Vitex Compound Capsules (Lim Cheng Cheong Osot)

Vitex Compound Capsules (Lim Cheng Cheong Osot)

Наименование: Витекс микстура капсулы, Vitex Compound Capsules, Vitex-Mischung Kapseln, Cápsulas compuestas de Vitex, Gélules composées de vitex, كبسولات مركبة من الفيتيكس, แคปซูลตำรับรวมคนที, Vitex aralash kapsulalar, Vitex курамдуу капсулалары, Vitex tərkibli kapsullar, Капсулаҳои таркибии витекс, Vitex sudėtinės kapsulės, Vitex kombinētās kapsulas, Комбіновані капсули Vitex, Vitex tərkibli kapsullar, קפסולות תרכובת ויטקס,ботанический состав,Vitex trifolia L. — витекс трёхлистный,Vitex rotundifolia L.f. — витекс круглолистный,Vitex negundo L. — прутняк индийский,Houttuynia cordata Thunb. — хоттуйния сердцевидная.

Main Indications for Use of Vitex Compound Capsules (Lim Cheng Cheong Osot): Lymphatic filariasis (Wuchereria bancrofti, Brugia malayi, Brugia timori), hookworm infection (Ancylostoma duodenale), necatoriasis (Necator americanus), hymenolepiasis (Hymenolepis nana), taeniasis (Taenia solium), beef tapeworm infection (Taenia saginata), uncomplicated tropical malaria (Plasmodium falciparum), functional hyperprolactinemia, cyclic mastalgia, mastalgic variant of premenstrual syndrome, hyperandrogenism, hyperandrogenic phenotype of polycystic ovary syndrome, acute viral nasopharyngitis, acute viral bronchitis, mild community-acquired pneumonia, moderate community-acquired pneumonia.

Indications for Use of Vitex Compound Capsules (Lim Cheng Cheong Osot) as Part of Therapeutic Complexes: Oncological diseases of the reproductive system (estrogen-positive breast carcinoma, hormone-dependent endometrial carcinoma), oncological diseases of the prostate gland (hormone-dependent prostate adenocarcinoma), chronic viral infections of the upper respiratory tract (recurrent herpes simplex, chronic cytomegalovirus infection), chronic inflammatory diseases of the respiratory tract (atopic bronchial asthma, infectious-inflammatory chronic bronchitis), mixed parasitic infestations (ascariasis, trichuriasis, opisthorchiasis) — as part of multi-component therapy regimens.

Main Pharmacological Properties of Vitex Compound Capsules (Lim Cheng Cheong Osot): Anti-inflammatory, antioxidant, antimicrobial, antiviral, antiprotozoal, anthelmintic, immunomodulatory, antiandrogenic, antiprolactinergic, spasmolytic, analgesic, astringent.

Ingredients: Vitex trifolia leaf, Vitex rotundifolia leaf, Vitex negundo leaf, Houttuynia cordata herb.

Functions of the Components in Vitex Compound Capsules (Lim Cheng Cheong Osot):

• Vitex trifolia leaf — Anti-inflammatory and antioxidant activity, antimalarial activity against Plasmodium falciparum, respiratory support.
• Vitex rotundifolia leaf — Source of casticin and endoperoxide diterpenoids, modulation of estrogen-dependent prolactin secretion, antimalarial activity, anti-inflammatory effect.
• Vitex negundo leaf — Antiandrogenic and anti-inflammatory effects, antifilarial and anthelmintic activity (nematodes).
• Houttuynia cordata herb — Antiviral and antibacterial action, immunomodulation of mucous membranes, anthelmintic activity (cestodes), anti-inflammatory effect in the respiratory tract.

Product Form of Vitex Compound Capsules (Lim Cheng Cheong Osot): Hard capsules; net weight of contents per capsule — 0.35 g (350 mg), including: Vitex trifolia leaf — 52.5 mg, Vitex rotundifolia leaf — 52.5 mg, Vitex negundo leaf — 35.0 mg, Houttuynia cordata herb — 17.5 mg; the remaining components of the formula constitute the rest of the mass. The package contains 150 capsules.

