CN107929258A - A kind of plant hollow capsule - Google Patents
A kind of plant hollow capsule Download PDFInfo
- Publication number
- CN107929258A CN107929258A CN201810001216.8A CN201810001216A CN107929258A CN 107929258 A CN107929258 A CN 107929258A CN 201810001216 A CN201810001216 A CN 201810001216A CN 107929258 A CN107929258 A CN 107929258A
- Authority
- CN
- China
- Prior art keywords
- cellulose
- capsule
- hollow capsule
- plant hollow
- cefixime
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
- A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of plant hollow capsule, it includes water, the first cellulose and second of cellulose, and for the first described cellulose at 20 DEG C, concentration is that the aqueous solution of 8wt% has the viscosity of 100~500mPas；For second of cellulose at 20 DEG C, concentration is that the aqueous solution of 8wt% has the viscosity of 10~99mPas, and the water content of plant hollow capsule is 1~30%.The plant hollow capsule intensity and good toughness of the present invention, friability is low, non-breakable during shipping storage, and physical property meets States Pharmacopoeia specifications and use demand；Disintegration time limited is short, and medicine easily discharges and absorbs, is quick in capsule；The content of beary metal of plant hollow capsule is low, and the harm to human body is low；Particularly the dissolution rate of Cefixime Capsules is more than 80% according to the test of Chinese Pharmacopoeia method.The plant hollow capsule of the present invention can be used for Cefixime Capsules.
Description
Technical field
The invention belongs to field of capsules, and in particular to a kind of plant hollow capsule.
Background technology
With the development of pharmaceuticals industry, capsule is since it may be used with nearly any medicine, free from extraneous odour, easily swallows, easily disappears
Change the features such as absorbing, is without side-effects to body, the development of capsule is very fast, is widely used in food, medicine and health products neck
Domain.Capsule is divided into Capsules shell and its content composition, and Capsules shell can be divided into gelatin hollow capsule and plant is empty
Heart-soothing capsule.Traditional Capsules shell is made of gelatin, and gelatin is by the connective tissues such as animal skin, bone, sarolemma, flesh evil spirit
Collagenous portion degraded form, gelatin main component is protein, easy microbial contamination, and water content is high, and water content is too
Low and easy friability, and reaction can be crosslinked with some medicines and makes drug failure.Plant hollow capsule is with plant origin thing
For the Capsules of raw material, specifically comprising starch hollow capsule, hypromellose Capsules and Propiram Capsules
Deng.Hypromellose is the poly- hydroxypropyl ether of part methyl and part of cellulose, is a kind of non-ionic compound ether, is system
The primary raw material of standby hypromellose Capsules.Capsules prepared therefrom, compared with gelatine capsule, water content
It is low, chemical stability is good, do not react with content, toughness is high, moreover it can be used to vegetarian, utilization are more extensive.
Cefixime is third generation oral cephalosporin, and bactericidal effect is played by inhibiting bacteria the synthesis of cell membrane.Head
Spore gram oxime is in vitro and in vivo to gram-positive cocci such as pneumococcus, micrococcus scarlatinae, and gram negative bacillus is such as
Bacillus influenzae, moraxelle catarrhalis, Escherichia coli, proteus mirabilis, gonococcus are respectively provided with good antibacterial action.Clinically cephalo
Gram oxime is used for pharyngitis caused by sensitive bacteria, tonsillitis, acute bronchitis, acute exacerbation of chronic bronchitis, tympanitis, urine
Road feel dye, Simple gonorrhea etc..
The cefixime preparation listed at present has capsule, tablet, dispersible tablet, chewable tablets, granule, dry suspensoid agent,
For oral administered dosage form.Cefixime preparation is all poor there are stability, and dissolution rate is relatively low, the absorption and distribution of medicine in vivo
Relatively slowly, the problems such as have impact on the treatment speed and effect of medicine.
The technical indicator of Cefixime Capsules agent includes dissolution rate one.Dissolution rate characterization capsule is disintegrated molten in human body
The speed of change, determines rate of release of the medicine in human body in capsule, influences the soak time of medicine and the therapeutic effect of medicine.
