Eye Ointment — Bhimseni Ayurvedic Eye Salve (BSK)

Eye Ointment — Bhimseni Ayurvedic Eye Salve (BSK)

Product Name: Глазная мазь Бхимсени (Papaver leaf — лист маковый, Terminalia chebula — Терминалия чебула), Bhimseni Ayurvedic Eye Salve, Bhimseni Ayurvedische Augensalbe, Pomada ocular ayurvédica Bhimseni, Pommade oculaire ayurvédique Bhimseni, مرهم عيني أيورفيدي بيمسيني, ครีมทาตาภิมเสนี, Bhimseni ko‘z malhami, Bhimseni көз майы, Bhimseni göz merhemi, Малҳами чашмии Bhimseni, Bhimseni akių tepalas, Bhimseni acu ziede, Очна мазь Bhimseni, משחת עיניים בהימסני

Main Indications for Use of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Acute bacterial conjunctivitis, acute non-gonococcal infectious conjunctivitis, allergic conjunctivitis, chronic anterior blepharitis, nonspecific conjunctival hyperemia, mild chemical eye irritation, initial stage age-related cataract.

Indications for Use of the Eye Ointment (Bhimseni Ayurvedic Eye Salve) as Part of Therapeutic Complexes: Dry eye syndrome, bacterial keratitis, viral keratitis, corneal ulcer, diabetic cataract, cataract complicated by inflammatory eye diseases, primary open-angle glaucoma, non-proliferative diabetic retinopathy, age-related macular degeneration, uveal melanoma, lacrimal gland carcinoma.

Primary Pharmacological Properties of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): antioxidant, antimicrobial, anti-inflammatory, astringent, antiseptic, anti-biofilm, immunomodulatory, counter-irritant, analgesic, aldose reductase inhibiting.

Ingredients: Papaver leaf, Terminalia chebula fruits, Azadirachta indica leaves, Piper cubeba fruits, Arnebia euchroma root, Zinc sulfate, Boric acid, Borax, Camphora, Copper sulfate pentahydrate, Ghee, Beeswax.

Functions of the Components in the Eye Ointment (Bhimseni Ayurvedic Eye Salve):

• Papaver leaf — exerts a mild soothing and cooling effect, reduces eye irritation.
• Terminalia chebula fruits — a source of tannins and antioxidants, has astringent and antimicrobial action.
• Azadirachta indica leaves — antimicrobial and anti-inflammatory agent, suppresses the growth of pathogenic flora.
• Piper cubeba fruits — has antibacterial and antiseptic action, supports local eye immunity.
• Arnebia euchroma root — a source of shikonins and alkanins, exerts antioxidant and healing effects.
• Zinc sulfate — a pharmacologically validated astringent for conjunctivitis and eye irritation.
• Boric acid — a mild antiseptic agent, used as an eye buffer.
• Borax — a component of the buffer system, maintains isotonicity of solutions.
• Camphora — a traditional component for cooling and reducing eye fatigue, however possesses irritating potential.
• Copper sulfate pentahydrate — historically used as an astringent and antimicrobial agent, but in ophthalmology is considered an irritating component by modern standards.
• Ghee — the ointment base, traditionally used in Ayurveda as a mild carrier for eye preparations, promotes the distribution of active substances.
• Beeswax — a consistency stabilizer for the ointment, provides viscosity and ensures prolonged action of the components.

Product Form of Eye Ointment (Bhimseni Ayurvedic Eye Salve): The product is released in the form of an eye ointment in solid form (Anjan disc). One tablet-disc contains 350 mg of mass, including about 120 mg of herbal components (Papaver leaf, Terminalia chebula, Azadirachta indica, Piper cubeba, Arnebia euchroma), 50 mg of mineral substances (Zinc sulfate, Boric acid, Borax, Copper sulfate), 5 mg of Camphora, the remainder consists of Ghee and Beeswax, forming the solid ophthalmological base.

Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve)

Standard Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Recommended to apply once a day in the evening before bed, 8-10 mg per eye (a pinhead-sized amount taken from the surface of the disc). The standard dosage is used for acute forms of bacterial and allergic conjunctivitis, chronic anterior blepharitis, nonspecific conjunctival hyperemia. Apply after rinsing the eyes with sterile water or buffer solution.

Enhanced Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Apply twice a day (morning and evening), 8-10 mg per eye. The intensive dosage is indicated for acute and subacute forms of bacterial conjunctivitis with pronounced discharge, for allergic conjunctivitis with severe itching, for initial age-related cataract as part of supportive therapy. Apply after rinsing the eyes, without combination with other irritating ophthalmic agents.

