CN1169283A

CN1169283A - Porous capsule

Info

Publication number: CN1169283A
Application number: CN 96106729
Authority: CN
Inventors: 陈甘霖
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-07-01
Filing date: 1996-07-01
Publication date: 1998-01-07

Abstract

The porous capsule is prepared by perforating and hardening process. Said perforating method can be adding foaming agent to gelatin solution, or mechanical perforating method and or feeding gas into gelatin solution. Said hardening method can be using hardening agent and binding agent, or microwave radiation, or irradiation method, and or gamma-ray radiation etc. phusical hardening method. Medicinal active components can be filled in the capsule to make a release-controlled medicinal composition, and farm chemical components also can be filled in the capsule to make a release-controlled farm product composition etc..

Description

Porous capsule

The present invention is a porous capsule, relates generally to capsule surface perforation, capsule cure process and fill pharmaceutical compositions in capsule, makes it to become the controlled capability capsule, belongs to medicine field.

General medicine has 70 to 80 percent to be to be that via oral throwing and, main cause this dosage form can reach advantages such as convenient use, curative effect height, side effect be low approximately.Peroral dosage form generally includes other solid preparations such as lozenge, capsule, and wherein the kenel of lozenge is comparatively commonly used.

When at the beginning of oral controlled release formulation (Controlled Release Dosage Form) appeared at for 1940 nineteen fifties at the year end first, can provide prolong drug action time, reduce the dispensing number of times.Thereafter many different loading systems are developed successively.

Usually the oral controlled release formulation manufacture method is as follows: 1. activated medicine periphery is coated with material little to the intestines and stomach liquid dissolubility or that the intestines and stomach liquid is insoluble.2. form chemical complex with medicine.3. medicine and ion exchange resin (Ion-Exchange Resins) are formed bond.4. medicine is embedded in a matter.

General medicine is different with rerum natura with the voltinism of itself structure, add various excipient such as diluent (diluents), lubricant (lubricants), correctives, collapse powder (disintegrants), binding agent (binders), or coloring agent, sweeting agent are made lozenge or other solid preparations so that the oral administration mode is offerd medicine, or add the phosphoric acid salt buffer and adjust acid-base value (pH value), make injection or other liquor dosage forms so that mode is offerd medicine outside gastrointestinal tract.Can inject down via eye, nose, percutaneous even, or implant in anus, rectum, vagina or the uterus, make it disengage active component gradually.

Known techniques is published in the 874th page of J.Pharm.Sci. the 50th volume in 1961 as: T.Higuchi and excipient such as medicine and polymer are mixed, beat ingot becomes a matter (Matrix) oral controlled-release and follow closely agent.This type of controlled release form must rely on complicated preparation process, or is adjusted the controlled-release effect that can reach ideal on recipe design.

A.G.Thombre contains the controlled release form of these fiber crops of Australia (Osmagent) in world patent office (WPI) patent application 94-199917/24 number, and with macromole solable matter coating in addition, reactive species wherein is positioned over anisotropic membrane.

People such as A.Olivieri are in world patent office (WPI) patent application 94-169606/21 number, the controlled release form that contains the two alcohol of ursol (Ursodeoxycholic acid), and be prepared into via extrusion ball-type (extrusion spheronisation) mode and contain the two alcohol of ursol (Ursodeoxycholic-acid) bulky grains, wherein also comprise suitable excipient, bonding agent.

People such as K.L.Branly put into huge capsule in world patent office (WPI) patent application 93-312854/40 number with herbicide (herbicide), and its material system links and contains the soft agent of water solublity by gelatin (gelatin) and glutaraldehyde (glutaraldehyde) and forms.This huge capsule is a core with the herbicide, has controlled-release effect.

People such as S.M.Herbig are for 92-079771/10 number medicine, nutrient (nutrients) to be put into a kind of polymeric membrane (polymerised membrane) be the porose shell of material in world patent office (WPI) patent application, have controlled-release effect.