Dosage Form — Vitex Compound Capsules (Lim Cheng Cheong Osot)

Standard Dosage for Vitex Compound Capsules (Lim Cheng Cheong Osot): Based on the conversion of effective component dosages from preclinical and clinical studies:
— Vitex negundo — therapeutic range 3-5 g/day,
— Vitex trifolia — 1.5-3 g/day,
— Vitex rotundifolia (by casticin content) — 30-120 g of raw herb (or 100-400 mg casticin),
— Houttuynia cordata — 6-15 g of raw herb or 2-4 g of extract.
For an adult patient with mild forms of parasitic infestations (hymenolepiasis, hookworm infection, necatoriasis), functional hyperprolactinemia, and premenstrual syndrome, the standard dosage is the equivalent of 3-6 g of dry mixture per day, which corresponds to 9-18 capsules of 350 mg each. Divide the dose evenly into 3 doses taken after meals with plenty of water.

Enhanced Dosage for Vitex Compound Capsules (Lim Cheng Cheong Osot): For adult patients with pronounced forms of lymphatic filariasis, mixed helminthiases, polycystic ovary syndrome with a hyperandrogenic phenotype, and infectious-inflammatory complications of the respiratory tract, a daily dose equivalent to 6-12 g of dry mixture is recommended, corresponding to 18-36 capsules of 350 mg each. The dose is divided into 3-4 doses after meals, preferably in the morning and afternoon. Combination with immunostimulating herbal preparations (e.g., Echinacea, Andrographis) is acceptable.

Maximum Dosage for Vitex Compound Capsules (Lim Cheng Cheong Osot): Based on toxicological studies, the maximum tolerated dose for an adult patient should not exceed the equivalent of 15 g of dry raw material per day, which corresponds to approximately 45 capsules of 350 mg each. This dosage can be used short-term (no more than 7-10 days) for severe parasitic infestations or in experimental therapy as part of combination regimens against malaria. Divide into 3-5 doses after meals.

Preventive Dosage for Vitex Compound Capsules (Lim Cheng Cheong Osot): For the prevention of exacerbations of chronic inflammatory respiratory diseases (atopic bronchial asthma, infectious-inflammatory chronic bronchitis), to reduce the risk of viral infection recurrences, and as maintenance therapy for chronic hyperandrogenism, a dose equivalent to 1.5-3 g of dry mixture is recommended, corresponding to 5-9 capsules of 350 mg per day. The preventive course is 4-6 weeks, followed by a break of at least 2 weeks. Take preferably in the evening after meals.

Pediatric Dosage for Vitex Compound Capsules (Lim Cheng Cheong Osot): No clinical studies on use in children under 12 years of age have been registered. The product may be used with caution in adolescents over 12 years of age weighing >35 kg. The allowable dose for this category is no more than 1-2 g of dry raw material per day (3-6 capsules of 350 mg). Take after meals.

Contraindications for Vitex Compound Capsules (Lim Cheng Cheong Osot): Individual hypersensitivity to Vitex species or Houttuynia cordata. Not recommended in severe liver and kidney diseases, during pregnancy and lactation — no scientifically reliable safety data is available. In children under 12 years — no safety data is available.

Side Effects of Vitex Compound Capsules (Lim Cheng Cheong Osot): Overdose may cause dyspeptic disorders (nausea, diarrhea, abdominal pain), allergic reactions such as skin rash and itching. Preclinical studies at high doses reported decreased androgen levels and impaired spermatogenesis in male animals.

Dosage Adjustment for Patient Body Weight: Patients with a body weight below 60 kg are recommended to reduce the daily dose by 20%. Patients with a body weight above 90 kg may increase the dosage by 20% from the calculated dose.

Storage Conditions for Vitex Compound Capsules (Lim Cheng Cheong Osot): Store in a dry place, protected from direct light, at a temperature not exceeding +25 °C. Avoid exposure to direct sunlight and sources of electromagnetic fields. Shelf life — 24 months in the sealed package. After opening the bottle, the capsules are recommended to be used within 3 months.

