CN102895215A - Cellulose and red alga polysaccharide plant empty capsule and raw material composition and preparation method thereof - Google Patents
Cellulose and red alga polysaccharide plant empty capsule and raw material composition and preparation method thereof Download PDFInfo
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- CN102895215A CN102895215A CN2012103979448A CN201210397944A CN102895215A CN 102895215 A CN102895215 A CN 102895215A CN 2012103979448 A CN2012103979448 A CN 2012103979448A CN 201210397944 A CN201210397944 A CN 201210397944A CN 102895215 A CN102895215 A CN 102895215A
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Abstract
The invention discloses a raw material composition of a cellulose and red alga polysaccharide plant empty capsule. The raw material composition of the cellulose and red alga polysaccharide plant empty capsule comprises the following raw materials in parts by weight: 77.5-98.5 parts of component A, 1.5-22.5 parts of red alga polysaccharide and 0.5-12.5 parts of alcohol, wherein the component A is a cellulose derivative or resin. The invention also discloses the cellulose and red alga polysaccharide plant empty capsule prepared from the raw material composition and a preparation method for the cellulose and red alga polysaccharide plant empty capsule. The plant empty capsule does not deform or crisp in an environment of high temperature, high humidity or cold, is low in moisture content and high in stability, and can be conveniently stored for a long time. Moreover, the requirements on the storage condition are low. Meanwhile, the plant empty capsule is stable in chemical property and has no cross-linking reaction or Maillard reaction or condensation reaction. Various physicochemical indexes of the plant empty capsule, such as disintegration time limit, completely accord with the specifications of the Chinese pharmacopoeia or national standard, and therefore, all defects and potential safety hazards of a gelatin capsule are completely eliminated. The industrial production of the cellulose and red alga polysaccharide plant empty capsule can be realized.
Description
Technical field
The present invention relates to the capsule filmogen, especially a kind of cellulose red seaweed polysaccharide plant hollow capsule and feedstock composition and preparation method.
Background technology
The hollow and hard capsule is existing for a long time as the application of pharmaceutical carrier, and it is generally take gelatin as raw material.The capsule material of gelatin Capsules is gelatin, is that skin, the bone by pig or cattle forms through hydrolysising purification, and its chemical nature is animal collagen and aminoacid, and the defective of physicochemical property causes gelatin poor with many drug compatibilities, and the shelf-life is short.Because animal collagen and aminoacid be easy to chemical constitution in amino medicine and macrolide antibiotics generation cross-linking reaction are arranged, form fine and close network structure, cause medicament capsule to be difficult to disintegrate or stripping, reduce the human bioavailability of medicine; Also can with the medicine that carbonyl is arranged particularly saccharide, ketone and medicine generation Maillard reaction (also claiming the reaction of non-brownization of enzyme) than strong reducing property is arranged, thereby cause the medicine variable color of going bad, capsule becomes fragile, such as D-glucosamine, propolis etc.; Also easily with (matter) acid of tanning condensation reaction occuring and generate water-fast tannalbin, makes disintegrate or stripping slow, even unqualified.
The water content of gelatin Capsules is 12.5%～17.5%, exceed this scope and just can not keep normal physical property, and can shift moisture to the medicine of filling, make the medicine moisture absorption of filling rotten, if the stronger medicine of hygroscopicity, gelatin Capsules itself just may the air slaking friability.The gelatin Capsules can absorb the water of 5～10 times of sole masses, extreme expansion after the suction, this also long-term taking be the major reason that the patient of the gelatine capsule of larger drug dose feels abdominal part distension discomfort or inappetence.
The good culture medium of gelatin or microorganism, gelatine capsule contain the optimum humidity condition that the moisture about 15 is just in time facilitated again microbial reproduction.Therefore, the gelatin Capsules must add the antiseptic of different cultivars or take sterilization process so that product reaches the requirement of limitation standard in microbe, ethylene oxide sterilizing as usual, and oxirane is harmful.