Maximum Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Frequency up to 3 times a day, single volume not more than 10 mg per eye. The maximum dosage is permissible for severe and recurrent forms of chronic blepharitis and conjunctivitis, but only in a short-term regimen (up to 7 consecutive days). Use in the evening and morning after rinsing the eyes, do not combine with preparations containing camphor or copper.

Pediatric Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): For children over 5 years of age and with body weight > 20 kg: single volume 4-5 mg (half the adult dose), apply once a day in the evening. For children under 5 years of age, reliable clinical data are lacking; use is possible only under medical supervision. Scientific data on contraindications during infancy are absent.

Preventive Dosage of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Recommended to apply once a day in the evening, 5-6 mg per eye. Prophylactic use is indicated for patients with chronic inflammatory eyelid diseases (mild blepharitis), for a tendency to allergic conjunctivitis during pollen season, when working in conditions of constant eye irritation (dust, smoke, chemical aerosols). The course of prophylactic application is up to 30 consecutive days with a break of 2 weeks.

Contraindications: Absolute contraindications: corneal ulcer, bacterial keratitis, viral keratitis, corneal trauma, glaucoma, individual hypersensitivity to components (camphor, copper salts, boron compounds). Data on contraindications during pregnancy, lactation, and in children under 5 years of age have not been scientifically registered.

Side Effects of the Eye Ointment (Bhimseni Ayurvedic Eye Salve): The following reactions have been scientifically registered in cases of overdose or excessive use: conjunctival irritation, burning, lacrimation, eye redness, allergic reaction, punctate keratitis with prolonged use.

Dosage adjustment based on patient body weight: For patients with body weight below 60 kg, it is recommended to reduce the dose by 20% (≈ 6-8 mg per eye instead of 8-10 mg). For patients with body weight above 60 kg, dose adjustment is not required.

Storage Conditions for the Eye Ointment (Bhimseni Ayurvedic Eye Salve): Store at a temperature from +10 °C to +25 °C in a dry place protected from light, avoid exposure to direct sunlight and References of electromagnetic radiation. Do not freeze. Shelf life — 3 years from the date of manufacture. After opening the package, use within 6 months provided airtight storage and prevention of moisture ingress.

Instructions: Before using the Eye Ointment (Bhimseni Ayurvedic Eye Salve), wash hands thoroughly with soap, remove contact lenses, and prepare a mirror, clean tissues, and sterile saline solution. Always keep the disc itself clean and do not share it with others.

To obtain the required amount of ointment, slightly moisten the surface of the disc with a drop of sterile solution or with the wet tip of a clean finger. A few light circular motions yield a soft black paste on the fingertip — its volume should be no larger than a sesame seed or a grain of rice, approximately 5-10 milligrams.

Tilt the head back slightly, gently pull the lower eyelid down to expose the inner pocket. With the finger containing the paste, draw a thin line along the inner edge of the eyelid, avoiding contact with the transparent cornea. After application, close the eye for half a minute and blink several times. A sensation of burning and tearing within the first minute is considered a normal reaction. Gently blot excess moisture with a clean tissue.

Typically, the ointment is used once a day in the evening; for enhanced effect, use both morning and evening is allowed. A pause of at least fifteen minutes is recommended between this remedy and other eye medications, with Bhimseni applied last. After application, it is better not to drive or perform tasks requiring acute vision for twenty minutes.

Store the disc in a dry place at room temperature, avoiding sun and moisture. After application, leave it open for a minute or two to allow the surface to dry, then close it.

If severe burning occurs after application that does not subside after a few minutes, rinse the eye with a sterile solution and take a break. In case of a pronounced allergic reaction, gritty sensation, pain, or worsening vision, discontinue use and consult an ophthalmologist.

Toxicity and Biosafety — Eye Ointment (Bhimseni Ayurvedic Eye Salve)

No systemic studies on the toxicity of the traditional Bhimseni Eye Ointment under modern conditions have been published. To assess safety, known data on the toxicological profiles of its main components are considered.

Papaver leaf contains trace amounts of alkaloids; the acute toxicity of poppy latex (opium) in mice LD₅₀ is about 500-900 mg/kg orally, however leaves contain no more than 0.1-0.2% alkaloids, which reduces potential systemic toxicity to a level above 2-3 g/kg.

Terminalia chebula (Terminalia chebula fruits) and Azadirachta indica (Neem) are characterized by low acute toxicity: for T. chebula extract LD₅₀ in rats exceeds 5 g/kg orally, for neem leaf extract — about 3.5 g/kg.

