Product Description:
Seaweed Polysaccaride Vacant Capsule, or HPMC Vacant Capsule (I) is made from HPMC and seaweed polysaccaride, the key processing is shaped with low temperature, the patent developed by Chinese Academy of Sciences and GGOG. Its Patent No. is 201410129728.4.
Enteric-coated capsules
Enteric-coated capsules refer to capsules that are insoluble in gastric juice and dissolve in intestinal juice with targeted release function. Enteric-coated capsules are divided into gelatin enteric-coated capsules and vegetable enteric-coated capsules according to different film-forming materials. This product is a vegetable enteric-coated capsule, which is used to fill the medicinal powder to release the medicinal effect in the intestinal juice.
Liquid-filled capsules
Common capsules cannot be filled with liquid whether it is gelatin capsule or vegetable capsule. This product is a vegetable-filled capsule. On the basis of common capsules, a waterproof coating is added to the inner wall of the capsule, which can not only fill oily liquids, but also fill water-soluble liquid drugs, which disintegrate in gastric juice. After the liquid-filled capsule is filled with liquid, it needs to be sealed at the condensation part of the capsule’s body and cap to prevent liquid leakage. This capsule disintegrates in the gastric juice.
Enteric-coated liquid-filled capsules
Enteric-coated liquid-filled capsules refer to enteric-coated capsules that can be filled with liquid. This product belongs to vegetable enteric-coated liquid-filled capsules. It is used as a pharmaceutical excipient to fill liquid medicines that release medicinal effects in intestinal juice.The capsule is insoluble in gastric juice and soluble in intestinal juice, and is suitable for releasing various liquid medicines in intestinal juice.
Physical property
◆ Loss on drying less than 8.0% applicable to the drugs which sensitive to the lack of water;
◆ Good flexibility, high strength and easy to power filling;
◆ Never weathering away and friability which beneficial to storage;
◆Dissolve in water directly, no water swelling, no abdominal distention after taking the drug;
◆ Disintegration property is stable and the disintegration time will not delay after long time storage.
Chemical property
◆ There is no risk of Cross-linking Reaction with aldehyde based drugs and the large ring lactone antibiotic to avoid the difficulties for disintegration and dissolution after long time storage;
◆ There is no risk of Maillard Reaction with carbohydrate drugs, the drugs will not change color and or caking;
◆There is no risk of Condensation Reaction with the tannins chemical composition existing in traditional Chinese medicine.
Safety Info.
◆ All the raw materials are form plant include sea natural plant, there is no pollution risk from chromium and pesticide residue;
◆ There is no any preservatives in the ingredients;
◆ There is no any chlorine alcohol residue due to the sterilization processing without ethylene oxide;
◆ Stability of chemical properties due to there are no Cross-linking Reaction, Condensation Reaction and Maillard Reaction.
◆ The heavy metal limited is twenty per million.
Applicability
◆ It apply to all kinds of people due to there is no any animal components;
◆ Different religions and different cultures will be suitable;
◆ The qualified filling rate more than 99%.
Quality Standards :
质量标准 Item | 中国药典标准 The Ch.P.2020 | 本品标准 This product |
松紧度 Tightness | ≤1 of 10 | ≤1 of 10 |
脆碎率 Broken rate | ≤2 of 50 | ≤1 of 50 |
崩解时限(min) Desintegration time (Min) | ≤15 | ≤10 |
亚硫酸盐(%) Sulfite (%) | N/A | N/A |
黏度(mm2/s) Viscosity (mm2/s) | N/A | N/A |
干燥失重(%) Loss on drying | ≤8 | ≤8 |
蛋白质类物质 Protein | 无规定 N/A | 不得检出 Not detected |
炽灼残渣(%) Residue on ignition | 透明≤3.0 Transparent 半透明≤5.0 Translucent 不透明≤9.0 non-transparent | 透明≤3.0 Transparent 半透明≤5.0 Translucent 不透明≤9.0 non-transparent |
铬(mg/kg) Chromium (mg/kg) | 无规定 N/A | 无规定 N/A |
砷盐(%) Arsenate (%) | ≤0.0002 | ≤0.0002 |
重金属(mg/kg) Heavy metal | ≤20 | ≤20 |
需氧菌(cfu/g) TPC (cfu/g) | ≤1000 | ≤500 |
霉菌(cfu/g) Mould (cfu/g) | ≤100 | ≤50 |
酵母菌(cfu/g) Yeast (cfu/g) | ≤100 | ≤50 |
大肠埃氏菌 Escherichia coli | 不得检出 Not detected | 不得检出 Not detected |
金黄色葡萄球菌 Staphylococcus aureus | 无规定 N/A | 不得检出 Not detected |
沙门氏菌 Salmonella bacteria | 无规定 N/A | 不得检出 Not detected |