The specificity of gelatin Capsules animal origin and complexity are not often accepted by the religious crowd of particular culture and vegetarianism crowd, and have many potential safety hazards.It is reported, be found when boiling the infringement of gelatin with the leather leftover pieces, for this reason, 2010 editions Chinese Pharmacopoeias have increased the inspection of chromium in the quality standard of gelatinum pro capsulae and gelatin Capsules.Chromium is the industrial chemicals that tan leather must be used---the main component of Arsenicum sablimatum is one of the most dangerous high carcinogen, just accumulates at liver in case enter human body, not by metabolism and drainage.On April 15th, 2012, CCTV's " weekly quality report " broadcast items " secret in the capsule ", blanket exposure the gelatine capsule industry hide for a long time " business secret ", mix low-quality cheapness " blue hide glue " and cause the event of chromium content overproof to cause that the whole nation causes a sensation.
In addition, have during the zoonosis such as bovine spongiform encephalopathy, foot and mouth disease in recent years popularly, the animal epidemic disease source infectious disease such as SARS, H1N1 bird flu raise fear once in human world eruption and prevalence, and people extremely worry its pathogen and metabolite health risk thereof.Therefore, take the skin of the animals such as pig, cattle, bone is subject to people as the safety of the gelatin of raw material query.Yet when needs carried out the retrospective investigation to medicine, the capsule raw material but often was difficult to follow the trail of.
Because there are above-mentioned many deficiencies in the capsule of making take gelatin as raw material, seeks the common recognition that safe and reliable regeneration product has become the insider.It is on the Capsules of raw material preparation that researcher focuses on attention with plant gum.U.S. FDA sends guide not long ago, wishes that the market share of plant hollow capsule reaches 80% on the American market, also is for this reason in recent years.
At present, more existing non-animal source filmogens are used to prepare plant hollow capsule in the world, mainly contain the EPG(Empty Vegetable Capsules that U.S. Wonder Laboratories company produces) plant hollow capsule, the Cellulose Capsules plant hollow capsule of India Natural Capsules Limited and the Qualicaps plant hollow capsule of the wild adopted company of Japanese salt etc., wherein, the power of influence maximum is the Qualicaps plant hollow capsule.The pharmaceutical college of some famous universities and institutes (such as the university on Britain London university, Finland Helsinki university and the ground such as Germany and Spain) is all with the representative sample of Qualicaps as research plant hollow capsule physicochemical property and medical science index.Yet, there are problems in the Qualicaps plant hollow capsule, basic reason is that the type selecting of plant gum and matter mark are improper, can cause the softgel shell intensity difference because used plant gum intensity is low, the higher meeting of used plant gum viscosity causes that bad, the upper probability of the softgel shell uniformity is low, product percent of pass is low, the problems such as production cost height.
Along with the research and development of vegetalitas filmogen, the domestic technology that plant hollow capsule also occurs preparing with the non-animal source filmogen successively.
Chinese patent application " a kind of plant gum Capsules and production technology thereof " (20031010801.2 open days on April 20th, 2005 of number of patent application) discloses a kind of plant hollow capsule and production technology thereof, its glue proportioning is as follows: plant gum 16～25%, reinforcing agent 2.0～5.0%, surfactant 0.02%～0.026%, wetting agent 0.15%～0.20%, surplus is water, plant gum is selected from pectin, a kind of in the carrageenan or two kinds, reinforcing agent is selected from chitosan, carboxymethyl starch, in the hydroxypropyl cellulose one or more, surfactant is sodium lauryl sulphate, and wetting agent is glycerol.The plant hollow hard capsule good stability that obtains accordingly, indeformable under high temperature or the high humidity environment, embrittlement not is convenient to permanent storage.Though do not add potassium salt, calcium salt in the production, the each component proportioning is not good, so that the disintegration time prolongation, is difficult to meet the quality standard of Chinese Pharmacopoeia (2010 editions).
Another Chinese patent " plant hollow and hard capsule and preparation method thereof " (200410012944.7 open days on January 12nd, 2005 of number of patent application) discloses a kind of plant hollow and hard capsule, is made by the raw material of following percentage by weight: modified konjac glucomannan 31%～51%, soybean protein isolate 25.4%～47.8%, coagulant 8.8%～27.5%, flocculation aid 3.3%～7% and water 3.4%～9%; Modified konjac glucomannan is Carboxymethyl Konjac Glucomannan, oxidation glucomannoglycan, maleic anhydride esterification glucomannoglycan, acetic anhydride esterification glucomannoglycan, and coagulant is carrageenan or yellow source glue, and flocculation aid is for providing cation Ca
2+, K
+Salt such as potassium chloride, potassium citrate, potassium phosphate, calcium chloride.This plant capsule all adopts plant material, need not storage at a constant temperature, can not propagate foot and mouth disease and bovine spongiform encephalopathy, be difficult for polluting, satisfied vegetarian diet culture person's requirement, be suitable for containing storage and the transportation of aldehyde radical medicine, but because potassium salt has affected disintegration, the protein of adding easily exceeds standard microorganism and also is not easy to store.
