Project Description
Properties
Safety and Applicability of Seaweed Polysaccaride Vacant Capsules
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.
Physical Property
◆Loss on drying less than 8.5% 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 Information
◆ 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%.
Raw Materials Information
◆All the raw materials of the ingredient are seaweed polysaccharide and hypromellose;
◆The seaweed hypromellose is main product in our group, the raw materials of seaweed hypromellose is from Australia natural seaweed;
◆The seaweed phyromellose have the properties which include the high strength of gel, good plasticity, easy to film, stability of chemical property. The components of phyromellose have also the function to decrease the blood fat, anti oxygenation, decrease the blood sugar, antitumor.
Specification
| Type | Length (mm) | Outer diameter(mm) | Weight | |||
| Cap | Body | Capsule | Cap | Body | （mg) | |
| 00# | 11.70±0.20 | 20.20±0.20 | 24.50±0.30 | 8.48±0.05 | 8.18±0.05 | 122±8 |
| 0# | 11.00±0.20 | 18.60±0.20 | 21.00±0.30 | 7.46±0.05 | 7.33±0.05 | 98±7 |
| 1# | 9.80±0.20 | 16.60±0.20 | 18.80±0.25 | 6.93±0.05 | 6.64±0.05 | 76±6 |
| 2# | 9.00±0.20 | 15.40±0.20 | 17.80±0.25 | 6.34±0.05 | 6.08±0.05 | 65±5 |
| 3# | 8.10±0.20 | 13.60±0.20 | 15.80±0.20 | 5.82±0.05 | 5.55±0.05 | 49±4 |
| 4# | 7.20±0.20 | 12.20±0.20 | 14.30±0.20 | 5.28±0.05 | 5.02±0.05 | 43±3 |
Filling Quantity With Difference Specific Gravity
| Type | Volume | Filling quantity (mg) | |||
| （cm3) | 0.6(g/cm3) | 0.8(g/cm3) | 1.0(g/cm3) | 1.2(g/cm3) | |
| 00# | 0.95 | 570 | 760 | 950 | 1140 |
| 0# | 0.68 | 408 | 544 | 680 | 816 |
| 1# | 0.5 | 300 | 400 | 500 | 600 |
| 2# | 0.37 | 222 | 296 | 370 | 444 |
| 3# | 0.3 | 180 | 240 | 300 | 360 |
| 4# | 0.21 | 126 | 168 | 210 | 252 |
Package
| Type | 00# | 0# | 1# | 2# | 3# | 4# |
| Ten thousand per case | 8 | 10 | 14 | 16 | 20 | 25 |
Quality Standards
| Item | The Ch.P. | This product |
|---|---|---|
| Tightness | ≤1 of 10 | ≤1 of 10 |
| Broken rate | ≤5 of 50 | ≤1 of 50 |
| Desintegration time (Min) | ≤15 | ≤10 |
| Sulfite (%) | ≤0.01 | No requirement① |
| Loss on drying | 3.0-8.0% | ＜6.0% |
| Protein | N/A | Not detected |
| Residue on ignition | ≤3.0% transparent | ≤3.0% transparent |
| Residue on ignition | ≤6.0% non-transparent | ≤6.0% non-transparent |
| Chromium (ppm) | N/A | No requirement② |
| Cadmium (ppm) | N/A | ≤1 |
| Arsenate (ppm) | N/A | Raw ≤2③ |
| Heavy metal (ppm) | ≤40 | ≤20 |
| TPC (cfu/g) | ≤500 | ≤500 |
| Mould Yeast(cfu/g) | ≤100 | ≤100 |
| Escherichia coli | Not detected | Not detected |
| Staphylococcus aureus and Pseudomonas aeruginosa | Not detected | Not detected |
| Salmonella bacteria | Not detected | Not detected |
①There is no sulfite to add into the ingredient as preservative ;
②All the ingredient and processing is no chromium;
③The Arsenate control in the phase of raw materials.
◆The storage condition
The product should be sealed up, the temperature is 10-30℃ and the humidity is 20%–65%.
◆Shelf-life