Cefixime dissolution rate test method is that the capsule containing Cefixime is molten in specific dissolution medium under certain condition
Certain time is solved, tests the mass fraction for the Cefixime being dissolved.Dissolution medium as defined in Chinese Pharmacopoeia and Japanese Pharmacopoeia is not
Together.Wherein, dissolution medium as defined in Chinese Pharmacopoeia is the potassium dihydrogen phosphate buffer solution of pH=7.2.It is molten as defined in Japanese Pharmacopoeia
Go out disodium hydrogen phosphate-citric acid solution that medium is pH=7.5.
Inventor has found that Cefixime is in commercially available hypromellose Capsules, according to Chinese Pharmacopoeia method, day
Cefixime Capsules dissolution test method test described in this CP method, dissolution rate are below 80%, i.e., commercially available hydroxypropyl
Encapsulated methylcellulose is not suitable for Cefixime.It is therefore desirable to a kind of hypromellose glue suitable for Cefixime
Capsule.
The content of the invention
To solve the above-mentioned problems, Cefixime Capsules dissolution rate is improved, the present invention provides a kind of plant hollow capsule,
It includes water, the first cellulose and second of cellulose, and for the first described cellulose at 20 DEG C, concentration is 8wt%'s
Aqueous solution has the viscosity of 501~1000mPas；For second of cellulose at 20 DEG C, concentration is the water-soluble of 8wt%
The weight ratio of viscosity of the liquid with 10~99mPas, the first described cellulose and second of cellulose is 90/10~70/
30, preferably 85/15~75/25.
Wherein, the cellulose be by glucose group into macromolecular polysaccharide and its derivative, specifically include natural fibre
Tie up one kind in element, methylcellulose, hydroxyethyl cellulose, carboxymethyl cellulose, hypromellose and their derivatives
It is or a variety of.
Further, the first described cellulose and second of cellulose are hypromellose or its derivative respectively
One or more in thing.
Cellulose aqueous solution viscosity characterizes mobility and viscosity of the aqueous solution under certain temperature and pressure, it with it is fine
Tie up the relating to parameters such as molecular weight and the concentration of element.The aqueous solution of the first cellulose has higher viscosity, containing such a cellulose
Plant capsule has preferable intensity, and and is easy to be molded.The solution viscosity of second of cellulose is smaller, containing such a cellulose
Plant capsule friability it is low, the dissolution rate of Cefixime Capsules is higher.Preferably, the first described cellulose is at 20 DEG C
When, concentration is that the aqueous solution of 8wt% has the viscosity of 600~800mPas；Second of cellulose is dense at 20 DEG C
The aqueous solution spent for 8wt% has the viscosity of 50~90mPas.
The first described cellulose and the weight ratio of second of cellulose are 90/10~70/30.When the first cellulose
When being more than 90/10 with the weight ratio of second of cellulose, the brittleness of plant hollow capsule is high, and tested according to Chinese Pharmacopoeia method
The dissolution rate of Cefixime is less than 80%；It is hollow when the weight ratio of the first cellulose and second of cellulose is less than 70/30
The intensity of capsule is poor, and the Cefixime Capsules dissolution rate tested according to Chinese Pharmacopoeia method is also below 80%.It is preferred that the first is fine
The weight ratio of dimension element and second of cellulose is 85/15~75/25.
Further, the mass percentage of moisture in the water content of plant hollow capsule, i.e. plant hollow capsule, is 1
~30%.When water content does not meet 1~30% requirement in plant hollow capsule, although capsule Cefixime dissolution rate is still
More than 80% can be more than, but mechanical performance, the performance of capsule can be impacted.When the water content of plant hollow capsule
Less than 1%, capsule is too crisp, easily damaged, influences the transport and storage of capsule；When the water content of plant hollow capsule is more than 30%
When, the moisture in capsule can reduce the storage time and drug effect of the medicine in capsule, easily failure.Preferably, hollow plant glue
The water content of capsule is 3~10%.
Further, the plant hollow capsule has following performance：The Cefixime tested according to Chinese Pharmacopoeia method
Capsule dissolubility is more than 80%.
Further, the plant hollow capsule, adds up to 100 parts by weight with the first cellulose and second of cellulose
Meter, also containing the third 5~10 parts by weight of cellulose, for the third described cellulose at 20 DEG C, concentration is the water-soluble of 8wt%
Liquid has the viscosity of 100~500mPas.