Itself there are many deficiencies in above patented technology, realizes relatively difficulty of industrialization.
Summary of the invention
The technical problem to be solved in the present invention provides that a kind of moisture is low, stable performance, long shelf-life and storage requirement require low, safety good and the cellulose red seaweed polysaccharide plant hollow capsule of the cultural faith obstacle of irreligion and feedstock composition and preparation method, this cellulose red seaweed polysaccharide plant hollow capsule and the every quality index of feedstock composition thereof meet the regulation of pharmacopeia or national standard fully, be applicable to pharmacy corporation, Health Products Enterprises, functional food and Management of Cosmetics Enterprises fill graininess and powdery content, satisfy plant capsule production industrialization demand.
For solving the problems of the technologies described above, the present invention adopts following technical scheme: the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule, 77.5～98.5 parts of the raw material that comprises following weight portion: component A, 1.5～22.5 parts of red seaweed polysaccharides, 0.5～12.5 part of alcohols, component A are cellulose derivative and or resin.
Cellulose derivative is one or more in hypromellose, ethyl cellulose, hydroxypropyl cellulose, the carboxymethyl cellulose.
Resin is one or more in polyvinyl alcohol, polyacrylic resin, the polyvidone.
Polyvinyl alcohol is PVAC polyvinylalcohol-0588 or PVAC polyvinylalcohol-1788, and its degree of polymerization is respectively 500 and 1700; Described polyacrylic resin is EUDRAGIT NE 30 D EUDRAGIT NE 30D Eudragit E30D, Eudragit E100 EudragitE100, methacrylic acid-methyl acrylate copolymer Eudragit L100-55, neutral EUDRAGIT NE 30 D EUDRAGIT NE 30D Eudragit NE30D, methacrylic acid three ammoniums ethyl ester-acrylate copolymer Eudragi t RL.
Component A is 92～96.5 parts.
The viscosity of component A is 0.003～0.006mpa.s.
The viscosity of component A is 0.004～0.005mpa.s.
Red seaweed polysaccharide is one or both in K-carrageenan, the ι-carrageenan, and the gel strength of K-carrageenan is 500～2000g/cm
2, the gel strength of ι-carrageenan is 300～1500g/cm
2
Red seaweed polysaccharide is 1～15 part of K-carrageenan, 0.5～7.5 part of ι-carrageenan.
Red seaweed polysaccharide is 4.3～6 parts of K-carrageenans, 2.1～3 parts of ι-carrageenans.
Alcohols is one or both in ethanol, the glycerol.
Alcohols is 1～2 part.
The cellulose red seaweed polysaccharide plant hollow capsule that the above-mentioned raw materials compositions is made.
The preparation method of above-mentioned cellulose red seaweed polysaccharide plant hollow capsule may further comprise the steps:
＜1〉batch weighing
Take by weighing by weight 77.5～98.5 parts of raw material components A, 1.5～22.5 parts of red seaweed polysaccharides, 0.5～12.5 part of alcohols, component A be cellulose derivative and or resin; Component A and red seaweed polysaccharide are mixed 2～6 hours to evenly with two dimension or three-dimensional mixer, stand-by;
＜2〉colloidal sol color matching
The purified water that in glue pot, adds 4～6 times of amounts of raw material weight, be warming up to 80～98 ℃, add step＜1 material of mix homogeneously, stir to adding alcohols after the dissolving fully, be cooled to 35～45 ℃ and form glue, what need toning adds corresponding pigment according to color;
＜3〉glue insulation
Step＜2〉glue that forms is 38～50 ℃ of lower insulations 1～24 hour;
＜4〉capsule processed
Step＜3〉glue make cellulose red seaweed polysaccharide plant hollow capsule semi-finished product softgel shell with semi-automatic or full-automatic capsule production line through dipping in glue, molding, drying, demoulding, cutting, fit;
＜5〉check, lettering, packing
Step＜4〉the semi-finished product softgel shell through the automatic capsule machines open defect is screened, namely get cellulose red seaweed polysaccharide plant hollow capsule finished product through lettering, packing again.
