Assessment of the 4-week repeated-dose oral toxicity and genotoxicity of GHX02.

Herbal medicines are widely utilized for disease prevention and health promotion. GHX02 consists of mixtures including Gwaruin (Trichosanthes kirilowii), Haengin (Prunus armeniaca), Hwangryeon (Coptis japonica) and Hwangkeum (Scutellaria baicalensis). It has been purported to have therapeutic effectiveness in cases of severe bronchitis. Non-clinical safety testing comprised a single-dose oral toxicity study and a 28-day repeated-dose oral toxicity study with a 14-day recovery period, and genotoxicity was assessed by a bacterial reverse mutation test, in vitro chromosomal aberration test, in vivo mouse bone marrow micronucleus test and single cell gel electrophoresis assay (comet assay). In the single-dose oral toxicity study, the approximate lethal dosage is estimated to be higher than 5000 mg/kg in rats. Thus, the dosage levels were set at 0, 1250, 2500 and 5000 mg/kg/day in the 28-day repeated-dose oral toxicity study, and 10 male rats and 10 female rats/dose were administered GHX02. No clinical signs of toxicological significance were recorded in any animal during the dosing and the observation period in the single-dose study. The no-observed-adverse-effect level of GHX02 was 5000 mg/kg/day when administered orally for 28 days to male and female Sprague-Dawley rats. Despite increases in the frequencies of cells with numerical chromosomal aberration in the in vitro test, the increases were not considered relevant to the in vivo genetic risk. Except for the increase of in vitro numerical chromosomal aberration, clear negative results were obtained from other genetic toxicity studies.

Comprehensive quality assessment for Rhizoma Coptidis based on quantitative and qualitative metabolic profiles using high performance liquid chromatography, Fourier transform near-infrared and Fourier transform mid-infrared combined with multivariate statistical analysis.

Rhizoma Coptidis (RC) originated from the dried rhizomes of Coptis herbal species is a widely used traditional Chinese medicine in history. In this study, a comprehensive quality assessment for RC medicines from C. chinensis, C. deltoidea, C. omeiensis and C. teeta species was performed based on quantitative and qualitative metabolic profiles obtained from high performance liquid chromatography (HPLC), Fourier transform near-infrared (FT-NIR) and Fourier transform mid-infrared (FT-MIR) combined with multivariate statistical analysis. Eight alkaloids including magnoflorine, groenlandicine, jatrorrhizine, columbamine, epiberberine, coptisine, palmatine and berberine were simultaneously identified and determined. Epiberberine, berberine, magnoflorine and groenlandicine were identified as possible index components. FT-NIR and FT-MIR profiles presented the holistic metabolic characterization of RC medicines. Principal component analysis (PCA) and hierarchical cluster analysis (HCA) were successively performed to clearly illustrate the metabolic variation and taxonomic relationship among four RC medicines. Additionally, taking berberine as an example, spectral quantification potential was investigated by referring HPLC data, using a conventional partial least squares regression (PLSR) algorithm. Data fusion strategy exhibited a better prediction for this compound than a single technique. Summary, these techniques can complement each other and provide a comprehensive and effective quality assessment for RC originated from different Coptis plants.

Assessment of the embryotoxicity of four Chinese herbal extracts using the embryonic stem cell test.

Rhizoma Atractylodes macrocephala, Radix Isatidis, Coptis chinensis and Flos Genkwa are common herbal remedies used by pregnant woman in China. In this study, their potential embryotoxicity was assessed using the embryonic stem cell test (EST) and a prediction model. The potential embryotoxicity of the herbs was based on three endpoints: the concentrations of the compounds that inhibited the proliferation of 50% of embryonic stem cells (ESCs) (IC50ES), the concentrations that inhibited 50% of 3T3 cells (IC503T3), and the concentrations that inhibited the differentiation of 50% of ESCs (ID50ES). The results revealed that Rhizoma Atractylodes macrocephala and Radix Isatidis are non-embryotoxic compounds. Coptis chinensis extracts appeared to demonstrated weak embryotoxicity, and Flos Genkwa exhibited strong embryotoxicity. These results may be useful in guiding the clinical use of these herbs and in expanding the application of the EST to the field of traditional Chinese medicine.

Assessment of the anti-diarrhea function of compound Chinese herbal medicine Cangpo Oral Liquid.

BACKGROUND: Diarrhea is a big problem in piglets. Cangpo Oral Liquid (COL) is a compound of Chinese herbal medicine. The preparation was fed to piglets had diarrheal disease in order to determine its anti-diarrhea activity and potential applications in vivo. MATERIALS AND METHODS: The contents of Berberine hydrochloride, Magnolol and Honokiol in COL were performed on HPLC analysis. Organ bath was used to investigate the effect of COL on peristaltic reflexes and peristaltic waves in vitro. And anti-diarrhea activity of COL was evaluated in clinical. RESULTS: Thin layer chromatography (TLC) and HPLC analyses showed that the contents of Berberine hydrochloride, Magnolol and Honokiol in COL were 970µg/mL, 130µg/mL and 300µg/mL, respectively. Administration of the COL to the organ bath caused a concentration-dependent inhibition of intestinal peristalsis. When the COL concentration in the bath was cumulatively increased, the amplitude and frequency of the peristaltic waves was lowered. The result of clinical efficacy of COL was very effective to diarrheic piglets. COL can possibly inhibit the curve of peristaltic waves in vitro; and clinical trial showed a statistically significant therapeutic effect in vivo. CONCLUSION: In conclusion, COL can be used as an effective therapeutic agent. However, the ingredients, pharmacokinetics and specific signaling pathways of COL need to be further studied.

