Os Sepiae — Cuttlebone

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Product code: THKLOS-009111
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Overview

Os Sepiae (Cuttlebone)

Product Name: кость каракатицы, Os sepiae, Sepiaschulp, hueso de sepia, os de seiche, عظم الحبار, กระดูกหมึก, сепия қояны суяги, сепия сөөгү, сепия sümüyü, устухони сепия, sepijos kaulas, sepijas kauls, кістка сепії, עצם הספיה

Synonyms: кость каракатицы, панцирь каракатицы, сепиевый камень, cuttlebone, sepia bone, sepia shell, sepia stone, Sepiaschulp, Tintenfischknochen, hueso de sepia, hueso de jibia, os de seiche, os de seppia, عظم الحبار, قشرة الحبار, กระดูกหมึก, กระดองหมึก

Parts Used: internal calcareous shell.

Main indications for use of Os sepiae: hypocalcemia, osteoporosis, osteomalacia, rickets, bone fragility, slow bone tissue regeneration, chronic gastritis with high acidity, peptic ulcer of the stomach and duodenum, heartburn, dyspepsia, gastroesophageal reflux disease, stomatitis, gingivitis, periodontitis, bleeding gums, microtraumas of the oral mucosa, dermatitis, superficial burns, abrasions, eczema.

Use of Os sepiae in mixtures and complexes: chronic renal failure, osteoarthritis, rheumatoid arthritis, osteochondrosis, post-traumatic rehabilitation of the musculoskeletal system, iron deficiency anemia, chronic obstructive pulmonary disease, bronchial asthma, chronic pancreatitis, irritable bowel syndrome, intestinal dysbiosis, chronic cholecystitis.

Pharmacological properties of Os sepiae

mineralizing, osteoprotective, wound healing, astringent, antacid, anti-inflammatory, hemostatic, adsorbent, remineralizing, epithelizing, keratoplastic, antimicrobial, antioxidant.


Dosage of pharmaceutical forms — Os sepiae

Powder — Os sepiae

Indications (Powder): hypocalcemia, osteoporosis, osteomalacia, rickets, bone fragility, slow bone tissue regeneration, chronic gastritis with high acidity, peptic ulcer of the stomach, peptic ulcer of the duodenum, heartburn, gastroesophageal reflux disease, stomatitis, gingivitis, periodontitis, bleeding gums.

Standard Dosage (Powder): orally, 0.5–1.0 gram of powder 2–3 times a day after meals, with warm water.

Enhanced Dosage (Powder): orally, 1.0–1.5 grams of powder 3 times a day for osteoporosis, osteomalacia, pronounced hypocalcemia, slow fracture consolidation.

Maximum Dosage (Powder): orally, 2.0 grams of powder 3 times a day for pronounced post-traumatic demineralization of bone tissue and severe osteoporosis, under serum calcium monitoring.

Preventive Dosage (Powder): orally, 0.5 grams of powder 1 time a day in courses of 20 days with a 40-day break for chronic gastritis with high acidity, chronic periodontitis, for elderly patients at risk of osteoporosis.

Pediatric Dosage (Powder): from 6 years of age, with body weight from 20 kg — 0.25–0.5 grams of powder 1–2 times a day, with warm water; data on use in children under 6 years of age are not scientifically documented.

Contraindications (Powder): hypercalcemia, nephrolithiasis with calcium stones, individual intolerance; no scientifically documented contraindications during pregnancy, lactation, and in children under 6 years of age.

Side Effects (Powder): in case of overdose — hypercalcemia, nausea, constipation.

Adjustment for Patient Body Weight (Powder): for body weight below 60 kg, use the lower dose limit; for body weight above 60 kg, use the average or upper dose limit depending on the patient's condition.

Preparation method (Powder): take 100 grams of purified internal calcareous cuttlebone, rinse under running water, dry at a temperature of 40 °C in a drying oven, grind in a ceramic mortar or mill to obtain a homogeneous powder without large particles, sieve through a 0.5 mm mesh sieve, package in airtight containers.

Storage Conditions and Shelf Life (Powder): store in tightly closed glass or ceramic containers, in a dry dark place at a temperature of 15–25 °C, away from sources of electromagnetic radiation, shelf life — 3 years; after opening the package, use within 6 months.


Dry Extract — Os sepiae

Indications (Dry Extract): osteoporosis, osteomalacia, hypocalcemia, chronic gastritis with high acidity, peptic ulcer of the stomach, peptic ulcer of the duodenum, stomatitis, gingivitis, periodontitis, bleeding gums, superficial burns, dermatitis, eczema.

