The Study On Moistureproof Of Nao Xin Tong Capsule

Objective:Nao Xin Tong capsule have a good effect on treat the cerebral-cardio vascular diseases.It contains sixteen kinds of herbal medicine such as Radix Ast.ragal,Radix Paeoniae Rubra and so on.The drug was a mixture of all the herbal medicine power.The porous powder of this drug was easy to absorb moisture and apt to caking sclerosis.It affects the quantity and curative of the medicine seriously.In order to decrease the moisture absorption,to improve the stability of the preparation,the study carried out by determined the hyproscopic property,screening excipents,film coating materials and packaging materials.Methods:This project included the determination of moisture absorption of each herbal medicine of Nao Xin Tong capsule,and the screening of excipents,the screening of film coating materials and packaging materials for Nao Xin Tong capsule.And the influence of the film coating process to the stability of Nao Xin Tong capsule.In the study of the determination of moisture absorption of each herbal medicine,the moisture absorption rate and critical relative humidity(CRH)were used as the evaluation indexes.And the method of moisture absorption was used to determine the moisture absorption.According to the proportion of 1:1,the sample of the selection of excipients was prepared with the powder of Nao Xin Tong and different excipents,90%ethanol was used as a binder for granulating.The moisture rate and parameters of hydroscopicity were used as the evaluation indexes of the damp-proof property of exipients,to screen suitable exipients.The binomial regression fitting of the moisture absorption curve.In the study of the selection of film coating materials,the top spraying fluidized bed was used to coat.Each coating using only a kind of material,and the weight gain levels were 5%,8%,10%.The method of powder moisture absorption was used,and choosing the moisture absorption rate,critical relative humidity(CRH)and angle of repose as the evaluation indexes of selection of film coating materials.The study of the packing materials involved the determination of the amount of water vapor transmission by weighing method and the heat sealing strength value of the packing materials.The influence study of the coating process on the stability of Nao Xin Tong capsule,was carried out by accelerated trial,which involved the determination of the content of paeoniflorin through the Hingh Performance Liquid Chromatography(HPLC),and the identification of the reference substances such as Tanshinone Ⅱ A,Astragaloside Ⅳ and so on through Thin Layer Chromatography(TLC).Results:The study of determination moisture absorption of every kind herbal medicine had shown that the initial moisture absorption velocity of every herbal medicine in a ascending order were Olibanum<Myrrha<Pheretima<Spatholabl Caulis<Cinnamomi Ramulus<Mori Ramulus<Paeoniae Radix Rubra<Persicae Semen<Chuanxiong Rizoma<Angelicae Sinensis Radix<Saviae Miltiorrhizae Radix Et Rhizoma<Hirudo<Carthami Flos<Scorpio<Astragali Radix<Achyranthis Bidentatae Radix.The moisture absorption acceleration of each herbal medicine in a ascending order were Olibanum<Myrrha<Pheretima<Spatholobl Caulis<Mori Ramulus=Cinnamomi Ramulus<Paeoniae Radix Ruhra<Persicae Semen<Chuanxiong Rizoma<Saviae Miltiorrhizae Radix Et Rhizoma<Scorpio=Hirudo<Angelicae Sinensis Radix<Carthami Flos<Astragali Radix=Achyranthis Bidentatae Radix.The moisture absorption rate of each herbal medicine in a ascending order were Olibanum<Myrrha<Pheretima<Spatholobl Caulis<Cinnamomi Ramulus<Mori Ramulus<Paeoniae Radix Rubra<Persicae Semen<Chuanxiong Rizoma<Angelicae Sinensis Radix<Hirudo<Saviae Miltiorrhizae Radix Et Rhizoma<Carthami Flos<Scorpio<Astragali Radix<Achyranthis Bidentatae Radix.The critical relative humidity(CRH)of every kind herbal medicine in a assending order were Spatholobl Caulis<Persicae Semen<Cinnamomi Ramulus<Pheretima<Carthami Flos<Angelicae Sinensis Radix<Hirudo=Astragali Radix<Achyranthis Bidentatae Radix<Olibanum<Chuanxiong Rizoma<Paeoniae Radix Rubra<Saviae Milliorrhizae Radix Et Rhizoma<Scorpio<Myrrha.The screening of exipients study had shown that the initial moisture absorption velocity of excipients of Nao Xin Tong capsule in a asending order were mannitol<dextrin<calcium hydrogen phosphate<lactose<ethyl cellulose<micro crystalline cellulose<hydroxypropyl methyl cellulose.The moisture adsorption acceleration of excipients of Nao Xin Tong capsule in a ascending order were mannitol =dextrin-calcium hydrogen phosphate<lactose<ethyl celluloselactose<micro crystalline cellulose<hydroxy propyl methyl cellulose.The moisture adsorption rate of excipients of Nao Xin Tong capsule in a ascending order were mannitol<dextrin<calcium hydrogen phosphate<lactose<ethyl cellulose<micro crystalline cellulose<hydroxy propyl methyl cellulose.The critical relative humidity(CRH)of excipients of Nao Xin Tong capsule in a ascending order were dextrin<lactose<calcium hydrogen phosphate=micro crystalline cellulose=ethyl cellulose = hydroxypropyl methyl cellulose<mannitol.The hygroscopic dynamics model met Biomial regression equation.The study of film coating materials had shown that the moistureproof effect of the coating materials was enhanced with the increase of weight gain.And the coating material PVA was chose to coat the medicine,and its weight gain was 10%.The study of packaging materials had shown that the moistureproof effect of packaging materials was enhanced with the increase of film thickness.The amount of water vapor transmission of the packaging materials in a descending order were BOPET>CPP/BOPA>CPP/BOPA/BOPET>CPP/AI/BOPA/BOPET.The intensity of heat sealing value of packaging materials in a descending order were CPP/AI/BOPA/BOPET>CPP/BOPA/BOPET>CPP/BOPA>BOPET.The study of influence of the coating process on the stability of Nao Xin Tong capsule had shown that the film coating can meet the needs of Nao Xin Tong capsule moistureproof.Conclusions:The study result indicates that through screening of excipients,film coating materials and packaging materials can provide satisfied moistureproof for Nao Xin Tong capsule increase the stability of the preparation.