空心胶囊

　　中文名： 拼音名：Kongxin Jiaonang　　英文名：Vacant Capsules　　书页号：2000年版二部－438

胶囊剂优势：

　　胶囊可容纳各种药粉、液体、半固体和药片。此外胶囊剂具有良好的生物利用度，原因是胶囊能迅速、可靠和安全地溶解。

的类型与型号：

　　1、胃溶：00#、0#、1#、2#、3#、4#、5#　2、肠溶：0#、1#、2#

颜色：

　　我们可以按顾客的要求生产各种颜色、规格的，并有十多种颜色的现有产品可供选择。

印字：

　　我们可以按顾客的要求在各种颜色、规格的上印上文字、商标与图案。

包装：

　　硬纸箱

储存：

　　1、因具有含水量过少容易碎裂、过多容易软化变形的特性，所以出厂的水份应控制在12.5–17.5%之间。　　2、装有胶囊的容器应置放于货架上，避开窗户和管道使其处于阴凉通风处，避免日光照射和靠近热源。　　3、不可随意放置和重压。　　4、未使用前包装容器应保持密封，如果已打开请采取相应灭菌措施，否则易造成细菌污染。　　5、库存温度应保持在15 - 25℃；相对湿度保持在35–65%。　　6、不可储藏于高温高湿条件下，否则会因受热变软而发生粘连和变形，也不可置放于温度过低或过于干燥的环境下，否则胶囊易产生发脆易碎现象。　　7、按上述储存条件储存，胶囊可完好地储存9个月以上。

运输：

　　在运输过程中注意防压、防晒、防潮、防热。

性状：

　　本品呈圆筒状，系由帽和体两节套合的质硬且具有弹性的空囊。囊体应光洁、色泽均匀、切口平整、无变形、无异臭。本品分透明、半透明、不透明三种。

鉴别：

　　（1）取本品0.25g，加水50ml，加热使溶化，放冷，取溶液5ml,加重铬酸钾试液－稀盐酸（4:1）的混合液数滴，即生成橙黄色絮状沉淀。　　（2）取鉴别（1）项下剩余的溶液1ml，加水50ml,摇匀,加鞣酸试液数滴,即发生浑浊。　　（3）取本品约0.3g,置试管中，加钠石灰少许，加热，产生的气体能使湿润的红色石蕊试纸变蓝色。

检查：

　　松紧度 取本品10粒，用拇指和食指轻捏胶囊两端，旋转拔开，不得有粘结、变形或破裂，然后装满滑石粉，将帽、体套合，逐粒在1m的高度处直坠于厚度为2cm的木板上，应不漏粉；如有少量漏粉，不得超过2粒。如超过，应另取10粒复试，均应符合规定。　　脆碎度：取本品50粒，置表面皿中，移入盛有硝酸镁饱和溶液的干燥器内，置25℃±1℃恒温24小时，取出，立即分别逐粒放入直立在木板（厚度2cm）上的玻璃管内（内径为24nm，长为200nm）内,将圆柱形砝码（材质为聚四氟乙烯，直径为22mm、重20g±0.1g）从玻璃管口处自由落下，视胶囊是否破裂，如有破裂，不得超过15粒。　　崩解时限：取本品6粒，装满滑石粉，照崩解时限检查法（附录Ⅹ Ａ），胶囊剂项下的方法检查，各粒均应在10分钟内全部溶化或崩解。如有1粒不能全部溶化或崩解，应另取6粒复试，均应符合规定。　　亚硫酸盐（以SO<[2]>计）：取本品5.0g，置长颈圆底烧瓶中，加热水100ml使溶化,加磷酸2ml与碳酸氢钠0.5g，即时连接冷凝管，以0.1mol/L碘溶液15ml为接收液，收集馏出液50ml,加水至100ml，摇匀，量取50ml，置水浴上蒸发，随时补充水适量，蒸至溶液几乎无色，加水至40ml，照硫酸盐检查法（附录Ⅷ B）检查，如显浑浊，与标准硫酸钾溶液7.5ml制成的对照液比较，不得更浓（0.02％）。　　氯乙醇：取氯乙醇适量，精密称定，加正己烷溶解并定量稀释成每1ml中约含22μg的溶液；精密量取2ml，置盛有正己烷24ml的分液漏斗中，精密加水2ml，振摇提取，取水溶液作为对照溶液。另取胶囊适量，剪碎，称取2.5g，置具塞锥形瓶中，加正己烷25ml，浸渍过夜，将正己烷液移至分液漏斗中，精密加水2ml，振摇提取,取水溶液作为供试品溶液。　　照气相色谱法（附录Ⅴ Ｅ）检查：用15％聚乙二醇－1500（或10％聚乙二醇-20M）柱，柱长2M，在柱温110℃下测定。供试品溶液中氯乙醇的峰面积或峰高不得超过对照溶液峰面积或峰高（此项适用于环氧乙烷灭菌工艺）。　　干燥失重：取本品1.0g，将帽、体分开，在105℃干燥6小时，减失重量应为12.5％～17.5％。　　炽灼残渣：取本品1.0g，依法检查（附录Ⅷ Ｎ），残渣分别不得过2.0％（透明）、3.0％（半透明或一节透明、另一节不透明）、4.0％（一节半透明，另一节不透明）、5.0％（不透明）。　　重金属：取炽灼残渣项下的残渣，依法检查（附录Ⅷ Ｈ第二法），含重金属不得过百万分之五十。　　黏度：取本品4.50g，置已称定重量的100ml烧杯中，加温水20ml，置60℃水浴中搅拌，使溶化。取出烧杯，擦干外壁，加水使胶液总重量达到下列计算式的重量（含干燥品15.0％），将胶液搅匀后倒入干燥的具塞锥形瓶中，密塞,置40℃±0.1℃水浴中，约10分钟后，移至平氏黏度计内，照黏度测定法（附录Ⅵ Ｇ*法,毛细管内径为2.0mm），于40℃±0.1℃水浴中测定，本品运动黏度不得低于60mm<2>/s。　　（1－干燥失重）×4.50×100胶液总重量（g）＝──15.0