ELAN Corp.PPLC company is for 85-110586/19 number methyldopa (methyldopa) controlled release agent of oral granule in world patent office (WPI) patent application, comprising acid and polymeric membrane (polymeric-membrane)

People such as N.K.Jain deliver laser Durchgangshohle controlled drug delivery system for the 1806th page in J.Pharm.Sci. the 73rd volume in 1984, it is that collapsing fast of tradition loose gelatine capsule through the formaldehyde steam treatment, make between gelatin molecule to produce and link Cross-Linkage) form the insoluble capsule of the intestines and stomach, handle capsule surface later with the laser duck eye that punctures.Medicine is dissolved in by duck eye disengages in the eluat, reaches controlled-release effect, and this laser Durchgangshohle controlled release capsule has the effect of slow release in vivo, and because therefore the location difficulty of laser Durchgangshohle process capsule can't automatization produce, is not accepted by pharmaceutical industry

In order to overcome above-mentioned deficiency, the objective of the invention is: the method for making a kind of " porous capsule " and manufacturing porous capsule.Its main purpose system discloses a kind of gelatin porous property capsule that has controlled-release effect itself.

The present invention's " porous capsule " but another purpose system disclose a kind of filling chemical compound and reach the gelatin porous property capsule of controlled-release effect.Wherein can dash the series of compounds of filling out and comprise compositionss such as medicine, agriculture extraction thing, spice, pigment, ferment, make it possess controlled-release effect with chemical compound, industrial chemical compound, make-up and beauty chemical compound, thing for health care, environmental health thing, natural goods (natural-products).Its controlled-release effect is not subjected to about rerum natura, the voltinism institute of institute's filling content.

The preparation method of porous capsule of the present invention, it is to select for use any following Durchgangshohle method then to handle:

Add foaming agent in gelatin solution;

The Mechanical Method Durchgangshohle;

The gas that feeds liquid, solid-state or gaseous state is in gelatin solution.

The present invention's " porous capsule " method for curing system selects formaldehyde (formaldehyde), glutaraldehyde (glutaraldehyde) and so on sclerosing agent for use; Or select for use can (Denacol) such as: Di Nai, methylglycerin ethyl ester [EX-131 (Methyl glycidyl ether)], ethylene polyethylene glyceryl diglycerol ethyl ester [EX-810 (Ethylene polyethylene glycol diglycidyl ether)], glyceryl polyglyceryl ethyl ester [EX-313 (Glycerol polyglycidyl ether)], polyglyceryl polyglyceryl ethyl ester [EX-512 (Polyglyceol polyglycidyl ether)] and so on links agent (crosslinking reagent); Or other physical hardening methods of other microwave irradiation methods, ultraviolet irradiation, cobalt irradiation method, an ancient woman's ornament agate roentgenization method or the like.Other microwave irradiation methods, ultraviolet irradiation, cobalt irradiation method, an ancient woman's ornament agate roentgenization method or the like other physical hardening methods.

The present invention's " porous capsule " no matter filling pharmaceutical compositions or be applicable to that the compositions of cosmetics, food, agricultural articles all possesses controlled-release effect, its controlled-release effect is not subjected to about the rerum natura, voltinism institute of institute's filling content.

More detailed argumentation, in the present invention's " porous capsule " but filling chemical compound and reach controlled-release effect, wherein the series of compounds of institute's filling comprises medicine, agriculture extraction thing with chemical compound, industrial chemical compound, make-up and beauty chemical compound, thing for health care, environmental health thing, natural goods (natural products), spice, pigment, ferment or the like, makes it possess controlled-release effect.

Though rerum natura, the voltinism of filling chemical compound in " porous capsule " do not influence its controlled-release effect, yet the filling content reaches effect such as effect, nourishing healthy, make-up and beauty, environmental health on suitable pharmacologically active, the agricultural in order to impel, therefore in case of necessity in the filling above-claimed cpd be main constituent simultaneously, also filling binding agent, excipient, pigment, correctives in the lump are to become a kind of controlled capability compositions.For example the effective ingredient of filling pharmaceutical active is selected verapamil (Verapamil HCl), card mist skin (Captopril), A Tamifen (Aactaminophen), aspirin (Aspirin), Ni Kadi hydrochlorate (Nicadipine HCl), the withered Luo Fen sodium of enlightening (Diclofenac) sodium, ferment, carbohydrate, polymer for use; And starch and so on excipient.Or the fertilizer, the Insecticides (tech) ﹠ Herbicides (tech) that need on the filling organophosphor, epoxide agriculturals such as (epoxide) be effective ingredient, and cooperate required implant, excipient, can become the compositions of controlled capability agricultural articles.Or on the filling nourishing healthy, or the extraction thing of needed vitamin (vitamin), natural goods (natural-products) is active effective ingredient in the make-up and beauty, and cooperate required spice, implant, binding agent, excipient, pigment, correctives, can become controlled capability nourishing healthy, make-up and beauty articles for use compositions.Or needed active effective ingredient on filling carbon amine insecticide, air freshener and so on environmental health, cooperate required implant, binding agent, excipient, pigment, correctives, can become the compositions of controlled capability environmental health articles for use.For example the industrial desired reflection material of thio agent of fillingization and so on, cooperate required implant, can become the compositions of controlled capability industrial goods.

