A hollow capsule consists of a capsule cap and a capsule shell refined from medicinal gelatin and auxiliary materials. Mainly used for holding solid drugs. Such as self-made powder, health care products, medicines, etc. It solves the problem of difficult eating and poor taste for users, and truly realizes that good medicine is no longer bitter. Hollow capsules are becoming more and more popular. First of all, capsules are slender and easy to swallow, which is the most popular dosage form for consumers. In addition, capsules can effectively mask the unpleasant taste and smell of the contents. Capsules come in various sizes, including No.00 Yanchang Capsule and No.5 Capsule. Capsules can also be printed with words, trademarks and patterns, presenting a unique customized appearance.

According to the standard of China Pharmacopoeia (20 10 edition), the chromium content in medicinal hollow capsules is limited to 2ppm(mg/kg), which can sensitively reflect whether industrial gelatin is used to produce medicinal hollow capsules. The United States Pharmacopoeia and Japanese Pharmacopoeia have no restrictions on the content of chromium in gelatin, while the European Pharmacopoeia limits chromium in gelatin to 10 ppm(mg/kg).

The following are ten aspects that should be paid attention to when purchasing hollow capsules:

1) compactness:

Take 10 capsules of this product, gently hold the two ends of the capsule with your thumb and forefinger, rotate and pull it away, then fill it with talcum powder, cover the lid, and drop it on a board with a thickness of 2cm one by one at the height of 1m, and no powder is allowed to leak; If there is a small amount of powder leakage, it shall not exceed 2 capsules. If more than, should take another 10 second interview, should comply with the regulations.

2) Brittleness:

Take 50 tablets of this product, put them in a mirror, move them into a dryer filled with saturated solution of magnesium nitrate, and keep the temperature at 25℃ 65438 0℃ for 24 hours. Immediately after taking them out, put them into a glass tube (with an inner diameter of 24nm and a length of 200nm) standing upright on a wooden board (with a thickness of 2cm), and put them into a cylindrical weight (made of PTFE, with a diameter of 22mm and a length of 200 nm).

3) disintegration time limit:

Take 6 capsules of this product and fill them with talcum powder. According to the disintegration time limit inspection method (appendix ⅹ A) and the method under capsules, all capsules should be dissolved or disintegrated within 10 minutes. If 1 tablet can't completely dissolve or disintegrate, 6 more tablets should be taken for a second interview, all of which meet the requirements.

4) sulfite (so

5) Chloroethanol: take an appropriate amount of chloroethanol, accurately weigh it, add n-hexane to dissolve it, and quantitatively dilute it into a solution containing about 22μg per 1ml; Accurately measure 2ml, put it in a separatory funnel filled with 24ml n-hexane, add 2ml water precisely, shake and extract, and take the water solution as the control solution. In addition, take an appropriate amount of capsules, cut them into pieces, weigh 2.5g, put them in a conical flask with a stopper, add 25ml of n-hexane, soak them overnight, transfer the n-hexane solution to a separating funnel, add 2ml of water accurately, shake and extract, and take the water solution as the test solution.

6) Check according to gas chromatography (Appendix Ⅴ E): Use a 2M-long 15% PEG- 1500 (or 10% PEG -20M) column and measure at the column temperature1kloc-0/0℃. The peak area or peak height of chloroethanol in the test solution shall not exceed that of the control solution (applicable to ethylene oxide sterilization process).

7) loss on drying: Take 65438±0.0g of this product, separate the bottle cap from the bottle body, and dry at 65438 005℃ for 6 hours. The weight loss rate should be 12.5% ~ 17.5%.

8) residue on ignition: Take this product 1.0g and check it according to law (Appendix VIII N). The residue left shall not exceed 2.0% (transparent), 3.0% (translucent or one section is transparent and the other section is opaque), 4.0% (translucent and opaque) and 5.0% (opaque) respectively.

9) Heavy metals: Take the residual residue from residue on ignition and check it according to law (Appendix VIII H, Second Method). The content of heavy metals shall not exceed 50 parts per million.

10) viscosity: take 4.50g of this product, put it in a weighed 100ml beaker, add 20ml warm water, and stir in a water bath at 60℃ to dissolve it. Take out the beaker, dry the outer wall, add water to make the total weight of the glue solution reach the following weight (including 15.0% dry product), stir it evenly, pour it into a dry conical flask with a stopper, plug it tightly, put it in a water bath at 40℃+1℃, and transfer it to a flat viscometer for viscosity measurement after about 10 minutes. 2 & gt/s .( 1- loss on drying) ×4.50× 100 Total weight of glue solution (g) =── 15.0.

References:

Baidu encyclopedia-hollow capsule