats and the ischemic rats.

Bioaccessibility of mercury in selected Ayurvedic medicines.

Five Ayurvedic medicines with mercury concentrations of 85mg/kg and higher were characterized with respect to their speciation and their bioaccessibility. X-ray absorption spectroscopy revealed that the mercury in the Ayurvedic medicines was inorganic and best matched to cinnabar, even in samples that had been hypothesized to contain mercury through plant sources only. The bioaccessibility (bioaccessible concentrations and percent bioaccessibility) was measured using two methods: a two-phase physiologically based extraction test (PBET gastric, G and gastric+intestinal phase, GI); and the fed organic estimation human simulation test (FOREhST). The percent bioaccessibility of mercury in all Ayurvedic samples was very low (<5%), corresponding to the low solubility of cinnabar, but it increased with increasing dissolved organic carbon content of the bioaccessibility solutions (PBET-G