In the prior art, capsular manufacturing process generally is: the 1. preparation of gelatin solution, 2. make the capsule blank, and 4. the cutting of 3. dry capsule blank formalizes, puts in order, checks and process such as packing.

And the present invention's " porous capsule " is no matter adopt Mechanical Method, chemical method or venting method all different with prior art method.

One of manufacture method of the present invention: Mechanical Method Durchgangshohle, mechanical type prepares the present invention's " porous capsule ", system uses a kind of pestle film that is covered with most 0.1～2mm shrinkage pools that has, take off device and possess thereon and be enough to the hollow boring bit corresponding with a kind of grabbing with shrinkage pool, after making the capsule blank, earlier take off device and on the capsule blank, press the hole, and grabbed and take off, cause the sclerosis capsule of 1～20 hole again via the formaldehyde sclerosis by grabbing.

Two of manufacture method of the present invention: chemical formula promptly adds foaming agent and prepares porous capsule of the present invention in gelatin solution, is weak acid and weak base reflection mode that employing can produce carbon dioxide.The gelatin solution that main process lies in general capsule raw material adds weak acid and weak base in regular turn, makes it produce a large amount of bubbles and is suspended in the capsule wall, causes most holes via the formaldehyde sclerosis again.

Usually the weak acid class of using is Fumaric acid (fumaric acid), citric acid (citric acid), tartaric acid (tartaric acid), maleic acid (maleic acid); The weak base class is sodium carbonate, potassium carbonate, calcium carbonate, magnesium carbonate, lithium carbonate.Mixed proportion between this weak acid and weak base is 8: 1 to 1: 8, and is advisable with 4: 1 to 1: 4.All the total amount of weak acid and weak base accounts for capsule 0.1% to 10%, and is advisable with 0.2% to 4%.

Three of manufacture method of the present invention: venting method prepares the present invention's " porous capsule ", promptly ventilate body in gelatin solution, lie in the general capsule raw material gelatin solution, feed the gas that does not produce reflection, the unobstructed noble gases such as air carbon dioxide, nitrogen, helium, blunt gas of selecting for use with capsule.Speed with per second 3～30CC enters gelatin solution by the porous filter.Through fully stirring the bubble volume in the gelatin solution is reduced, and keep even aeration status, thereby made the capsule that capsule wall presents most natural mode holes.The present invention's " porous capsule " also can add not other form (as liquid, solid-state, gaseous state) that produces the reaction above-mentioned gas with capsule and in gelatin solution, be prepared.

The hardening process of capsule is the mode of appearance that keeps capsule, the manufacturing process that general prior art method for example utilizes oxidant, radiation method all can be used in the present invention also can be added in addition as formaldehyde (formaldehyde), glutaraldehyde (glutaraldehyde) and so on sclerosing agent about 0.1 to 6 hour of its hardening process.Or use radiation method to harden, can select dosage 1 to 5 beautiful Randt's (Mrad) an ancient woman's ornament agate ray or cobalt 60 for use; Or select the microwave of 400～1200W intensity for use, shone 0.1 to 20 minute; Or select for use the ultraviolet of 280～2800mj/cm intensity to shine

In general, the viscosity of gelatin solution, the time of being stained with glue are depended in the thickness of capsule wall system, with the speed of pulling out the film pestle.Gelatin viscosity is relevant with the control of interpolation gelatin addition and temperature, and when addition that increases gelatin or reduction temperature, then the viscosity of this gelatin is bigger, otherwise then little.Then what are relevant with the glue amount that stops on the mould pestle in the control of being stained with the glue time and pulling out mould pestle speed, unnecessary down landing of glue amount mat action of gravity on the mould pestle when being stained with glue, the gelatin of residue then rests on the mould pestle, so it is too fast to be stained with glue speed, or the time that the mould pestle takes out is too fast, its wall attenuation of made capsule, otherwise thickening then.Note when therefore making capsule:

1. the viscosity of gelatin solution, addition;

2. be stained with glue time and the control of being stained with glue speed.

