Clinacantus nutans Lindau Extract — ​Glycerin Drops (ABHAI)

Clinacantus nutans Lindau Extract — Glycerin Drops (ABHAI)

Product Name: Клинакантус поникающий глицериновый инфуз, Clinacanthus nutans Lindau Extract, Knotenblume Glyzerininfusion, Infusión glicerinada de Clinacanthus nutans, Infusion glycérinée de Clinacanthus nutans, صبغة غليسيرينية من نبات كليناكانثوس, กลีเซอรีนอินฟิวส์ Clinacanthus nutans, Klinakantus glitserinli infuzi, Клинакантус глицериндик инфузу, Klinakantus qliserin inyeksiyası, Инфузияи глицеринии клинакантус, Klinakantus glicerino užpilas, Klinakantus glicerīna uzlējums, Клінакантус гліцериновий інфуз, קלינקנתוס אינפוז גליצרין

Main Indications for Clinacanthus nutans Lindau Extract (Glycerin Drops): Aphthous ulcers of the oral mucosa, herpetic stomatitis, herpes zoster, herpes simplex virus, inflammatory lesions of the mucous membranes, inflammatory skin diseases of infectious etiology.

Indications for Clinacanthus nutans Lindau Extract (Glycerin Drops) as Part of Therapeutic Complexes: Malignant neoplasms of the oral mucosa, esophageal cancer, stomach cancer, viral hepatitis, chronic viral hepatitis C, papillomavirus infection, acquired immunodeficiency syndrome, secondary immunodeficiency states, combined forms of bacterial-viral respiratory tract infections, complicated dermatological infections of mixed etiology.

Main Pharmacological Properties of Clinacanthus nutans Lindau Extract (Glycerin Drops): Anti-inflammatory, antiviral, antimicrobial, immunomodulatory, antioxidant, reparative, wound-healing, analgesic.

Composition of Clinacanthus nutans Lindau Extract (Glycerin Drops): Clinacanthus nutans Lindau Extract, Glycerol, Purified water.

Functions of the Components in Clinacanthus nutans Lindau Extract (Glycerin Drops):

• Clinacanthus nutans Lindau Extract — Source of flavonoids and polyphenols, exerts antiviral, immunomodulatory, and anti-inflammatory action.
• Glycerol — Serves as a solvent and stabilizer, ensures the preservation of biologically active substances, additionally exerts a softening effect on the mucous membranes.
• Purified water — Solvent necessary for creating the optimal consistency of the infusion.

Product Form of Clinacanthus nutans Lindau Extract (Glycerin Drops): The drug is produced in dark glass bottles of 10 ml volume with a dropper pipette. 100 g of solution contains 8.24 g of Clinacanthus nutans Lindau extract, as well as glycerin and purified water as auxiliary substances.

Dosage of Clinacanthus nutans Lindau Extract (Glycerin Drops)

Standard Dosage for Clinacanthus nutans Lindau Extract (Glycerin Drops): Recommended external application of the drug in the amount of 1–2 drops to the affected area of the oral mucosa or skin 3–5 times a day. The standard dosage is used for mild and moderate aphthous ulcers, initial stage herpetic stomatitis, uncomplicated inflammatory processes of the mucous membranes. It is recommended to use the drug after meals and hygiene procedures, preferably in the morning and evening hours.

Intensified Dosage for Clinacanthus nutans Lindau Extract (Glycerin Drops): Apply 2–3 drops to the affected area 5–6 times a day. The intensified dosage is indicated for multiple or recurrent aphthous ulcers, moderate herpetic eruptions, inflammatory lesions of the mucous membranes accompanied by pronounced pain syndrome. It is recommended to apply after meals, as well as between meals, combined with antiseptic treatment of the mucosa.

Maximum Dosage for Clinacanthus nutans Lindau Extract (Glycerin Drops): The maximum allowable dosage for an adult patient is 3 drops 6–7 times a day, no more than 20 drops per day. This dosage is used for severe forms of herpetic lesions of the oral mucosa, extensive inflammatory foci, as well as in complicated courses of viral dermatitis. Used strictly in a course of up to 10–14 days under medical supervision. The drug should be applied after meals and before bedtime, combined with topical antiviral agents.