Step＜4〉in gelatin viscosity be controlled at 3000～5000mpa.s, glue temperature is controlled at 38～50 ℃, and molding time is controlled at 6～10 seconds, and baking temperature is controlled at 25～30 ℃, dry humidity is controlled at 30～40%, and cutting fit size is carried out by national standard.
In order to realize goal of the invention, the inventor has carried out various exploitative experiment researchs to the plant gum monomer.
Sargassum polysaccharides can be divided into red seaweed polysaccharide, fucoidin, blue algae polysaccharide and chlorella polysaccharide by the raw material sources difference.Carrageenan is the Chondrus (Chondrus) from red algae, Eucheuma (Eucheuma), the general designation of the Sargassum polysaccharides that extracts in the kind Sargassums such as China fir Trentepohlia (Gigartina) and husky Lepidium (Hypnea), separate sources has different fine structures, its colloidal nature also is not quite similar, named have a kappa (card handkerchief), iota (A Outa), lambda (Lyme reaches), mu (Miao), nu (knob), theta (plug tower), xi (west) type carrageenan etc., but the carrageenan of commercially producing mainly is first three kind.That even the carrageenan of same type also has is refining, half refining or semifinished product minute, difference so different purposes should be selected different model and grade, is only most economical effective selection mainly at gel strength, solution transparency etc.The inventor once with the ι-carrageenan of the K-carrageenan of percetage by weight 78%～85% and 15%～22% through the abundant mix homogeneously of three-dimensional mixer, make glue behind the high-temperature digestion.The test discovery, the glue gelling temp is up to 80 ℃, and viscosity is not suitable for the plant capsule processing technology up to 35000mpa.s.This may be the higher event of gel strength of K-carrageenan and ι-carrageenan itself.
For reducing gelling temp and viscosity, the inventor is studied the lower cellulose derivative of viscosity.Once with the carboxymethyl cellulose of the hypromellose of percetage by weight 55%～68%, 23%～31% ethyl cellulose, 15%～18% hydroxypropyl cellulose and 6%～13% through the abundant mix homogeneously of three-dimensional mixer, make glue after the dissolving.The test discovery, gelatin viscosity is low to moderate 800mpa.s, but gelling temp is too low, and room temperature is gel not, also is not suitable for the plant capsule processing technology.This may be due to the characteristic of cellulose derivative itself, essential add a certain amount of gel can gel.
Deeply experimental studies have found that, only can't make qualified plant capsule with the monomer plant gum at all.The inventor is by proper proportion blending ingredients A(cellulose derivative and or resin) 77.5～98.5 parts, 1.5～22.5 parts of red seaweed polysaccharides, 0.5～12.5 part of alcohols, form a kind of feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule, by controlling the stability of its viscosity and gelling temp, made the cellulose red seaweed polysaccharide plant hollow capsule that meets the Chinese Pharmacopoeia standard.
The present invention has following outstanding advantages:
1. the raw material of this plant capsule all derives from the fully natural green plant, and the superiority of its chemical nature and physicochemical property be able to overcome and avoid the defective of gelatine capsule.
2. this plant capsule water content can both keep outstanding physical property below 8%, and can regulate arbitrarily according to customer requirement, neither shifts moisture to the medicine of filling, and also can not absorb the moisture of filling medicine, and this just can ensure the long-time stability of medicine.
3. high, non-efflorescing cementitious, the friability not of this plant capsule good toughness, intensity, the friability rate is generally zero less than 1%, and the operating condition of therefore storing and filling medicine is looser.
4. this plant capsule not imbibition in course of dissolution, but directly be dissolved in water, avoided the patient of long-term taking capsule to feel abdominal part distension discomfort or inappetence problem.
5. this plant capsule can be stored 4 years at ambient temperature, and disintegrating property still keeps stable after storing, when dispatching from the factory without significant change.
6. this plant capsule stable chemical performance is good with the compatibility of content medicine, without cross-linking reaction, Maillard reaction and condensation reaction.
7. this plant capsule is without the danger of animal epidemic disease source infection and the risk of pollution of chromium, and safety is good.
8. this plant capsule market fit scope is wide, the obstacle of irreligion culture faith.
9. plant capsule production technology of the present invention can be utilized existing equipment slightly to do change to get final product, small investment, and technique is simple.
