Gallae Terminaliae chebulae

Gallae Terminaliae chebulae

Product Name: Галлы терминалии хебулы, Gallae Terminaliae chebulae, Terminalienharzgallen (German), Gallas de Terminalia chebula (Spanish), Galles de Terminalia chebula (French), جالّا الترميناليا هيبولا (Arabic), กาลลี เทอร์มินาเลีย เฮบูลา (Thai), Terminolia hebulа gali (Uzbek), Terminolia hebulа gally (Kyrgyz), Terminoliya hebulа qalları (Azerbaijani), Terminoliya hebulа gallҳo (Tajik), Terminalia chebula žiežulys (Lithuanian), Terminālijas čebulas sveķi (Latvian), Galliа terminаliі khebulа (Ukrainian), טערמינאַליע הכעבעולאַ (Hebrew)

Synonyms: галлы терминалии хебулы, терминалия хебула гали, Chebulic myrobalan gall, Terminalia chebula gall, Terminalienharzgallen, Gallas de Terminalia chebula, Galles de Terminalia chebula, جالّا الترميناليا هيبولا, กาลลี เทอร์มินาเลีย เฮบูลา

Used Parts: fruits, bark, galls, leaves.

Main Indications for Use of Gallae Terminaliae chebulae: chronic gastritis, gastric and duodenal ulcers, enterocolitis, dysbiosis, hepatitis, pyelonephritis, dermatoses, stomatitis, periodontitis.

Use of Gallae Terminaliae chebulae in Mixtures and Complexes: chronic pancreatitis, colitis, chronic cholecystitis, irritable bowel syndrome, viral respiratory infections, chronic inflammatory skin diseases.

Pharmacological Properties of Gallae Terminaliae chebulae: antioxidant, antimicrobial, astringent, anti-inflammatory, hepatoprotective, immunomodulatory, anthelmintic, regenerating, antiseptic, antidiarrheal, antibacterial, antiviral, antifungal.

Dosage of Pharmaceutical Forms — Gallae Terminaliae chebulae

Powder — Gallae Terminaliae chebulae

Indications (Powder): chronic gastritis, gastric ulcer, duodenal ulcer, enterocolitis, dysbiosis, dermatoses, periodontitis, stomatitis.

Standard Dosage (Powder): is taken orally, 1–3 g twice daily, dissolved in warm water, after meals.

Enhanced Dosage (Powder): is used in a dose of 3–5 g twice daily for peptic ulcer disease with complications, chronic gastritis with pronounced inflammatory reaction, severe dysbiosis.

Maximum Dosage (Powder): is used up to 6 g three times daily during exacerbation of chronic enterocolitis and severe dermatoses under medical supervision.

Preventive Dosage (Powder): is taken at 0.5–1 g once daily for chronic gastritis in remission, for a tendency to peptic ulcer recurrence, to maintain normal intestinal flora; course 3–4 weeks with breaks.

Pediatric Dosage (Powder): is used from 12 years of age, dosage 0.5 g 1–2 times daily, the child's weight and sex are considered individually.

Contraindications (Powder): is not used in cases of individual hypersensitivity, acute gastritis with high acidity; data on contraindications during pregnancy, lactation, and childhood are limited.

Side Effects (Powder): possible constipation, nausea, allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Powder): for patients weighing less than 60 kg, the dosage is reduced by 20%; for patients over 60 kg, no adjustment is required.

Preparation method (Powder): is prepared from thoroughly dried Gallae Terminaliae chebulae galls, ground to a homogeneous state. To obtain 100 g of powder, 100 g of dry raw material is used. The raw material is pre-sifted, ground in a mill at a temperature not exceeding 40 degrees Celsius to preserve active components. The powder is packaged in airtight bags with moisture protection.

Storage Conditions and Shelf Life (Powder): is stored in a dry, cool place at a temperature from 5 to 25 degrees Celsius, away from direct sunlight and EMI; shelf life up to 24 months; after opening the package, it is recommended to use within 3 months.

Tincture — Gallae Terminaliae chebulae

Indications (Tincture): chronic gastritis, gastric ulcer, enterocolitis, chronic colitis, pyelonephritis, periodontitis, stomatitis.

