scholarly journals SAFETY EVALUATION OF DE-020 EYE DROPS : Eye irritation test and subacute toxicity test in rabbits

1980 ◽  
Vol 5 (1) ◽  
pp. 79-89
Author(s):  
Yoshitame YAMAMOTO ◽  
Yuko KITAJIMA ◽  
Masayuki NOMURA
PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0249356
Author(s):  
Jun Wu ◽  
Ying Zhang ◽  
Zhongming Lv ◽  
Ping Yu ◽  
Weiqing Shi

Aloe vera has been widely used in health and nutritional supplements in Chinese herbal medicine. Furthermore, Aloe vera production has been an emerging industry for making cosmetics and functional food. However, the reported adverse effects raised questions as to whether Aloe vera and its products were safe enough to be used in medicine and health care. In view of this, the safety evaluation of Aloe vera products before marketing is very important. The present study aimed to assess the toxicological profile of Aloe vera soft capsule (ASC), through acute, subacute toxicity and genotoxicity tests. Male and female ICR mice were received by oral gavage 15000 mg/kg bodyweight of ASC in the acute toxicity test. Male and female SD rats were fed on diet blended with different doses of ASC (equivalent to 832.5, 1665 and 3330 mg/kg bodyweight of ASC) for the subacute toxicity test. In the acute toxicity study, no mortality or behavioral changes were observed, indicating the LD50 was higher than 15000 mg/kg bodyweight. In the subacute toxicity test, no significant changes were observed in bodyweight, food consumption, hematological, biochemical or histopathological parameters in the rats exposed. These data suggested that ASC used in this study did not produce any marked subacute toxic effects up to a maximum concentration of 3330 mg/kg bodyweight. In the genotoxicity study, ASC showed no mutagenic activity in the Ames test and no evidence of potential to induce bone marrow micronucleus or testicular chromosome aberrations in ICR mice exposed to 10000 mg/kg bodyweight. Collectively, ASC could be considered safe before it was marketed as a laxative and moistening health food.


2008 ◽  
Vol 36 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Markus Frentz ◽  
Miriam Goss ◽  
Martin Reim ◽  
Norbert F. Schrage

The prediction of side-effects is a key issue in the REACH initiative on chemicals, in the production of cosmetics and in the preclinical testing of drugs. A new ex vivo test for repeated substance application is presented, that is able to identify corrosive and irritant effects on the eye by using crucial endpoints, such as cellular and morphological damage, and healing characteristics. The test is intended to replace the Draize eye test and to improve the preclinical testing of drugs and chemicals that are likely to come into direct contact with the cornea. The Ex Vivo Eye Irritation Test (EVEIT) is a self-healing system, involving living corneas obtained from abattoir rabbit eyes. The corneas are cultured in a similar way to the method used during the transplantation of corneal grafts. The corneas are exposed to multiple small, mechanical abrasions, and then test substances are repeatedly dropped onto the centres of the corneas. The test substances applied in this study were citrate-buffered hyaluronate eye drops and an artificial tear replacement, with increasing concentrations of up to 0.1% benzalkonium chloride. A dose-dependent inhibition of recovery and impairment of the lactate production mechanism in the cornea was observed with benzalkonium chloride treatment.


1994 ◽  
Vol 8 (4) ◽  
pp. 715-717
Author(s):  
S.A. Martin ◽  
T.A. Roy ◽  
K.A. Saladdin ◽  
B.A. Fleming ◽  
C.R. Mackerer

2021 ◽  
Author(s):  
Wenqing Wu ◽  
Wenxuan Cao ◽  
Ye Cai ◽  
Menghe Zhang ◽  
Tiantian Chen ◽  
...  

Abstract The purpose of this article is to develop an in-situ liquid crystal gel that can be used as a novel ocular delivery system for pilocarpine nitrate (PN). The phytantriol (PT) -based in situ liquid crystal gels were prepared by a vortex method using PT, PEG400, Triglyceride (TAG) and water (in the ratio of 61.15:30:3.85:5, w/w). Firstly, the internal structure of the PN-loaded liquid crystal gel was characterized by polarizing microscope (PLM), small-angle X-ray scattering (SAXS), differential scanning calorimetry (DSC) and rheology. In vitro drug release behavior and ex vivo corneal permeation were investigated. Finally, eye irritation test,preocular residence time evaluation,were studied in vivo and compared with eye drops.Based on various characterization techniques, it is proved that the internal structure of the gel is a hexagonal phase.In vitro release results identified that PN could be released continuously from HII gel over a period of 24 h. The in vitro obvious permeability coefficient of HII gel was 3.19-fold (P < 0.01) higher than that of the eye drops. Compared with eye drops,the HII gel had good bioadhesion and displayed longer residence time on the eyeballs surface using fluorescent labeling technology.In addition, through Corneal hydration level and eye irritation test ., it is conjectured that HII gel will not cause eye irritation. In short, the formulation has the advantages of high efficiency, slow release and non-toxicity, and will become a promising pharmaceutical strategy to improve the efficacy of glaucoma.


2021 ◽  
Author(s):  
Yongchun Li ◽  
Hui Zhang ◽  
Shanshan Chen ◽  
Liutao Zhao ◽  
Jie Wu ◽  
...  

Abstract Qing Hao Gan Cao (QHGC), a Chinese medicinal formula containing Artemisia annua and Glycyrrhizae Radix et Rhizoma, has been used to treat sunstroke and as an antiviral agent for more than 800 years. It has not previously been subject to a toxicological safety evaluation in acute and subacute (28 days) studies. Therefore, the acute and subacute toxicity of an aqueous extract of QHGC were evaluated in vivo. For the QHGC preparation, the botanical raw materials were crushed into pieces and mixed in the ratio of 10:1 in distilled water for 12 h, then boiling three times for 2 h each time. The three decoctions were mixed and filtered, then spray-dried with hot air at 160°C for 30 min, and stored at room temperature. For the acute toxicity test, 72.0 g/kg of QHGC extract was administered by gavage to male and female mice. Body weight, general observations, and autopsy results were recorded. No mortality or toxicity signs were observed during the studies. For the subacute toxicity test, 4.0, 8.0, or 16.0 g/kg/day of QHGC extract was administered to rats for 28 days. General observations and mortality, body weight, biochemical and hematological parameters, organ weight, and pathological morphology were analyzed. The acute and subacute toxicity studies did not show significant changes in body weight, general observations, hematology and biochemical parameters, organ weight, and liver, spleen, stomach, duodenum, testis, ovary, lung, heart, and kidney histopathological analyses. The consumption of QHGC aqueous extract can be considered safe within the conditions of this study.


1995 ◽  
Vol 26 (1) ◽  
pp. 20-31
Author(s):  
J. F. SINA ◽  
D. M. GALER ◽  
R. G. SUSSMAN ◽  
P. D. GAUTHERON ◽  
E. V. SARGENT ◽  
...  

1998 ◽  
Vol 12 (4) ◽  
pp. 455-461 ◽  
Author(s):  
M. Stern ◽  
M. Klausner ◽  
R. Alvarado ◽  
K. Renskers ◽  
M. Dickens

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