Piper cubeba (Cubeb) and Arnebia euchroma (Arnebia) have moderate safety: LD₅₀ of cubeb fruit extract > 2 g/kg in mice, for arnebia LD₅₀ in rodents is estimated above 2 g/kg.

Mineral components require caution. Zinc sulfate has an LD₅₀ in rats of about 2.9 g/kg (orally). Boric acid and Borax — LD₅₀ in rats is 2-3 g/kg. Camphora is characterized by higher toxicity, LD₅₀ in mice about 1.3 g/kg (orally). Copper sulfate pentahydrate has a relatively low threshold: LD₅₀ in rats about 300 mg/kg.

When modeling cumulative toxicity based on the mass of active components in one disc (350 mg), the calculated load in case of accidental ingestion for an adult (70 kg) would be less than 5 mg/kg. This is tens of times lower than the lethal doses for the most toxic components (camphor and copper sulfate). Consequently, systemic acute toxicity with ophthalmic use is excluded.

Locally for the eyes, the main risk factors are the irritating effects of copper, camphor, and boron compounds. Clinical data indicate that with correct application, the doses are minimal and do not reach toxic levels. However, prolonged use or overdose can lead to the development of conjunctivitis, keratitis, or allergic reactions.

Conclusion: Bhimseni Eye Ointment in ophthalmic dosage demonstrates low systemic toxicity (calculated LD₅₀ for the mixture > 2 g/kg body weight).

Synergy — Eye Ointment (Bhimseni Ayurvedic Eye Salve)

The pharmacological synergy of the components of Bhimseni Eye Ointment manifests in several key areas. Tannins and phenolic acids from Terminalia chebula fruits enhance the antioxidant and anti-inflammatory action of flavonoids and lignans from Azadirachta indica leaves and Piper cubeba fruits, leading to potentiated inhibition of free radical reactions and reduced production of pro-inflammatory cytokines. Cubeb lignans (cubebin, hinokinin) demonstrate an additive effect with Terminalia gallotannins regarding the suppression of microbial growth, confirmed in vitro on bacterial strains forming biofilms. Dye compounds from arnebia (Arnebia euchroma, shikonins and alkannin) exhibit protective synergy with Terminalia antioxidants, providing prolonged inhibition of lipid peroxidation and additionally modulating the expression of antioxidant defense enzymes. Mineral components, such as zinc sulfate, demonstrate potentiating action with polyphenols and azadirachtin from neem, enhancing barrier and astringent effects at the cellular level. Boric acid and borax in low concentrations create an optimal buffer background, increasing the bioavailability and stability of plant metabolites, ensuring tissue-specific synergy. Camphor in small doses exhibits a modulating effect, potentiating local microcirculation and thereby promoting the delivery of phenolic and terpene compounds to epithelial structures. The combination of Papaver leaf with Terminalia and neem demonstrates a mild sedative and counter-irritant additive effect, manifested in reduced sensitivity of nerve endings and additional protection of the mucosa. Thus, a comprehensive synergy is formed in the preparation: antioxidant and anti-inflammatory activity is enhanced additively, antimicrobial and anti-biofilm properties are potentiated by the combination of herbal and mineral components, buffer and carrier substances (ghee, wax) create a protective and prolonged base for the release of active compounds.

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

Pharmacodynamics of the Eye Ointment (Bhimseni Ayurvedic Eye Salve)

The pharmacodynamic action of Bhimseni Eye Ointment is due to the combination of polyphenolic, terpene, lignanoid, and mineral components, forming a local and partially systemic activity profile. Antioxidant compounds of Terminalia (gallotannins, ellagic acid, chebulinic acid) and Arnebia (shikonins, alkannin) ensure the suppression of free radical oxidation reactions at the cellular level, reducing lipid peroxidation of epithelial cell membranes. Flavonoids and terpenoids from Azadirachta indica leaves inhibit NF-κB and COX-2 cascades, manifesting in the modulation of pro-inflammatory mediators and cytokines. Cubeb lignans bind to bacterial enzymes, disrupting cell wall synthesis, and complement the antimicrobial spectrum of neem. Camphor activates TRP channels, providing a local cooling sensation and a mild counter-irritant effect. Mineral components, particularly zinc sulfate, exert an astringent effect on mucosal proteins, reducing its permeability and exudation, while boric acid and borax form a stabilizing buffer system that maintains the physiological pH of the tear film. Copper and boron compounds in small doses possess antiseptic and modulating action, but in high concentrations can cause local irritation. Bases of ghee and beeswax ensure slow release of active substances, creating a prolonged effect and supporting even distribution over the mucosal surface. Collectively, these mechanisms provide local antioxidant, anti-inflammatory, antimicrobial, and protective activity, modulation of neurosensory responses, and stabilization of the epithelial barrier.

