Maytenus ilicifolia

Maytenus ilicifolia (Espinheira-Santa): A Comprehensive Reference

1. Identity, Taxonomy, and Botanical Description

Monteverdia ilicifolia (Mart. ex Reissek) Biral, family Celastraceae (synonym: Maytenus ilicifolia Mart. ex Reissek), is used in Brazil as a folk medicine to treat gastrointestinal disorders. The species is most widely known and cited in the scientific literature under its former binomial, Maytenus ilicifolia Mart. ex Reissek, a name retained throughout this article for consistency with the published research base.

The species carries several synonyms in older nomenclature, including Maytenus officinalis, Maytenus muelleri, Maytenus macrodonta, Maytenus castaneiformis, and Maytenus castaneaeformis.

A large number of studies on M. ilicifolia are found in the literature, making it one of the most commonly used species in its genus; commercial herbal medicines prepared from this species are already available for the treatment of gastric ulcers. It is native to the southern part of Brazil, Paraguay, Uruguay, and northern Argentina.

It is a medium-sized shrub or small tree that can reach heights of up to 5 meters. Its leaves are elliptical or lance-shaped, characterized by their serrated edges that resemble the shape of holly. The plant produces small, inconspicuous flowers that later develop into red berries.

Common vernacular names include:

• Espinheira-santa, erva-cancerosa, espinho-de-deus, and salva-vidas (Brazil)
• Cancorosa, espinheira-divina, and erva-santa (also used in South America, in reference to the spiny leaf margins)

2. Regulatory and Pharmacopeial Status

M. ilicifolia, known as "espinheira-santa," has been widely used in Brazil to manage mainly gastrointestinal diseases. This species has been listed in the Brazilian Pharmacopeia and in the National List of Essential Medicines (RENAME).

The presence of terpenes and polysaccharides has also been described in the literature for this species. It is important to note that this species is presented in the National List of Essential Medicines published by the Brazilian Health Ministry, including some pharmaceutical forms which need to be analyzed carefully.

3. Traditional and Historical Use

Maytenus ilicifolia Mart. ex Reiss is a plant native to South America, popularly used in the treatment of gastric disorders. The historical record of its use is more extensively documented in urban South American herbal practice than in Amazonian or strictly indigenous tribal contexts.

Espinheira-santa has a much longer and better-documented history of use in urban areas and South American herbal medicine practices than in tribal areas, probably because of the types of illnesses it treats. In Brazil, the leaves of the plant are brewed into a tea for the treatment of ulcers, indigestion, chronic gastritis, and dyspepsia.

Numerous medicinal uses are associated with Maytenus genus species, with the use of roots, barks, and leaves for the treatment of gastric ulcers, anti-inflammatory, analgesic, anti-allergy, and antitumor purposes in South America.

It has been used by some native groups in Paraguay, where women use the plant as a contraceptive and fertility regulator, and to induce menstruation and abortions. Espinheira-santa has a much longer and better-documented history of use in urban areas and South American herbal medicine practices.

In southern South America, the leaves are seen as anodyne, antacid, antiasthmatic, anticancer, anti-inflammatory, antiseptic, antiulcer, blood purifier, carminative, depurative, digestive, diuretic, emmenagogue, mildly laxative, and stomachic.

Traditional preparations center primarily on the leaves:

• Infusions (teas): Dry leaves, prepared by infusion or decoction, have been traditionally used in Brazilian herbal medicine.
• Hydroalcoholic extracts and tinctures: documented in both folk and commercial preparations across the region.

4. Key Constituents and Phytochemistry

The health benefits derived from consuming M. ilicifolia have been attributed to its high content of phenolic compounds, such as flavonoids, and the corresponding condensed tannins. The presence of other classes of active molecules including terpenes and polysaccharides has also been described in the literature.

4.1 Flavonoids and Condensed Tannins

HPLC-ESI-MS/MS characterization of the hydroethanolic extract demonstrated the presence of polyphenols represented by tannins (Type B proanthocyanidin dimers and trimers) and flavonoids including (epi)gallocatechin, (epi)catechin, epiafzelechin, quercetin-rutinoside-glucoside, quercetin rhamnosylrutinoside, quercetin-glucoside, and kaempferol-glucoside.

