Patrinia

Patrinia: A Comprehensive Reference

1. Identity and Botanical Classification

1.1 Taxonomy and Nomenclature

The genus Patrinia belongs to the family Valerianaceae (sometimes reclassified under Caprifoliaceae in modern phylogenetic treatments) and encompasses approximately 20 species of herbaceous plants bearing yellow or white flowers, distributed across Korea, China, Siberia, and Japan. Two species — Patrinia scabiosaefolia Fisch. (abbreviated PS) and Patrinia villosa Juss. (abbreviated PV) — are officially recognised as sources of the herbal drug known as Herba Patriniae in the pharmaceutical industry.

Patrinia scabiosaefolia is commonly referred to as "yellow Patrinia" owing to its yellow flowers, while Patrinia villosa is called "white Patrinia." Both species are recorded in the Chinese Pharmacopoeia under the single Chinese name Baijiangcao (败酱草), reflecting their shared therapeutic application in traditional Chinese medicine. Additional medicinally relevant species include Patrinia scabra Bunge, Patrinia heterophylla Bunge, and Patrinia rupestris (Pall.) Juss., from which numerous chemical constituents have also been isolated and characterised.

1.2 Botanical Description and Habitat

Patrinia scabiosaefolia generally grows in roadsides, grassy areas, thickets, forest margins, and forests at an altitude of (50–) 400–2100 (–2600) m. It is a perennial herb with a height of 30–100 (–200) cm. The rhizomes can be horizontal or oblique, and the plant has yellow-green to yellow-brown erect stems. Its basal leaves are rosulate, ovate, elliptic, or elliptic-lanceolate, simple to pinnatifid or pinnatisect, and up to 1.8–10.5 cm long and 1.2–3 cm wide; petiole 3–12 cm; the upper surface appears dark green whereas the underside appears pale green. Patrinia villosa is a perennial herb that typically develops in verdant areas, thickets, or along the edges of forests. In China, the genus appears chiefly in the provinces of Sichuan, Jiangxi, and Fujian.

1.3 Pharmacopoeial Status and Common Preparations

The whole plants (Herba Patriniae) are collected in autumn, dried in the shade, and cut into segments for use. In contemporary practice, the drug is prepared and administered in multiple forms. The standard dosage of Baijiangcao in decoction is controlled at 6–15 g, and it can be made into decoctions, injections, or mashed for external use. Aqueous decoctions remain the classical mode of preparation in traditional Chinese medicine (TCM). The herb is also produced as standardised ethanol extracts for pharmacological research, as injectable preparations for clinical use, and as components in multi-herb TCM formulae.

2. Traditional and Historical Use

2.1 China: Classical Texts and TCM Tradition

Herba Patriniae has been used for thousands of years in China as a traditional Chinese medicine with heat-clearing and detoxicating effects. Within the framework of TCM, the herb is characterised by bitter and acrid tastes and a slightly cold thermal nature. Its traditional functions are described as clearing heat, resolving toxicity, expelling pus, invigorating blood, and relieving pain.

Patrinia villosa is one of the plant resources of the famous TCM "Bai jiang cao (herba patriniae)," possessing the function of eliminating heat/toxic materials and removing blood to relieve pain according to the theory of TCM. Patrinia villosa is considered to function at the stomach, large intestine, and liver meridians, thereby treating diseases of these organs as demonstrated by the traditional theory of TCM.

The genus Patrinia plays an important role in Asian medicine for the treatment of erysipelas, conjunctival congestion with swelling and pain, peri-appendicular abscesses, lung carbuncle, dysentery, leucorrhea, and postpartum disease. Classically, the herb was applied to internal heat conditions producing suppurative infections — what TCM practitioners termed "intestinal abscess" (corresponding in part to appendicitis and pelvic abscess) and "lung carbuncle" (pulmonary suppuration). In TCM practice, Baijiangcao clears heat, relieves toxicity, and expels pus for intestinal abscess, sores, and swellings; it also dispels blood stasis and stops pain, particularly for heat-induced blood stasis in the abdomen and chest, as well as for post-partum pain and post-operative pain.

2.2 Korea and East Asian Folk Medicine

Among the species found in Korea — including P. scabiosaefolia (yellow Patrinia), P. saniculaefolia, P. villosa (white Patrinia), and P. rupestris — several members of the genus have long been used in folk medicine for the treatment of inflammation, wound healing, ascetics (fluid accumulation), and abdominal pain after childbirth.

