Repeated-dose (28 days) oral toxicity study in rats of an antiacne formula (BC-AF) derived from plantsby Shengli Li, Yingshu Zou, Kun Jiao, Xin Qiao, Ray Jiao, Ju Wang

Drug and Chemical Toxicology

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Introduction

Acne is one of the most prevalent skin conditions, affecting 85% of individuals 12–24 years of age (Reich et al., 2007). Moreover, if left untreated, acne often has serious physical and psychological consequences, including permanent scarring, disfigurement, anxiety, and depression (Henkel et al., 2002;

Katsambas and Papakonstantinou, 2004). Current mainstream acne treatment, including retinoids, antimicrobials, and hormonal therapy, have some effect. However, side effects, such as irritation, premature skin aging, mood swings, weight gain, and development of drug resistance, etc. (Thielitz and

Gollnick, 2009), can become big issues in long-term use or for prophylactic use, especially for people who are prone to relapse.

Recently, some cosmetic acne products that combine natural ingredients with examples of BC-AF have emerged on the market, but there are few oral complementary botanical products available that are designed to manage acne effectively following oral admisistration.

BC-AF is an oral antiacne herbal formula composed from danshen, loquat leaf, and Chinese licorice extracts at a specific ratio of 5:3:2. The formulation of

BC-AF is based on both traditional applications and modern scientific studies. Danshen (the root of Salvia mitiorrhiza Bunge (Labiatac)) is widely used in traditional Chinese medicine (TCM) as a heat-clearing, detoxicating medicinal. The clinical applications of its fatty-soluble components are very well documented (Wang et al., 2007; Weckesser et al., 2007).

Danshen contains tanshinones, which are considered to be the active compounds, and over 30 tanshinones have been isolated and identified from this fraction (Cai et al., 2002). Total tanshinone (TS) has been reported to have antibacterial activities against

Propionobacterium acnes, which is the closest related strain to acne, as well as against Staphylococcus aureus

Drug and Chemical Toxicology, 2010; 34(1): 77–84

R E S E A R C H A R T I C L E

Repeated-dose (28 days) oral toxicity study in rats of an antiacne formula (BC-AF) derived from plants

Shengli Li, Yingshu Zou, Kun Jiao, Xin Qiao, Ray Jiao, and Ju Wang

Department of Laboratory Animal Sciences, Capital Medical University, Beijing, China

Abstract

To evaluate the safety of a formula (BC-AF) consisting of the extracts of danshen (Salvia miltiorrhiza), loquat leaf (Glycyrrhiza uralensis), and licorice (Eriobotrya japonica), a preliminary 28-day, repeated-dose oral toxicity study was performed in Sprague-Dawley rats. Eighty animals were divided into four groups, with each group comprising 10 male and 10 female rats. BC-AF was administered once-daily by oral gavage at doses of 0 (control), 2.5 (low), 5 (middle), and 10 (high) g/kg body weight successively for each group for 28 days, respectively. Rats in all groups were sacrificed on day 29, except half of the males and females in the highdose group that were kept for an additional 2 weeks to observe any possible toxicity after drug withdrawal.

In 4 weeks, there were no toxicity reactions or abnormal deaths in any animal groups. There was no significant difference, in comparison to the control group, in clinical signs, organ weights, hematological and serological parameters, or histopathologic findings. In conclusion, the 28-day repeated-dose oral toxicity study demonstrates that BC-AF produced no effects in either male or female rats following oral administration of up to 10 g/kg.

Keywords: BC-AF; Salvia miltiorrhiza; Glycyrrhiza uralensis; Eriobotrya japonica; repeated-dose toxicity

Address for Correspondence: Ju Wang, Department of Laboratory Animal Sciences, Capital Medical University, No. 10 Xitoutiao, Beijing 100069, China.

Fax: (+8610) 83911685; E-mail: lilaoshi@ccmu.edu.cn (Received 28 January 2010; accepted 12 March 2010)

ISSN 0148-0545 print/ISSN 1525-6014 online © 2010 Informa Healthcare USA, Inc.

DOI: 10.3109/01480541003777450 http://www.informahealthcare.com/dct

Drug and Chemical Toxicology 1 2010 77 34 84 0148-0545 1525-6014 © 2010 Informa Healthcare USA, Inc. 10.3109/01480541003777450 28 January 2010 12 March 2010 00 00 0000

DCT 478267

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L ib ra rie s o n 12 /2 7/ 14

Fo r p er so na l u se o nl y. 78 Shengli Li et al. (Xu et al., 2007; Wang, 1983). Loquat leaf (Eriobotrya japonica (Thunb.) Lindl) is usually used in TCM remedies to treat respiratory disease, such as the cough, and now it is also used to alleviate skin disorders.

Ursolic acid is a well-known cosmetic ingredient obtained from loquat leaf extract and has been long recognized to have anti-inflammatory properties (Tsai and Yin, 2008) and can also inhibit the action of the enzyme, elastase, leading to protection of the structural proteins in the skin (Ying et al., 1991). The extract of Chinese licorice (Glycyrrhiza uralensis Fisch) has a wide variety of applications, as both a health food and a drug, in Asian and European traditional medicines.

In TCM, Chinese licorice is used in almost all remedies for the purpose of “harmonizing” ingredients within a formula. At the same time, Chinese licorice can modulate the body’s endocrine system, as it contains isoflavones (phytoestrogens) (Thompson et al., 2007). These flavanoides can also be useful in alleviating postinflammatory hyperpigmentation (PIH) and melasma (Armanini et al., 2003; Nomura et al., 2002;

Baumann et al., 2006).

The daily dose of danshen extract, as recommended by a TCM formula known as “tanshinone capsules” for acne treatment, was 3–4 g per day (tanshinone capsules, containing 228–304 mg cryptotanshinone as its active compound; Chinese Pharmacopoeia

Commission, 1998). In spite of its clear efficacy (Wang and Liu, 1980), some allergic reactions have been observed, which may be due to the large dose used and which may restrict its application. The combination of the three herbs in BC-AF aims to, while maintaining efficacy, reduce the dose to its minimum (i.e., 1–2 g daily) to achieve a wider safety window and ensure safe, long-term use. A volunteer consumption study has shown encouraging results against acne, with no reported side effects.