Among the secondary metabolites, the triterpenes, flavonoids, and tannins group's components are especially highlighted. The pharmacological effects have been attributed to polyphenolic compounds, triterpenes, tannins, flavonoids, gallic acid, and caffeic acid, exhibiting a variety of modes of action.

A particularly notable flavonoid-related finding comes from leaf fractions: chemical investigation of the flavonoid-rich fraction showed galactitol (25%), epicatechin (3.1%), and catechin (2%) as the major components.

4.2 Quinonemethide Triterpenes

The most commonly found bioactive metabolites in root bark extracts of Celastraceae species are quinonemethide triterpenes (QMTs) and sesquiterpene pyridine alkaloids (SPAs). Quinonemethide triterpenes display cytotoxic, anti-ulcerogenic, and antioxidant effects, as well as anticancer activity against different human cancer cell lines.

Key QMTs isolated from M. ilicifolia root barks include maytenin and pristimerin.

4.3 Sesquiterpene Pyridine Alkaloids

The sesquiterpene pyridine alkaloids (SPAs) display insect antifeedant, insecticidal, cytotoxic, immunosuppressive, anti-HIV, antiprotozoal, anti-hepatitis C, and antitumor activities.

4.4 Maytansinoids

A large variety of biologically active secondary metabolites have been isolated from Maytenus species, including a series of triterpenoids such as friedelane triterpenoids, lupane triterpenes, oleanane triterpenes, sesquiterpenes, and their alkaloids. Between 1976 and 2021, nearly 270 new compounds were isolated and elucidated from the genus Maytenus. Among these, maytansine and its homologues are extremely rare in nature.

Early research performed in Brazil in the early 1970s revealed that espinheira-santa, as well as a few other species in the Maytenus family, contains maytansinoid chemical compounds that showed potent antitumor and antileukemic activities in vivo and in vitro at very low dosages. In a 1976 plant screening program by the National Cancer Institute, an alcohol and water extract of the leaves was documented with toxicity to cancer cells at very low dosages, and U.S. and European pharmaceutical companies began to show interest in it.

4.5 Polysaccharides

The leaf tea (infusion) of M. ilicifolia has yielded a polysaccharide after several purification steps. It consisted of arabinose, galactose, galacturonic acid, 4-O-methylglucuronic acid, rhamnose, and glucose. Structural analysis indicated it is a Type II arabinogalactan containing a (1→3)-linked β-d-Galp main chain.

4.6 Friedelane Triterpenoids

Four new terpenoids were isolated from the root bark of Maytenus ilicifolia. Friedelane triterpenoids with their aromatized characteristic structures and sesquiterpene pyridine alkaloids have been isolated from the genus Maytenus, and these have shown good anti-tumor and anti-bacterial characteristics.

5. Mechanisms of Action

5.1 Gastric Acid Secretion Inhibition

The flavonoid-rich fraction separated from the leaves was evaluated for its gastroprotective properties and the mechanisms involved. Intraperitoneal administration potently protected rats from experimentally induced chronic (ED₅₀ = 79 mg/kg) and acute gastric lesions by ethanol (ED₅₀ = 25 mg/kg) and indomethacin (ED₅₀ = 4 mg/kg) without altering the decreased amount of cytoprotective glutathione and mucus amount in the injured gastric mucosa.

A potent reduction of gastric acid hypersecretion (ED₅₀ = 7 mg/kg, i.p.) was accompanied by a reduction of nitric oxide release (ED₅₀ = 1.6 mg/kg, i.p.) in the gastric secretion of 2-hour pylorus-ligated rats, suggesting an important role for nitric oxide-dependent mechanisms. Inhibition of gastric acid secretion in vivo was correlated with the in vitro inhibition of rabbit gastric H⁺,K⁺-ATPase activity (IC₅₀ = 41 μg/mL).