Inventor has found that dissolution medium has the dissolution rate of Cefixime a large effect, and Chinese Pharmacopoeia method and Japanese medicine
The dissolution medium of allusion quotation method has difference, the plant containing the first cellulose and second of cellulose that weight ratio is 90/10~70/30
The Cefixime Capsules dissolution rate of thing Capsules meets the regulation of Chinese Pharmacopoeia, but does not meet the regulation of Japanese Pharmacopoeia.3rd
Capsule contributes to the Cefixime of Capsules to the sensitiveness of dissolution medium when kind of cellulose helps to reduce dissolution rate test
Dissolution rate meets the regulation of Chinese Pharmacopoeia and Japanese Pharmacopoeia at the same time, it is preferred that at 20 DEG C, concentration is the third cellulose
The aqueous solution of 8wt% has the viscosity of 200~400mPas.100 weight are added up to the first cellulose and second of cellulose
Part meter, when the content of the third cellulose is less than 5 parts by weight, the Cefixime dissolution rate of Capsules cannot meet China at the same time
The regulation of pharmacopeia and Japanese Pharmacopoeia；When the content of the third cellulose is more than 10 parts by weight, Cefixime Capsules can be reduced on the contrary
Dissolution rate.Preferably 6~8 parts by weight.
Further, the plant hollow capsule is big according to the Cefixime Capsules dissolution rate that Japanese Pharmacopoeia method is tested
In 80%.
Further, the hydroxypropoxy content of the first described cellulose and second of cellulose is 8~12% (quality
Percentage composition), the hydroxypropoxy content of the third cellulose is 4~7% (mass percentages).Inventor's discovery,
Meet these requirements the first, second and the third cellulose there is better characteristics, help to improve Capsules
The characteristics such as dissolution rate, friability, disintegration time limited.
Further, the plant hollow capsule, the Cefixime tested according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method
Capsule dissolubility is more than 90%.
Further, plant hollow capsule of the invention, can also contain gelling agent, coagulant, plasticising as required
The additives such as agent, adhesive, PH conditioning agents, pigment, but preferable additives content is less than 5% (mass percent), it is further excellent
Choosing does not contain the additive beyond pigment.
Wherein, the gelling agent refers in capsule manufacturing process, can make hypromellose and its derivative water
Solution is gradually transformed into uniform semi-rigid solid gel and keeps former shaped additive.Can be acetylation gellan gum,
Deacetylation gellan gum, κ types carragheen, β types carragheen, ι types carragheen, agar, pectin, sodium alginate, xanthans, western radix astragali
In glue, Karaya Gum, locust bean gum, furcellaran, tamarind gum, tara gum, the poly- glue in sclerotium Portugal, microbial alginate or carbomer
One or more.
The coagulant refers in capsule manufacturing process, can improve hypromellose and its derivative aqueous solution
Gradually it is transformed into uniform semi-rigid solid gel and keeps the additive of original shape rate.Can be potassium chloride, chlorination
One or more in calcium, potassium phosphate or potassium citrate.
The plasticizer is the additive that can improve hypromellose and its derivative processing performance, Ke Yishi
Glycerine, D-sorbite, polyethylene glycol, ethylene glycol, ethyl acetate, 1,3 butylene glycol, 1,4 butanediols, xylitol, glycerine diethyl
One kind in ester, triacetin, monoacetin, mannitol, inositol, maltitol, glucose or polypropylene glycol etc.
It is or a variety of.
The adhesive can be starch, dextrin, polyethylene pyrrole network alkanone, carboxymethyl chitin, polyvinyl alcohol, sesbania
Glue, Arabic gum, meat silica gel, Propiram, elsinan, Indian gum, glucose or ethene pyrrole network alkanone and vinyl acetate copolymerized
One or more in thing.
The PH conditioning agents are used for the pH value for adjusting the aqueous solution of raw material in plant hollow capsule preparation process, Ke Yishi
Sodium carbonate, potassium carbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium acid carbonate, saleratus, ammonium carbonate, sodium dihydrogen phosphate,
One or more in potassium dihydrogen phosphate or dipotassium hydrogen phosphate.
The pigment be can be plant hollow capsule colouring additive, can be turmeric, riboflavin, quinoline yellow,
One in chlorophyll, indigo, tomato red, capsanthin, lutein, anthocyanidin, beet red, titanium dioxide, calcium carbonate or arnotto etc.
Kind is a variety of.