Standard Dosage (Dry Extract): orally, 0.3–0.5 grams of dry extract 2 times a day after meals, with warm water or milk.

Enhanced Dosage (Dry Extract): orally, 0.5–0.75 grams of dry extract 2–3 times a day for pronounced hypocalcemia, osteoporosis, long-term non-healing gastric and duodenal ulcers.

Maximum Dosage (Dry Extract): orally, 1.0 gram of dry extract 3 times a day for severe forms of osteoporosis or when accelerated bone tissue regeneration is necessary, only under medical supervision.

Preventive Dosage (Dry Extract): orally, 0.25 grams of dry extract 1 time a day for 20 days every 3 months for the prevention of osteoporosis in postmenopausal women and in patients over 60 years of age.

Pediatric Dosage (Dry Extract): from 6 years of age, with body weight from 20 kg — 0.15–0.25 grams of dry extract 1–2 times a day; data on use in children under 6 years of age are not scientifically documented.

Contraindications (Dry Extract): hypercalcemia, nephrolithiasis with calcium stones, individual intolerance; no scientifically documented contraindications during pregnancy, lactation, and in children under 6 years of age.

Side Effects (Dry Extract): in case of overdose — hypercalcemia, dyspepsia, constipation.

Adjustment for Patient Body Weight (Dry Extract): for body weight below 60 kg — lower dose limit; above 60 kg — average or upper dose limit depending on the patient's condition.

Preparation method (Dry Extract): take 500 grams of purified and ground cuttlebone, place in a glass container, pour 1500 milliliters of 70% ethanol (the solvent is used for extraction only and is not a component of the finished product), infuse at room temperature for 7 days, shaking daily, filter through filter paper, evaporate the filtrate in a water bath at a temperature not exceeding 50 °C until the alcohol smell completely disappears, dry under vacuum to a powder state, sieve, package in airtight containers; permissible residual ethanol content in the finished product — not more than 500 ppm.

Storage Conditions and Shelf Life (Dry Extract): store in tightly closed dark glass containers, at a temperature of 15–25 °C, in a dry place, away from sunlight and sources of electromagnetic radiation, shelf life — 2 years; after opening, use within 3 months.


Rectal Suppositories — Os sepiae

Indications (Rectal Suppositories): hypocalcemia, osteoporosis, osteomalacia, bone fragility, slow bone tissue regeneration, chronic proctitis, anal fissures, hemorrhoids, inflammation of the rectal mucosa, erosive-ulcerative lesions of the rectal mucosa.

Standard Dosage (Rectal Suppositories): 1 suppository (contains 0.5 grams of shell powder) 1–2 times a day after defecation, course 10–14 days.

Enhanced Dosage (Rectal Suppositories): 1 suppository 2–3 times a day for acute anal fissures, pronounced hemorrhoids, erosive-ulcerative proctitis.

Maximum Dosage (Rectal Suppositories): 1 suppository 3 times a day for severe inflammatory process or slow mucosal epithelialization, only under medical supervision.

Preventive Dosage (Rectal Suppositories): 1 suppository 1 time a day for a course of 7–10 days every 3 months for patients with chronic hemorrhoids or chronic proctitis in remission.

Pediatric Dosage (Rectal Suppositories): from 12 years of age — 1 suppository 1 time a day; data on use in children under 12 years of age are not scientifically documented.

Contraindications (Rectal Suppositories): hypercalcemia, individual intolerance to suppository components; no scientifically documented contraindications during pregnancy, lactation, and in children under 12 years of age.

Side Effects (Rectal Suppositories): in case of overdose — local irritation, hypercalcemia with long-term use.

Adjustment for Patient Body Weight (Rectal Suppositories): for body weight below 60 kg — use standard dosage 1 time a day; for body weight above 60 kg — possible increase to 2 times a day.

Preparation method (Rectal Suppositories): for 100 grams of finished product: cuttlebone shell powder — 10 grams, coconut oil — 85 grams, beeswax — 5 grams. Melt the coconut oil and beeswax in a water bath at a temperature of 50 °C, add the shell powder, mix thoroughly until homogeneous, pour into suppository molds, cool at a temperature of 4–6 °C until completely solidified, package in blister packs.

Storage Conditions and Shelf Life (Rectal Suppositories): store in a cool dry place at a temperature of 8–15 °C, away from heat and light sources, shelf life — 1 year; after opening the package, use within 10 days.