5.2 Histamine H2 Receptor Antagonism

After application of a lyophilized extract, the gastric mucosa effect was observed by antagonizing histamine H2 receptors. Further studies confirmed that polysaccharides (Type II arabinogalactan), but not the triterpenes friedelan-3β-ol and friedelin, from M. ilicifolia are responsible, at least in part, for significant gastroprotective effects.

5.3 Mucosal Barrier Protection

Isolated polysaccharides demonstrated a gastroprotective effect in an ethanol-induced gastric damage model. The authors suggested that those active polysaccharides of M. ilicifolia could act as a mucosal barrier agent.

The arabinogalactan polysaccharide liberated from the infusion significantly inhibited ethanol-induced gastric lesions in rats with an ED₅₀ of 9.3 mg/kg, suggesting a protective anti-ulcer effect.

5.4 Antioxidant Mechanisms

Research has been conducted to assess whether M. ilicifolia presents an antioxidant profile, since it has about 19% of polyphenols in the form of tannins not derived from catechin condensate. Using ethanolic extract, the root bark has been confirmed to present antioxidant action through its ability to scavenge free radicals.

The arabinogalactan also showed potent scavenging activity against the DPPH radical with an IC₅₀ value of 9.3 μM in vitro.

5.5 Anti-Adhesive Activity Against Helicobacter pylori

One study investigated whether the plant can be correlated to anti-virulence activity against Helicobacter pylori. Hydroalcoholic and hydroacetonic extracts did not influence bacterial proliferation and had no relevant bactericidal effect, but the study explored whether the extracts could reduce the bacterium's adherence to gastric cells — a putative anti-virulence (anti-adhesive) mechanism.

5.6 Cytochrome P450 and P-glycoprotein Modulation

The increase in the consumption of herbal products associated with conventional medications demands attention for the potential risks of interactions. The aim of one study was to evaluate potential pharmacokinetic interactions due to coadministration of M. ilicifolia extracts with drug substrates of P-glycoprotein (P-gp) and cytochrome P450 3A4 isoform (CYP3A4).

The results suggest that M. ilicifolia can inhibit the intestinal metabolism and transport of drugs mediated by CYP3A and P-gp, respectively; however, the involvement of other transporters and the clinical relevance of such interaction still need to be clarified.

6. Scientific Evidence by Area of Use

6.1 Gastrointestinal Disorders (Gastric Ulcer, Dyspepsia, GERD)

This is by far the most investigated area, with both preclinical and some human clinical data available.

Preclinical Evidence

One of the Brazilian medicinal plants most cited in ethnopharmacological surveys for the treatment of ulcers and gastric diseases was evaluated for efficacy and toxicity. Maytenus ilicifolia leaf extract (MIE) was acutely and chronically (180 days) administered to rats, mice, and dogs. Acute tests included the antiulcer effect and toxicological trials. Chronic tests included weight gain/loss, behavioral parameters, estrus cycle, effects on fertility, teratogenic studies, and mutagenic tests in addition to the Ames and micronucleus test. The results showed a clear antiulcer activity for MIE from 70 mg/kg and an absence of toxicological effects in the three animal species, even when given in high doses or over a long period.

A study evaluated the activity of the dried extract of Maytenus ilicifolia against stomach ulcers in Wistar rats. Wistar rats received three different doses (140, 280, and 420 mg/kg) of the dried extract intraperitoneally and, after 60 minutes, were immobilized and placed at 4°C for two hours (cold-restraint stress). The animals were sacrificed and the stomach removed and examined. A significant reduction in the ulceration index was observed, as well as a significant increase in the volume and pH of the gastric secretion, for all doses administered.

The effectiveness of M. ilicifolia as gastroprotective has been determined against several models of experimentally induced gastric ulcers and hypersecretion when given both orally and intraperitoneally. The potent gastroprotective actions of M. ilicifolia can be explained, at least in part, by the inhibition of gastric acid secretion through blockade of the gastric H⁺,K⁺-ATPase activity and by the modulation of nitric oxide formation by its constituents.