Water content in the moulding capsules has suitable importance for the quality of capsule, generally is controlled between the capsule gross weight 12～15%.If water content is lower than at 10% o'clock, capsule becomes fragile easily and easily splits, or because of atrophy changes the size of capsule, can't the filling medicine.When water content is higher than 16%, capsule is easy to deliquescing and viscosity increases, to such an extent as to the mechanical strength of forfeiture capsule, causing can't capsule-containing filling machine filling medicine.

In the capsule manufacture process, temperature must be adjusted to 50～80 ℃ and humidity and be lower than 80%, the addition of foaming agent must be controlled at 0.01～5.5%.

The ratio of keeping 30: 60: 2 according to gelatin, distilled water, foaming agent is prepared, handles the porous capsule that is formed by sclerosing agent with formaldehyde (formaldehyde) again.In this capsule, be packed into 1: 4 even pharmaceutical active effective ingredient verapamil (verapamil HCl) and corn starch of mixed, form the pharmaceutical compositions that contains pharmaceutical active effective ingredient verapamil (verapamil HCl).

The shared following accompanying drawing of the present invention:

Fig. 1. the medicine that is the porous capsule that obtains of different production batch is molten from figure

Eluat ... water (n=6)

1 ... first are 2 years old ... second batch 3 ... the 3rd batch

Fig. 2. its medicine of porous capsule through the processing of formaldehyde different time is molten from figure

Eluat ... water (n=6)

1 ... 2 hours 2 ... 4 hours 3 ... 7 hours

Fig. 3. be molten from figure through its medicine of porous capsule of formaldehyde different time processing

(n＝6)

1 ... 2 hours eluats ... water

2 ... 2 hours eluats ... hydrochloric acid

3 ... 4 hours eluats ... water

4 ... 4 hours eluats ... hydrochloric acid

Fig. 4. its medicine of porous capsule that is the different content foaming agent is molten from figure

Eluat ... water (n=6)

1…2.17％ 2…1.01％ 3…0.55％

Fig. 5. its medicine of porous capsule that is different hole numbers is molten from figure

Eluat ... water (n=6)

1 ... 8 holes 2 ... 6 holes

3 ... 4 holes 4 ... 2 holes

Fig. 6. its medicine of porous capsule that is cure process in microwave is molten from figure

Eluat ... water (n=6)

Fig. 7. its medicine of porous capsule through 2 beautiful Randt (Mrad) radiation hardening processing is molten from figure

Eluat ... water (n=6)

Fig. 8. be more than the formaldehyde cure process permeability to fill its medicine of pharmacy composition capsule molten from figure

Eluat ... water (n=6)

Fig. 9 table 1. is molten from parameter through its medicine of porous capsule of formaldehyde different time processing

Eluat ... water (n=6)

Fig. 9 table 2. is molten from parameter through its medicine of porous capsule of formaldehyde different time processing

Eluat ... 0.1N hydrochloric acid (n=6)

The amount of Fig. 9 table 3. filling foaming agent and its medicine of porous capsule molten from parameter

Hereby reaching by reference to the accompanying drawings form is described in detail as follows:

See also shown in Figure 1, Fig. 1 system contains this pharmaceutical compositions porous capsule gained take water as eluat molten from Figure. As can be seen from Figure, prepared its pharmaceutical active active ingredient verapamil of three batches of capsules of different time (verapamil HCl) molten from standard deviation very little, between three batches of capsules good repeatability is arranged, showing should be many When the permeability capsule was made, bubble was dispersed in gelatin solution.

