Studies On Extraction And Formation Process Of Yifuning Soft Gelatin Capsule

Background and Objectives:The woman in menopause will appear a series of physiological and pathological changes such as climacteric period syndromes(CS),lipid metabolism disorder, hypertension,osteoporosis,the atrophy of reproductive organ,etc,which is due to the decline of ovary function and decrease of estradiol level.In the opinion of Traditional Chinese Medicine,the blood is produced by the essence and can nourish the body in normal condition.Many kinds of complicate syndrome will appear which is caused by function disorder of organ for renal deficiency,so the main treatment is invigorating the kidney.It's better to add the herbals which has the effect of dissipate phlegm,promoting blood circulation to remove meridian obstruction,clearing hot and making qi smooth.Our traditional Chinese medicine formula YiFuning Soft Gelatin Capsules (YFN)is made into soft capsules by choosing and proving of prescription and dosage form.This product,which is made up of Oviductus Ranae and Rhizoma Curcumae,has a very good clinical application.It can nourish the kidney and activate blood.The former clinical and experimental results all proved that YFN could improve the function of endocrine system effectively and increase the level of estrin, it could also adjust immune function,improve disorder of hormone secretion of hypothalamus-pituitary-gonadal axis,increase content of neurotransmitter,make internal environment stable and relieve menopausal syndrome.In experiments YFN also had the effect of preventing cardiovascular diseases on ovariectomized rats with postmenopause by adjusting the level of sex hormone,nitrogen monoxidum(NO), nitricoxide synthase(NOS),hemocuprein(SOD),malondialdehyde(MDA).In addition,YFN showed a good effect on Postmenopaursal Osteoporosis(PMO).The therapeutic mechanisms is not only by increasing the content of E₂ in serum,but also by increasing the ER expression in bone and increasing the content of microelements in the bone,so as to strengthen the quality of bone.All of these provide evidence for clinical use.Soft gelatin capsule is a dosage form suitable particularly for administration of sensitive drugs posing technological problems,which could mask the unpleasant taste or smell of the drug and the colour combinations increase the safety of therapy by excluding interchangings.Their manufacture is undemanding,it depends on the quality of gelatin and the gelatin mass for the shell of the capsules,on the properties of the content,on mutual interactions between the content and the shell,and on a special know-how,which is an unconditional precondition of successful manufacture of this dosage form.The paper is a review characterizing soft gelatin capsules, processes of their manufactures,and quality evaluation.This subject aims at discovering and researching a kind of safe,effective and convenient drug for the disease.It mainly deals with the extraction technology and formation technology.The main content:1 The identification of Oviductus Ranae.2 Comparative investigation in TLC of three different diameter of powder in Oviductus Ranae.3 Studies on extraction process of YFN. 4 Studies on formation process of YFN.Methods:1 Qualitative analyses of Oviductus Ranae were performed on shape, properties,observation by microscope and degree of swell.2 Ultramicro-pulverization was applied to Oviductus Ranae,to investigate dissolution speciality of active substance by TLC,in order to investigate the dissolution speciality of chemical components of powder in Oviductus Ranae of different granule diameters.3 The active component of Rhizoma Curcumae was ascertained by using pharmacolgical methods.Both the best extraction technology of volatile oil from Rhizama Curcumae and the optimum crush method were selected by using orthogonal design.Comminution degree of Rhizoma Curcumae(decoction pieces, exceed 8 mesh powder,coarse powder),water adding quantity(6 times,8 times, 10 times)and distillation time(3h,5h,7h)were selected for the indexes of the research on extraction technology of volatile oil in Rhizoma Curcumae.4 According to the characterstic of the soft capsules,the supplementary material of the contents were selected.Results:1 There is considerable difference between Oviductus Ranae and toad's oviduct,which is one of the fake of OR.Oviductus Ranae's karyon is bigger and could be easily observed whereas the fake is on the contrary.2 In TLC inspection The blotch of ultramicro-powder is in rich color,compared with those regular ones of Oviductus Ranae.3 Evaporable part from Rhizoma Curcumae applied to extraction technology.A₃B₂C₃(coarse powder,8 times water,distilled 7h)is the best extraction condition of volatile oil from Rhizoma Curcumae.The optimal pulverization parameter conditions of Oviductus Ranae was crushing the coarse powder 20 minutes under-20℃.4 The results show that when olive oil was chosen as diluents and beeswax was selected as suspending agent,the formation of the capsules was good and it assured the successful process of the pressing and the stability of capsules.Conclusions:1 The active chemical substance could be easily released after Ultramicro-pulverization,which also could simplify the extraction of Oviductus Ranae.2 The extraction process way was designed reasonable and has directive meaning to industrial production.3 In formation process,glycerin glutin proportion is the key in shaping soft capsule and it look forward far study in the practice works.4 It overcomes the shortcoming of original medicine,realize the "three effects, three small and five convenience" and more economical and social benefits.To make this product into soft capsule,which could improve its bioavailability,make it easily taken.