Ointment — Os sepiae

Indications (Ointment): superficial burns, abrasions, dermatitis, eczema, trophic ulcers, skin fissures, inflammation of the oral mucosa, bleeding gums, periodontitis, slow tissue regeneration, wounds of various etiologies.

Standard Dosage (Ointment): apply a thin layer to the affected area 1–2 times a day, course 7–14 days.

Enhanced Dosage (Ointment): apply a thin layer 2–3 times a day for trophic ulcers, long-term non-healing wounds, second-degree burns.

Maximum Dosage (Ointment): apply a thin layer up to 4 times a day to limited skin areas for severe lesions, only under medical supervision.

Preventive Dosage (Ointment): apply 1 time a day for a course of up to 7 days every 2–3 months for the prevention of skin fissures in patients with chronic dermatitis or dry skin.

Pediatric Dosage (Ointment): from 3 years of age — apply a thin layer 1 time a day; data on use in children under 3 years of age are not scientifically documented.

Contraindications (Ointment): individual intolerance to ointment components; no scientifically documented contraindications during pregnancy and lactation.

Side Effects (Ointment): in case of overdose — local irritation, hypercalcemia when treating large areas for a long time.

Adjustment for Patient Body Weight (Ointment): for external use, dose adjustment by body weight is not required.

Preparation method (Ointment): for 100 grams of finished product: cuttlebone shell powder — 10 grams, coconut oil — 70 grams, beeswax — 20 grams. Melt the coconut oil and beeswax in a water bath at a temperature of 50 °C, add the shell powder, stir for 10 minutes until a homogeneous mass is obtained, pour into sterile jars, cool at room temperature, close with lids.

Storage Conditions and Shelf Life (Ointment): store in a dark dry place at a temperature of 15–25 °C, avoid direct sunlight, shelf life — 1 year; after opening, use within 30 days.


Cream — Os sepiae

Indications (Cream): dermatitis, eczema, skin fissures, dry skin, superficial burns, abrasions, slow tissue regeneration, inflammation of the lip mucosa, inflammation of the oral mucosa, periodontitis in remission.

Standard Dosage (Cream): apply a thin layer to the affected area of skin or mucous membrane 1–2 times a day, course 7–14 days.

Enhanced Dosage (Cream): apply a thin layer 2–3 times a day for pronounced dry skin, fissures, and slow wound epithelialization.

Maximum Dosage (Cream): apply a thin layer up to 4 times a day to limited skin areas for severe lesions, only under medical supervision.

Preventive Dosage (Cream): apply 1 time a day for a course of up to 10 days every 2–3 months for the prevention of dry skin and fissures in patients with chronic dermatitis, in winter, or when working in dry air conditions.

Pediatric Dosage (Cream): from 3 years of age — apply a thin layer 1 time a day; data on use in children under 3 years of age are not scientifically documented.

Contraindications (Cream): individual intolerance to cream components; no scientifically documented contraindications during pregnancy and lactation.

Side Effects (Cream): in case of overdose — local irritation, hypercalcemia when treating large skin areas for a long time.

Adjustment for Patient Body Weight (Cream): for external use, dose adjustment by body weight is not required.

Preparation method (Cream): for 100 grams of finished product: cuttlebone shell powder — 5 grams, coconut oil — 50 grams, shea butter — 20 grams, beeswax — 15 grams, distilled water — 10 grams. Melt the oil phase (coconut oil, shea butter, beeswax) in a water bath at a temperature of 50 °C, heat the water phase (distilled water) to 45 °C, slowly introduce the water phase into the oil phase with constant stirring until a homogeneous emulsion is obtained, add the shell powder, stir for 5–7 minutes until the particles are completely distributed, pour into sterile jars, cool at room temperature.

Storage Conditions and Shelf Life (Cream): store in a dark cool place at a temperature of 8–15 °C, avoid direct light, shelf life — 6 months; after opening, use within 30 days.


Toxicity and biosafety of Os sepiae

According to modern toxicological studies, powder of the internal calcareous cuttlebone (Os sepiae), consisting primarily of calcium carbonate, has extremely low acute toxicity. Experimental studies on laboratory animals have shown that with oral administration, the LD₅₀ exceeds 10,000 mg/kg body weight, which classifies it as a practically non-toxic substance. With external use of the powder and ointment forms based on it, no signs of systemic toxicity or irritating effects on the skin and mucous membranes have been detected. The product does not have sensitizing properties. Long-term use in therapeutic doses is safe provided there is no hypercalcemia or nephrolithiasis.