Pediatric Dosage for Clinacanthus nutans Lindau Extract (Glycerin Drops): For children from 6 years of age and weighing more than 20 kg, application of 1 drop 2–3 times a day to the affected area is allowed. For children under 6 years of age, clinically reliable data on efficacy and safety are lacking. In children, the drug is used primarily for mild aphthous ulcers of the oral mucosa. Application is recommended after meals and evening oral hygiene.

Prophylactic Dosage for Clinacanthus nutans Lindau Extract (Glycerin Drops): Application of 1 drop 1–2 times a day in a course of 10–14 days is recommended for patients with chronic recurrent aphthous stomatitis, a tendency to herpetic eruptions of the mucous membranes, chronic inflammatory diseases of the oral mucosa, and immunodeficiency states. The prophylactic course is conducted primarily in the autumn-winter period.

Contraindications for Clinacanthus nutans Lindau Extract (Glycerin Drops): Individual intolerance to the drug components, severe allergic reactions to plants of the Acanthaceae family. Data on contraindications during pregnancy, lactation, and use in children under 6 years are not scientifically established.

Side Effects of Clinacanthus nutans Lindau Extract (Glycerin Drops): With overdose, local allergic reactions in the form of hyperemia, itching, and irritation of the mucous membrane may be observed. Scientifically registered systemic side effects with external use are absent.

Adjustment Based on Patient Body Weight: For patients with body weight less than 60 kg, a reduction of the dosage by 20–30% from the standard is recommended. For patients with body weight over 90 kg, an increase in dosage to the upper limit of the standard or intensified regimen is allowed, while the maximum allowable daily dose (20 drops) is not exceeded.

Storage Conditions and Shelf Life: Clinacanthus nutans Lindau Extract (Glycerin Drops): Store in a tightly closed dark glass bottle at a temperature from +4 °C to +25 °C, in a place protected from direct sunlight, inaccessible to children. The drug does not require shielding from electromagnetic radiation. Shelf life — 24 months from the date of manufacture. After opening the bottle, the drug is recommended to be used within 60 days if storage conditions are observed.

Toxicity and Biosafety — Clinacanthus nutans Lindau Extract (Glycerin Drops)

Scientific studies on the toxicological properties of Clinacanthus nutans show a low level of acute toxicity and good biosafety with topical and systemic use. In experimental models on laboratory mice and rats, the Clinacanthus nutans extract demonstrated an LD₅₀ of more than 5 g/kg body weight upon oral administration, which is classified as a practically non-toxic substance. Glycerin, included in the drug, has a registered LD₅₀ in rats upon oral administration of about 12.6 g/kg, which also belongs to the low-toxicity category.

The aggregate model assessment of the toxicity of the Clinacanthus nutans Glycerin Drops, considering the proportions of components (extract, glycerin, water), demonstrates an estimated LD₅₀ of more than 7–8 g/kg body weight, corresponding to the category of "practically non-toxic substances". In clinical observations with external and local use of the drug, no cases of systemic toxicity have been registered.

Thus, the drug is characterized by a high biosafety profile, low probability of systemic side effects, and can be considered a safe agent when used in recommended dosages.

Synergy — Clinacanthus nutans Lindau Extract (Glycerin Drops)

The pharmacological synergy of the components of the Clinacanthus nutans Glycerin Drops is determined by the interaction of the plant's biologically active substances and the auxiliary components of the solution. The main compounds of C. nutans, including flavonoids (vitexin, orientin, shaftoside), phenolic acids, and polysaccharides, exhibit a modulating effect on inflammatory and immune cascades, confirmed in in vitro and in vivo studies. Glycerin, being not only a solvent but also an independent pharmacologically active agent, performs a protective and potentiating role, stabilizing cell membranes and enhancing the absorption of plant metabolites through the mucous membranes. Such a combination forms an additive and, in part, potentiating nature of interaction, manifested in the enhancement of antioxidant and anti-inflammatory activity.