2.3 Traditional Preparations

Historically, the most common preparation was aqueous decoction. The whole dried herb — including rhizomes, roots, and aerial parts — was boiled in water and the resulting liquid consumed. It has been commonly used in the treatment of chronic inflammation diseases, such as intestinal carbuncle, pulmonary carbuncle, dysentery, postpartum petechial abdominal pain, and carbuncle. External preparations, including decoctions used in sitz baths and fumigation, were also employed. The sitz bath and fumigation with decoction was used to treat perianal abscess, incarcerated hemorrhoids, anal fissures, anal fistula, hemorrhoid bleeding, postoperative anal edema, and other anorectal diseases. Patrinia was also incorporated into complex multi-herb formulae — a hallmark of TCM practice — combined with other herbs according to the specific clinical presentation.

2.4 Sedative and Hypnotic Use

Patrinia scabiosaefolia Fisch is used in folk medicines to treat intestinal abscesses, acute appendicitis, and dysentery in Asia. Recent reports also indicate that Patrinia scabiosaefolia has sedative and anti-tumor effects. The sedative and hypnotic properties attributed to Patrinia in traditional use have been investigated pharmacologically (see Section 5), with the rhizome and root identified as the relevant plant parts in this context.

3. Phytochemistry: Key Constituents and Active Compounds

3.1 Overview of Chemical Diversity

A total of 233 compounds have been identified in Herba Patriniae, including triterpenoid saponins, flavonoids, organic acids, iridoids, and volatiles. Extensive studies of the chemical components of Patrinia have led to the identification of compounds including essential oils, iridoids, sesquiterpenes, triterpenes, saponins, flavonoids, coumarins, and lignans. Importantly, there is a marked phytochemical distinction between the two official species: PS (P. scabiosaefolia) is rich in triterpenoid saponins and volatiles, while PV (P. villosa) contains more flavonoids.

3.2 Triterpenoids and Triterpenoid Saponins

Triterpenoid aglycones and triterpenoid saponins are considered the main active constituents of Patrinia scabiosaefolia. Typical representatives of triterpenoid aglycones in Patrinia scabiosaefolia include ursolic acid, hederagenin, and oleanolic acid. Hederagenin-based saponins are particularly characteristic: a triterpenoid saponin designated patrinia saponin H3 was isolated from the aerial parts of Patrinia scabiosaefolia Fisch. and determined to be 3-O-β-D-glucopyranosyl(1→3)-α-L-rhamnopyranosyl (1→2)-α-L-arabinopyranosyl hederagenin 28-O-α-L-rhamnopyranosyl (1→4)-β-D-glucopyranosyl(1→6)-β-D-glucopyranosyl ester. Additional triterpenoid constituents include novel compounds: three new triterpenoids, patrinolides B–D, and two new iridoids, patriscabioins K–L, were isolated from the whole plants of Patrinia scabiosaefolia; compounds 1, 9, and 10 contained the unique substituents found in the Valerianaceae family, such as isovaleryl and 3-methylcrotonyl groups, while compound 2 was a 24-nor-ursane triterpenoid. Rutin, α-hederin, and kalopanax saponin B, and a mixture of hederagenin and 23-hydroxyursolic acid, have been isolated from the aerial parts of Patrinia scabiosaefolia Fisch.

3.3 Iridoids

Iridoids represent a structurally distinctive compound class within Patrinia. Patrinoside — a glycosidic iridoid first reported in the 1970s — is among the earliest characterised constituents. Patrinoside and patrinoside A have been isolated from P. scabiosaefolia, with demonstrated capacity to significantly improve insulin resistance by activating the PI3K/AKT signalling pathway. New iridoids isolated from Patrinia have been found to exert hypoglycaemic effects: the anti-diabetic evaluation of isolated iridoid compounds revealed that selected compounds significantly increased glucose absorption in 3T3-L1 cells (P < 0.01), with further mechanism investigations demonstrating that one compound promoted glucose uptake in dexamethasone-treated 3T3-L1 adipocytes by activating PI3K/Akt signalling pathway, with concurrent upregulation of GLUT4 mRNA and protein expression.

