空心膠囊

　　中文名： 拼音名：Kongxin Jiaonang　　英文名：Vacant Capsules　　書頁號(hào)：2000年版二部－438

膠囊劑優(yōu)勢(shì)：

　　膠囊可容納各種藥粉、液體、半固體和藥片。此外膠囊劑具有良好的生物利用度，原因是膠囊能迅速、可靠和安全地溶解。

的類型與型號(hào)：

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

顏色：

　　我們可以按顧客的要求生產(chǎn)各種顏色、規(guī)格的，并有十多種顏色的現(xiàn)有產(chǎn)品可供選擇。

印字：

　　我們可以按顧客的要求在各種顏色、規(guī)格的上印上文字、商標(biāo)與圖案。

包裝：

　　硬紙箱

儲(chǔ)存：

　　1、因具有含水量過少容易碎裂、過多容易軟化變形的特性，所以出廠的水份應(yīng)控制在12.5–17.5%之間。　　2、裝有膠囊的容器應(yīng)置放于貨架上，避開窗戶和管道使其處于陰涼通風(fēng)處，避免日光照射和靠近熱源。　　3、不可隨意放置和重壓。　　4、未使用前包裝容器應(yīng)保持密封，如果已打開請(qǐng)采取相應(yīng)滅菌措施，否則易造成細(xì)菌污染。　　5、庫(kù)存溫度應(yīng)保持在15 - 25℃；相對(duì)濕度保持在35–65%。　　6、不可儲(chǔ)藏于高溫高濕條件下，否則會(huì)因受熱變軟而發(fā)生粘連和變形，也不可置放于溫度過低或過于干燥的環(huán)境下，否則膠囊易產(chǎn)生發(fā)脆易碎現(xiàn)象。　　7、按上述儲(chǔ)存條件儲(chǔ)存，膠囊可完好地儲(chǔ)存9個(gè)月以上。

運(yùn)輸：

　　在運(yùn)輸過程中注意防壓、防曬、防潮、防熱。

性狀：

　　本品呈圓筒狀，系由帽和體兩節(jié)套合的質(zhì)硬且具有彈性的空囊。囊體應(yīng)光潔、色澤均勻、切口平整、無變形、無異臭。本品分透明、半透明、不透明三種。

鑒別：

　　（1）取本品0.25g，加水50ml，加熱使溶化，放冷，取溶液5ml,加重鉻酸鉀試液－稀鹽酸（4:1）的混合液數(shù)滴，即生成橙黃色絮狀沉淀。　?。?）取鑒別（1）項(xiàng)下剩余的溶液1ml，加水50ml,搖勻,加鞣酸試液數(shù)滴,即發(fā)生渾濁。　?。?）取本品約0.3g,置試管中，加鈉石灰少許，加熱，產(chǎn)生的氣體能使?jié)駶?rùn)的紅色石蕊試紙變藍(lán)色。

檢查：

　　松緊度 取本品10粒，用拇指和食指輕捏膠囊兩端，旋轉(zhuǎn)拔開，不得有粘結(jié)、變形或破裂，然后裝滿滑石粉，將帽、體套合，逐粒在1m的高度處直墜于厚度為2cm的木板上，應(yīng)不漏粉；如有少量漏粉，不得超過2粒。如超過，應(yīng)另取10粒復(fù)試，均應(yīng)符合規(guī)定。　　脆碎度：取本品50粒，置表面皿中，移入盛有硝酸鎂飽和溶液的干燥器內(nèi)，置25℃±1℃恒溫24小時(shí)，取出，立即分別逐粒放入直立在木板（厚度2cm）上的玻璃管內(nèi)（內(nèi)徑為24nm，長(zhǎng)為200nm）內(nèi),將圓柱形砝碼（材質(zhì)為聚四氟乙烯，直徑為22mm、重20g±0.1g）從玻璃管口處自由落下，視膠囊是否破裂，如有破裂，不得超過15粒。　　崩解時(shí)限：取本品6粒，裝滿滑石粉，照崩解時(shí)限檢查法（附錄Ⅹ Ａ），膠囊劑項(xiàng)下的方法檢查，各粒均應(yīng)在10分鐘內(nèi)全部溶化或崩解。如有1粒不能全部溶化或崩解，應(yīng)另取6粒復(fù)試，均應(yīng)符合規(guī)定。　　亞硫酸鹽（以SO<[2]>計(jì)）：取本品5.0g，置長(zhǎng)頸圓底燒瓶中，加熱水100ml使溶化,加磷酸2ml與碳酸氫鈉0.5g，即時(shí)連接冷凝管，以0.1mol/L碘溶液15ml為接收液，收集餾出液50ml,加水至100ml，搖勻，量取50ml，置水浴上蒸發(fā)，隨時(shí)補(bǔ)充水適量，蒸至溶液幾乎無色，加水至40ml，照硫酸鹽檢查法（附錄Ⅷ B）檢查，如顯渾濁，與標(biāo)準(zhǔn)硫酸鉀溶液7.5ml制成的對(duì)照液比較，不得更濃（0.02％）。　　氯乙醇：取氯乙醇適量，精密稱定，加正己烷溶解并定量稀釋成每1ml中約含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，振搖提取，取水溶液作為對(duì)照溶液。另取膠囊適量，剪碎，稱取2.5g，置具塞錐形瓶中，加正己烷25ml，浸漬過夜，將正己烷液移至分液漏斗中，精密加水2ml，振搖提取,取水溶液作為供試品溶液。　　照氣相色譜法（附錄Ⅴ Ｅ）檢查：用15％聚乙二醇－1500（或10％聚乙二醇-20M）柱，柱長(zhǎng)2M，在柱溫110℃下測(cè)定。供試品溶液中氯乙醇的峰面積或峰高不得超過對(duì)照溶液峰面積或峰高（此項(xiàng)適用于環(huán)氧乙烷滅菌工藝）。　　干燥失重：取本品1.0g，將帽、體分開，在105℃干燥6小時(shí)，減失重量應(yīng)為12.5％～17.5％。　　熾灼殘?jiān)喝”酒?.0g，依法檢查（附錄Ⅷ Ｎ），殘?jiān)謩e不得過2.0％（透明）、3.0％（半透明或一節(jié)透明、另一節(jié)不透明）、4.0％（一節(jié)半透明，另一節(jié)不透明）、5.0％（不透明）。　　重金屬：取熾灼殘?jiān)?xiàng)下的殘?jiān)?，依法檢查（附錄Ⅷ Ｈ第二法），含重金屬不得過百萬分之五十。　　黏度：取本品4.50g，置已稱定重量的100ml燒杯中，加溫水20ml，置60℃水浴中攪拌，使溶化。取出燒杯，擦干外壁，加水使膠液總重量達(dá)到下列計(jì)算式的重量（含干燥品15.0％），將膠液攪勻后倒入干燥的具塞錐形瓶中，密塞,置40℃±0.1℃水浴中，約10分鐘后，移至平氏黏度計(jì)內(nèi)，照黏度測(cè)定法（附錄Ⅵ Ｇ*法,毛細(xì)管內(nèi)徑為2.0mm），于40℃±0.1℃水浴中測(cè)定，本品運(yùn)動(dòng)黏度不得低于60mm<2>/s。　　（1－干燥失重）×4.50×100膠液總重量（g）＝──15.0

用途：

　　用于盛裝固體藥物。

貯藏：

　　密封，在陰涼干燥處保存。

英語簡(jiǎn)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（植物膠囊）, 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 （胃溶膠囊） 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.