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An introduction and application of soft capsules
1.1 Description Soft Capsules Soft capsules are relatively flexible elastic capsule , which capsule shell contains water , increasing agent, the ratio between these three substances determines the size of the volume of soft capsules , the first soft capsule preparation of vitamin A, D capsules, since 1933 since the rotary die encapsulation machine , a pharmaceutically acceptable soft capsule not only in reducing the production costs , but also greatly improve the yield .
1软胶囊引见与使用
1.1软胶囊引见软胶囊归于比拟灵敏的惯性胶囊，其囊壳中含有水、增型剂，这三种精神之间的对于于于比决议了软胶囊容积的巨细，最先的软胶囊药剂是维他命A、D洁白丸，自1933年缭绕拉模包囊机以来，药用软胶囊岂但在消费中升高了利润，并且还大猛进步了产量。
1.2 Application of soft capsules soft capsules applications in medicine is widespread , both for oral administration may also be external, their specifications , color and shape can vary. In addition to medical , but also can be used in industrial areas ( such as the food industry , chemical , household chemical products , etc. ) . Because of its sealed good, save a long time , non-perishable, every one , is also very convenient to use and carry , so quickly swept the world , the price is much higher than ordinary skin care products .
1.2软胶囊使用软胶囊在医药的使用中很宽泛，既能够用来内服，也能够外用，其规格相反，色彩与外形也各不相反。除了了非医用以外，还能够使用于轻工业畛域（如药品轻工业、化学、家化必需品等）。
2 soft capsule formulation and analysis of process parameters to explore
2.1 Preparation of Soft Capsule Soft Capsule in the process of preparation process: sol - Ingredients - pressure pills - drying - light inspection - within the packaging - packaging.
2.2 Sol Technology Innovation Soft capsules production process is a key step in the sol , it can determine whether smoothly to the next step , the process changes the properties of gelatin . Capsule liquid as the intermediate product , which directly affects the quality of the quality characteristics of gelatin capsules . Better glue viscosity at 3.6 blood in sacrifice . OE range, the viscosity is inversely proportional to the size and quality of the good or bad , poor quality may be insufficient toughness is also not suitable for industrial production . Therefore, we investigated based on the technology of sol viscosity index . Swelling rubber block is to take the appropriate amount of water and gelatin to swell under reduced pressure at room temperature for 30 minutes, then add other materials stirred at 69 ° C was dissolved , and then in the 0.07 - 0.08 MPa pressure until the solution was degassed under a transparent and bubble free , and so it can be properly maintained after cooling to room temperature.
Determination of the viscosity of the rubber block 758 is set to take the 520 ml beaker, add 240 ml of water , heated to about 39-49 degrees , maintaining and stirred until complete dissolution , and other cool to 39 degrees in the glue used to take about 210 ml Grace s viscometer ( ambient temperature of 40 degrees Celsius ) for the determination of the viscosity , write down the glue out with a stopwatch time using the same method to measure the time required for 240 ml water , the ratio between the two is the time required for sample viscosity.
( 1 ) for time during swelling examination of the gelatin amount of water , respectively at a normal temperature under a reduced pressure swelling O, 29,59,119 mln, then adding prescribed amount of glycerin , and other materials, at a constant temperature of 69 ℃ shock a water bath with stirring to a 0.08MPa 0.07 intermittent vacuum degassing under pressure until the gelatin solution is clear and transparent without bubble formation , while it is poured into a beaker into heat , until cooled and then removed and its viscosity was measured . Results : With the swelling time, the viscosity tends to decrease , wherein the swelling time is 29min, 59min, 119min, the viscosity closer , omin the hot melt method is used , maximum viscosity , which may be such as to fully swell sol time is shortened , the viscosity is reduced accordingly , taking into account the actual production and cost 29min to meet the requirements.
( 2 ) examine the amount of vacuum pressure water and gelatin under reduced pressure at room temperature, swelling 29min, then add the prescribed amount of glycerin and other accessories at a constant temperature of 69 ℃ water bath stirring to dissolve shock , respectively, at 0.05 a 0.06Mpa, 0.06 a o.07Mpa, 0.07 an intermittent pressure 0.08MPa vacuum degassing to gelatin solution clear and transparent without bubbles , hot pour into it , to be removed after cooling , the viscosity was measured . Results : With the pump pressure increases , the viscosity tends to decrease , which may be due to pressure increases, the glue off the bubbles easier to clean, the sol time is shortened , the viscosity is reduced accordingly , so choose -0.08 0.07 Mpa is the best vacuum pressure .
( 3 ) examine the thickness of rubber on rubber Bohou molding and product quality on the capsules have a great impact . Rubber is too thin , so that the difference in hardness resistant capsules , easy to bake in a net transport of produce or leaking . Results : Soft Capsule rubber with reduced thickness , disintegration time is shortened trend. Found in the actual production of rubber thickness of 0.6mm , the capsules rupture easily , so choose both the contents were tight encapsulation , and can effectively shorten the disintegration time , 0.7mm to meet the requirements.
( 4 ) the temperature of the sol and study the amount of water and gelatin to swell under reduced pressure at room temperature, 29min, then add the prescribed amount of glycerin , and other materials , respectively, at 59 ℃, 69 ℃, 79 ℃ constant temperature water bath shock while stirring , at 0.07 a 0.08MPa really a vacuum pump pressure intermittent degassing , clear and transparent to the gelatin solution without bubbles , hot pour into it , to be removed after cooling , the viscosity was measured . Results: The temperature was 79 ℃ when the sol , the viscosity , followed by the 59 ℃, 69 ℃. This may be gelatin sensitivity to temperature is relatively large , which increases as the temperature of the sol , the viscosity also will increase , at the same time , so that the sol sol prolonged low temperature , the glue is heated state for a long time , resulting in a viscosity increases, so I chose the sol temperature of 69 ℃ is better .
( 5 ) sol process validation test by a single factor screening test to determine the optimum conditions for the swelling time of 30min, sol temperature is 70 ℃, vacuum pressure of 0.08 a 0.09MPa, prepare three batches glue to the viscosity was measured as an index . Results: The average three batches of glue viscosity of 3.64 , close to the expected value , indicating that the process is stable and reliable.
( 6 ) the drying temperature and the drying time of the inspection if the temperature is above 39 ℃ its long-term heating , the gelatin molecule will promote water-soluble peptide chain rupture , resulting in changes in the structure of gelatin , therefore , during the soft capsule drying process, to observe the principle of low-temperature drying , and dry strength is not too large , the temperature is not too high, if dried properly will result in rupture, adhesions and other undesirable phenomena occur , which seriously affected the quality of the product . Results: The capsule shell moisture and soft capsules disintegration time is almost directly proportional to the extension of time as dry and dry temperature, the moisture content of the capsule shell becomes less and less , so since its disintegration time will become faster , as early as when the capsule shell water content of 9% or less, the soft capsules can be substantially less than a 9-minute rapid disintegration . But this does not mean that the moisture content of the capsule shell , the lower the better , in the actual production , we found that if the water content of the capsule shell is too low , it will become hard capsules , and easy to brittle fracture, the storage, administration , packaging and transportation will cause a lot of negative factors. So choose Select 25-30 degrees Celsius by drying 7-9 hours until the moisture content of the capsule shell is 8 a 10% to meet the requirements.
Conclusion : In recent years, research and development of new soft capsule preparation of traditional Chinese medicine preparation has become a hot spot , and more widely. This paper analyzes and summarizes the characteristics of soft capsules in the future development prospects in medicine soft capsule preparation and research , there are positive role in guiding .
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