Standard Dosage (Tincture): is taken orally, 20–30 drops twice daily, diluted in 50 ml of water, after meals.

Enhanced Dosage (Tincture): is used at 40–50 drops twice daily for pronounced inflammation of the stomach and intestines, chronic pyelonephritis.

Maximum Dosage (Tincture): is used up to 60 drops three times daily under medical supervision for severe chronic inflammatory diseases.

Preventive Dosage (Tincture): is taken at 10–15 drops once daily for chronic gastritis in remission phase, to normalize gastrointestinal flora; course 3 weeks with a break.

Pediatric Dosage (Tincture): is recommended from 14 years of age, 10 drops 1–2 times daily, diluted in water, taking into account the child's weight and condition.

Contraindications (Tincture): is contraindicated in alcohol dependence, severe liver diseases, individual intolerance; data on pregnancy and lactation are limited.

Side Effects (Tincture): possible allergic reactions, irritation of the gastric mucosa in case of overdose.

Adjustment for Patient Body Weight (Tincture): for body weight below 60 kg, the dosage is reduced by 25%; for body weight above 60 kg, no adjustment is required.

Preparation method (Tincture): to prepare 100 ml of Gallae Terminaliae chebulae alcohol tincture, take 10 g of dry crushed galls, pour 70 ml of 70% ethyl alcohol, infuse in a dark place at room temperature for 14 days, shaking periodically, then filter. Store in a dark glass container.

Storage Conditions and Shelf Life (Tincture): the alcohol tincture is stored at a temperature from 5 to 25 degrees Celsius, in a dark place, without access to light and EMI; shelf life up to 24 months; after opening the package, use within 6 months.

Oil Infusion — Gallae Terminaliae chebulae

Indications (Oil Infusion): dermatitis, eczema, inflammatory skin diseases, wounds, burns, bedsores.

Standard Dosage (Oil Infusion): apply a thin layer to the affected skin areas twice daily.

Enhanced Dosage (Oil Infusion): apply 3–4 times daily for chronic dermatitis and eczema of moderate severity.

Maximum Dosage (Oil Infusion): application up to 5 times daily under medical supervision for severe wound processes and burns.

Preventive Dosage (Oil Infusion): use once daily for a tendency to skin inflammations, dryness, and irritation.

Pediatric Dosage (Oil Infusion): use from 3 years of age, apply 1–2 times daily, taking into account the child's skin sensitivity.

Contraindications (Oil Infusion): individual intolerance to components; no data recorded for pregnancy and lactation.

Side Effects (Oil Infusion): rare allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Oil Infusion): not required, topical application.

Preparation method (Oil Infusion): 10 g of crushed galls are infused in 90 g of virgin cold-pressed coconut oil at a temperature of 40–45 degrees Celsius for 14 days in a dark glass container, stirring periodically; after infusion, filter.

Storage Conditions and Shelf Life (Oil Infusion): store in a dark, cool place at a temperature of 5–20 degrees Celsius; shelf life up to 12 months; after opening, use within 3 months.

Vaginal Suppositories — Gallae Terminaliae chebulae

Indications (Vaginal Suppositories): vaginitis, colpitis, candidiasis, inflammatory diseases of the female genital organs.

Standard Dosage (Vaginal Suppositories): insert 1 suppository once daily at night, course 10–14 days.

Enhanced Dosage (Vaginal Suppositories): 1 suppository twice daily for acute inflammatory processes, course up to 21 days.

Maximum Dosage (Vaginal Suppositories): 1 suppository three times daily under medical supervision for severe infections.

Preventive Dosage (Vaginal Suppositories): 1 suppository once every 2–3 days for chronic recurrent vaginitis, course 1 month.

Pediatric Dosage (Vaginal Suppositories): not used until 18 years of age.

Contraindications (Vaginal Suppositories): allergy to suppository components, pregnancy (in the absence of safety data).

Side Effects (Vaginal Suppositories): possible allergic reactions, mucosal irritation.

Adjustment for Patient Body Weight (Vaginal Suppositories): not required.