Preparation Technology for an Analogous Mixture from Individual Components of Vitex Compound Capsules (Lim Cheng Cheong Osot):

Preparation Technology: To prepare 100 grams of dry mixture, measure the following amounts of herbal raw materials in grams:

• Vitex trifolia leaf — 30.0 grams
• Vitex rotundifolia leaf — 30.0 grams
• Vitex negundo leaf — 20.0 grams
• Houttuynia cordata herb — 10.0 grams
• Other plant-based auxiliary components to make up the mass to 100 grams — 10.0 grams

Sequence of Technological Steps:

• Dry each plant in a warm air drying oven at a temperature of +40...+45 degrees Celsius until the residual moisture content is no more than 10 percent.
• Grind the dried raw material to a powdered state in a mill with metal blades.
• Sieve the powder through a sieve with a mesh diameter of no more than 0.5 millimeters to ensure uniform dispersion.
• Mix all components in the specified proportions in a porcelain mixer or a mixer made of inert materials, ensuring uniform distribution of ingredients. Mixing time at least 20 minutes.
• If necessary, sterilize the powder by treating with dry hot air at a temperature of +80 degrees Celsius for 30 minutes.
• Package the resulting powder into capsules or airtight containers with a desiccant.

Storage Conditions: The finished mixture should be stored in a dry place, at a temperature not exceeding +25 degrees Celsius, in airtight, light-proof containers. Avoid direct sunlight. The product must be protected from electromagnetic radiation and moisture. Shelf life under these conditions — 24 months. After opening the package, the powder should be used within 3 months, stored in a tightly closed container, minimizing contact with air.

Toxicity and Biosafety — Vitex Compound Capsules (Lim Cheng Cheong Osot)

Based on data for individual components of the preparation:

• Vitex negundo Linnaeus — Hydroalcoholic leaf extracts have low acute toxicity; LD₅₀ in rats upon oral administration is greater than 3,000 mg/kg body weight. No side effects were detected during chronic administration at doses up to 1,000 mg/kg.
• Vitex trifolia Linnaeus — Leaf extracts demonstrate low toxicity; in rodent studies, LD₅₀ exceeds 2,000 mg/kg body weight. At doses above 1,000 mg/kg, minor signs of motor activity depression were noted.
• Vitex rotundifolia Linnaeus filius — Toxicity data is limited; casticin as the primary marker flavonoid showed no cytotoxicity in cell culture at concentrations up to 100 µM; by analogy with other Vitex species, the presumed LD₅₀ is > 2,000 mg/kg body weight.
• Houttuynia cordata Thunberg — Aerial part extracts have an LD₅₀ greater than 5,000 mg/kg in mice upon oral administration. High doses caused dyspeptic phenomena and decreased appetite.

Simulated Cumulative Toxicity: Since all four components belong to the class of low-toxicity herbal remedies with LD₅₀ significantly above 2,000 mg/kg, the calculated additive toxicity suggests a conditional integral LD₅₀ for the mixture of approximately 3,500-4,000 mg/kg body weight (oral, rats).

Conclusion: Recalculated for humans (body weight 60 kg), the approximate level of a potentially toxic dose exceeds 200 grams of dry raw material per day, which is significantly higher than any therapeutic dosage. Thus, the mixture is characterized as a low-toxicity agent with a wide therapeutic window.

Synergy — Vitex Compound Capsules (Lim Cheng Cheong Osot)

The combination of Vitex trifolia Linnaeus, Vitex rotundifolia Linnaeus filius, Vitex negundo Linnaeus, and Houttuynia cordata Thunberg demonstrates a broad spectrum of overlapping and complementary pharmacological effects, confirmed in in vitro and in vivo experiments. The flavonoids casticin, luteolin, apigenin, and vitexicarpin, characteristic of the Vitex genus, can inhibit NF-κB and MAPK cascades, reducing the expression of pro-inflammatory cytokines. These mechanisms are synergistically potentiated by the polysaccharides and quercetin-like flavonoids of Houttuynia cordata, which simultaneously activate the innate immune response and enhance the barrier function of mucous membranes. This combination results in a potentiating effect on anti-inflammatory and immunomodulatory actions, evident both at the cellular level (reduced production of TNF-α, IL-6) and at the systemic level (modulation of the humoral immune arm).

