Bromelain

1026.9

226.106583

253-387-5

White to tan amorphous powder

35079090

483

-2.17

yellow-brown powder

1.4±0.1 g/cm3

656.2±55.0 °C at 760 mmHg

350.7±31.5 °C

1.591

H2O: soluble

−20°C

Peritoneal-rat LD50: 85 mg/kg; peritoneal-mouse LD50: 37 mg/kg

Thermal decomposition emits irritating smoke

3

36/37/38-42

22-24-26-36/37-36/37/39

B,Xn

Warehouse ventilated, low temperature and dry

Its optimal temperature range is generally 50 to 60 °C and can withstand a temperature of up to about 70 °C before inactivation occurs.

S22-S24-S26-S36/37

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal, aquatic, and plant life; and conformance with environmental and public health regulations.

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: stem bromelain is included in digestive aid products.|Substance added directly to human food affirmed as generally recognized as safe (GRAS).

Kelly GS; Bromelain: A Literature Review and Discussion of its Therapeutic Applications; Alt Med Rev 1 (4): 243-57 (1996)

|Danger|H315: Causes skin irritation [Warning Skin corrosion/irritation]|P261, P264, P271, P280, P285, P302+P352, P304+P340, P304+P341, P305+P351+P338, P312, P321, P332+P313, P337+P313, P342+P311, P362, P403+P233, P405, and P501|H315 (35.09%): Causes skin irritation [Warning Skin corrosion/irritation]|Aggregated GHS information provided by 1382 companies from 8 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

highly toxic

Concomitant use of bromelain and ammoxicillin or tetracycline have been reported to increase the serum levels of these antibiotics.|Bromelain may enhance the anticoagulant activity of drugs such as warfarin.|Bromelain may enhance the antithrombotic activity of drugs such as aspirin.

LD50 rat parenteral application 85.2 mg/kg|LD50 mice parenteral application 30-35 mg/kg|LD50 rabbit parenteral application >20 mg/kg

Bromelain is a mixture of proteolytic enzymes from the main stump of Ananas comosus.|Enzymes from protein-digesting and milk-clotting enzymes found in pineapple fruit juice and stem tissue are called fruit bromelain and stem bromelain, respectively.

Bromelain has /shown/ some success as a substitute for trypsin and pepsin in cases of pancreatic insufficiency and post-pancreatectomy.|Acute postoperative and post-traumatic conditions of swelling, especially of the nasal and paranasal sinuses.|In an open case observation study involving patients with blunt injuries to the musculoskeletal system, the efficacy and tolerability of high-dose Bromelain POS, a plant-derived enzyme preparation, were investigated. The investigating physician was an orthopedic surgeon who, in addition to the usual therapeutic measures, treated 59 of his patients with the bromelaine preparation. The duration of the application was determined by the nature and severity of the lesion, and varied between one and three weeks. The test criteria were swelling, pain at rest and during movement, and tenderness. These parameters were evaluated on the day of the injury and on five subsequent dates. Treatment with bromelaine resulted in a clear reduction in all four parameters tested. Both swelling and the symptoms of pain had improved appreciably at all evaluation time points as compared with baseline. The tolerability of the preparation was very good, and patient compliance was correspondingly high.

Gastrointestinal symptoms such as nausea and vomiting, diarrhea and cramping have been reported. There are occasional reports of metrorrhagia and menorrhagia.|As with papain and other proteases, bromelain may cause contact allergenic reactions in certain individuals.|Bromelain supplements should be avoided by pregnant women and nursing mothers.|In one double-blind study of 73 patients with acute thrombophlebitis, bromelain, used with analgesics, reduced pain, edema, redness, tenderness, elevated skin temperature and disability.|Those on anticoagulants or antithrombotic agents should exercise caution in the use of bromelain. Bromelain may have blood thinning activity in some.

Evidence that bromelains (I) is absorbed from the gastrointestinal tract of rats after oral administration is demonstrated in a bioavailability study in which 125I is given by oral route to rats and blood levels sampled at various times thereafter. A maximum level of 270 ng/ml I was found at one hr after administration.|Bromelain, a standardized complex of proteases from the pineapple plant, is absorbed unchanged from the intestine of animals at a rate of 40% ... .