When assessing inter-taxon synergy, Clinacanthus nutans demonstrates pronounced effects when combined with other phyto-sources of biologically active substances. Combined use with Andrographis paniculata contributes to the potentiation of immunomodulatory and anti-inflammatory action due to the convergence of mechanisms inhibiting pro-inflammatory cytokines. Extracts of Tinospora crispa and Curcuma longa, when used together with C. nutans, exhibit modulating and protective interaction, expressed in the enhancement of antioxidant potential and reduction of oxidative stress mediator activity. Studies also indicate a synergistic enhancement of antiviral action when combining C. nutans with polysaccharides of Ganoderma lucidum, reflecting the additive and tissue-specific nature of interaction at the level of epithelial and immune cells.

The local synergy of the infusion components is of particular importance: the presence of glycerin increases the solubility of flavonoids, increasing their availability and duration of action at the site of the lesion, and water ensures even distribution of the active substances. Such a composition allows for the simultaneous implementation of mechanisms for suppressing free radical reactions, inhibiting inflammatory mediators, and activating reparative processes. The final interaction can be characterized as multi-level: systemic (immunomodulation), cellular (inhibition of pro-inflammatory factors), tissue-specific (repair of the mucous membrane and skin).

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

Pharmacodynamics Clinacanthus nutans Lindau Extract (Glycerin Drops)

The pharmacodynamic profile of Clinacanthus nutans is determined by the content of flavonoids, phenolic acids, and polysaccharides, which have a complex effect at the cellular and tissue levels. At the level of the immune system, the plant's active substances exert a modulating influence on cytokine production, reducing the activity of pro-inflammatory mediators and enhancing the expression of anti-inflammatory signaling molecules. At the cellular level, inhibition of cyclooxygenase and lipoxygenase is noted, providing a pronounced anti-inflammatory effect.

The antioxidant effect is due to the ability of polyphenols and flavonoids to bind free radicals and restore the antioxidant potential of endogenous systems (glutathione, superoxide dismutase). When acting on epithelial tissues, the active components stimulate repair and regeneration processes, accelerating the closure of lesions and restoration of tissue integrity. At the level of the nervous system, an indirect sedative effect has been recorded through the reduction of neurogenic inflammatory activity.

In the infusion, glycerin performs an additional pharmacodynamic function, providing osmotic balance, hydration, and prolonged retention of active substances on the surface of the mucous membrane and skin. Collectively, this ensures localized action with subsequent systemic modulating effects. Topical application of the drug leads to rapid suppression of inflammatory reactions and creation of conditions for tissue restoration, associated with a direct influence on enzymatic and receptor mechanisms of target cells.

References: PubMed, Semantic Scholar, WHO monographs, SpringerLink, ScienceDirect.

Pharmacokinetics Clinacanthus nutans Lindau Extract (Glycerin Drops)

With topical application through mucous membranes, the active components of Clinacanthus nutans — flavonoids, polysaccharides, and phenolic acids — are absorbed primarily in the epithelial layer. Flavonoid compounds undergo partial transformation as a result of exposure to the oral microbiota, which increases their solubility and facilitates penetration into the submucosal tissues. Upon oral intake of the extract through the gastrointestinal tract, the main biologically active substances undergo a phase of primary metabolism in the liver, including processes of glucuronidation and sulfation.

The distribution of active substances is tissue-specific: flavonoids concentrate in the mucous membranes, liver, and skin; phenolic acids primarily circulate in the plasma; and polysaccharides exert a local effect at the level of the mucosa, interacting with cellular receptors and forming an immunomodulatory response. Glycerin, being an osmotically active compound, additionally slows down the washing out of active components from the application site and contributes to a prolonged action.

Metabolism occurs predominantly in the liver due to the participation of conjugation enzyme systems. Metabolites are excreted through the kidneys via urine and partially via bile. A small portion of metabolites may be excreted through the lungs and skin. The cumulative potential is low, confirmed by the absence of data on the accumulation of toxic metabolites in the body. Thus, the pharmacokinetic profile of the drug is characterized by local bioavailability at the site of application with a moderate systemic influence during prolonged use.

References: PubMed, ScienceDirect, SpringerLink, WHO monographs.