Further, preferably, plant hollow capsule of the present invention, also with following performance：
Friability：Capsule is crushed in 50 and is no more than 5；
Disintegration time limited<10min；
Content of beary metal<40ppm.
Wherein, the mechanical strength of the friability reaction capsule of capsule, ensures that plant hollow capsule and Cefixime Capsules exist
There is very low breakage rate in packaging and transportational process.
Disintegration refers to that all disintegration leaches or into particle solid pharmaceutical preparation under prescribed conditions, except insoluble coating material or broken
Outside broken capsule shells, it should all pass through sieve.Disintegration time limited refers to solid pharmaceutical preparation in defined medium, in defined manner into
Row checks that all disintegration leaches or into particle and by the limit the time required to sieve.In general, disintegration time limited is shorter, capsule
The therapeutic effect of agent is better.
Content of beary metal refers to the percentage composition of heavy metal in Capsules, and heavy metal is hazardous to the human body, its content is got over
Low, the harm to human body is smaller.
Preferably, the plant hollow capsule has following performance：
Friability：Capsule is crushed in 50 and is no more than 2, is most preferably crushed without capsule；
Disintegration time limited<6min, most preferably<4min
Content of beary metal<20ppm, most preferably<5ppm.
Above performance can be measured according to the method that Chinese Pharmacopoeia is recorded.
Further, present invention also offers a kind of capsule, the capsule has used the plant hollow capsule of the present invention
For shell, and include content.The content is the composition containing medicine.The medicine can be Cefixime or head
One or more in the derivative of spore gram oxime.The capsule, can be specifically the capsule containing Cefixime.This hair
The bright capsule containing Cefixime is suitable for bacterial infectious diseases of the treatment to Cefixime sensitivity, and capsule is whole
A to swallow, in good taste, free from extraneous odour, dissolution rate is high in vivo, there is more preferable treatment rate and effect.
The effect of the present invention
1st, the dissolution that the Cefixime Capsules loaded with the plant hollow capsule of the present invention are tested according to Chinese Pharmacopoeia method
Degree is more than 80%, higher than the capsule on current market, can improve the release absorption rate of Cefixime Capsules in vivo, see
Effect is fast.The Cefixime Capsules that the plant hollow capsule of optimization formula loads are tested according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method
Dissolution rate is both greater than 80%, and even greater than 90%, it can not only apply to Chinese market, Japanese market can also be applied to, have
There are good market prospects.
2nd, plant hollow capsule intensity of the invention and good toughness, friability is low, non-breakable during shipping storage,
Physical property meets States Pharmacopoeia specifications and use demand；Disintegration time limited is short, and medicine easily discharges and absorbs, is quick in capsule；Plant is empty
The content of beary metal of heart-soothing capsule is low, and the harm to human body is low.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein are not precluded from one or more
A other materials, component, performance, state, element or its presence or addition for combining；" being more than ", " being less than " all include numerical value sheet
Body.
Embodiment
The present invention is further illustrated below by the mode of embodiment, does not therefore limit the present invention to the embodiment
Among scope.The techniques implemented on the basis of the foregoing are all within the scope of the present invention.For being familiar with this area
For personnel, other modification is easily achieved, thus it is general general being limited without departing substantially from claim and equivalency range
Under thought, the present invention is not limited to specific details.
Test event of the present invention and its assay method are as follows, unless otherwise instructed, respectively test all at 25 DEG C into
OK.
1st, Cefixime Capsules dissolution rate：
Chinese Pharmacopoeia test method：
By version in 2015《Chinese Pharmacopoeia》Cefixime Capsules dissolution test method is recorded to be tested.In Cefixime
The tolerant content produced using Shanghai marine rainbow in Cefixime Capsules, content weight about 120mg/, active ingredient weight is about
100mg/.During test, Shanghai marine rainbow is produced into the content in Cefixime Capsules and is loaded into test Capsules capsule
In (0#), loadings are 480 ± 5mg/, active ingredient about 400mg/.
Japanese Pharmacopoeia test method：
Press《17th correction Pharmacopeia of Japan》The Cefixime Capsules dissolution test method of record is tested.Cephalo
Gram oxime content is using the content in Shanghai marine rainbow production Cefixime Capsules, content weight about 120mg/, active ingredient
Weight about 100mg/.During test, Shanghai marine rainbow is produced into the content in Cefixime Capsules and is loaded into test Capsules
In capsule (0#), loadings are 480 ± 5mg/, active ingredient about 400mg/.