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


Pharmacodynamics — Os sepiae

Os sepiae is a natural mineralized material, the basis of which is calcium carbonate in the crystalline form of aragonite, supplemented with small amounts of organic matrix, magnesium, phosphorus, and trace elements. The pharmacodynamic action is mainly due to the high concentration of calcium, which is involved in maintaining electrolyte balance and the functional activity of the nervous, muscular, endocrine, and skeletal systems. With local application, the powder and ointment forms have an adsorbent, astringent, epithelizing, and keratoplastic effect, creating a protective mineralized layer on the tissue surface that reduces permeability and the inflammatory reaction.

At the systemic level, Os sepiae exhibits a mineralizing and osteoprotective effect, helping to replenish calcium and phosphate stores in tissues with a high degree of mineralization, including bones and teeth. Calcium carbonate is involved in regulating neuronal excitability and myocyte contractile activity, stabilizing the membrane potential and maintaining the physiological transmission of nerve impulses. Through its influence on calcium-dependent enzyme systems, the mineral indirectly modulates the activity of endocrine regulation, including the functions of the parathyroid glands.

In the immune system, Os sepiae has a modulating effect, supporting the functions of innate immune cells by optimizing intracellular calcium metabolism, which improves phagocytic activity and regenerative processes in tissues. At the level of the skin and mucous membranes, it has a barrier and reparative effect, accelerating epithelial restoration and reducing exudation. When applied to damaged areas, it has a hemostatic effect due to mechanical closure of microvessels and stimulation of local thrombus formation.

The antacid effect is due to the chemical interaction of calcium carbonate with hydrochloric acid of gastric juice, which leads to a decrease in acidity and creates conditions for the restoration of mucous membranes. This property is accompanied by a moderate astringent and enveloping effect, especially when used in powder form.

The antioxidant effect in complex forms is associated with the presence of trace elements and organic matrix components that participate in reducing oxidative stress and stabilizing cell membranes.

References: https://pubmed.ncbi.nlm.nih.go...   https://www.sciencedirect.com/science/article/pii/S0142961212004048


Pharmacokinetics — Os sepiae

Following oral administration, calcium carbonate from Os sepiae undergoes partial dissociation in the acidic environment of the stomach with the formation of calcium ions, which are then absorbed in the small intestine, mainly in the proximal sections. Absorption occurs via active transport mechanisms and passive diffusion, with absorption efficiency depending on the acidity of gastric juice and the level of vitamin D in the body. The undissolved part of the calcium carbonate passes through the intestine and is excreted in the feces.

With local application, absorption of calcium through intact skin is minimal, but when applied to mucous membranes or a damaged surface, limited resorption of a local nature is possible. In rectal forms and when applied to mucous membranes, part of the calcium ions enters the systemic circulation, but the main action remains local.

The distribution of calcium in the body occurs with the participation of plasma proteins and in free ionized form; it is deposited mainly in bone tissue and teeth, and also in smaller amounts in muscles and intracellular structures. The organic matrix of the shell, including protein and polysaccharide fragments, does not undergo significant systemic absorption and has its effect mainly at the site of application.

Calcium metabolism is not associated with its chemical transformation, but it is regulated by hormonal mechanisms, including calcitriol and parathyroid hormone. Excretion of calcium ions occurs mainly through the kidneys in the urine and to a lesser extent through the intestines with bile. A negligible amount may be excreted through the skin with sweat.

With long-term use, calcium accumulation in bones is possible, which is a normal process at physiological doses, but with excessive intake, it can lead to its deposition in soft tissues.

References: https://pubmed.ncbi.nlm.nih.go...   https://www.sciencedirect.com/science/article/abs/pii/S0141813017331065


Mechanisms of Action and Scientific Rationale — Os sepiae

The mineralized structure of Os sepiae consists mainly of calcium carbonate in the form of aragonite, and also contains an organic matrix including β-chitin and low molecular weight peptides. Following oral administration, calcium ions are involved in regulating membrane excitability, maintaining voltage-gated calcium channels, and activating calcium-dependent enzymes, including calmodulin-dependent protein kinase and phospholipase A₂. This contributes to the modulation of nerve impulse transmission, contraction of muscle fibers, and regulation of secretory processes in endocrine glands. Locally, Os sepiae powder has an astringent effect by binding exudate proteins and forming a protective film, as well as a mechanical hemostatic effect, accelerating the formation of the primary thrombus. The organic matrix stimulates the activity of fibroblasts and keratinocytes, accelerating epithelization processes. The chitin component interacts with pattern recognition receptors (PRRs) on macrophages and neutrophils, inducing the release of cytokines that regulate local inflammation and tissue repair.

