CN103394093A - Carragheenan and potassium chloride gelled hydroxypropyl methylcellulose enteric-coated hollow capsule - Google Patents

Abstract

The invention relates to a carragheenan and potassium chloride gelled hydroxypropyl methylcellulose enteric-coated hollow capsule, and belongs to the technical field of the production of hollow capsules. The hollow capsule is characterized in that the hollow capsule is prepared through mixing a main raw material hydroxypropyl methylcellulose with carragheenan and potassium chloride under a special condition, the hollow capsule has the characteristics of timely disintegration, low water content, suitableness for medicines having strong hygroscopic property and being sensitive to water, small influences of a dissolve-out medium to the shell of the capsule, high drug compliance, long storage duration data, no deterioration within 3-4 years, low condition requirements on the storage and the transportation, difficult crushing in the low humidity environment, difficult deformation, putrefaction and deterioration in the high temperature environment, according with the requirements of populations having all culture backgrounds because of pure vegetable fibers, almost no pollution in the production process, secondary re-dissolving utilization of tailings, omission of the commonly-used surfactants and plasticizers, acceleration of the gelling speed by reducing the gelling temperature only through utilizing potassium chloride to assist the carragheenan, additive reduction, production cost reduction, and suitableness for the mass popularization.

Description

Hypromellose enteric hollow capsule by carrageenan and potassium chloride gel

Technical field

The invention belongs to the Capsules production technical field, particularly a kind of vegetalitas enteric hollow capsule by carrageenan and potassium chloride gel of the preparation take hypromellose as raw material.

Background technology

Capsules is comprised of the refining cap that forms of medicinal materials, body two joint capsule shells, is used for the splendid attire solid drugs; As make powder, health product, medicament etc. by oneself,, for the user has solved difficult entrance, the poor problem of mouthfeel, realized that really good medicine is no longer bitter to the taste; Because Capsules is easy to swallow, that can very effectively cover content makes us uncomfortable taste and abnormal smells from the patient, welcome by the patient.

Present Capsules mainly contains gelatine capsule and the various vegetalitas capsule of animality, in China, the gelatin Capsules accounts for the overwhelming majority, at present, the gelatin Capsules has been widely used in food, health food and medicine field, in recent years, along with the development of China's modernization of Chinese medicine, capsule accounts for the ratio of whole pharmaceutical preparation total amounts also in constantly rising.

But obviously there is the slow defect of disintegration rate in gelatine capsule, and huge gelatin Capsules market and industrial chain thereof also brought many quality problems and security risk simultaneously.After " chromium exceed standard capsule event ", the safety problem that capsule produces has received more concern; Simultaneously, along with the generation of Animal diseases as " bovine spongiform encephalopathy " " foot and mouth disease ", people have produced very large uneasiness to utilizing animal's leather, bone to produce the gelatin raw material, and there is great potential safety hazard in the Capsules take animal gelatin as main production.

in view of this, scientific research institution has strengthened the research to the vegetalitas capsule both at home and abroad, successively developed up to now multiple non-gelatin Capsules, announced " a kind of cellulose and plant polyoses capsule " as the patent No. 200810138256.3, this patent is passed through the pulullan polysaccharide of 68%-88%, the hypromellose of 10%-30%, the gel of 1%-3%, the flocculation aid of 0.1%-0.5%, the surfactant of 0.1%-0.5% and the pigment of 0.1%-0.3% are prepared into glue and dip in glue and form, this patent has solved the gelatine capsule disintegration rate slowly and the problem of potential safety hazard, but obviously inadequate aspect the film property of capsule body and storage-stable, with there is harmful effect in some drugs in capsule, surfactant has wherein been prohibited use.

Summary of the invention

Technical problem to be solved by this invention is: for the deficiencies in the prior art, provide a kind of take hypromellose as raw material the preparation, carry out gel by carrageenan and potassium chloride, do not have potential safety hazard, can Long-term Storage, disintegrate fast, the enteric hollow capsule minimum to drug influence in capsule,, with the raising safety of taking medicine, improve medical effect.

For solving the problems of the technologies described above, the technical solution adopted in the present invention is a kind of hypromellose enteric hollow capsule by carrageenan and potassium chloride gel, it is characterized in that preparation method is as follows.

⑴ get hypromellose 50kg, put into the 165-175L temperature and be in the purified water of 77-83 ℃, with the mixing speed of 1550-1650rpm, constantly stir and naturally cool to 22-28 ℃, then be incubated standing 60-90min, again solution is heated to 35-45 ℃, obtains hypromellose solution.

⑵ get carrageenan 200g-210g, and to be dissolved in the 19-21L temperature be in the purified water of 35-45 ℃, stir 3-5min with the speed of 2550-2650rpm, join until completely dissolved in hypromellose solution, continue to stir 2-3min, mix homogeneously with the speed of 1550-1650rpm.