In the made porous capsule of the gelatin solution that contains the 1.17%W/W blowing agent, respectively with formaldehyde (formaldehyde) for after curing

agent processes

2,4 and 7 hours, be filled into the pharmacy that mixes with 1: 4 ratio Active active ingredient verapamil (verapamil HCl) and cornstarch, this cornstarch consumption 180mg. With water For eluat carries out external dissolving-separating test, its result and returns the parameter of dissolving-separating test such as table 1 as shown in Figure 2 Show. With the data substitution, the n value of gained shows that it disengages and is zero mode that this medicine is released according to the Korsmeyer pattern Go out speed and descend along with the growth in formaldehyde (formaldehyde) processing time, that is show that gelatin molecule produces It is extremely complete to link (Cross-linkage) effect.

During take 0.1N hydrochloric acid as eluat, it is molten from the result as shown in Figure 3, and its regression parameter is as shown in table 2. Comply with With the data substitution, the n value of gained shows that it disengages and is zero mode that this medicine disengages speed according to the Korsmeyer pattern Rate descends along with the growth in formaldehyde (formaldehyde) processing time. Even so, at identical formaldehyde (formaldehyde) under the processing time, 0.1N hydrochloric acid is that eluat can obtain comparatively fast molten than take water as eluat Go out speed.

Except outside the Pass formaldehyde (formaldehyde) processing time and dissolution rate have, the addition of blowing agent is foot also To affect the molten from speed of porous capsule. Add the porous capsule of different content blowing agent, all equally through first Aldehyde (formaldehyde) was processed 2 hours, and molten from figure take water as the eluat gained, as shown in Figure 4, and its time Return parameter as shown in table 3. With the data substitution, the n value of gained shows that it disengages is zero according to the Korsmeyer pattern The level pattern. Owing to the consumption difference of blowing agent, how many amounts that produces blowing agent has reach the difference of size therebetween.

Learn that by Fig. 4 and table 3 this medicine release rate is to rise along with rising on the blowing agent addition. Yet add Add too many blowing agent, it is excessive to cause the bubble of generation too much to reach volume, causes on the contrary the degree of difficulty of being stained with the glue processing, And capsule wall is too thick. Capsule wall is too thick so that can't fit between the Gai Yuti of capsule. And addition is very few. Will To cause the bubble that is formed too fine, the skewness phenomenon in capsule wall is enough to cause medicine to be released Go out to take place maximum error. Because of the suitable addition of blowing agent at 0.5～2.5%.

In sum, select add blowing agent in gelatin solution, Mechanical Method Durchgangshohle or ventilation body in gelatin solution it Any Durchgangshohle method is then carried out the prepared porous capsule of cure process, can make the pharmacy group of filling in it Compound becomes the controlled capability pharmaceutical compositions.

Embodiment 1:

In 400 ml beakers, inject 120 ml distilled waters, keep water temperature in 80～85 ℃, under this temperature, slowly add the gelatin powder of 60 grams, be stirred well to gelatin and dissolve fully, make gelatin solution with the bath method.To make appropriate gelatin solution and be reduced to 60 ℃ with the purgation temperature.Have on the mould pestle (Pin and mold) with No. 2 capsules diameter 0.2mm shrinkage pool each two, with the sunflower oilcloth lubricated after, respectively the mould pestle is inserted in the gelatin solution, slowly take out and place on the shaping frame, excise with the sharp sword edge that capsule is unnecessary after about 20 minutes, to be prepared into capsule lid and capsule body.

Through put do after, take off device with grabbing of the hollow boring bit corresponding and on the capsule blank, press the hole, and grabbed and take off with the tool shrinkage pool, cause the capsule body in 4 holes.This capsule body was placed formaldehyde (formaldehyde) steam 2 hours, take out and place 30 minutes formaldehyde (formaldehyde) of 50 ℃ of baking ovens to remove remnants.

To according to the even pharmaceutical active effective ingredient verapamil (verapamil HCl) of 1: 4 mixed and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 5 from figure.

Embodiment 2:

In 400 ml beakers, inject 120 ml distilled waters, keep water temperature in 80～85 ℃, under this temperature, slowly add the gelatin powder of 60 grams, be stirred well to gelatin and dissolve fully, make gelatin solution with immersion method.To make appropriate gelatin solution and be reduced to 60 ℃ with the purgation temperature.Add potassium carbonate and the

citric acid powder

1,2 or 4 grams of equivalent respectively, continue stirring until gelatin solution and present the cream shape, remove the cream on upper strata, the mould pestle of No. 2 capsules is lubricated with the sunflower oilcloth.