Human / Clinical Evidence

Maytenus ilicifolia is a plant widely used in South American folk medicine as an effective anti-dyspeptic agent. A Phase I clinical and toxicological study selected 24 volunteers (12 women and 12 men) between 20 and 40 years of age and put them through clinical/laboratory screening and testing to ascertain psychomotor functions (simple visual reaction, speed and accuracy, finger tapping tests). M. ilicifolia tablets were administered in increasing weekly dosages, from an initial dose of 100 mg to a final dose of 2000 mg. The volunteers' clinical and biochemical profiles and psychomotor functions were evaluated weekly, and they also completed a questionnaire about any adverse reactions.

In a randomized double-blind controlled clinical trial evaluating the plant in gastroesophageal reflux disease (GERD), overall 75.6% of the participants showed adherence without any differences among the experimental groups. All groups had significant reductions in both QS-GERD and HBQOL scores. Omeprazole and 400 and 860 mg of M. ilicifolia decreased the QS-GERD total scores at the endpoint compared to baseline (Chi-square = 129.808; p < 0.0001), including individual item scores such as heartburn intensity (Chi-square = 93.568, p < 0.0001) and heartburn after meals (Chi-square = 126.426, p < 0.0001). There were no differences among the experimental groups after the intervention. The results suggest that capsules with a standardized dry extract from the leaves of M. ilicifolia at a dosage of 400 or 860 mg are non-inferior to omeprazole, a proton pump inhibitor.

Evidence strength: Preclinical evidence (animal) is substantial and mechanistically informative. The single randomized double-blind GERD trial reports promising non-inferiority findings; however, clinical studies about M. ilicifolia are rare. Further large-scale, independently replicated clinical trials are needed before definitive efficacy conclusions can be drawn.

6.2 Anti-Inflammatory and Analgesic Effects

Preliminary studies of the hexane and ethyl acetate extracts of M. ilicifolia leaves inhibited the second phase of the formalin test in mice and paw edema induced by carrageenan in rats. In addition to these effects, protection against gastric lesions was also observed.

Maytenus ilicifolia is a native plant in many regions of South America, including southeast Brazil. This plant has various possible medicinal actions including analgesic, anti-inflammatory, antitumor, antiulcer, and antioxidant effects.

Evidence strength: Preliminary; studies are limited to animal models and in vitro work. No controlled human clinical trials evaluating analgesic or anti-inflammatory outcomes have been identified in the peer-reviewed literature.

6.3 Anticancer / Cytotoxic Activity

Two chemicals, named maytansine and mayteine, were extracted and tested in cancer patients in the United States and South America in the 1970s following the NCI research. Although there were some significant regressions in ovarian carcinoma and some lymphomas with maytansine, further research was not continued due to the toxicity at the dosages used.

The apoptotic effects of a spray-dried extract of M. ilicifolia (SDEMI) were evaluated using human hepatocellular cells (HepG2), colorectal carcinoma cells (HT-29), and normal keratinocytes (HaCaT). Cells were treated with SDEMI for 4 and 24 hours, then assayed for levels of apoptosis, caspase-3, and Bcl-2 by flow cytometry, immunostaining, and Western blot. Significant differences between groups were determined using analysis of variance (P < 0.05).

Quinonemethide triterpenes display cytotoxic, anti-ulcerogenic and antioxidant effects, as well as anticancer activity against different human cancer cell lines.

A concise review gathered existing literature on the anticancer potential of extracts and compounds isolated from Celastraceae species, covering six genera including Maytenus and their 33 isolates. Studies carried out using different cell lines have shown remarkable indications of anticancer activity; however, only a restricted number of human studies exist.

Evidence strength: In vitro and early-phase human drug trials (maytansine in the 1970s) are on record; however, the clinical antitumor research was halted due to toxicity at effective doses. Contemporary cell-line research with whole extracts and QMTs is in vitro only. No current controlled clinical trials in oncology have been identified.