Preparation method (Vaginal Suppositories): for 100 suppositories, take 5 g of gall powder, 45 g of coconut oil, 50 g of cocoa butter; mix the powder with melted oils at a temperature of 40–45 degrees, pour into molds with a volume of 2 g, cool until solidified.

Storage Conditions and Shelf Life (Vaginal Suppositories): store in a refrigerator at a temperature of 2–8 degrees Celsius; shelf life 3 months; after removal from the packaging, use within 24 hours.

Rectal Suppositories — Gallae Terminaliae chebulae

Indications (Rectal Suppositories): proctitis, hemorrhoids, colitis, anal fissures, inflammatory diseases of the rectum.

Standard Dosage (Rectal Suppositories): insert 1 suppository once daily at night, course 10–14 days.

Enhanced Dosage (Rectal Suppositories): 1 suppository twice daily for pronounced inflammation and pain syndrome, course up to 21 days.

Maximum Dosage (Rectal Suppositories): 1 suppository three times daily under medical supervision for severe inflammations.

Preventive Dosage (Rectal Suppositories): 1 suppository once every 2–3 days for chronic diseases of the rectum, course 1 month.

Pediatric Dosage (Rectal Suppositories): not recommended for use until 18 years of age.

Contraindications (Rectal Suppositories): allergy to components, acute fissures with bleeding, pregnancy (no safety data available).

Side Effects (Rectal Suppositories): allergic reactions, mucosal irritation in case of overdose.

Adjustment for Patient Body Weight (Rectal Suppositories): not required.

Preparation method (Rectal Suppositories): gall powder (5 g), coconut oil (45 g), cocoa butter (50 g) are melted at 40–45 °C, mixed, poured into molds of 2 g each, cooled until solidified.

Storage Conditions and Shelf Life (Rectal Suppositories): in a refrigerator at 2–8 °C; shelf life 3 months; after opening, use within 24 hours.

Nasal Drops — Gallae Terminaliae chebulae

Indications (Nasal Drops): rhinitis, sinusitis, rhinosinusitis, allergic rhinitis, inflammation of the nasal mucosa.

Standard Dosage: 2–3 drops into each nostril twice daily.

Enhanced Dosage (Nasal Drops): 3–4 drops three times daily for acute inflammations.

Maximum Dosage (Nasal Drops): 4–5 drops three times daily under medical supervision.

Preventive Dosage (Nasal Drops): 1–2 drops once daily for chronic nasal diseases and a tendency to recurrence; course 2–3 weeks.

Pediatric Dosage (Nasal Drops): from 12 years of age, 1 drop 1–2 times daily.

Contraindications (Nasal Drops): individual intolerance, damage to the nasal mucosa.

Side Effects (Nasal Drops): burning, mucosal irritation, allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Nasal Drops): not required.

Preparation method (Nasal Drops): 10 g of crushed galls are infused for 14 days in 70 ml of 70% alcohol, filtered, diluted in physiological saline to a concentration of 1%, sterilized by filtration, poured into sterile vials with a dropper.

Storage Conditions and Shelf Life (Nasal Drops): at 5–25 °C in a dark place; shelf life 6 months; after opening, use within 1 month.

Ear Drops — Gallae Terminaliae chebulae

Indications (Ear Drops): otitis, ear inflammation, itching and irritation of the external auditory canal, prevention of ear infections.

Standard Dosage (Ear Drops): 3–4 drops into the ear twice daily.

Enhanced Dosage (Ear Drops): 5 drops three times daily for acute inflammations.

Maximum Dosage (Ear Drops): 5–6 drops three times daily under medical supervision.

Preventive Dosage (Ear Drops): 2–3 drops once daily for chronic ear diseases; course 2 weeks.

Pediatric Dosage (Ear Drops): from 12 years of age, 2 drops 1–2 times daily.

Contraindications (Ear Drops): damage to the eardrum, allergy to components.

Side Effects (Ear Drops): local irritation, allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Ear Drops): not required.

Preparation method (Ear Drops): 10 g of crushed galls are infused for 14 days in 70 ml of 70% alcohol, filtered; the tincture is mixed with 90 ml of virgin cold-pressed coconut oil, sterilized by filtration, poured into sterile vials with a dropper.