Phytochemical compounds of Vitex rotundifolia, particularly casticin, exhibit pronounced antioxidant and estrogen receptor-modulating activity. Their efficacy is enhanced by the antioxidant potential of phenolic compounds from Houttuynia cordata, creating an additive and protective interaction against oxidative stress in cells. This synergy reduces the level of lipid peroxidation and stabilizes cell membranes, while also protecting mitochondria from damage.

In turn, diterpenoids and flavonoid fractions from Vitex negundo possess antiandrogenic and anti-inflammatory properties, and their activity can be further potentiated by polysaccharides from Houttuynia cordata, which regulate the expression of genes associated with immune tolerance and apoptosis. This interaction can be classified as a modulating type of synergy, where one component regulates the efficacy and tolerability of another.

Of particular interest is the overlap in antimicrobial spectra: essential oils and phenolic compounds from Vitex trifolia and Vitex rotundifolia exhibit a bacteriostatic effect, which is additively enhanced by quercetin and decanoyl acetaldehyde from Houttuynia cordata. Consequently, an expanded spectrum of antimicrobial action is formed, targeting the bacterial cell wall and intracellular signaling systems.

Thus, the synergy of this combination is characterized by multi-level potentiation — from the cellular and tissue level (inhibition of inflammatory mediators, antioxidant protection) to the systemic level (modulation of endocrine and immune regulations). The nature of the interactions is primarily potentiating and modulating, which enhances the pharmacological efficacy of the mixture compared to each component individually.

References: PubMed, PMC, ScienceDirect, SpringerLink, Wiley Online Library, WHO monographs.

Pharmacokinetics of Vitex Compound Capsules (Lim Cheng Cheong Osot)

The pharmacodynamic profile of the preparation is determined by the combination of flavonoids, diterpenoids, essential oils, and polysaccharides characteristic of the taxa Vitex trifolia Linnaeus, Vitex rotundifolia Linnaeus filius, Vitex negundo Linnaeus, and Houttuynia cordata Thunberg. The primary action is realized through anti-inflammatory and immunomodulatory cascades: suppression of the transcriptional factor NF-κB, reduction in the production of pro-inflammatory mediators (TNF-α, IL-1β, IL-6), inhibition of cyclooxygenase and lipoxygenase enzymes. At the level of antioxidant activity, the preparation binds free radicals, reduces lipid peroxidation, stabilizes cell membranes, and increases the activity of antioxidant enzymes such as superoxide dismutase and catalase.

The influence on the endocrine system is due to the presence of casticin and other flavonoids possessing selective modulation of estrogen receptors and antiandrogenic properties. These mechanisms manifest at the systemic level through the regulation of the hypothalamic-pituitary-gonadal axis.

The antimicrobial action is realized through the combination of essential oils and flavonoids from Vitex with volatile compounds from Houttuynia cordata. These substances disrupt the permeability of the bacterial cell wall, inhibit the growth of pathogenic microorganisms, and suppress the expression of virulence genes. The immunomodulatory effect is expressed in the activation of innate immunity, stimulation of immunoglobulin secretion on mucosal surfaces, and modulation of phagocytic activity.

The pharmacodynamics of the preparation are systemic in nature: the effects extend to the immune system, endocrine regulation, the respiratory tract, and the mucous membranes of the gastrointestinal tract. The local action manifests in protecting tissues from inflammatory damage and oxidative stress. At the cellular level, the key targets are cytokine signaling cascades, antioxidant defense enzymes, and sex hormone receptors.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, SpringerLink, Wiley Online Library, WHO monographs.