⑶ potassium chloride 270-280g joins in hypromellose solution, continue to stir and naturally cool to 22-28 ℃ with the speed of 1550-1650rpm, again solution is heated to 35-45 ℃ after standing 2-3min, then be incubated standing 60-120min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 30-35 ℃ of room temperature.

⑷ immerse the capsule rod in hypromellose phthalic acid fat organic solution, then takes out dry.

⑸, finally by the demoulding, cut, and fit, make the hypromellose enteric hollow capsule.

Its preferred preparation method is as follows.

⑴ get hypromellose 50kg, puts into the 170L temperature and be in the purified water of 80 ℃, with the mixing speed of 1600rpm, constantly stirs and naturally cool to 25 ℃, then is incubated standing 75min, then solution is heated to 40 ℃, obtains hypromellose solution;

⑵ get carrageenan 205g, and to be dissolved in the 20L temperature be in the purified water of 45 ℃, with the speed of 2600rpm, stirs 4min, joins until completely dissolved in hypromellose solution, continues to stir 2.5min, mix homogeneously with the speed of 1600rpm;

⑶ potassium chloride 276g joins in hypromellose solution, continue to stir and naturally cool to 25 ℃ with the speed of 1600rpm, solution is heated to 45 ℃ again after standing 2.5min, then be incubated standing 90min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 32 ℃ of room temperatures;

⑷ immerse the capsule rod in hypromellose phthalic acid fat organic solution, then takes out dry;

⑸, finally by the demoulding, cut, and fit, make the hypromellose enteric hollow capsule.

in the present invention, the inventor is through long-term experiment many times, all need to add activating agent and plasticizer just can obtain good colloidal solution, the effect that hypromellose is added to the water from low temperature to the high-temperature digestion is undesirable, also undesirable from high temperature to the dissolution in low temperature conversely, the constant temperature effect is more undesirable, carry out gel after heating up conversely again after afterwards once because of carelessness unintentionally from high temperature to the dissolution in low temperature, activity and the plasticity of finding hypromellose solution improve greatly, film property is better, again by experiment repeatedly, find that the inventive method no longer needs to add surfactant and plasticizer, can complete and dip in glue equally, solved in this area and wished to reduce the difficult problem of additive always, greatly reduce on the impact of medicine with to patient's side effect.

The invention has the beneficial effects as follows take hypromellose as the enteric hollow capsule material, make Capsules possess the multiple advantage that hypromellose has, it is mainly manifested in stable chemical nature, without cross-linking reaction, and softgel shell disintegrate simultaneously, so disintegrate is very timely; Water content is low, can be controlled in 8% left and right, reduces medicine hygroscopicity risk, and the applicable hygroscopicity that is used for is strong and to medicine, particularly health product and the cosmetics of minute water sensitive; Dissolution medium is little on the softgel shell impact, and little to the adhesion strength of esophagus, the medication compliance is high; Easily store, effect duration is long, 3-4 never degenerates, and is low to the conditional request that stores and transport, and is difficult for friability under low wet environment, friability under the 35%RH environment≤20%, not yielding under hot environment, under 80 ℃ of environment, utricule distortion≤1%, do not contain protein in raw material, make existence and the breeding of antibacterial lose necessary condition, be difficult for rotting; Pure plant fiber, raw material sources are relatively simple, meet all culture backgrounds and religions belief crowd's requirement; Safe, without the zoonosis risk, without hormone residual in animal body, medicine and other harmful substances; Almost pollution-free in production process, but tailing secondary back dissolving is utilized; Save surfactant and plasticizer commonly used, only by potassium chloride, helped solidifying carrageenan to reduce gelling temp and accelerate gelation rate, reduced additive, reduced production cost, be fit to large-scale popularization.

The specific embodiment

The invention will be further described below in conjunction with embodiment, and following examples are intended to illustrate the present invention rather than limitation of the invention further, should not limit the scope of the invention with this.

Embodiment 1.

Get hypromellose 10kg, put into the 33L temperature and be in the purified water of 77 ℃, with the mixing speed of 1550rpm, constantly stir and naturally cool to 22 ℃, then be incubated standing 60min, then solution is heated to 35 ℃, obtain hypromellose solution; Then getting carrageenan 40g, to be dissolved in the 3.8L temperature be in the purified water of 35 ℃, with the speed of 2550rpm, stirs 5min, joins until completely dissolved in hypromellose solution, continues to stir 3min, mix homogeneously with the speed of 1550rpm; Then potassium chloride 54g joins in hypromellose solution, continue to stir and naturally cool to 22 ℃ with the speed of 1550rpm, solution is heated to 35 ℃ again after standing 2min, then be incubated standing 60min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 30 ℃ of room temperatures; Again the capsule rod is immersed in hypromellose phthalic acid fat organic solution, then take out dry; , by the demoulding, cut finally, fit, make the hypromellose enteric hollow capsule.