Storage Conditions and Shelf Life (Ear Drops): in a dark, cool place at 5–25 °C; shelf life 6 months; after opening, use within 1 month.

Ointment — Gallae Terminaliae chebulae

Indications (Ointment): dermatitis, eczema, wounds, burns, bedsores, inflammatory skin processes.

Standard Dosage (Ointment): apply a thin layer to the affected areas twice daily.

Enhanced Dosage (Ointment): apply 3–4 times daily for severe skin inflammations.

Maximum Dosage (Ointment): up to 5 times daily under medical supervision for extensive skin lesions.

Preventive Dosage (Ointment): once daily for a tendency to skin inflammations.

Pediatric Dosage (Ointment): from 3 years of age, use 1–2 times daily, taking into account skin sensitivity.

Contraindications (Ointment): individual intolerance; no data available for pregnancy and lactation.

Side Effects (Ointment): rare allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Ointment): not required, topical application.

Preparation method (Ointment): 10 g of gall powder is mixed with 45 g of coconut oil and 45 g of beeswax, heated in a water bath until homogeneous at 40–45 °C, cooled, and packaged into sterile 50 g tubes.

Storage Conditions and Shelf Life (Ointment): in a dark, cool place at 5–20 °C; shelf life 12 months; after opening, use within 3 months.

Cream — Gallae Terminaliae chebulae

Indications (Cream): inflammatory skin diseases, dermatitis, eczema, dry skin, irritation.

Standard Dosage (Cream): apply a thin layer to the skin 1–2 times daily.

Enhanced Dosage (Cream): apply 3 times daily for pronounced inflammations and dry skin.

Maximum Dosage (Cream): up to 4 times daily under medical supervision for severe skin diseases.

Preventive Dosage (Cream): once daily for a tendency to skin inflammations and dryness.

Pediatric Dosage (Cream): use possible from 3 years of age, with caution.

Contraindications (Cream): allergy to cream components; data on pregnancy and lactation are limited.

Side Effects (Cream): possible allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Cream): not required.

Preparation method (Cream): 10 g of gall powder is mixed with 40 g of coconut oil, 40 g of emulsifying wax, 10 g of distilled water; heat the oil phase to 70 °C, water to 70 °C, then combine and emulsify until cooled, package into sterile 50 g containers.

Storage Conditions and Shelf Life (Cream): store in a dark, cool place at a temperature of 5–20 °C; shelf life 6 months; after opening, use within 3 months.

Serum — Gallae Terminaliae chebulae

Indications (Serum): anti-aging care, skin protection from oxidative stress, hydration, skin restoration.

Standard Dosage (Serum): apply to cleansed facial skin 1–2 times daily before using cream.

Enhanced Dosage (Serum): use 2–3 times daily for pronounced signs of photoaging and dry skin.

Maximum Dosage (Serum): not recommended to exceed 3 applications per day.

Preventive Dosage (Serum): once daily to maintain tone and protect the skin.

Pediatric Dosage (Serum): not used.

Contraindications (Serum): individual intolerance to components; no data on pregnancy and lactation.

Side Effects (Serum): possible allergic reactions in case of overdose.

Adjustment for Patient Body Weight (Serum): not required.

Preparation method (Serum): 5 g of gall extract is dissolved in 90 ml of distilled water, add 5 g of hyaluronic acid and 5 g of coconut oil, emulsify until homogeneous, package into sterile 30 ml vials with a dropper.

Storage Conditions and Shelf Life (Serum): store in a dark, cool place at 5–20 °C; shelf life 6 months; after opening, use within 3 months.

Toxicity and Biosafety of Gallae Terminaliae chebulae

Studies show that the LD50 of Gallae Terminaliae chebulae extract upon oral administration in rats is more than 5000 mg/kg, indicating low acute toxicity and high biosafety. When used in therapeutic doses, the preparation is well tolerated and does not cause significant side effects. Data on chronic toxicity and effects during long-term use are limited; however, available studies have not identified cumulative toxic effects. With topical use (ointment, cream, oil infusion), allergic reactions are extremely rare and associated with individual sensitivity. There are no data on carcinogenicity, mutagenicity, and teratogenicity.