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

Pharmacokinetics of the Eye Ointment (Bhimseni Ayurvedic Eye Salve)

Bhimseni Eye Ointment is applied locally to the conjunctival surface as a thin paste, which determines its pharmacokinetic profile. Absorption of active substances occurs primarily through the ocular mucosa and partially through conjunctival vessels. Polyphenolic compounds of Terminalia chebula fruits and flavonoids of Azadirachta indica leaves have limited permeability; however, in the presence of a lipid base (ghee and beeswax), their penetration into epithelial tissues is enhanced. Lignans of Piper cubeba and naphthoquinones of Arnebia euchroma are characterized by greater lipophilicity, which promotes their local accumulation in the epithelium and tear film. Mineral components — zinc sulfate, boric acid, and borax — remain in the aqueous phase and act superficially, binding to mucosal proteins. Camphor, having high volatility and lipophilicity, is partially absorbed through the mucous membranes and may reach the systemic bloodstream in minimal amounts, being excreted primarily through the liver and kidneys.

Distribution of active substances is limited to the superficial layers of the conjunctiva, cornea, and tear fluid. The main phenolic compounds undergo metabolism involving enzymes of ocular tissues and the microbiota of the tear film. When part of the substance enters the systemic circulation, metabolism occurs primarily in the liver via conjugation pathways of glucuronidation and sulfation. Terpenoids and phenolic acids are excreted by the kidneys as metabolites, while lipophilic lignans and naphthoquinones — primarily with bile. Mineral components are excreted by the kidneys or secreted into the tear fluid.

Overall, the pharmacokinetics of Bhimseni Eye Ointment are characterized by local action with limited systemic absorption. The bioavailability of active substances is enhanced by the lipid base and buffer systems, and excretion occurs mainly through the kidneys and liver in the form of metabolites, minimizing the risk of systemic accumulation.

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

Mechanisms of Action and Scientific Rationale: Eye Ointment (Bhimseni Ayurvedic Eye Salve)

Liver and Gastrointestinal Tract. Polyphenols of Terminalia chebula and flavonoids of Azadirachta indica possess membrane-stabilizing and lipotropic properties, modulating antioxidant enzymes (catalase, superoxide dismutase) and reducing lipid peroxidation activity. These compounds also demonstrate additive inhibition of cyclooxygenase and lipoxygenase enzymes, reducing the production of prostaglandins and leukotrienes. Terpenoids of camphor and nimbin enhance the protective functions of the GI tract epithelium, exhibiting potentiating antioxidant and cytoprotective action.
References: PubMed (PMID: 28438926), ScienceDirect (doi:10.1016/j.phymed.2018.03.061).

Immune System. Flavonoids of neem and lignans of cubeb modulate cytokine expression, reducing TNF-α and IL-6 levels and stimulating IL-10 secretion. Polyphenols of Terminalia exert an additive effect on the phagocytic activity of macrophages and neutrophils. Anthocyanin-like pigments of Arnebia exhibit immunomodulatory activity, stabilizing neutrophil membranes and reducing their degranulation. Mineral salts (zinc, boron) play a potentiating role in the formation of barrier defense and activation of antibacterial enzymes.
References: SpringerLink (doi:10.1007/s11010-016-2836-1), PMC (PMID: 31434223).

Nervous System. Camphor acts through the activation of TRP channels and modulation of calcium flows, providing a sensory cooling effect and reduced irritation. Polyphenols of Terminalia exert an additive inhibitory effect on acetylcholinesterase, reflecting the modulation of cholinergic transmission. Poppy leaves contain trace amounts of isoquinoline alkaloids, which in combination with terpenes demonstrate a mild sedative effect.
References: Wiley Online Library (doi:10.1002/jps.2600581034), PubChem.

Endocrine and Metabolic Regulation. Phenolic compounds of Terminalia and nimbin from neem exhibit a modulating effect on NF-κB and MAPK signaling cascades, reducing the expression of inflammatory mediators and regulating cellular metabolism. Lignans of cubeb and alkannin of Arnebia demonstrate additive inhibition of reactive oxygen species formation in mitochondria, increasing the energy stability of cells. Mineral components, including zinc, play a potentiating role in activating antioxidant defense enzymes.
References: Semantic Scholar (Corpus ID: 47089122), ScienceDirect (doi:10.1016/j.freeradbiomed.2019.05.031).