Quality Quarantee For The Product Of Soft Ganoderma Spore Oil Capsule

Improving immunity was one of the most important functions of Ganoderma spore oil. The study was used to better understand the production process of Ganoderma spore oil soft capsule and the physiology and quality were measured about the standards. The main results were as follows:1. According to the quality requirements of Ganoderma spore oil soft capsule, Application of the principles of health food GMP, we planned and built production plant and workshop well. Designed rational craft of product processing, scilicet through acceptance of raw materials、mixing、dissolving、stereotypy、cleaning、drying、choosing、 packaging、inbounding, determined critical control points such as the feeding of raw materials、the temperature and time of dissolving、cleanliness of the capsules, etc, and refined operation points.2. Be focused on checking the production critical of the specifications for 0.35g/tablet of Ganoderma spore oil soft capsule and calculating material balance. In addition, formulated the health situation to the operators、clean area was level 100000、production line and auxiliary producing quota and any other aspects.3. Ganoderma spore oil soft capsule was composed by Ganoderma spore oil, gelatin and glycerin. According to national standards and product standards, we tested and verified raw materials and finished products about sensory, physiology and quality, microbial and so on. Results indicated that under the conditions of both sensory and physiology were qualified, the triterpenoids was 11.6g/100g, total numbers of colony was 12cfu/g, coliform bacteria was 26Mpn/100g in Ganoderma spore oil and triterpenoids was 9.7g/100g, total numbers of colony was 10cfu/g, coliform bacteria was 15Mpn/100g in soft capsule. The enterprise standard provided that triterpenoids was ≥8.0g/100g, total numbers of colony was<1000cfu/g, coliform bacteria was ≤40Mpn/100g. So the product is qualified.4. We carried out toxicological evaluation of safety such as animal acute virulence test, genetic toxicity test and 30 days feeding trial and function tests like delayed type hypersensitivity, lymphocyte transformation test, antibody formation test, determination of the activity of NK cells. The results reflected Ganoderma spore oil soft capsule had no toxicity and could improve immunity.