6.4 Antiprotozoal Activity (Leishmaniasis, Chagas Disease)

The leishmanicidal and trypanocidal activities of two quinonemethide triterpenes, maytenin and pristimerin, isolated from M. ilicifolia root barks, were studied. The compounds were effective against Leishmania amazonensis, Leishmania chagasi, and Trypanosoma cruzi, etiologic agents of leishmaniasis and Chagas' disease, respectively. The QMTs exhibited marked in vitro leishmanicidal activity against promastigotes and amastigotes with IC₅₀ values of less than 0.88 nM. Both compounds showed IC₅₀ lower than 0.3 nM against Trypanosoma cruzi epimastigotes.

The two compounds showed potent activity when compared to the positive controls pentamidine for L. amazonensis (IC₅₀ = 6.75 nM) and L. chagasi (IC₅₀ = 4.0 nM), and benznidazole for T. cruzi (IC₅₀ = 31.20 μM).

Evidence strength: In vitro only; no human clinical trials have been conducted for these applications.

6.5 Antioxidant Activity

Research related to antioxidant action showed promising results from Maytenus ilicifolia. M. ilicifolia in its extract form showed efficiency in healing action both in the skin and in gastric tissue (in ulcers); however, in tincture form it showed low healing capacity, requiring further studies. Regarding antioxidant action, M. ilicifolia showed characteristics of high antiradical power, eliminating free radicals.

Evidence strength: Predominantly in vitro and animal data; the evidence remains preliminary and no clinical trials have specifically measured antioxidant biomarkers in humans.

6.6 Wound Healing

Wounds treated with the hydroethanolic extract of M. ilicifolia (MiHE) showed accelerated closure after 3 and 7 days of treatment. After 3 days, the percentages of wound area closure were greater in wounds treated with 2% MiHE (21.1 ± 1.1%), 4% MiHE (20.8% ± 1.8%), and 6% MiHE (30.2% ± 2.6%) in relation to the control group (10.3% ± 1.1%).

Topical treatment with M. ilicifolia accelerated the healing of skin wounds. The extract also showed pro-angiogenic and pro-fibrogenic activity in wounds, and MMP-9 was increased in wounds treated with M. ilicifolia.

Evidence strength: Animal/preclinical only; the topical wound-healing application has not been evaluated in controlled human trials.

6.7 Otoprotection (Cisplatin-Induced Ototoxicity)

Maytenus ilicifolia is a native plant from South America with several medicinal properties including antioxidant effects. Using an original cisplatin-induced ototoxicity model, researchers evaluated a possible otoprotection caused by Maytenus ilicifolia extract. The selection was made because of its antioxidant properties (presence of flavonoids and alkaloids), few side effects in human beings, and its ability to minimize the toxic action of a variety of agents.

Evidence strength: Exploratory preclinical model; clinical application remains unvalidated.

7. Dosage Forms and Reported Dosages

Dosages described in the scientific literature include the following:

• Preclinical (animal) antiulcer models: Wistar rats received three different doses — 140, 280, and 420 mg/kg — of the dried extract intraperitoneally.
• Phase I clinical toxicology study: M. ilicifolia tablets were administered in increasing weekly dosages, from an initial dose of 100 mg to a final dose of 2000 mg.
• Randomized double-blind GERD clinical trial: Capsules with a standardized dry extract from the leaves at a dosage of 400 or 860 mg were tested.
• ANVISA regulatory dosage: The national regulatory agency ANVISA recommends the M. ilicifolia dose of 860 mg twice a day, as described in the Phytotherapeutic Memento of the Brazilian Pharmacopoeia.
• Preclinical antiulcer (flavonoid-rich fraction): Intraperitoneal administration of the flavonoid-rich fraction protected rats from experimentally induced acute gastric lesions by ethanol (ED₅₀ = 25 mg/kg). Gastric acid hypersecretion was reduced with an ED₅₀ of 7 mg/kg (i.p.).
• Preclinical arabinogalactan polysaccharide: The arabinogalactan significantly inhibited ethanol-induced gastric lesions in rats with an ED₅₀ of 9.3 mg/kg.