2nd, friability：By version in 2015《Chinese Pharmacopoeia》The test method of four gelatin hollow capsule friabilities is surveyed
Examination.
3rd, disintegration time limited：By version in 2015《Chinese Pharmacopoeia》The test method of four gelatin hollow capsule disintegration time limiteds carries out
Test.
4th, content of beary metal：By version in 2015《Chinese Pharmacopoeia》The test method of four gelatin hollow capsule heavy metals carries out
Test.
5th, hydroxypropoxy content：By version in 2015《Chinese Pharmacopoeia》The assay of four hydroxypropyl methylcellulose propoxyls
Method is tested.
6th, viscosity：Measured with dark type viscometer at 20 DEG C.
7th, moisture determination：By version in 2015《Chinese Pharmacopoeia》Middle dry weightless mensuration is measured.
The raw material of plant hollow capsule prepared by the present invention：
The first cellulose
A1：The carefree production of South Korea, hydroxypropoxy content 9.3%, the viscosity for the aqueous solution that concentration is 8wt% is 853mPa
s；
A2：The carefree production of South Korea, hydroxypropoxy content 7.4%, the viscosity for the aqueous solution that concentration is 8wt% is 675mPa
s。
Second of cellulose
B1：The carefree production of South Korea, hydroxypropoxy content 8.2%, the viscosity for the aqueous solution that concentration is 8wt% is 42mPa
s；
B2：The carefree production of South Korea, hydroxypropoxy content 11.0%, the viscosity for the aqueous solution that concentration is 8wt% is 87mPa
s。
The third cellulose
C1：The carefree production of South Korea, hydroxypropoxy content 8.8%, the viscosity for the aqueous solution that concentration is 8wt% is 145mPa
s；
C2：The carefree production of South Korea, hydroxypropoxy content 10.2%, the viscosity for the aqueous solution that concentration is 8wt% are
232mPa·s。
Embodiment 1~15
According to the composition of raw materials shown in table 1, plant hollow capsule of the invention is prepared according to following preparation method：
1st, three kinds of celluloses in table 1 are uniformly mixed by weight, add water and be configured to cellulose (embodiment 1~2
Comprising the first and second of cellulose, embodiment 3~15 also includes the third cellulose) mass percentage is 20%
Liquid, is heated to 90 DEG C and is uniformly mixed that glue is made；
2nd, mixed glue solution is cooled to 40~50 DEG C, stands 4h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out after dipping in glue, shaping with 0# moulds, is sent into drying baker, baking oven temperature
80 DEG C of degree, dries certain time, after making the water content of Capsules for the value shown in table 1, takes out cutting, body cap sleeve is closed and planted
Thing Capsules finished product.Finished product is 0# Capsuleses, and weight is 98 ± 7mg/.
Table 1
Remarks："/" represents not adding the raw material.
Comparative example 1
1st, the first cellulose A1 and water are hybridly prepared into the liquid that cellulose mass percentage is 20%, are heated to
90 DEG C are uniformly mixed glue are made；
2nd, mixed glue solution is cooled to 40~50 DEG C, stands 4h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out after dipping in glue, shaping with 0# moulds, is sent into drying baker, baking oven temperature
80 DEG C of degree, dries certain time, after the water content for making Capsules is 10%, takes out cutting, body cap sleeve obtains plant sky after closing
Heart-soothing capsule finished product.Finished product is 0# Capsuleses, and weight is 98 ± 7mg/.
Comparative example 2
1st, second of cellulose B1 of the first cellulose A1 of 60 parts by weight and 40 parts by weight is uniformly mixed, then with water
It is hybridly prepared into the liquid that cellulose (comprising the first cellulose and second of cellulose) mass percentage is 20%, heating
It is uniformly mixed to 90 DEG C and glue is made；
2nd, mixed glue solution is cooled to 40~50 DEG C, stands 4h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out after dipping in glue, shaping with 0# moulds, is sent into drying baker, baking oven temperature
80 DEG C of degree, dries certain time, after the water content for making Capsules is 10%, takes out cutting, body cap sleeve obtains plant sky after closing
Heart-soothing capsule finished product.Finished product is 0# Capsuleses, and weight is 98 ± 7mg/.