3.4 Flavonoids

Seven flavonoid compounds have been isolated from ethyl acetate and n-butanol extract of Patrinia villosa and identified as: 5-hydroxyl-7,3′,4′-trimethoxy flavone, 5-hydroxyl-7,4′-dimethoxy flavone, luteolin, quercetin, isoorientin, isovitexin, and 8-C glucosylprunetin. Studies have shown that flavonoids found in Patrinia scabiosaefolia, such as quercetin, luteolin, apigenin, and isoorientin, can enhance the cytotoxic effects of various chemotherapeutic agents on tumour cells. The flavone linarin (acacetin-7-O-β-D-rutinoside) has emerged as a pharmacologically active constituent of particular interest. Network pharmacology analysis identified linarin as the core active component of HP and screened out six hub targets, including Cyclin Dependent Kinase 1/4 (CDK1/4), Cyclin A2/B1 (CCNA2/B1), and Checkpoint Kinase 1/2 (CHEK1/2), which were found to be mainly enriched in cell cycle and senescence pathways. A flavonol glycoside, flavovilloside, has been isolated from seeds of Patrinia villosa (Thunb.) Juss., with its structure determined as 3-O-α-L-rhamnopyranosyl-(1→3)-α-L-rhamnopyranosyl-(1→6)-β-D-galactopyranosyl quercetin.

3.5 Volatile Oils (Essential Oil Constituents)

Forty-four components, representing 83.919% of the total oil, have been identified in the essential oil of P. scabiosaefolia (EO-PS). The major constituents include caryophyllene oxide (12.802%), caryophyllene (6.909%), α-caryophyllene (2.927%), β-damascenone (3.435%), calarene (5.621%), and phenol (3.044%). Volatile oils are more abundant in P. scabiosaefolia than in P. villosa, accounting for the differences in characteristic odour between the two species.

3.6 Other Phenolic and Lignan Constituents

Nine compounds have been isolated from the acetic acid ethyl ester and n-butanol fractions of P. villosa, identified as β-sitosterol, villosol, quercetin, ferulic acid, ursolic acid, β-daucosterol, and rutin; ferulic acid, ursolic acid, and rutin were reported for the first time from this species. Chemical investigation indicates that saponins, flavonoids, coumarins, cycloethene terpenoids, lignans, and volatile oils are the main active ingredient classes of P. villosa.

4. Established and Proposed Mechanisms of Action

4.1 Anti-Cancer Mechanisms

Studies suggest that Herba Patriniae acts through several signalling pathways to inhibit colorectal cancer (CRC), with its high flavonoid content playing a pivotal role. These flavonoids suppress cell proliferation, induce apoptosis, mediate cell cycle arrest, suppress angiogenesis in the tumour microenvironment, and ameliorate drug resistance.

Apoptosis induction: Studies evaluating the effect of the ethanol extract of Patrinia scabiosaefolia (EEPS) on proliferation and apoptosis in human multiple myeloma U266 cells — which persistently express phosphorylated STAT3 — found that EEPS inhibited the phosphorylation of STAT3 in U266 cells. These findings demonstrated that Patrinia scabiosaefolia inhibits proliferation and promotes apoptosis of cancer cells via inhibition of the STAT3 pathway, which may in part explain its anti-cancer activity.

Anti-angiogenic activity: Data indicate that Patrinia scabiosaefolia inhibits CRC growth likely via suppression of tumour angiogenesis. Angiogenesis is an essential process for tumour development and metastasis; therefore, inhibition of tumour angiogenesis has become a promising strategy for anticancer treatments, and Patrinia scabiosaefolia has been shown to be effective in the clinical treatment of gastrointestinal cancers.

Mitochondrial apoptotic pathway: EEPS inhibited CRC growth both in vivo and in vitro without apparent adverse side-effects; EEPS treatment also promoted apoptosis in CRC tumour tissues and in HT-29 cells, suggesting that the inhibitory effect of EEPS on tumour growth operates through this pathway.

AKT pathway and chemoresistance: Investigations into chemoresistance used the 5-fluorouracil-resistant human colorectal carcinoma cell line HCT-8/5-FU and its parental cells HCT-8, treated with EEPS at concentrations of 0, 0.25, 0.50, 1 or 2 mg/mL. Results demonstrated that EEPS could inhibit AKT phosphorylation and modulate Bcl-2 and Bax expression, contributing to overcoming 5-FU resistance.