8. Body Systems Associated with Maytenus ilicifolia

• Gastrointestinal system: Primary and best-documented area; gastric ulcer, GERD, dyspepsia, gastritis, and diarrhea. The plant is used to treat stomach disorders such as gastric ulcers, dyspepsia, and diarrhea in Brazilian traditional medicine.
• Immune/inflammatory system: Medicinal uses in folk medicine include antitumor, anti-asthmatic, treatment for stomach problems, antioxidant, analgesic, anti-inflammatory, and antimicrobial applications.
• Integumentary system (skin/wound healing): Topical application has been studied in preclinical wound models.
• Auditory system: Explored preclinically for otoprotection against cisplatin toxicity.
• Oncology: In vitro and early-phase human trials with isolated maytansinoids; current evidence is not sufficient for clinical application.
• Reproductive system: Historical traditional use as a contraceptive and emmenagogue; preclinical evidence raises abortifacient concerns (detailed in Safety, Section 9).

9. Safety Considerations and Drug Interactions

9.1 General Toxicological Profile

In extensive preclinical testing, Maytenus ilicifolia leaf extract showed a clear antiulcer activity from 70 mg/kg and an absence of toxicological effects in three animal species (rats, mice, and dogs), even when given in high doses or over a long period (180 days).

The plant is commonly used to treat ulcer and gastritis, and despite the general absence of toxicity regarding its consumption, possible interactions when co-administered with conventional drugs were previously unknown.

9.2 Potential Hepatotoxicity

An in vitro safety study aimed to investigate the potential pharmacokinetic interaction and hepatotoxicity and intestinal toxicity of an aqueous extract of M. ilicifolia and its main phytocompounds, catechin, epicatechin, and quercetin. The in vitro findings highlighted, for the first time, the potential hepatotoxicity induced by an aqueous extract of the plant. These findings came from ex vivo liver and intestinal slice incubation and require confirmation in in vivo and clinical contexts.

9.3 Reproductive and Gestational Risks

Maytenus ilicifolia is used in Brazilian herbal medicine particularly for stomach disorders, but it is also used, as in other parts of South America, for fertility control. To verify its potential as an abortifacient, the lyophilized hydroalcoholic extract of its leaves was administered orally at a dose of 1000 mg/kg/day to mice between the first and third day of pregnancy (DOP), between the fourth and sixth DOP, or between the seventh and ninth DOP. The extract caused a pre-implantation embryonic loss, but it did not have an effect on implantation or organogenesis. Morphological alterations of the reproductive system were not found. Estrogenic activity of the extract, exhibited by a uterotrophic effect, suggests that it may be interfering with the uterine receptivity to the embryo.

A review of medicinal plants that should be avoided during pregnancy listed Maytenus ilicifolia among those with evidence of potential abortifacient and/or teratogenic activity in preclinical studies.

9.4 Drug Interactions — CYP3A4 and P-glycoprotein

The increase in the consumption of herbal products associated with conventional medications demands attention for the potential risks of interactions. One study evaluated potential pharmacokinetic interactions due to coadministration of M. ilicifolia extracts with drug substrates of P-glycoprotein (P-gp) and cytochrome P450 3A4 isoform (CYP3A4).

The results suggest that M. ilicifolia can inhibit the intestinal metabolism and transport of drugs mediated by CYP3A and P-gp, respectively; however, the involvement of other transporters and the clinical relevance of such interaction still need to be clarified. Drugs known to be CYP3A4 or P-gp substrates may potentially be affected, though the magnitude and clinical significance of this interaction in humans remains under investigation.

9.5 Quality Control Concerns

Using untargeted metabolomics, it was observed that the chemical profile of most commercial samples was not compatible with M. ilicifolia leaves, indicating the need for stricter quality control of this material. The analytical method described could be used for quality control; moreover, its concept could be adapted and used for an ample variety of medicinal plant products.

9.6 Overall State of Evidence for Safety

Most published research on Brazilian medicinal plants, including Maytenus ilicifolia, is preliminary and only reports the effects of crude extracts in both in vitro and in vivo studies. Only very few studies have been dedicated to investigating the mechanisms of action of isolated compounds. Studies on safety (toxicology), pharmacokinetics, and especially well-conducted clinical trials are rare.

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