Bear bile: dilemma of traditional medicinal use and animal protection.

Bear bile has been used in Traditional Chinese Medicine (TCM) for thousands of years. Modern investigations showed that it has a wide range of pharmacological actions with little toxicological side effect and the pure compounds have been used for curing hepatic and biliary disorders for decades. However, extensive consumption of bear bile made bears endangered species. In the 1980's, bear farming was established in China to extract bear bile from living bears with "Free-dripping Fistula Technique". Bear farming is extremely inhumane and many bears died of illness such as chronic infections and liver cancer. Efforts are now given by non-governmental organizations, mass media and Chinese government to end bear farming ultimately. At the same time, systematic research has to be done to find an alternative for bear bile. In this review, we focused on the literature, laboratory and clinical results related to bear bile and its substitutes or alternative in English and Chinese databases. We examined the substitutes or alternative of bear bile from three aspects: pure compounds derived from bear bile, biles from other animals and herbs from TCM. We then discussed the strategy for stopping the trading of bear bile and issues of bear bile related to potential alternative candidates, existing problems in alternative research and work to be done in the future.

[Quality assessment for Coptis chinensis with different cultivating system].

OBJECTIVE: To evaluate the quality of Coptis chinensis planted with four kinds of cultivating system. METHOD: The samples, which were planted below the artificial shading, the forest of Chinese ceder wood, Mmulbery wood, Magnolia officinal wood were chosen respectivley, UV and HPLC were used to determine of total alkaloids and berberine of samples. RESULT: There was no significant difference among four kinds of cultivating system on the contents of total alkaloids and berberine. The contents of total alkaloids and berberine were obviously higher than in the criterion of Chinese Pharmacopoeia. CONCLUSION: The roots of C. chinensis planted in the four kinds of planting system can be used as medicinal material of high quality.

[Quality assessment of Coptis chinensis in China].

OBJECTIVE: To study the dynamic change of the ingredients of Coptis chinensis and evaluate the quality of the crude drugs from main producing areas. METHOD: The ingredients of samples from Shizhu and Wuxi counties in Chongqing, Hongya and Dayi counties in Sichuan, Zhenping county in Shanxi, Lichuan county in Hubei were analyzed for berberine, coptisine, jatrorrhizine, palmatine and the total alkaloids by HPLC and UV methods. RESULT AND CONCLUSION: The contents of measured indexes were mostly highest in 5-years-old C. chinensis. Considering factors such as the yield, it is reasonable to harvest the 5-years-old C. chinensis. There are minor differences in condents of C. chinensis from different areas, all tested samples met the pharmacopoeial standards. It is concluded that the general quality of C. chinensis was good and acceptable.

[Quality assessment for Coptis chinensis planted with ecological techniques].

OBJECTIVE: To evaluate the quality difference between Coptis chinensis planted with ecological techniques and shelf planted Coptis chinensis. METHODS: Ultraviolet-visible spectrophotometry, alcohol extract mensuration, moisture mensuration, and ash mensuration were used to determine the contents of total alkaloids, alcohol extract, water, and total ash of Coptis chinensis, which were planted in shelf, Rhus chinensis wood, M mulbery wood, corn wood, Magnolia officinalis wood, fruiter wood, shading net, and firry wood, respectively. RESULTS: The contents of total alkaloids and alcohol extract of Coptis chinensis Table planted with ecological techniques were higher than those of Coptis chinensis planted in shelf. The contents of water and total ash were less than 12% and 5%, respectively, which met the provisions of the pharmacopoeia. CONCLUSION: The quality of Coptis chinensis planted with ecological techniques is similar to that of Coptis chinensis planted in shelf. These ecological techniques for Coptis chinensis have become mature and practical.

[Analysis and assessment of Coptis chinensis for different parts, ages, and heights using Fourier transform infrared spectroscopy].

OBJECTIVE: To study the infrared (IR) fingerprint spectra of Coptis chinensis for different parts, ages, and heights, and to analyze the integrate rules about the content of berberine component in Coptis chinensis for different parts, ages, and heights. METHOD: The Fourier transform infrared (FTIR) spectroscopy was applied to detect the infrared spectra of Coptis chinensis samples rapidly and non-separately. RESULTS: The IR spectra of the root, leafstalk, and fibre of Coptis chinesis have their unique features. The content of berberine component in Coptis chinensis was different for different parts and the sequence: root > leafstalk > fibre. When Coptis chinensis grows, the content of berberine component in leafstalk also increases. The content of berberine component in leafstalk which planting in 1 200 m was less than that in 1 300, 1 400, and 1 500 m. The ages and heights provide no obvious influences on the content of berberine in the root of Coptis chinensis. CONCLUSION: Using FTIR spectroscopy, the quality of Coptis chinensis can be controlled, which provides a useful method for the standardized planting of Coptis chinensis.