Cell cycle arrest and senescence (linarin): In vitro assays showed that linarin dose-dependently (0–200 μM) inhibited NSCLC cell proliferation, induced G0/G1 phase arrest, and promoted cellular senescence and apoptosis in both A549 and H1299 cell lines, irrespective of p53 status. Molecular docking confirmed strong binding affinities between linarin and the hub targets, and Western blotting confirmed that linarin downregulated CCNA2/B1 and CHEK1. This demonstrates that linarin exerts potent anti-NSCLC effects by inducing G0/G1 arrest, senescence, and apoptosis.

Dichloromethane extract effects on leukaemia: Dichloromethane extract from P. scabiosaefolia (DEPS) reduced cell viability, arrested the cell cycle in the G2/M phase, disrupted mitochondrial membrane potential, increased reactive oxygen species (ROS) production, and upregulated the expression of Bax/Bcl-2 and cleaved caspase-3 in acute myeloid leukaemia cells.

4.2 Anti-Inflammatory Mechanisms

Bioactive compounds from Patrinia scabiosaefolia correspond to 134 targets of pelvic inflammatory disease with dampness-heat stasis syndrome, including vascular endothelial growth factor A (VEGFA), von Willebrand factor (VWF), interleukin 6 (IL6), tumour necrosis factor (TNF), and nuclear transcription factor 1 (NFκB1), acting on signalling pathways including AGE-RAGE, focal adhesion, Toll-like receptor, and NF-κB pathways. In vitro validation demonstrated that selected active components of Patrinia scabiosaefolia — including acacetin, kaempferol, linarin, isovitexin, and sinoacutine — could significantly inhibit the release of NO induced by LPS; moreover, different doses of acacetin, kaempferol, isovitexin, and sinoacutine significantly inhibited TNF-α production.

In RAW264.7 cells, patrinoside and patrinoside A significantly inhibited the transcription and secretion of inflammatory mediators NO, TNF-α, and IL-6. Western blot analysis showed that significant inhibition of phosphorylation of IκB and P65 and P38, ERK, and JNK suggested that these effects were exerted through NF-κB and MAPK pathways.

4.3 Hepatoprotective Mechanisms

Patrinia villosa can inhibit hepatitis virus, improve liver function, and promote hepatocyte regeneration and bile secretion. Experimental evidence reveals alterations of the bile acid profile in CCl₄-induced liver injury and demonstrates that inhibiting apoptosis and autophagy is involved in P. villosa-elicited liver protection, providing a scientific basis for the clinical utilisation of P. villosa as a natural hepatic protective agent.

4.4 Anti-Diabetic and Metabolic Mechanisms

Iridoids from P. scabiosaefolia promote glucose uptake in dexamethasone-treated 3T3-L1 adipocytes by activating the PI3K/Akt signalling pathway. The expression of GLUT4 mRNA and protein is also upregulated, providing scientific references for the potential use of P. scabiosaefolia as a functional food to manage hyperglycaemia.

4.5 Nitric Oxide Synthase and Acetylcholinesterase Inhibition

Inhibitory activities against nitric oxide synthase (NOS) of all triterpenoids were tested. Results showed that one compound had moderate inhibitory activity with IC₅₀ of 10.1 μM, and it also showed the strongest inhibitory activities on acetylcholinesterase (AChE) with IC₅₀ values of 10.0 μM. These findings are preliminary and derive solely from in vitro assays.

5. Scientific Evidence by Area of Use

5.1 Colorectal Cancer

Patrinia species have been traditionally used by Chinese medicine practitioners for various kinds of disorders, especially colon cancer. In recent years, Patrinia species have been documented with a number of research studies in phytochemistry and pharmacology which are related to its traditional usage.

The role of TCM and its natural active ingredients in enhancing the therapeutic effects of radiotherapy and chemotherapy and preventing the recurrence and metastasis of CRC has been increasingly recognised. Herba Patriniae has shown significant clinical efficacy for the treatment of CRC. Flavonoids have been found to be one of the main active anticancer components of Herba Patriniae. A recent review summarises the latest findings from clinical trials and in vitro studies on anticancer mechanisms of Herba Patriniae, and discusses the role of the flavonoids in combination therapy against CRC.