Minerals and trace elements in Os sepiae, including magnesium and phosphorus, affect bone metabolism by activating osteoblasts and inhibiting osteoclastic activity through the RANK/RANKL/OPG signaling cascades. At the gastrointestinal level, calcium carbonate interacts with hydrochloric acid, leading to the formation of calcium chloride and bicarbonate, exerting an antacid effect and reducing the aggressiveness of the acidic environment. This is accompanied by inhibition of pepsin activity due to increased pH and stabilization of the mucosal barrier. In conditions of damage to the skin and mucous membranes, Os sepiae modulates the expression of growth factors, including TGF-β and VEGF, which accelerates angiogenesis and restores microcirculation. The presence of chitin fibers helps activate the blood coagulation cascade by enhancing platelet adhesion to the damaged endothelium.

Referenceshttps://pubmed.ncbi.nlm.nih.go...   https://www.sciencedirect.com/science/article/pii/S0142961212004048


Synergy — Os sepiae

Scientific data indicate significant pharmacological synergy of Os sepiae with other natural and mineralized substances. The combination with Crassostrea gigas (Pacific oyster) powder exhibits additive and potentiating effects on bone tissue mineralization processes due to the complex intake of calcium in different salt forms and trace elements, including zinc. The combination with Centella asiatica extract enhances the reparative and angiogenic effect, modulating collagen production and stimulating the MAPK and TGF-β signaling cascades. When used together with Calendula officinalis oil, an enhancement of the anti-inflammatory and epithelizing effect is noted, due to the parallel inhibition of prostaglandin synthesis through COX-2 suppression and local stimulation of granulation tissue.

In in vitro and in vivo experiments, it has been established that the combination of Os sepiae with pearl powder (Pinctada maxima) has a modulating effect on the activity of osteoblasts and osteoclasts, realized through a combined influence on the expression of osteocalcin and type I collagen. In combination with Aloe vera aqueous extract, potentiation of antioxidant activity is observed, which is associated with the simultaneous suppression of NF-κB activity and an increase in superoxide dismutase activity in epithelial cells.

This interaction of various natural substances forms a complex effect, which can be systemic (with oral administration) or tissue-specific (with external use), aimed at optimizing mineralization processes, epithelial restoration, modulating the inflammatory response, and protecting cellular structures from oxidative stress.

References: https://pubmed.ncbi.nlm.nih.go...   https://www.sciencedirect.com/science/article/pii/S0022395619300042


Geography of use and traditional medicine — Os sepiae

Os sepiae has a long history of use in various cultural and medical traditions of the coastal regions of Europe, Asia, Africa, and the Middle East. In ancient Greco-Roman medicine, cuttlebone powder was mentioned in the writings of Dioscorides and Galen as a mineral remedy for strengthening the body and local treatment of injuries. In traditional Chinese medicine (under the name "海螵蛸" — hǎi piāo xiāo), it was used as a mineral substance of animal origin in complex powders and external preparations; information about such use is recorded in the pharmacopoeia "Bencao Gangmu" (16th century). In Indian Ayurvedic practice, cuttlebone was used in the form of finely ground powder as part of mineral-herbal mixtures. In the Arab medical tradition of the Middle Ages, reflected in the works of Avicenna, the use of ground shell of marine cephalopods as a strengthening agent is mentioned.

In Southeast Asia, including Thailand, Vietnam, and Indonesia, Os sepiae was used in folk medicine for external treatments of skin and mucous membranes, as well as a mineral supplement. In Madagascar and the coastal regions of East Africa, local peoples used ground cuttlebone for oral care and as an absorbent agent. In European folk medicine of the 19th–20th centuries, shell powder was part of tooth powders and was used in home cosmetics.

In addition to medical use, Os sepiae also had non-medical, including symbolic, significance. In the Mediterranean region, cuttlebone was sometimes used in amulets and as an object to ward off evil spirits, especially in coastal settlements. Among some peoples of Southeast Asia, cuttlebone was used in ritual practices for cleansing and protecting the home. In European culture, cuttlebone was also used as a source of calcium for poultry and ornamental animals, which has deep roots in the agrarian tradition.

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Made by Asiabiopharm Co Ltd
Country of origin Thailand
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