用途：

　　用于盛装固体药物。

贮藏：

　　密封，在阴凉干燥处保存。

英语简介：

　　Introduction:　　Empty （Vacant） capsule is one of the most common choices for medicine filling, and it has acquired an important position in the industry of medicine manufacture. Since the quality and material of the vacant capsules directly affects the effect and safety in medicine usage, our factory has always been searching for new and good material to improve the quality of the capsule shells, and try to make the best products to our customers.　　The empty capsule is a kind of capsule shell with designated colors （prepared at the specific requirement of the customer） and shape made of gelatin as main material. It is usually used as the special packing for those medicines or health products with bad smell, light sensitiveness or labialisation in wet or hot conditions. No bond or additional pressure is required in producing capsules with vacant capsules. In addition, the specific capsules are easy to disintegrate in the gastric juice. Compared with tablets and pills, the capsules can offer a better bioavailability and other advantages in convenient preparation, carriage and usage and safe airproof packing.　　Vegetable（cellulose） capsules（植物胶囊）, different from the traditional glutin capsules, are made of HPMC（hydroxy, propyl, methyl and cellulose） with the basic elements of polysaccharides and plant cell wall. In addition to its advantage in natural concept, it can also promote the absorption and digestion of albumen, fat and carbohydrate, which absent in the traditional glutin capsules. Along with the growing of vegetarianism and the sense of health protection, as well as the influence of the religion etc., the natural vegetable capsule products are rising to the leading position in its industry.　　Vegetable capsule is made of HMPC by new technique, it’s a natural high-tech product.　　Unlike gelatin capsules, vegetable capsules are made from natural plant cellulose in order to satisfy vegetarian and cultural lifestyle needs. While retaining all the advantages of traditional gelatin capsules, vegetable capsules also starch-free, gelatin-free and contains no preservatives. It does not need to be sterilized with ethyleneoxide.　　HPMC（hydroxy, propyl, methyl and cellulose） is made of plant cellulose. It has been widely applied in food, cosmetics and pharmaceutics industries all over the world. HPMC used to produce veg-capsules meet USP/BP standard.　　Veg-capsule can also be colored by natural edible colorants, and imprinted with natural printing inks to identify your products in the market. Besides, veg-capsules run smoothly on all kinds of hgh speed and semi-automatic filling machines.　　The gastric coated capsules （胃溶胶囊） is a kind of capsule shell with designated colors （prepared at the specific requirement of the customer） and shape made of gelatin and gastric coating as main material. It is a capsule designed with specific target, it’s disintegrating quickly in the gastric juice. It's usually used in the packing of the medicines or health products with excitation to the stomach, labialisation in acid environment or specific requirement to disintegrate in the gastric juice to take effect. The specific gastric-oriented capsules help to promote the effect with a less dosage while reducing the adverse reaction, which is convenient for the patients. In addition, it helps to reduce the degradation to the medicine or health products caused by oral application and supply the best place for absorption.