Evidence assessment: Although there is a body of in vitro and animal (xenograft) data supporting anti-CRC activity through multiple mechanisms (STAT3 inhibition, pro-apoptotic mitochondrial pathways, anti-angiogenesis, AKT suppression), many studies have supported the efficacy of Herba Patriniae in preventing and treating CRC, although the underlying mechanisms of action remain unclear. High-quality, prospective randomised controlled trials (RCTs) in human CRC patients using Patrinia as a defined, isolated intervention are not yet established in the published peer-reviewed literature accessible at the time of this writing. Existing clinical evidence is largely observational or embedded within multi-herb formula trials, which limits the ability to attribute efficacy solely to Patrinia.

5.2 Pelvic Inflammatory Disease (PID)

Patrinia scabiosaefolia Fisch (PSF), a well-known TCM, is clinically used as a "heat-clearing and detoxifying" agent. Several chemical components including triterpenes, iridoids, saponins, and lactones have been identified in PSF. PSF showed multiple bioactivities including inhibiting colorectal cancer, promoting apoptosis of human multiple myeloma cells and breast carcinoma MCF-7 cells, sedative, hypnotic, antiulcerative colitis, antipancreatitis, anti-inflammatory in RAW264.7 cells, and antibacterial activity. PSF is usually prescribed as a constituent in TCM prescriptions used for PID treatment.

A metabolomic study in a rat model investigated the preventive effect of PSF on multipathogen-induced PID, examining changes in inflammatory markers (CRP, IL-1β, IL-6) using ELISA and histological analysis of uterine and fallopian tube tissue. This study provided preliminary evidence for the anti-inflammatory mechanism of Patrinia scabiosaefolia against pelvic inflammatory disease with dampness-heat stasis syndrome, and offers a preliminary foundation and novelty ideas for future research on the herb.

Evidence assessment: Evidence is predominantly preclinical (animal models, in vitro). Patrinia is routinely incorporated into TCM clinical formulae for PID, but high-quality human RCT data isolating Patrinia as a single agent are sparse in the primary peer-reviewed literature.

5.3 Ulcerative Colitis

Patrinia scabiosaefolia Fisch is used in folk medicines to treat intestinal abscesses, acute appendicitis, and dysentery in Asia. To determine the effects and mode of action of the methanol extract of the roots of Patrinia scabiosaefolia (PME) on colitis, a mouse model of colitis induced by dextran sulphate sodium (DSS) was used. DSS was administered to 5-week-old ICR mice over 7 days, with assessment of disease activity index (DAI) including body weight, stool consistency, gross bleeding, and tissue myeloperoxidase (MPO) accumulation.

A study investigating the mechanisms by which P. scabiosaefolia improves ulcerative colitis used combined UHPLC-OE-MS/MS, network pharmacology, molecular docking, and animal experiments. A total of 72 compounds were detected in the extraction, with 15 key components selected for further analysis. GO enrichment analysis suggested that PS may alleviate UC-related dysfunction by modulating immune responses, inflammation, and cell signalling pathways. Molecular docking revealed strong binding free affinity (<−7 kcal/mol) of active components (Vulgarin and 4-(Diphenylphosphino)benzoic acid) with TNF, AKT1, CASP3, BCL2, and MMP9.

Evidence assessment: Evidence is preclinical (murine DSS-colitis models, network pharmacology, molecular docking). No published human RCTs were identified in which Patrinia is administered as a controlled single intervention for ulcerative colitis.

5.4 Non-Small-Cell Lung Cancer (NSCLC)

Herba Patriniae has long been used for respiratory disorders and exhibits anti-cancer potential; however, the therapeutic effects of HP on NSCLC and the underlying mechanisms have not been fully elucidated. In a 2026 study published in Pharmaceuticals: The anti-cancer effects of the core HP component linarin on NSCLC cells were characterised using p53 wild-type A549 and p53-null H1299 cell lines. Network pharmacology analysis identified linarin as the core active component of HP and screened out six hub targets, including CDK1/4, CCNA2/B1, and CHEK1/2, enriched mainly in cell cycle and senescence pathways. In vitro assays showed that linarin dose-dependently (0–200 μM) inhibited NSCLC cell proliferation, induced G0/G1 phase arrest, and promoted cellular senescence and apoptosis in both cell lines, irrespective of p53 status.

Evidence assessment: Entirely preclinical (in vitro cell-line work combined with network pharmacology). No human clinical trials were identified.