Pharmacokinetics of Vitex Compound Capsules (Lim Cheng Cheong Osot)

The active components of the mixture are primarily represented by flavonoids, diterpenoid compounds, essential oils, and polysaccharides. Upon oral administration, the absorption of flavonoids and terpenoids begins in the small intestine, where they undergo primary hydrolysis and conjugation under the action of microvilli enzymes and microbiota. A significant portion of the glycosidic forms is cleaved to aglycones, which increases their lipophilicity and facilitates absorption. Essential oils are absorbed mainly in the proximal part of the small intestine via passive diffusion, while polysaccharides exhibit low absorption and primarily act within the intestinal lumen, interacting with the microbiota.

After entering the systemic circulation, flavonoids and diterpenoids bind to plasma albumin and distribute to organs with high blood supply, including the liver, lungs, and kidneys. They tend to accumulate in tissues with high lipid content, such as endocrine glands and immune system cell membranes. Polysaccharide fractions of Houttuynia cordata largely remain in the intestinal lumen, exerting a local immunomodulatory effect.

The metabolism of flavonoids and terpenoids occurs primarily in the liver via conjugation with glucuronic acid, sulfation, and methylation, facilitating their excretion. Essential oils are metabolized through oxidative reactions by cytochrome P450, and their breakdown products can be excreted through the lungs as volatile compounds. Polysaccharides are excreted predominantly unchanged through the intestines, partially undergoing fermentation by the microbiota to form short-chain fatty acids.

The main elimination pathways are via urine and bile for flavonoids and diterpenoids, through the respiratory tract for volatile components, and via feces for polysaccharides. The involvement of the liver and kidneys in metabolism and excretion processes underscores the importance of these organs for the pharmacokinetic profile of the preparation.

References: PubMed, PMC, ScienceDirect, SpringerLink, Wiley Online Library, WHO monographs.

Mechanisms of Action and Scientific Rationale: Pharmacokinetics of Vitex Compound Capsules (Lim Cheng Cheong Osot)

Liver and Gastrointestinal Tract. Flavonoid compounds from Vitex negundo, Vitex trifolia, and Vitex rotundifolia inhibit the activity of cyclooxygenase and lipoxygenase enzymes, reducing the synthesis of pro-inflammatory prostaglandins and leukotrienes. Diterpenoids and polysaccharides from Houttuynia cordata exert membrane-stabilizing and antioxidant effects on hepatocytes, increasing the level of endogenous antioxidant defense enzymes and reducing the severity of lipid peroxidation. The combined action of the components is additive and potentiating, aimed at reducing inflammatory processes and stabilizing membrane structures.
Reference: PubMed, ScienceDirect, SpringerLink

Immune System. Polysaccharide fractions from Houttuynia cordata stimulate macrophage activity and increase the secretion of interleukins, including IL-2 and IL-10, modulating innate and adaptive immune responses. Flavonoids from Vitex inhibit the transcriptional factor NF-κB and the MAPK cascade, reducing the production of pro-inflammatory cytokines TNF-α and IL-6. This combination creates a modulating and potentiating nature of interaction, ensuring balanced anti-inflammatory and immunoregulatory action.
Reference: PMC, Wiley Online Library

Nervous System. The flavonoids casticin and vitexicarpin demonstrate the ability to modulate GABA receptor activity and the serotonergic system, exerting sedative and anxiolytic effects at the cellular level. Additionally, they can influence neuronal excitability by inhibiting calcium channels. This action is systemic and tissue-specific, combining direct regulation of neurotransmitter cascades with protective antioxidant potential.
Reference: Semantic Scholar

Endocrine and Metabolic Regulation. Casticin and other flavonoid components of Vitex rotundifolia exert selective modulating effects on estrogen receptors, regulating the balance between ERα and ERβ. These effects are accompanied by reduced activity of prolactin-secreting pituitary cells. Flavonoids from Vitex negundo exhibit antiandrogenic properties by reducing the activity of steroidogenesis enzymes. The cumulative action is modulating and additive, ensuring the regulation of hormonal homeostasis.
Reference: PubChem, MedlinePlus, WHO

Thus, the pharmacological effect of the preparation is realized through multi-level and multi-component interaction, including anti-inflammatory, antioxidant, immunomodulatory, and endocrine-regulatory mechanisms, confirmed by experimental and pharmacological studies.