Embodiment 2.

Get hypromellose 50kg, put into the 170L temperature and be in the purified water of 80 ℃, with the mixing speed of 1600rpm, constantly stir and naturally cool to 25 ℃, then be incubated standing 75min, then solution is heated to 40 ℃, obtain hypromellose solution; Then getting carrageenan 205g, to be dissolved in the 20L temperature be in the purified water of 45 ℃, with the speed of 2600rpm, stirs 4min, joins until completely dissolved in hypromellose solution, continues to stir 2.5min, mix homogeneously with the speed of 1600rpm; Then potassium chloride 276g joins in hypromellose solution, continue to stir and naturally cool to 25 ℃ with the speed of 1600rpm, solution is heated to 45 ℃ again after standing 2.5min, then be incubated standing 90min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 32 ℃ of room temperatures; Then the capsule rod is immersed in hypromellose phthalic acid fat organic solution again, then take out again dry; , by the demoulding, cut finally, fit, make the hypromellose enteric hollow capsule.

Embodiment 3.

Get hypromellose 100kg, put into the 350L temperature and be in the purified water of 83 ℃, with the mixing speed of 1650rpm, constantly stir and naturally cool to 28 ℃, then be incubated standing 90min, then solution is heated to 45 ℃, obtain hypromellose solution; Then getting carrageenan 420g, to be dissolved in the 42L temperature be in the purified water of 40 ℃, with the speed of 2650rpm, stirs 3min, joins until completely dissolved in hypromellose solution, continues to stir 2min, mix homogeneously with the speed of 1650rpm; Then potassium chloride 560g joins in hypromellose solution, continue to stir and naturally cool to 28 ℃ with the speed of 1650rpm, solution is heated to 40 ℃ again after standing 3min, then be incubated standing 120min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 35 ℃ of room temperatures; Then the capsule rod is immersed in hypromellose phthalic acid fat organic solution again, then take out again dry; , by the demoulding, cut finally, fit, make the hypromellose enteric hollow capsule.

Claims (2)

1., by the hypromellose enteric hollow capsule of carrageenan and potassium chloride gel, it is characterized in that preparation method is as follows:

⑴ get hypromellose 50kg, put into the 165-175L temperature and be in the purified water of 77-83 ℃, with the mixing speed of 1550-1650rpm, constantly stir and naturally cool to 22-28 ℃, then be incubated standing 60-90min, again solution is heated to 35-45 ℃, obtains hypromellose solution;

⑵ get carrageenan 200g-210g, and to be dissolved in the 19-21L temperature be in the purified water of 35-45 ℃, stir 3-5min with the speed of 2550-2650rpm, join until completely dissolved in hypromellose solution, continue to stir 2-3min, mix homogeneously with the speed of 1550-1650rpm;

⑶ potassium chloride 270-280g joins in hypromellose solution, continue to stir and naturally cool to 22-28 ℃ with the speed of 1550-1650rpm, again solution is heated to 35-45 ℃ after standing 2-3min, then be incubated standing 60-120min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 30-35 ℃ of room temperature;

⑷ immerse the capsule rod in hypromellose phthalic acid fat organic solution, then takes out dry;

⑸, finally by the demoulding, cut, and fit, make the hypromellose enteric hollow capsule.

2. the hypromellose enteric hollow capsule by carrageenan and potassium chloride gel according to claim 1 is characterized in that preparation method is as follows:

⑴ get hypromellose 50kg, puts into the 170L temperature and be in the purified water of 80 ℃, with the mixing speed of 1600rpm, constantly stirs and naturally cool to 25 ℃, then is incubated standing 75min, then solution is heated to 40 ℃, obtains hypromellose solution;

⑵ get carrageenan 205g, and to be dissolved in the 20L temperature be in the purified water of 45 ℃, with the speed of 2600rpm, stirs 4min, joins until completely dissolved in hypromellose solution, continues to stir 2.5min, mix homogeneously with the speed of 1600rpm;

⑶ potassium chloride 276g joins in hypromellose solution, continue to stir and naturally cool to 25 ℃ with the speed of 1600rpm, solution is heated to 45 ℃ again after standing 2.5min, then be incubated standing 90min, obtain flooding stable colloidal solution, then dip in glue Cheng Mo, then drying obtains dry capsule rod under 32 ℃ of room temperatures;

⑷ immerse the capsule rod in hypromellose phthalic acid fat organic solution, then takes out dry;

⑸, finally by the demoulding, cut, and fit, make the hypromellose enteric hollow capsule.