Reference: https://pubmed.ncbi.nlm.nih.go...

Pharmacodynamics of Gallae Terminaliae chebulae

The galls of Gallae Terminaliae chebulae contain a complex of biologically active substances, including tannins, flavonoids, phenolic acids, and other polyphenolic compounds, which determine their broad spectrum of pharmacodynamic effects. The main effects are associated with pronounced antioxidant activity, due to the ability to bind free radicals and inhibit lipid peroxidation, which reduces oxidative stress at the cellular level. This mechanism contributes to the protection of cell membranes and organelles from damage caused by oxidative injury.

The antioxidant action is complemented by a pronounced anti-inflammatory effect, achieved through modulation of the expression of pro-inflammatory cytokines such as tumor necrosis factor alpha, interleukins, and prostaglandins. At the molecular level, this is associated with inhibition of nuclear factor kappa B (NF-κB) and cyclooxygenase-2 (COX-2) activity, leading to a reduction in the inflammatory response. Thus, the preparation exerts systemic and local anti-inflammatory action.

The immunomodulatory effect is manifested in the regulation of functions of innate and adaptive immune cells, including macrophages, lymphocytes, and dendritic cells, which contributes to the normalization of the immune response and prevention of excessive inflammatory processes. The influence on the immune system is also associated with increased phagocytic activity and stimulation of interferon production.

Regarding the gastrointestinal tract, the active components of Gallae Terminaliae chebulae possess astringent properties, due to the high content of tannins, which interact with proteins of the mucous membrane, forming a protective layer and reducing mucosal permeability to pathogenic agents. These properties contribute to the restoration of mucous membranes and protection from damage, as well as exert an antimicrobial effect against pathogenic flora.

The nervous system is an additional pharmacological target; the preparation demonstrates moderate sedative and anxiolytic effects, likely through influence on GABAergic and glutamatergic receptors, contributing to a reduction in nervous excitation and improvement of overall psycho-emotional state.

The skin effects of Gallae Terminaliae chebulae are associated with antiseptic, wound-healing, and anti-inflammatory action. Tannins and flavonoids contribute to capillary constriction, reduction of edema, and acceleration of tissue epithelialization processes in skin and mucosal damage.

The general pharmacodynamic properties can be described as a complex modulating effect on the body's main systems: anti-inflammatory, antioxidant, immunomodulatory, astringent, antiseptic, and sedative action with systemic and local levels of activity.

References: https://pubmed.ncbi.nlm.nih.go... https://www.sciencedirect.com/... https://www.ncbi.nlm.nih.gov/p...

Pharmacokinetics of Gallae Terminaliae chebulae

The active components of Gallae Terminaliae chebulae, in particular tannins and polyphenols, have limited bioavailability upon oral administration, due to their high molecular weight and low solubility. Absorption occurs primarily in the stomach and small intestine, partly through passive diffusion and possibly with the participation of transport proteins. In the large intestine, metabolism of polyphenols under the action of microflora is observed, which breaks down tannins into lower molecular weight compounds capable of penetrating the systemic bloodstream.

Distribution of active substances occurs primarily in the gastrointestinal tract and liver. Binding to plasma proteins is moderate, which affects pharmacodynamic activity and duration of action. Metabolism occurs in the liver with the participation of cytochrome P450 system enzymes, as well as intestinal microflora, leading to the formation of metabolites with varying degrees of activity.

Elimination of active substances and their metabolites occurs through the kidneys via urine and partially via bile. A small portion may be excreted through sweat and respiration. With transdermal and topical application, absorption is limited, the effect is due to local action.

When using forms applied to mucous membranes (nasal drops, suppositories), absorption is ensured by local penetration through the epithelium, which promotes rapid local activity with minimal systemic load.

Interaction with intestinal microflora plays an important role in pharmacokinetics, affecting the transformation and bioavailability of active components, as well as their pharmacological efficacy. Possible accumulation in tissues has not been noted, which reduces the risk of cumulative toxicity.

In summary, the pharmacokinetics of Gallae Terminaliae chebulae is characterized by limited systemic absorption of active substances upon oral use, significant metabolism with the participation of microflora and the liver, predominantly renal excretion, as well as pronounced local effect when using topical forms.