Comparative example 3
1st, the third cellulose C1 and water are hybridly prepared into the liquid that cellulose mass percentage is 20%, are heated to
90 DEG C are uniformly mixed glue are made；
2nd, mixed glue solution is cooled to 40~50 DEG C, stands 4h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out after dipping in glue, shaping with 0# moulds, is sent into drying baker, baking oven temperature
80 DEG C of degree, dries certain time, after the water content for making Capsules is 10%, takes out cutting, body cap sleeve obtains plant sky after closing
Heart-soothing capsule finished product.Finished product is 0# Capsuleses, and weight is 98 ± 7mg/.
The plant hollow capsule being prepared with regard to embodiment and comparative example, corresponding performance survey is carried out to plant hollow capsule
Examination, test result are as shown in table 2 below.
Table 2
Capsule prepared by embodiment 1~15, friability crush capsule no more than 5 to test in 50, disintegration time limited<
10min, content of beary metal<5ppm.Wherein, the capsule that prepared by embodiment 8~10,14~15, friability do not have to test in 50
There is capsule to crush, disintegration time limited<4min, content of beary metal<5ppm.
Also, from table 2 it can be seen that the Cefixime dissolution rate of the plant hollow capsule of the present invention is according to Chinese Pharmacopoeia method
Test both greater than 80%, the Cefixime dissolution rate of the plant hollow capsule of embodiment 4~15 is according to Chinese Pharmacopoeia method and Japan
CP method test both greater than 80%, the Cefixime dissolution rate of the plant hollow capsule of embodiment 9~15 is according to Chinese Pharmacopoeia method
With Japanese Pharmacopoeia method test both greater than 90%.In addition, the difference of plant hollow capsule water content, friability, the dissolution rate of capsule
There is a different with disintegration time limited, the friability of embodiment 10,14,15 of the plant capsule water content in preferred scope,
Dissolution rate and disintegration time limited are all better than embodiment 11~13.
And the Cefixime dissolution rate of the plant hollow capsule of comparative example 1~3 is according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method
Test both less than 80%, is unfavorable for release and absorption of the Cefixime in human body, influences the therapeutic effect of Cefixime.
Claims (10)
- A kind of 1. plant hollow capsule, it is characterised in that including water, the first cellulose and second of cellulose, described For a kind of cellulose at 20 DEG C, concentration is that the aqueous solution of 8wt% has the viscosity of 501~1000mPas；Described second Cellulose at 20 DEG C, concentration be 8wt% aqueous solution have 10~99mPas viscosity, the first described cellulose and The weight ratio of second of cellulose is 90/10~70/30, preferably 85/15~75/25.
- 2. plant hollow capsule according to claim 1, it is characterised in that the water content of plant hollow capsule is by weight For 1~30%.
- 3. plant hollow capsule according to claim 1, it is characterised in that the first described cellulose and second of fibre Dimension element is the one or more in hypromellose or derivatives thereof respectively.
- 4. plant hollow capsule according to claim 1, it is characterised in that there is following performance：According to Chinese Pharmacopoeia method The Cefixime Capsules dissolution rate of test is more than 80%.
- 5. plant hollow capsule according to claim 1, it is characterised in that with the first cellulose and second of cellulose Total 100 parts by weight meters, also containing the third 5~10 parts by weight of cellulose, the third described cellulose is at 20 DEG C, concentration There is the viscosity of 100~500mPas for the aqueous solution of 8wt%.
- 6. plant hollow capsule according to claim 5, it is characterised in that the Cefixime tested according to Japanese Pharmacopoeia method Capsule dissolubility is more than 80%.
- 7. plant hollow capsule according to claim 5, it is characterised in that the first described cellulose and second of fibre The hydroxypropoxy content of dimension element is 8~12%, and the hydroxypropoxy content of the third cellulose is 4~7%.
- 8. plant hollow capsule according to claim 7, it is characterised in that surveyed according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method The Cefixime Capsules dissolution rate of examination is more than 90%.
- 9. according to claim 1~8 any one of them plant hollow capsule, it is characterised in that also with following performance：Friability Degree：Capsule is crushed in 50 and is no more than 5；Disintegration time limited<10min；Content of beary metal<40ppm.