The specific embodiment
Further specify the present invention below in conjunction with embodiment.
Wherein, the gel strength of the K-carrageenan of embodiment 1 to 24 is about 500～2000g/cm
2, the gel strength of ι-carrageenan is about 300～1500g/cm
2The viscosity of component A is about 0.003～0.004mpa.s among the embodiment 1 to 6, and the viscosity of component A is about 0.004～0.005mpa.s among the embodiment 7 to 10, and the viscosity of component A is about 0.005～0.006mpa.s among the embodiment 11 to 24.
Embodiment 1
＜1〉batch weighing
Take by weighing by weight raw material components A(hypromellose) 1 kilogram of 95 kilograms, red seaweed polysaccharide 4 kilograms (3 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol); Component A and red seaweed polysaccharide are mixed 6 hours to evenly with two-dimensional mixing machine, stand-by;
＜2〉colloidal sol color matching
In glue pot, add the purified water of 5 times of amounts of raw material weight, be warming up to 90 ℃, add step＜1 material of mix homogeneously, stir to adding alcohols after the dissolving fully, be cooled to 40 ℃ and form glues;
＜3〉glue insulation
Step＜2〉glue that forms is 45 ℃ of lower insulations 6 hours;
＜4〉capsule processed
Step＜3〉glue make cellulose red seaweed polysaccharide plant hollow capsule semi-finished product softgel shell with full-automatic capsule production line through dipping in glue, molding, drying, demoulding, cutting, fit; Wherein, gelatin viscosity is controlled at 3000～5000mpa.s, and glue temperature is controlled at 38～50 ℃, and molding time is controlled at 6～10 seconds, and baking temperature is controlled at 25～30 ℃, and dry humidity is controlled at 30～40%, and cutting fit size is carried out by national standard.
＜5〉check, lettering, packing
Step＜4〉the semi-finished product softgel shell through the automatic capsule machines open defect is screened, namely get cellulose red seaweed polysaccharide plant hollow capsule finished product through lettering, packing again.
Disintegrate is complete in the cellulose red seaweed polysaccharide plant hollow capsule that the present embodiment is made, gastric solubleness 8 minutes, loss on drying 7.8%, and the shelf-life is 48 months under normal operation.Every physical and chemical index meets the quality standard of 2010 editions Pharmacopoeia of the People's Republic of China defineds fully.
In following examples 2 to 24, mainly be that the raw material composition is not identical with embodiment 1, other equipment and technique are substantially the same manner as Example 1, specifically:
The equipment aspect
Mix to adopt two dimension or three-dimensional mixer, capsule processed is with semi-automatic or full-automatic capsule production line.
Process aspect
＜1〉in the batch weighing, component A and red seaweed polysaccharide are mixed 2～6 hours to evenly, stand-by;
＜2〉in the colloidal sol color matching, in glue pot, add the purified water of 4～6 times of amounts of raw material weight, be warming up to 80～98 ℃, add step＜1 material of mix homogeneously, stir to adding alcohols after the dissolving fully, be cooled to 35～45 ℃ and form glues;
＜3〉in the glue insulation, step＜2〉glue that forms is 38～50 ℃ of lower insulations 1～24 hour.