This mould pestle immersed in gelatin solution slowly takes out, place on the shaping frame, after about 20 minutes with the sharp sword edge excision that capsule is unnecessary, place following 2 hours dryings of room temperature after, with the capsule lid and the capsule body demoulding.Place the 800W microwave irradiation to be hardened in 1 minute this capsule body.To be filled into this porous capsule with corn starch according to 1: 4 even pharmaceutical active effective ingredient verapamil (verapamil HCl) of mixed, after weighing, be that eluat carries out dissolving-separating test with water, obtains molten as shown in Figure 6 from figure.

Embodiment 3:

In 400 ml beakers, inject 120 ml distilled waters, keep water temperature in 80～85 ℃, under this temperature, slowly add the gelatin powder of 60 grams, be stirred well to gelatin and dissolve fully, make gelatin solution with immersion method.To make appropriate gelatin solution and be reduced to 60 ℃ with the purgation temperature.Feed the air 10 seconds of per second 7.5mL flow in this gelatin solution, with the mould pestle of No. 2 capsules with the sunflower oilcloth lubricated after, immerse in the solution and slowly take out, place on the shaping frame, after about 20 minutes, with the excision of sharp sword edge that capsule is unnecessary, place following 2 hours dryings of room temperature after, with the capsule lid and the capsule body demoulding.With 2 beautiful Randt (Mrad) radiation dose Co-60 irradiation, make it the sclerosis pharmaceutical active effective ingredient verapamil (verapamil HCl) that 1: 4 mixed is even and corn starch filling in this porous capsule.Through weighing, be that eluat carries out dissolving-separating test with water, obtain molten as shown in Figure 7 from figure.

Embodiment 4:

Prepare porous capsule according to embodiment 2 methods, the sharp sword edge excision that capsule is unnecessary after about 20 minutes, place following 2 hours dryings of room temperature after, with the capsule lid and the capsule body demoulding.This capsule body was placed formaldehyde (formaldehyde) steam 2 hours, take out and place 30 minutes formaldehyde (formaldehyde) of 50 ℃ of baking ovens to remove remnants.

Will according to 1: 4 mixed even dredge ylmethyl oxy-propyl levoproline (Captopril) and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 8 from figure.

Enforcement power 5:

To according to the even A Tamifen (actaminophen) of 1: 5 mixed and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 8 from figure.

Embodiment 6:

To according to the even aspirin (aspirin) of 1: 4 mixed and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 8 from figure.

Embodiment 7:

Prepare porous capsule according to embodiment 2 methods, the sharp sword edge excision that capsule is unnecessary after about 20 minutes, place following 2 hours dryings of room temperature after, with the capsule lid and the capsule body demoulding.This capsule body was placed formaldehyde (formaldehyde) steam 2 hours, take out and to place 50 ℃ of baking ovens 30 minutes to remove residual formaldehyde (formaldehyde).

To according to the even diclofenac sodium (Diclofenac sodium) of 1: 4 mixed and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 8 from figure.

Embodiment 8:

To according to the even Ni Kadi hydrochlorate (Nicadipine HCL) of 1: 2 mixed and corn starch filling in this porous capsule, write down the weight of each single capsule respectively through weighing.With water is that eluat carries out dissolving-separating test, obtains molten as shown in Figure 8 from figure

Claims

1. porous capsule, it is characterized in that: this capsule can adopt any following Durchgangshohle method then to carry out cure process;

A. add foaming agent Durchgangshohle method in gelatin solution;

B. mechanical Durchgangshohle method;

C. the body Durchgangshohle method in gelatin solution of ventilating.

2. a kind of porous capsule according to claim 1 is characterized in that: this interpolation foaming agent Durchgangshohle method in gelatin solution, it is to utilize weak acid class and weak base class to produce the foamable reaction of gas.

3. a kind of porous capsule according to claim 1, it is characterized in that: this foaming agent system selects any following acids, Fumaric acid (fumaric acid), citric acid (citricacid), Tartaric acid (tartaric acid), maleic acid (maleic acid) for use; Select any following weak base class for use, sodium carbonate, potassium carbonate, calcium carbonate, magnesium carbonate, lithium carbonate.