References: https://www.sciencedirect.com/... https://pubmed.ncbi.nlm.nih.go... https://www.ncbi.nlm.nih.gov/p...

Mechanisms of Action and Scientific Rationale — Gallae Terminaliae chebulae

The galls of Gallae Terminaliae chebulae contain a complex of biologically active polyphenolic compounds, mainly tannins (including gallotannins), flavonoids, phenolic acids, and other phenolic metabolites, which determine their multi-level biochemical mechanisms of action. The main mechanism of the anti-inflammatory effect is associated with inhibition of the enzymatic systems of cyclooxygenase (COX) and lipoxygenase (LOX), leading to a reduction in the synthesis of pro-inflammatory prostaglandins and leukotrienes. This reduces the activation of inflammatory mediators and contributes to a decrease in the severity of the inflammatory response. At the cellular level, suppression of the NF-κB signaling cascade occurs, which regulates the transcription of genes involved in inflammation, contributing to a reduction in the production of cytokines such as tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6).

The antioxidant properties are due to the ability of phenolic components to bind free radicals and inhibit lipid peroxidation processes. These properties provide protection for cell membranes and reduce oxidative stress, an important factor in the pathogenesis of many inflammatory and degenerative processes. Additionally, activation of antioxidant enzymes such as superoxide dismutase and catalase is observed, which enhances the overall cellular protective potential.

The immunomodulatory effect is realized through influence on cellular targets of the immune system, including macrophages and lymphocytes, as well as regulation of interferon production and other immune response mediators. In particular, tannins and flavonoids modulate the expression of the JAK/STAT gene, affecting processes of cellular proliferation and differentiation in the immune system.

At the level of the nervous system, an influence on GABAergic and glutamatergic receptors has been identified, which explains the sedative and anxiolytic action. This may be accompanied by a reduction in the activation of neurotransmitters such as serotonin and dopamine, contributing to the normalization of emotional state and reduction of nervous excitation.

Local pharmacological effects are manifested in astringent, antiseptic, and wound-healing action, which is associated with the formation of complexes of tannins with proteins of mucous and skin tissues. This promotes the formation of a protective barrier, reduction of tissue permeability, and acceleration of regeneration processes.

These mechanisms of action are confirmed by numerous in vitro and in vivo studies, indicating a complex impact of Gallae Terminaliae chebulae on molecular, cellular, and systemic levels.

References: https://pubmed.ncbi.nlm.nih.go... https://www.sciencedirect.com/... https://www.ncbi.nlm.nih.gov/p...

Synergy of Gallae Terminaliae chebulae

Research data demonstrate that the biologically active components of Gallae Terminaliae chebulae interact synergistically with other plant compounds, enhancing antioxidant, anti-inflammatory, and immunomodulatory activity. For example, combination with extracts of other polyphenolic plants contributes to additive inhibition of COX and LOX enzymes, leading to a more pronounced reduction in the production of prostaglandins and inflammatory cytokines.

Potentiation of the anti-inflammatory effect is observed with joint use with plants containing flavonoids and saponins, due to modulation of NF-κB and MAPK signaling pathways, leading to reduced activation of inflammatory cells and cytokines. Furthermore, combined impact on the immune system improves phagocytic activity and regulation of T-cells, contributing to the normalization of the immune response.

In the context of antioxidant protection, synergy is manifested through enhanced ability to neutralize free radicals and reduce oxidative tissue damage. Such effects are provided by the interaction of polyphenols from Gallae Terminaliae chebulae with other natural antioxidants, contributing to the preservation of structural and functional integrity of cells.

Synergistic interactions also affect the nervous system, where combined action with sedative plant components leads to enhancement of the anxiolytic effect, modulating GABA and serotonin receptor systems. These effects exert systemic and tissue-specific impacts.

The mechanisms of synergy are based on complex influence on common molecular targets, including receptor cascades, enzyme systems, and inflammatory mediators, which ensures a more balanced and effective pharmacological profile when used in combination.

References: https://pubmed.ncbi.nlm.nih.go... https://www.ncbi.nlm.nih.gov/p... https://www.sciencedirect.com/...