Safety Evaluation of a Standardized <i>Macleaya cordata</i>Extract in a Ninety Day Feeding Study in Weaned Piglets

The aim of this study was to assess the effects of Sangrovit?, a standardized preparation of Macleaya cordata extract (MCE), on the health status and performance in weaned piglets. A total of 128 weaned piglets were randomly divided into four groups (n = 32, 16/sex/group) and fed either a control feed (T1) or the control feed supplemented with 100 mg/kg (T2), 500 mg/kg (T3), or 1000 mg/kg (T4) Sangrovit? (resulting in 0, 3.5, 17.5, 35 mg MCE/kg feed, respectively) for ninety days. The parameters for growth and health status were evaluated during the trial and blood was collected on Day 0 and Day 91 for hematology and biochemistry analysis. After the animals were sacrificed, the weight of the major organs and tissues was measured and histopathological examination on the organs from 8 animals in each group (4/sex/group) was performed. The results showed no statistically significant differences in live weight, feed intake, and average daily weight gain between the treatment and control groups. The feed containing 100, 500, or 1000 mg/kg Sangrovit? was well tolerated by piglets, with no adverse effects noted during the feeding period or in the histopathological results. The majority of the hematological and blood biochemistry parameters displayed no significant changes between the control and treatment groups. Compared to the control group, some hematological parameters including MCV, platelets concentration, and APTT were modified in some but not all treatment groups. Some significant changes in the blood biochemistry parameters were found in the treatment groups including levels in bile acid, haptoglobin, total serum protein, and GTT, as well as creatine kinase activity, but those changes were not toxicologically significant because no observed changes were seen in other similar biomarkers. In sum, this study demonstrated that the addition of Sangrovit? to swine feed at up to 1000 mg/kg does not result in any toxicological effects to the health status and growth of weaned piglets.

Residue Study for a Standardized <i>Macleaya cordata</i>Extract in Growing-Finishing Swine

The aim of this study was to assess the effects of Sangrovit&reg;, a standardized preparation of Macleaya cordata extract (MCE), on the health status and retained residues in growing-finishing swine. A total of twelve growing-finishing swine (n = 6 for each group) were randomly divided into two groups and fed either a control feed or the control feed supplemented with 100 mg/kg Sangrovit&reg;(3.5 mg/kg MCE) for 28 days. The parameters for growth and health status were evaluated during the trial and after which the animals were slaughtered. Residual levels of MCE in swine organs and tissues were determined by measuring sanguinarine and chelerythrine levels by LC-MS/MS. The results showed no statistically significant differences in live weight, feed intake and average daily gain between the treatment and control groups. The feed supplemented with 100 mg/kg Sangrovit&reg;was well tolerated by the swine, with no adverse effects noted during the feeding period or in the necropsy results. Residue analysis indicated that levels of sanguinarine or chelerythrine were under the limit of detection in all the examined tissues and organs from the treated swine. This study demonstrates that Sangrovit&reg;, a standardized preparation of MCE when fed to growing-finishing swine for 28 days, at the level of 100 mg/kg in feed, does not result in sanguinarine or chelerythrine residues in the organs or tissues.

Tolerance Study for Standardized <i>Macleaya cordata</i>Extract Added to Chicken Layer Diet

The objective of this study was to assess the effects of Sangrovit?, a standardized preparation of Macleaya cordata extract (MCE), on the health status and egg laying parameters of layer chickens. Layer chickens (N = 360) were randomly divided into four groups (90 birds/treatment, 10 birds/pen) and fed either a standard basal feed (T1) or a basal diet that was supplemented with 100 mg/kg (T2), 500 mg/kg (T3) or 1000 mg/kg (T4) Sangrovit? (providing 0, 3.7, 18.5, and 37.0 mg MCE/kg feed, respectively) for 56 consecutive days. Live Weight (LW), Average Daily Feed Intake (ADFI) and the Feed Conversion Ratios (FCR) were calculated during the study, and biochemical and hematological endpoints were obtained at the end of the study (Day 56). Eggs were analyzed for the isoquinoline alkaloids sanguinarine and chelerythrine. No statistically significant (P > 0.05) differences were found between control and treatment groups for LW, ADFI and FCR. There was a significant increase in the % laying in groups T3 and T4 for the study overall, but no significant differences in egg size during the study. Blood biochemical analyses showed a near-significant trend for decreased bilirubin in the T2 and T4 groups, but this was not dose-dependent and not considered treatment-related. The percent hemoglobin was significantly decreased in the high dose group, but was not considered treatment-related as it was not a dose-dependent effect. No treatment-related changes were found after necropsy of the selected organs. No quantifiable sanguinarine or chelerythrine was found in the eggs after 56 days administration of the MCE preparation to the hens. The results of this study show that consumption of a standardized MCE preparation at up to 1000 mg/kg feed in laying hens had no adverse effect on the hen or eggs, and no residual sanguinarine or chelerythrine was transferred to the eggs.