5.5 Hepatoprotection and Liver Injury

Modern research indicated that the herb has pharmacological effect on liver injury caused by inflammation. For the purpose of discovering the therapeutic effect and metabolomic mechanism of P. villosa on liver injury, 40 Sprague–Dawley rats were divided into normal, model, and P.V groups (0.98, 1.97, and 2.96 g/kg). The model group and P.V groups were injected intraperitoneally with 40% CCl₄ to establish a liver injury model. After administration of P.V for seven consecutive days, the results were analysed; P.V could decrease serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels of liver injury rats in a dose-dependent manner.

In a complementary study, UPLC QTOF-MS/MS was used to analyse the profile of PV. Male Sprague–Dawley rats were categorised into five groups, and PV groups (125 and 375 mg/kg) were administered by oral gavage for seven consecutive days. The model of liver injury was induced by intraperitoneal injection of 40% CCl₄ oil solution. The results revealed the alteration of the bile acid profile in CCl₄-induced liver injury and demonstrated that inhibiting apoptosis and autophagy was involved in P. villosa-elicited liver protection, providing a scientific basis for the clinical utilisation of P. villosa as a natural hepatic protective agent.

Evidence assessment: Hepatoprotective evidence is exclusively from animal experiments (CCl₄-induced rodent models). No human clinical trials were identified.

5.6 Sedative and Hypnotic Effects

Modern medical research has found that Patrinia villosa has various pharmacological activities including anti-inflammatory, sedative and hypnotic, anti-viral, anti-tumour, liver-protecting, and immunity-enhancing actions. Historical clinical observation of sedative and hypnotic effects was reported in a 1986 study (Luo et al., J Tradit Chin Med 1986) that provided pharmacological investigation of these effects using the rhizome and root of Patrinia scabiosaefolia Fisch; however, full text details of specific outcomes and population size are not extensively reproduced in the accessible secondary literature. Two source species of Herba Patriniae gave similar pharmacological effects on anti-cancer, anti-inflammatory, antioxidant, antimicrobial, sedative, and hypnotic effects.

Evidence assessment: Sedative effects are supported by animal models and early clinical observations in TCM settings. These findings are preliminary and do not rise to the level of evidence from rigorous RCTs with defined populations, validated outcome measures, or placebo comparisons.

5.7 Antimicrobial Activity

Supercritical carbon dioxide extraction was used to extract effective compounds from P. scabiosaefolia. In the extract, 24 chemical constituents were identified by GC-MS, which showed obvious inhibitory effect on Staphylococcus aureus, Salmonella, and Shigella flexneri by the agar diffusion method. The ethanol extract of P. scabiosaefolia can inhibit Salmonella, Shigella flexneri, and Staphylococcus aureus, but not Escherichia coli. The ethanol extract of P. villosa can inhibit Escherichia coli, Staphylococcus aureus, Proteus, and Bacillus subtilis.

Evidence assessment: Antimicrobial evidence is in vitro only. No clinical trials were identified evaluating Patrinia as an antimicrobial agent in human populations.

5.8 Anti-Diabetic Effects

Both source species of Patrinia offer similar pharmacological benefits including anti-cancer, anti-inflammatory, antioxidant, antimicrobial, sedative, and hypnotic effects. However, there are no reports on antipruritic, proangiogenic, and anti-diarrheal effects for P. scabiosaefolia, and there are no studies on anti-diabetic effects of P. villosa. Anti-diabetic investigation has focused on P. scabiosaefolia, where iridoid constituents and patrinoside analogues have shown glucose-lowering properties in cell models.

Evidence assessment: Anti-diabetic evidence is confined to in vitro cell models and is preliminary.

5.9 Antioxidant Activity

All isolated flavonoid compounds exhibited good antioxidant activities in vitro. DPPH radical scavenging assays have been used to quantify the antioxidant capacity of Patrinia extracts and essential oil fractions. One Patrinia extract showed an EC₅₀ of 32.01 μg/mL to DPPH and 50.90 μg/mL to ABTS⁺ radical cation in antioxidant assays.

Evidence assessment: Antioxidant activity is established in vitro. Clinical relevance has not been demonstrated in human trials.