It has been postulated that a minor enzymatic component present in bromelain is responsible for the release of a kinin, which stimulates the production of prostaglandin E1-like compounds; These PGE1-like compounds are then responsible for the physiological activities of bromelain.|Bromelain's digestant activity is based on its ability to hydrolyze proteins to oligopeptides and amino acids. Bromelain's proteolytic enzymes are cysteine proteases. Cysteine proteases cleave peptide bonds by nucleophilic attack via active-site cysteine residues.|The mechanism of the putative anti-inflammatory activity ... may be accounted for, in part, by activation of plasmin production from plasminogen and reduction of kinin via inhibition of the conversion of kininogen to kinin. Other possibilities, may include proteolytic degradation of circulating immune complexes and inhibition of signaling by extracellular regulated kinase (ERK-2) and p21 ras.|Bromelain has been shown to increase CD2-mediated T cell activation, to enhance antigen-independent binding to monocytes and to increase interferon (IFN)-gamma-dependant, tumor necrosis factor (TNF)-alpha, Interleukin (IL)-1 beta, and interleukin (IL)-6 production in peripheral blood monocytes. These effects are thought to be due to bromelains proteolytic activity at cell surfaces, whereby it either removes surface molecules or reveals ones that already exist on cell membranes, thereby altering receptor-ligand interactions.|For more Mechanism of Action (Complete) data for BROMELAINS (7 total), please visit the HSDB record page.

Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poison A and B/|Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in respiratory arrest. Positive pressure ventilation techniques with a bag valve mask device may be beneficial. Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start an IV with D5W /SRP: "To keep open", minimal flow rate/. Use lactated Ringer's if signs of hypovolemia are present. Watch for signs of fluid overload. Consider drug therapy for pulmonary edema ... . For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam (Valium) ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poison A and B/

/HUMAN EXPOSURE STUDIES/ ...Papain and Bromelain are used as tenderizers of meat and to clarify beer. Therefore, these enzymes are also potential ingestive allergens and may represent an unrecognized cause of an allergic reaction following a meal. As contact allergens the enzymes play a minor role; biodetergents in particular present no increased risk of skin damage for the user.|/CASE REPORTS/ A comparative study of 17 female employees of the blood grouping laboratory with exposure to bromelain and 15 unexposed healthy females revealed increases in bromelain specific IgE antibodies in seven women in the exposed group. Four of these women showed clinical symptoms indicative of bromelain allergy. None of the women in the control group showed bromelain specific IgE antibodies or clinical symptomology. The authors conclude that bromelain is a strong sensitizer with sensitization occurring through occupational inhalation.|/CASE REPORTS/ Bromelain induced asthma was reported in four women who prepared hydrous solutions of bromelain for a blood grouping laboratory. The women presented with asthma, difficulties in swallowing, itching in the throat, conjunctivitis, wheezing, eye irritation, and rhinitis after handling bromelain. One woman had anaphylactic reactions to fresh pineapple and another had vomiting upon the consumption of fresh pineapple. Three patients had positive prick tests with bromelain in a concentration of 0.0001 mg/mL, and two of the patients had asthmatic reactions 3 hours post testing. Bromelain specific immunoglobulin-E (IgE) antibodies were determined in all four women. None of the patients showed positive test reactions to various inhalation and food allergens or to papain, and no papain specific IgE antibodies were determined.|/CASE REPORTS/ ... Four cases of occupational allergy to bromelain in workers of a blood grouping laboratory /are reported/. These observations prompted us to investigate the sensitization rate to bromelain in all workers of the particular diagnostic laboratory who had contact with bromelain. These results were compared with those obtained from healthy, randomly selected individuals without evident bromelain exposure. Our findings indicate that (i) bromelain is a strong sensitizer, (ii) sensitization usually occurs due to inhalation and not to ingestion, (iii) bromelain allergy is occupationally acquired, and adequate precautions are necessary. We can further state that (iv) skin testing with relatively pure allergens such as isolated proteases like bromelain may induce systemic reactions, even at very high dilutions.

Ananase

Bromelain 2400 Maximum Strength; (Vitaline Corp.)|Bromanase; (Kramer-Novis)

Bromelain, fruit: ACTIVE|XU - indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711).

Human drugs -> Rare disease (orphan)|Food Additives -> ENZYME_PREPARATION; -> JECFA Functional Classes

Food Additives -> ENZYME_PREPARATION;