Embodiment 2
Raw material components A(hypromellose) 1 kilogram of 88 kilograms, red seaweed polysaccharide 11 kilograms (10 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 3
Raw material components A(hypromellose) 1 kilogram of 93.7 kilograms, red seaweed polysaccharide 5.3 kilograms (4.3 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 4
Raw material components A(hypromellose) 1 kilogram of 93 kilograms, red seaweed polysaccharide 6 kilograms (5 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 5
Raw material components A(hypromellose) 1 kilogram of 92 kilograms, red seaweed polysaccharide 7 kilograms (6 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 6
Raw material components A(hypromellose) 1 kilogram of 96 kilograms, red seaweed polysaccharide 3 kilograms (2 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 7
Raw material components A(hypromellose) 1 kilogram of 87 kilograms, red seaweed polysaccharide 12 kilograms (11 kilograms of K-carrageenans, 1 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 8
Raw material components A(hypromellose) 1 kilogram of 94.9 kilograms, red seaweed polysaccharide 5.1 kilograms (3 kilograms of K-carrageenans, 2.1 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 9
Raw material components A(hypromellose) 1 kilogram of 86 kilograms, red seaweed polysaccharide 13 kilograms (10 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 10
Raw material components A(hypromellose) 1 kilogram of 89.7 kilograms, red seaweed polysaccharide 9.3 kilograms (4.3 kilograms of K-carrageenans, 5 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 11
Raw material components A(hypromellose) 1 kilogram of 88 kilograms, red seaweed polysaccharide 11 kilograms (5 kilograms of K-carrageenans, 6 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 12
Raw material components A(hypromellose) 1 kilogram of 92.2 kilograms, red seaweed polysaccharide 6.8 kilograms (6 kilograms of K-carrageenans, 0.8 kilogram of ι-carrageenan), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 13
Raw material components A(hypromellose) 0.8 kilogram of 93.2 kilograms, red seaweed polysaccharide 6 kilograms (3 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 14
Raw material components A(hypromellose) 1.5 kilograms of 90.5 kilograms, red seaweed polysaccharide 8 kilograms (5 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 15
Raw material components A(hypromellose) 2 kilograms of 89 kilograms, red seaweed polysaccharide 9 kilograms (6 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 16
Raw material components A(hypromellose) 2.5 kilograms of 87.5 kilograms, red seaweed polysaccharide 10 kilograms (7 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 17
1 kilogram of raw material components A 86 kilograms (74 kilograms of hypromelloses, 12 kilograms of ethyl celluloses), red seaweed polysaccharide 13 kilograms (10 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 18
1 kilogram of raw material components A 86 kilograms (12 kilograms of ethyl celluloses, 25 kilograms of hydroxypropyl celluloses, 49 kilograms of carboxymethyl celluloses), red seaweed polysaccharide 13 kilograms (10 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 19
1 kilogram of raw material components A 90 kilograms (25 kilograms of hydroxypropyl celluloses, 65 kilograms of carboxymethyl celluloses), red seaweed polysaccharide 9 kilograms (6 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 20
1.5 kilograms of 90.5 kilograms of raw material components A (89 kilograms of hypromelloses, PVAC polyvinylalcohol-05881.5 kilogram), red seaweed polysaccharide 8 kilograms (5 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 21
1.5 kilograms of 90.5 kilograms of raw material components A (88 kilograms of hypromelloses, PVAC polyvinylalcohol-17882.5 kilogram), red seaweed polysaccharide 8 kilograms (5 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 22
1.5 kilograms of raw material components A 90.5 kilograms (89 kilograms of hypromelloses, 1.5 kilograms of ethyl acrylate), red seaweed polysaccharide 8 kilograms (5 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 23
1.5 kilograms of raw material components A 90.5 kilograms (90 kilograms of hypromelloses, 0.5 kilogram of dimethylaminoethyl methacrylate), red seaweed polysaccharide 8 kilograms (5 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Embodiment 24
1 kilogram of raw material components A 86 kilograms (58 kilograms of ethyl celluloses, 25 kilograms of hydroxypropyl celluloses, 3 kilograms of neutral ethyl acrylate), red seaweed polysaccharide 13 kilograms (10 kilograms of K-carrageenans, 3 kilograms of ι-carrageenans), alcohols (glycerol), other Processes and apparatus are substantially the same manner as Example 1.
Detect the cellulose red seaweed polysaccharide plant hollow capsule of embodiment 1 to 24 according to standards of pharmacopoeia, result such as table 1.
Table 1 cellulose red seaweed polysaccharide plant hollow capsule physics and chemistry matter mark detects
For investigating the stability of cellulose red seaweed polysaccharide plant hollow capsule, by the requirement of Chinese Pharmacopoeia two appendix of version in 2010 " medicine stability test guideline " and relevant technologies guideline, carried out stability test research.
One, test sample
Choose three batches wantonly in the cellulose red seaweed polysaccharide plant hollow capsule that above-described embodiment 1-24 makes: the cellulose red seaweed polysaccharide plant hollow capsule that embodiment 6, embodiment 8, embodiment 20 make is test sample.
Two, instrument and model
Three, experimental condition and result
(1) influence factor's test
1, high-temperature is tested: get each 50 of test samples and put in the culture dish, put in the drying baker and placed 10 days under 60 ℃ of conditions, in the 5th day and sampling in the tenth day, detect related index.The results are shown in Table 2:
Table 2 hot test is table as a result
The result shows that other indexs are without significant change except loss on drying and viscosity slightly descend.