4. a kind of porous capsule according to claim 1, it is characterized in that: this ventilation body Durchgangshohle method in gelatin solution, system selects not the blunt gas such as air, carbon dioxide, nitrogen, helium that produce reaction with gelatin solution for use, or the liquid state of this gas, solid-state other phase that waits.

5. a kind of porous capsule according to claim 1 is characterized in that: this hardening process system selects the microwave irradiation method for use, links agent (cross linking reagent), sclerosing agent, ultraviolet irradiation, an ancient woman's ornament agate roentgenization method.

6. a kind of porous capsule according to claim 5 is characterized in that: this hardening process system selects for use any sclerosing agent of formaldehyde (formaldehyde), glutaraldehyde (glutaraldehyde) to be hardened.

7. a kind of porous capsule according to claim 5, it is characterized in that: this hardening process system selects for use the Di Nai can (Denacol), methylglycerin ethyl ester EX-131 (Methylglycidylether), ethylene polyethylene glyceryl diglycerol base ethyl ester EX-810 (Ethylene, polyethylene glycol diglycidyl ether), glyceryl polyglyceryl ethyl ester EX-313 (Glycerol polyglycidyl ether), arbitrary binding agent of polyglyceryl polyglyceryl ethyl ester EX-512 (Polyglycerol ether) is hardened.

8. a kind of porous capsule according to claim 5 is characterized in that: this hardening process system selects for use the microwave irradiation of 400～1200W intensity to be hardened in 0.1 to 20 minute.

9. a kind of porous capsule according to claim 5 is characterized in that: this hardening process system selects for use the ultraviolet of 280～2800ml/cm2 intensity to be shone.

10. a kind of porous capsule according to claim 5 is characterized in that: this hardening process system selects for use an ancient woman's ornament agate ray of 1～5Mrad intensity or cobalt 60 to be shone.

11. porous capsule, it is characterized in that: lie in the active ingredient of filling pharmaceutical active in this capsule, make controlled capability pharmaceutical active active ingredient compositions, fill agriculture required composition, make controlled capability agricultural articles compositions, fill the nourishing healthy composition, make controlled capability nutritive health products compositions, fill the make-up and beauty composition, make controlled capability make-up and beauty articles for use compositions, fill environment hygienic article composition, make controlled capability environmental health articles for use compositions, fill the industrial goods composition, make industrial goods compositions and binding agent, excipient, pigment, correctives.

12. the porous capsule according to claim 11 is characterized in that: this controlled capability pharmaceutical compositions is to select any following active ingredient for use; The withered Luo Fen sodium of enlightening (Diclfenacsdium), Varapamil HCl, Ni Kadi hydrochlorate (Nicardipine HCl), A Tamifen (Acetaminophen), aspirin (Aspirin), and fill excipient such as corn starch, carbohydrate, polymer.

13. the porous capsule according to claim 11 is characterized in that: this controlled capability agricultural articles compositions is to fill agriculture needed fertilizer, Insecticides (tech) ﹠ Herbicides (tech), and cooperates required implant, excipient.

14. the porous capsule according to claim 11, it is characterized in that: this controlled capability nutritive health products compositions, needed active active ingredient on the nourishing healthy, the extraction thing of natural goods, spice, pigment, ferment are filled by system, and cooperate required implant, correctives, excipient.

15. the porous capsule according to claim 11, it is characterized in that: this controlled capability make-up and beauty articles for use compositions, needed active active ingredient in the make-up and beauty, the extraction thing of natural goods, spice, pigment, ferment are filled by system, and cooperate required implant, correctives, excipient.

16. the porous capsule according to claim 11, it is characterized in that: this controlled capability environmental health articles for use compositions, needed active active ingredient on the environmental health, the extraction thing of natural goods, spice, pigment, ferment are filled by system, and cooperate required implant, correctives, excipient.

17. the porous capsule according to claim 11, it is characterized in that: this controlled capability industrial goods compositions, the active active ingredient of the industrial required reacting substance of system's filling, the extraction thing of natural goods, ferment etc., and cooperate required implant, correctives, excipient.