تركيبة البروبايوتيك كبسول كمكمل غذائي فموي 17- تصييغ

Abstract

Abstract Probiotic capsule is a simple formula that contains a friendly microbes strains Lactobacillus acidophilus. The aim of study is to develop anew pharmaceutical formula containes one billion live cells of bacteria ( Lactobacillus acidophilus).which has the ability to survive in the intestinal tract used as dietary supplement. In this present study, high quality probiotics were used, vegetarian empty capsules are gelatin free, offer stable performance and are the most recommended shells in the pharmaceutical industry today. Several trials were carried out to prepare stable formula consisting of a mixture of freeze dried Lactobacillus acidophilus bacteria, free from artificial colors, flavors, preservatives, yeast and gluten. Evaluation of final formula was carried out to identify live active cells of survived bacteria founds in the formula, microbial limit test and the activity against pathogenic bacteria. The stability study was carried out for three and six months after storing at room temperature below ( 30°C). Now a days Probiotic capsules are widely used as dietary supplement used to help building and maintaining a healthy digestive system ,so the present project may be used as a promised formula in this field.

Key word: probiotic, lactobacillus acidophilus

Introduction The world health organization ( WHO) definition of probiotic is ( live microorganisms which when administered in adequate amount confer a health benefit on the host). The term probiotics means “for life”. Probiotics are referred to as “good ” bacteria because of the numerous health benefit associated with them. Probiotics have a long history of safe use in the food supply because of is found in fermented milk such as yogurt,no pathogenic characteristics, no production of enterotoxins, no production of cytotoxins, no entero invasiveness, no pathogenic adhesion facor, no heamolysin, no serum resistance, no uropathgenisity and no antibiotic resistance genes. Probiotics capsule is a dietary supplement contains a minimum of one billion live cell culture of Lactobacillus acidophilus per one capsule with other exipients. Lactobacillus acidophilus is a Gram- positive bacteria, non pathogenic, non spore forming, homofermentative, catalase negative rod. Probiotic is available in many dosage forms such as tablet, capsule, powder and oral solution used as a dietary supplement in many cases of irritable bowel syndrome (IBS). Antibiotic associated diarrhea, ulcerative colitis and building and maintaining a health digestive system.

Experimental work The materials used in this study are presented in table (1) and the following procedure are follow Table (1) ingredients to produce capsules of probiotic

No. Ingredients 1 Lactobacillus acidophilus ( La -14) lyophilized powder 2 Magnesium stearate 3 Potato starch 4 Lactose anhydrous

1-In a sterile conditions “laminar flow” freeze- dried Lactobacillus acidophilus powder was weighted. 2-In a suitable container potato starch, magnesium stearate and lactose anhydrous were mixed. 3-The portions in step (1) and step (2) were mixed together. 4-The final powder were sieved at sieve mesh No.60. 5-powder in each vegetarian empty capsule size 0 were filled. 6-Samples to microbiological lab.were sent for testing.

Table (2) specifications of probiotic capsule

Composition Each vegetarian capsule contains one billion spores of Lactobacillus acidophilus (La-14) 100 mg lyophilized powder Appearance White fine powder Average weight 475 mg ±5% Solubility ≥ 98% in water Active live cell (cfu) 90% Disintegration time Less than 30 minutes Route of administration Oral Shelf life 1 billion live cells/ 24 months Pack size Each blister contains 10 capsules in Aluminum /PVC Storage condition Store below 30°C in cool and dry place and in tightly closed containers Total aerobic microbial count < 10 cfu/1 gm Yeast and molds < 10 cfu/1 gm

Results and discussion In the present study different formulation were carried out to obtain a suitable effective formula of probiotic capsule. Stability study was carried out according the GCC Guidelines after stored the probiotic capsule at room temperture below 30C to observe the influnce of heat. The assessment of in vitro release of viable cell count of probiotic culture from stored formula did not reveal significant alteration in parameters . The results of experimental studies of probiotic proved that the formula was good and the viable cell count for lactobacillus acidophilus is more than 9 x 109 cfu after a few numbers of bacterial cells were lost the viability. Accelerated stability study for (6) months shows that the formula was stable and comply with the specification limits which mentioned in GCC Guidelines. From the results above we observed that the studied formula meets within acceptable limits therefore , the shelf- life should not more than two years from the date of manufacturing .

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