2, high humility test
Getting each 50 of test samples is tiled in the culture dish, put in the electro-heating standing-temperature cultivator, placed 10 days under 25 ℃ of temperature of control, RH92% ± 5% (test sample bottom set section has in the exsiccator of the potassium nitrate saturated solution) condition, in the 5th day and sampling detection in the 10th day.The results are shown in Table 3:
Table 3 high humility result of the test table
The result shows, this product moisture absorption is slow, and loss on drying is up to 10.1% rear substantially no longer moisture absorption in the time of 10 days.
3, strong illumination test
Get each 50 of test samples and put in the lighting box that daylight lamp is housed, under illumination 4500LX ± 500LX condition, placed 10 days, in the 5th day and sampling detection in the 10th day.The results are shown in Table 4:
Table semi-finals rayed result of the test table
The result shows that indices is without significant change.
﹙ Er ﹚ accelerated test
Get test sample by the listing packing, put in the electro-heating standing-temperature cultivator, 40 ± 2 ℃ of control temperature, relative humidity 75 ± 5 ﹪ (test sample bottom set section has in the exsiccator of saturated nacl aqueous solution) were respectively at 0 month, 1,2,3,6 month pick test.The results are shown in Table 5:
Table 5 accelerated test result
The result shows that indices does not all have significantly to change, and can think that the quality that this product was preserved 6 months under the accelerated test condition is stable.
﹙ San ﹚ long term test
Get test sample, by listing packing, under 25 ± 2 ℃ of temperature, relative humidity 60 ± 10% conditions, test, respectively at 0 month, January, March, June, December, 24 months, 48 months pick test.The results are shown in Table 6:
Table 6 long-term test results
The result shows: this product was deposited 48 months at ambient temperature, and every investigation index does not all have significantly to change, steady quality, and storage period is long.
Claims (15)
1. the feedstock composition of a cellulose red seaweed polysaccharide plant hollow capsule, it is characterized in that comprising 77.5～98.5 parts of the raw material of following weight portion: component A, 1.5～22.5 parts of red seaweed polysaccharides, 0.5～12.5 part of alcohols, component A is cellulose derivative and or resin.
2. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1, it is characterized in that: described cellulose derivative is one or more in hypromellose, ethyl cellulose, hydroxypropyl cellulose, the carboxymethyl cellulose.
3. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1, it is characterized in that: described resin is one or more in polyvinyl alcohol, polyacrylic resin, the polyvidone.
4. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 3, it is characterized in that: described polyvinyl alcohol is PVAC polyvinylalcohol-0588 or PVAC polyvinylalcohol-1788, and its degree of polymerization is respectively 500 and 1700; Described polyacrylic resin is EUDRAGIT NE 30 D EUDRAGIT NE 30D Eudragit E30D, Eudragit E100 EudragitE100, methacrylic acid-methyl acrylate copolymer Eudragit L100-55, neutral EUDRAGIT NE 30 D EUDRAGIT NE 30D Eudragit NE30D, methacrylic acid three ammoniums ethyl ester-acrylate copolymer Eudragit RL.
5. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1, it is characterized in that: described component A is 92～96.5 parts.
6. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1, it is characterized in that: the viscosity of described component A is 0.003～0.006mpa.s.
7. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 6, it is characterized in that: the viscosity of described component A is 0.004～0.005mpa.s.
8. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1, it is characterized in that: described red seaweed polysaccharide is one or both in K-carrageenan, the ι-carrageenan, the gel strength of K-carrageenan is 500～2000g/cm
2, the gel strength of ι-carrageenan is 300～1500g/cm
2
9. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 8, it is characterized in that: described red seaweed polysaccharide is 1～15 part of K-carrageenan, 0.5～7.5 part of ι-carrageenan.
10. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 9, it is characterized in that: described red seaweed polysaccharide is 4.3～6 parts of K-carrageenans, 2.1～3 parts of ι-carrageenans.
11. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1 is characterized in that: described alcohols is one or both in ethanol, the glycerol.
12. the feedstock composition of cellulose red seaweed polysaccharide plant hollow capsule according to claim 1 is characterized in that: described alcohols is 1～2 part.
13. the cellulose red seaweed polysaccharide plant hollow capsule made of described feedstock composition according to claim 1.