6. Body Systems and Health Areas of Association

• Gastrointestinal system: Treatment of intestinal abscess, appendicitis, dysentery, ulcerative colitis, CRC, and gastric cancer (primarily preclinical evidence).
• Gynaecological / reproductive system: Pelvic inflammatory disease, leucorrhea, post-partum pain and blood stasis (traditional and preliminary animal-model evidence).
• Hepatobiliary system: Acute hepatitis, chronic liver injury, bile acid metabolism (animal models).
• Respiratory system: Lung carbuncle (traditional use), non-small-cell lung cancer (preclinical in vitro evidence).
• Haematological / oncological: Multiple myeloma, acute myeloid leukaemia, breast carcinoma, colorectal carcinoma, and cervical cancer (preclinical in vitro and xenograft animal evidence).
• Central nervous system: Sedative and hypnotic effects (animal and limited early clinical observation).
• Endocrine / metabolic: Insulin resistance, glucose uptake, anti-diabetic potential (preclinical in vitro only, primarily for PS).
• Immune system: Anti-inflammatory via NF-κB, MAPK, and TLR pathways (in vitro and animal evidence).
• Cardiovascular / vascular: Anti-angiogenic effects relevant to tumour vasculature (in vitro and animal evidence).

7. Dosage Forms and Reported Dosages

The dosage of Baijiangcao in decoction is controlled at 6–15 g, and it can be made into decoctions, injections, or mashed for external use. From toxicological and dose-ranging studies: as the dose increases up to 20 mg/kg in mice, mild side effects were found. The dose that causes side effects in humans was up to 4–12 g/day, with individual differences noted.

In preclinical animal studies, the following dosages were used:

• In a CCl₄-induced liver injury rat model, P. villosa was administered at doses of 0.98, 1.97, and 2.96 g/kg.
• P. villosa groups in a liver injury model were administered by oral gavage at 125 and 375 mg/kg for seven consecutive days.
• In a 5-FU-resistant CRC cell study, EEPS was tested at concentrations of 0, 0.25, 0.50, 1 or 2 mg/mL in cell culture.
• Linarin was tested at concentrations of 0–200 μM in NSCLC cell lines.

The pharmacokinetics of Herba Patriniae is lacking, and a range of pharmacokinetic studies on its active compounds are needed to provide comprehensive data for clinical application.

8. Safety Considerations

8.1 General Safety Profile at Clinical Doses

In general, it is safe to consume Patrinia at clinical doses, as it is non-toxic. However, mild side effects such as temporary leukopenia, dizziness, and nausea may occur with excessive and large doses.

8.2 Dose-Dependent Side Effects

Individual patients taking Patrinia scabiosaefolia may experience dry mouth, anorexia, vomiting, or stomach upset. Excessive use may cause temporary leukopenia, dizziness, or nausea. After using Patrinia villosa injection in 134 patients with acute bacterial inflammation, leukopenia occurred in 3 patients. Leukocytes returned to normal about 1 week after drug withdrawal.

8.3 Differences Between Species in Adverse Effect Profile

Herba Patriniae has displayed significant medicinal value in clinic, but differences in phytochemistry, pharmacological effects, and the content of compounds have been found between the two official recorded species. Side effects and pharmacokinetic characteristics have not been well studied between the two species.

8.4 Quality Variability

The variety, growth environment, growth time, and harvest time not only affect the content of compounds but also the pharmacological activities of the bioactive compounds. This introduces variability between batches and preparations, with implications for both efficacy and safety. A conclusive summary of the specific effects of P. scabiosaefolia species or P. villosa cannot be made, as included trials seldom report the exact species of Patrinia Herba used. The composition of phytochemicals differs between herbal preparations, and the methods of preparation vary; these could not be considered equivalent and should be evaluated separately.

8.5 Gaps in Pharmacokinetic Knowledge

Pharmacokinetics can provide scientific explanations for pharmacological and toxicological findings. Unfortunately, the pharmacokinetics of Herba Patriniae is lacking, and a range of pharmacokinetic studies on its active compounds are needed to provide comprehensive data for clinical application.

8.6 Overall Evidence Characterisation

For better clinical use of Herba Patriniae, it is urgent to establish systematic pharmacology, quality control, pharmacokinetics, and clinical research on the same/different characteristics between PS and PV. The body of research on Patrinia is growing but remains heavily weighted toward in vitro cell studies, network pharmacology analyses, and rodent models. Rigorously conducted, placebo-controlled human clinical trials using well-defined, standardised Patrinia preparations as single agents are largely absent from the published literature in Western evidence databases. The herb's integration into complex TCM formulae, while reflecting its traditional use, complicates attribution of specific effects to Patrinia alone.

References

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