- 10. a kind of capsule, it is characterised in that used the plant hollow capsule described in claim 1~9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810001216.8A CN107929258A (en) | 2018-01-02 | 2018-01-02 | A kind of plant hollow capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810001216.8A CN107929258A (en) | 2018-01-02 | 2018-01-02 | A kind of plant hollow capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107929258A true CN107929258A (en) | 2018-04-20 |
Family
ID=61937267
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810001216.8A Pending CN107929258A (en) | 2018-01-02 | 2018-01-02 | A kind of plant hollow capsule |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107929258A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
| CN116392452A (en) * | 2023-04-10 | 2023-07-07 | 山东赫尔希胶囊有限公司 | Hydroxypropyl methylcellulose empty capsule and application thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101595133A (en) * | 2006-10-27 | 2009-12-02 | 辉瑞产品公司 | Hydroxypropyl methyl cellulose hard capsules and preparation method |
| CN102119026A (en) * | 2008-06-13 | 2011-07-06 | 葛兰素集团有限公司 | Hydroxypropyl cellulose capsule shell |
| CN103933574A (en) * | 2014-04-01 | 2014-07-23 | 中国科学院化学研究所 | Vegetable jelly for preparing hollow capsules, and applications of vegetable jelly |
| CN106265592A (en) * | 2016-09-30 | 2017-01-04 | 山东赫尔希胶囊有限公司 | Hypromellose empty hard capsule and preparation method thereof |
-
2018
- 2018-01-02 CN CN201810001216.8A patent/CN107929258A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101595133A (en) * | 2006-10-27 | 2009-12-02 | 辉瑞产品公司 | Hydroxypropyl methyl cellulose hard capsules and preparation method |
| CN102119026A (en) * | 2008-06-13 | 2011-07-06 | 葛兰素集团有限公司 | Hydroxypropyl cellulose capsule shell |
| CN103933574A (en) * | 2014-04-01 | 2014-07-23 | 中国科学院化学研究所 | Vegetable jelly for preparing hollow capsules, and applications of vegetable jelly |
| CN106265592A (en) * | 2016-09-30 | 2017-01-04 | 山东赫尔希胶囊有限公司 | Hypromellose empty hard capsule and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
| CN116392452A (en) * | 2023-04-10 | 2023-07-07 | 山东赫尔希胶囊有限公司 | Hydroxypropyl methylcellulose empty capsule and application thereof |
| CN116392452B (en) * | 2023-04-10 | 2023-11-10 | 山东赫尔希胶囊有限公司 | Hydroxypropyl methylcellulose empty capsule and application thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP0946637B1 (en) | Polymer film compositions for capsules | |
| EP1117736B2 (en) | Modified starch film compositions | |
| AU2010358565B2 (en) | Film-forming composition for soft capsules | |
| EP1748763A1 (en) | Improved pullulan capsules | |
| US6635275B1 (en) | Modified starch film compositions | |
| EP1849461A1 (en) | Process for manufacturing films | |
| JPWO2006082842A1 (en) | Hard capsule with improved solubility | |
| EP1580229A1 (en) | Biopolymer compositons and products thereof | |
| WO2007063553A1 (en) | Aqueous film coating composition containing sodium alginate and preparation thereof | |
| EP1072633A1 (en) | Pullulan film compositions | |
| CN107929258A (en) | A kind of plant hollow capsule | |
| US20220105045A1 (en) | Pullulan empty hard capsule and preparation method therefor | |
| CN108042505A (en) | A kind of plant hollow capsule for being exclusively used in Cefixime | |
| WO2021145296A1 (en) | Hard capsule containing cellulose derivative as base material and having improved mechanical strength and oxygen permeability | |
| CN110507629B (en) | Plant cellulose soft capsule rubber and preparation method thereof | |
| CN104473879B (en) | A kind of Enrofloxacin pellet and preparation method thereof | |
| CN115429771B (en) | Composite glue for capsules and preparation method and application thereof | |
| CN116196289A (en) | Medical capsule composite adhesive and raw material proportion and preparation method thereof | |
| CN112336701A (en) | Norfloxacin capsule and preparation method thereof | |
| WO2022244713A1 (en) | Non-gelatin hard capsule and method for producing same | |
| CN107095856A (en) | Cefaclor Capsules production technology |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180420 |
|
| RJ01 | Rejection of invention patent application after publication |