14. the preparation method of described cellulose red seaweed polysaccharide plant hollow capsule according to claim 13 is characterized in that may further comprise the steps:
＜1〉batch weighing
Take by weighing by weight 77.5～98.5 parts of raw material components A, 1.5～22.5 parts of red seaweed polysaccharides, 0.5～12.5 part of alcohols, component A be cellulose derivative and or resin; Component A and red seaweed polysaccharide are mixed 2～6 hours to evenly with two dimension or three-dimensional mixer, stand-by;
＜2〉colloidal sol color matching
The purified water that in glue pot, adds 4～6 times of amounts of raw material weight, be warming up to 80～98 ℃, add step＜1 material of mix homogeneously, stir to adding alcohols after the dissolving fully, be cooled to 35～45 ℃ and form glue, what need toning adds corresponding pigment according to color;
＜3〉glue insulation
Step＜2〉glue that forms is 38～50 ℃ of lower insulations 1～24 hour;
＜4〉capsule processed
Step＜3〉glue make cellulose red seaweed polysaccharide plant hollow capsule semi-finished product softgel shell with semi-automatic or full-automatic capsule production line through dipping in glue, molding, drying, demoulding, cutting, fit;
＜5〉check, lettering, packing
Step＜4〉the semi-finished product softgel shell through the automatic capsule machines open defect is screened, namely get cellulose red seaweed polysaccharide plant hollow capsule finished product through lettering, packing again.
15. the preparation method of described cellulose red seaweed polysaccharide plant hollow capsule according to claim 14, it is characterized in that: step＜4〉in gelatin viscosity be controlled at 3000～5000mpa.s, glue temperature is controlled at 38～50 ℃, molding time is controlled at 6～10 seconds, baking temperature is controlled at 25～30 ℃, dry humidity is controlled at 30～40%, and cutting fit size is carried out by national standard.
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| CN103405775A (en) * | 2013-07-30 | 2013-11-27 | 浙江工业大学 | Hollow gracilaria polysaccharide capsule and preparation method thereof |
| CN104758271A (en) * | 2015-03-16 | 2015-07-08 | 中华生物科技有限公司 | Plant vacant capsule compounded from cellulose gum and red alga KAPPA gum and preparation method thereof |
| CN104799286A (en) * | 2015-04-30 | 2015-07-29 | 南京中生生物科技有限公司 | Composition for improving immunity and preparation method of composition |
| CN105434394A (en) * | 2015-12-16 | 2016-03-30 | 刘松林 | Polyvinyl alcohol (PVA) hollow capsule |
| CN110876736A (en) * | 2019-11-06 | 2020-03-13 | 巢湖学院 | Astragalus polysaccharide capsule shell and preparation method thereof |
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| CN103405775A (en) * | 2013-07-30 | 2013-11-27 | 浙江工业大学 | Hollow gracilaria polysaccharide capsule and preparation method thereof |
| CN103405775B (en) * | 2013-07-30 | 2015-08-05 | 浙江工业大学 | A kind of hollow gracilaria polysaccharide capsule and preparation method thereof |
| CN104758271A (en) * | 2015-03-16 | 2015-07-08 | 中华生物科技有限公司 | Plant vacant capsule compounded from cellulose gum and red alga KAPPA gum and preparation method thereof |
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| CN104799286B (en) * | 2015-04-30 | 2017-04-19 | 南京中生生物科技有限公司 | Composition for improving immunity and preparation method of composition |
| CN105434394A (en) * | 2015-12-16 | 2016-03-30 | 刘松林 | Polyvinyl alcohol (PVA) hollow capsule |
| CN105434394B (en) * | 2015-12-16 | 2019-01-25 | 刘松林 | A kind of polyvinyl alcohol Capsules |
| CN112472813A (en) * | 2016-10-28 | 2021-03-12 | 北京药源世纪生物科技有限公司 | Cellulose red algae polysaccharide film coating premix and preparation method thereof |
| CN110876736A (en) * | 2019-11-06 | 2020-03-13 | 巢湖学院 | Astragalus polysaccharide capsule shell and preparation method thereof |
| CN110876736B (en) * | 2019-11-06 | 2021-08-24 | 巢湖学院 | Astragalus polysaccharide capsule shell and preparation method thereof |
| CN116196289A (en) * | 2023-03-09 | 2023-06-02 | 上海荃吉康医药科技有限公司 | Medical capsule composite adhesive and raw material proportion and preparation method thereof |
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