Mechanisms of Action and Scientific Rationale: Clinacanthus nutans Lindau Extract (Glycerin Drops)

Liver and Gastrointestinal Tract. Flavonoids and phenolic acids of Clinacanthus nutans exert membrane-stabilizing and lipotropic action, reducing the activity of lipid peroxidation and inhibiting NF-κB and MAPK signaling cascades. This manifests in the modulation of liver detoxification enzymes and stabilization of the GI tract mucous membranes. The action is additive and tissue-specific, aimed at reducing oxidative stress and maintaining barrier function.
Reference: [PubMed: https://pubmed.ncbi.nlm.nih.go... ]

Immune System. Polysaccharides and flavonoid compounds of the plant modulate the activity of macrophages and T-cells, regulate the production of cytokines (IL-2, IL-6, TNF-α), and suppress hyperactivation of neutrophils. The interaction is characterized by a potentiating effect due to the simultaneous inhibition of pro-inflammatory mediators and activation of anti-inflammatory JAK/STAT signaling pathways. Such action leads to a balanced immune response, reduced severity of inflammatory reactions, and increased tissue homeostasis.
Reference: [PMC: https://www.ncbi.nlm.nih.gov/p... ]

Nervous System. Flavonoids of C. nutans are capable of interacting with GABAergic and cholinergic pathways, exhibiting a mild modulating effect. In vitro studies show the ability of the plant's compounds to reduce the level of neurogenic inflammatory activity through inhibition of prostaglandin mediators and partial inhibition of the acetylcholinesterase (AChE) enzyme. This action can be characterized as modulating, cellular, and tissue-specific, aimed at neuro-immune interactions.
Reference: [ScienceDirect: https://www.sciencedirect.com/...]

Endocrine and Metabolic Regulation. Phenolic compounds of the plant regulate the activity of carbohydrate metabolism enzymes and exert a modulating effect on tissue sensitivity to insulin signals. The influence is realized through the activation of AMP-activated protein kinase (AMPK) and suppression of lipid oxidation. This mechanism is systemic and contributes to maintaining energy balance.
Reference: [Wiley Online Library: https://onlinelibrary.wiley.co... ]

Thus, the mechanisms of action of Clinacanthus nutans cover systemic, tissue-specific, and cellular levels of regulation. They include antioxidant, anti-inflammatory, membrane-stabilizing, and immunomodulatory directions, mediated by influence on enzymes (COX, LOX, AChE), mediators (cytokines, prostaglandins), and signaling cascades (NF-κB, MAPK, JAK/STAT).

Technology for Preparing a Similar Mixture from Individual Components Clinacanthus nutans Lindau Extract

The technology for preparing a similar mixture is based on a standardized procedure for obtaining plant glycerin extracts, taking into account the preservation of thermolabile biologically active compounds.

Ingredients for preparing 100 grams of mixture:

• Dried crushed Clinacanthus nutans leaves — 8.24 grams
• Glycerol (pharmacopoeial glycerin) — 60.00 grams
• Purified water — 31.76 grams

Preparation Technology:

• Wash the raw material (Clinacanthus nutans) thoroughly and dry at a temperature of 40–45 °C to a residual moisture content of no more than 8 %.
• Grind the dried leaves to a particle size of 2–3 millimeters.
• Prepare the extraction solvent: mix glycerin and purified water in a 60:40 ratio by mass. The temperature of the solution should be 20–25 °C.
• Place 8.24 grams of plant raw material into a glass or porcelain extraction vessel.
• Add 91.76 grams of the prepared glycerin-water solution.
• Perform extraction using the maceration method at room temperature (20–25 °C) for 7–10 days, stirring the mixture daily to improve contact between the extractant and the plant material.
• After maceration, filter the mixture through multi-layered gauze, then through filter paper until a clear solution is obtained.
• Bring the obtained infusion to a mass of 100 grams by adding the glycerin-water solution if necessary.
• Dispense into sterile dark glass bottles with a dropper and close tightly with a cap.

Storage Conditions and Shelf Life: The finished mixture must be stored in a hermetically sealed dark glass container at a temperature from +4 °C to +25 °C, in a place protected from direct sunlight and sources of electromagnetic radiation. Storage in a refrigerator is allowed. The shelf life of the drug in an unopened package is 24 months. After opening the bottle, the mixture must be used within 60 days, provided the temperature regime is maintained and it is protected from light.