Toxicological Studies On The Safety Of Cistanche Deserticola Extract Ⅱ

2 Results

2.1 Acute oral toxicity test in rats

The rats' activities, eating, and drinking were normal during the entire test period, and the feces were normal. No obvious behavioral changes and poisoning symptoms were observed, and no animal deaths were observed. At the end of the test, the animal body weight increased significantly. The acute oral LD50 of Cistanche deserticola extract for SD female and male rats was >10.0g/kg·bw, which is actually non-toxic.

NATURAL CISTANCHE FOR KIDNEY DISEASE

2.2 Ames test

The results of the positive control test of this Ames test are reliable. The number of reverted mutant colonies of each dose of Cistanche deserticola extract for each experimental strain with or without the addition of S9 metabolic activation system did not exceed 2 times the number of spontaneous reverted mutant colonies, and there was no dose-response relationship. It can be considered that Cistanche deserticola extract has no genetic toxicity in the Ames test.

2.3 Mouse bone marrow polychromatic erythrocyte micronucleus test

As shown in Table 1, the micronucleus rates of female and male Kunming mice in the positive control group were 28.2‰ and 26.2‰, respectively, and the test results were reliable. Compared with the solvent control group, there was no statistically significant difference in the micronucleus rates of female and male mice in each dose group (χ2 = 3.036, 1.755, both P>0.05). Under the conditions of this experiment, Cistanche deserticola extract had no ability to induce an increase in the micronucleus rate in the mouse bone marrow.

Table1 The effect of Cistanche deserticola extract on micronucleus rate in mouse

2.4 In vitro mammalian cell chromosome aberration test

As shown in Table 2, the chromosome aberration rates of CHL cells in the positive control groups [methyl methanesulfonate (MMS) and cyclophosphamide (CP)] were 17.0% and 12.0%, respectively, which were statistically significant compared with the corresponding solvent control groups (χ2 = 13.244, 9.955, P<0.05). The chromosome aberration rates of CHL cells in the Cistanche deserticola extract groups were 1.0%, 2.0%, 2.0% and 0%, 1.0%, 1.0%, respectively, which were not statistically significant compared with the corresponding solvent control groups (χ2 = 0.436, 1.008, both P>0.05). Under the conditions of this experiment, Cistanche deserticola extract did not cause an increase in the chromosome aberration rate of CHL cells.

Table2 The effect of Cistanche deserticola extract on chromosome aberration rate of CHL cells

Table3 The effect of Cistanche deserticola extract on blood routine indicators of rats (x ±s,n = 10)

Table The effect of Cistanche deserticola extract on biochemical indexes of rats (x ±s,n = 10)

2.5.3 Results of organ weight and organ coefficient The weight and organ coefficient of the liver, kidney, spleen and testis of rats were normal. See Table 5.

Table The effect of Cistanche deserticola extract on viscera weight and viscera coefficient of rats (x ±s,n = 10)

2.5.4 Histopathological examination

Obvious necrosis was found in the liver of one male rat in the solvent control group, and mild vacuolar degeneration was found in the liver of one male rat in the high-dose group. No obvious abnormalities were found in the other animals in the high-dose and positive control groups, indicating that Cistanche deserticola extract had no pathological changes in rat organs[9].

3 Discussion

Cistanche deserticola extract contains a variety of effective active ingredients with a variety of health functions, among which galactitol has a laxative effect[10] and polysaccharides have a cellular immune function regulation effect[11]. Although Cistanche deserticola has health functions such as liver protection and anti-oxidation[12-13], there is currently a lack of systematic safety toxicology research. In order to understand the edible safety of Cistanche deserticola extract, this study conducted a toxicological evaluation on it.

General toxicity refers to the systemic toxicity of foreign substances in the environment to the body. According to the contact and duration of the foreign substances on the body, it can be divided into acute toxicity tests, short-term toxicity tests and long-term toxicity test. A toxicity test is a comprehensive method for detecting toxic effects. Genotoxicity refers to the special toxic effects of foreign substances on the body. According to the toxic endpoints of toxicity test, it can be generally divided into gene mutation test, chromosome aberration test and primary DNA damage, etc. [14-15].

Studies have shown [16] that allantoin extract from Cistanche deserticola has no general toxicity and genotoxicity, and is a non-toxic substance with high food safety. In the animal toxicity test of allantoin extract from Cistanche deserticola, only acute toxicity test and 30-day feeding test were carried out, and no longer-term safety evaluation was conducted. In this study, a 90-day feeding test with a longer administration time was used to evaluate the safety of Cistanche deserticola extract, and the administration method was more accurate in dose calculation. The selected administration dose was significantly increased. By changing the research test conditions and methods, the food safety of Cistanche deserticola extract was further evaluated.

The results of this study showed that the oral LD50 of Cistanche deserticola extract for rats was greater than 10.0 g/kg·bw, which is a practically non-toxic level. The results of the three mutagenicity tests were all negative, indicating that under the test conditions, Cistanche deserticola extract had no damaging effect on mammalian somatic cell chromosomes and genes, and Cistanche deserticola extract had no genotoxicity [17-18], which is consistent with the results of the literature.

During the test, the rats grew and developed normally. The rats were fed with Cistanche deserticola extract for 90 consecutive days, and their blood routine and biochemical indicators were normal. At the end of the test, the weight and organ coefficient of the rats' liver, kidney and spleen were normal compared with the control group, and no sample-related lesions were found in the histopathological examination. The 90-day oral toxicity test of rats showed that the animals did not show obvious poisoning reactions after continuous intake of a certain dose of Cistanche deserticola extract for a long time.

This experiment studied the general toxicity and genetic toxicity of Cistanche deserticola extract on animals and found that it has good safety within the recommended dosage range, and further functional research can be carried out[19].

References

[1] Wang Nan, Gao Taixiang, Zhang Hongxiong, et al. Determination of active ingredients in tranquilizing and sleeping tea and safety evaluation[J]. Journal of Central South Pharmacy, 2023, 21(9): 2322-2327.

[2] Wang FJ, Li RY, Tu PF, et al. Total glycosides of Cistanche deserticola promote neurological function recovery by inducing neurovascular regeneration via Nrf- 2 / Keap - 1 pathway in MCAO/ R rats[ J] . Front Pharmacol, 2020, 11: 236.

[3] Guo Meng, Huang Yong, Chen Xin, et al. Analysis of mineral element distribution characteristics of different germplasms of Cistanche deserticola by ICP-MS[J]. Spectroscopy and Spectral Analysis, 2022, 42(8): 2452-2455.

[4] Zhang X,Zheng FJ,Zhang Z. Therapeutic effect of Cistanche deserticola on defecation in senile constipation rat model through stem cell factor/ C-kit signaling pathway[J]. World J Gastroenterol,2021,27(32):5392-5403.

[5] Wang C,Li F,Li Y, et al. Cistanche deserticola for regulation of bone metabolism: Therapeutic potential and molecular mechanisms on postmenopausal osteopor osis[J]. Chin J Integr Med,2023,29(1):74-80. (page 989)