CN108042505A - A kind of plant hollow capsule for being exclusively used in Cefixime - Google Patents
A kind of plant hollow capsule for being exclusively used in Cefixime Download PDFInfo
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- CN108042505A CN108042505A CN201810000896.1A CN201810000896A CN108042505A CN 108042505 A CN108042505 A CN 108042505A CN 201810000896 A CN201810000896 A CN 201810000896A CN 108042505 A CN108042505 A CN 108042505A
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- 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
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- 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
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- 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
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- Pharmacology & Pharmacy (AREA)
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- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
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Abstract
The invention discloses a kind of plant hollow capsules for being exclusively used in Cefixime, have following performance：The Cefixime Capsules dissolution rate tested according to Chinese Pharmacopoeia method is more than 80%, higher than the capsule on current market, can improve the release absorption rate of Cefixime Capsules in vivo, quick.Meanwhile plant hollow capsule intensity of the invention and good toughness, friability is low, non-breakable during shipping storage, and physical property meets States Pharmacopoeia specifications and use demand.
Description
Technical field
The present invention relates to a kind of Capsuleses, and in particular to a kind of plant hollow capsule for being exclusively used in Cefixime.
Background technology
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 for caused by sensitive bacteria pharyngitis, 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 drug in vivo
Relatively slowly, the problems such as affecting the treatment speed and effect of drug.
The technical indicator of Cefixime Capsules agent includes dissolution rate one.Dissolution rate characterization capsule is disintegrated molten in human body
The rate of change determines that drug in the in vivo rate of release of people, influences the soak time of drug and the therapeutic effect of drug in capsule.
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.
Cefixime Capsules agent is made of Capsules shell and its content Cefixime pharmaceutical composition, Capsules shell
Raw material and recipe-imposed Cefixime Capsules agent dissolution rate.Capsules shell is broadly divided into plant hollow capsule and gelatin is empty
Heart-soothing capsule, gelatin hollow capsule are formed by the collagenous portion degradation in the connective tissues such as animal skin, bone, sarolemma, flesh evil spirit
Gelatin is prepared, specific such as ox bone, pigskin；Plant hollow capsule is the Capsules using plant origin object as raw material, tool
Body includes hypromellose Capsules and Propiram Capsules etc..Hypromellose is the part first of cellulose
The poly- hydroxypropyl ether of base and part is a kind of non-ionic compound ether.Capsules prepared therefrom, compared with gelatine capsule, tool
There is the advantage that water content is low, chemical stability is good, toughness is high, moreover it can be used to which vegetarian, utilization are more extensive.
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,
The Cefixime Capsules dissolution rate tested according to Chinese Pharmacopoeia method is more than 80%.
The inventors discovered that the plant hollow capsule including following components can reach the head tested according to Chinese Pharmacopoeia method
Spore gram oxime capsule dissolubility is more than 80% index：
The plant hollow capsule includes the first cellulose, second of cellulose and water, the first described fiber
For element at 20 DEG C, concentration is that the aqueous solution of 8wt% has the viscosity of 100~500mPas；Second of cellulose is 20
DEG C when, concentration be 8wt% aqueous solution have 10~99mPas viscosity；Water content is the 1~30% of Capsules weight.
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 or 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 object.
Solution viscosity characterizes mobility and viscosity of the aqueous solution under certain temperature and pressure, during it is with aqueous solution
The relating to parameters such as the molecular weight of solute and concentration.The aqueous solution of the first cellulose has higher viscosity, containing such cellulose
Plant capsule has preferable intensity, and and is easy to be molded.The solution viscosity of second of cellulose is smaller, containing such 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 200~400mPas；Second of cellulose is dense at 20 DEG C
The aqueous solution spent for 8wt% has the viscosity of 50~90mPas.
Further, the weight ratio of the first described cellulose and second of cellulose is 99/1~60/40.When first
When the weight ratio of kind cellulose and second of cellulose is more than 99/1, the brittleness of plant hollow capsule is high, and according to Chinese Pharmacopoeia
The dissolution rate of the Cefixime of method test is not up to standard；When the weight ratio of the first cellulose and second of cellulose is less than 60/40
When, the intensity of Capsules is poor, and also not up to standard according to the dissolution rate of the Cefixime Capsules of Chinese Pharmacopoeia method test.It is preferred that
The weight ratio of the first cellulose and second of cellulose is 90/10~80/20.
When water content does not meet the requirement of 1~30% (weight ratio) in plant hollow capsule, although capsule Cefixime
Remaining to for dissolution rate is up to standard, but mechanical performance, the performance of capsule can be impacted.It is aqueous when plant hollow capsule
Amount is less than 1% (weight ratio), and capsule is too crisp, easily damaged, influences the transport and storage of capsule；It is aqueous when plant hollow capsule
When amount is more than 30% (weight ratio), the barrier property of capsule is decreased obviously, and reduces the storage time and drug effect of the drug in capsule.It is excellent
Choosing, the water content of plant hollow capsule is 3~10% (weight ratios).
Further, the plant hollow capsule is big according to the Cefixime Capsules dissolution rate that Japanese Pharmacopoeia method is tested
In 80%.
Inventor has found that dissolution medium has large effect to the dissolution rate of Cefixime, and capsule is in Chinese Pharmacopoeia and Japan
Cefixime dissolution rate in the different dissolution mediums of States Pharmacopoeia specifications may be different.When the first cellulose and second
When the weight ratio of kind cellulose is 99/1~60/40, the Cefixime dissolution rate of capsule meets Chinese Pharmacopoeia regulation, but is not inconsistent day
This States Pharmacopoeia specifications.In order to meet regulation in Chinese Pharmacopoeia and Japanese Pharmacopoeia simultaneously, further, with the first cellulose and the
Two kinds of celluloses add up to 100 parts by weight meters, also containing the third 1~5 parts by weight of cellulose.The third described cellulose is 20
DEG C when, concentration be 8wt% aqueous solution have 501~1000mPas viscosity.The third cellulose, which helps to reduce, to be dissolved out
Capsule contributes to the Cefixime dissolution rate of Capsules to meet Chinese Pharmacopoeia simultaneously the sensibility of dissolution medium during degree test
With the regulation of Japanese Pharmacopoeia.Preferably, the third cellulose is at 20 DEG C, and the aqueous solution that concentration is 8wt% has 700~
The viscosity of 900mPas.Added up to by the first cellulose and second of cellulose in terms of 100 parts by weight, if the third cellulose
Content be less than 1 parts by weight, capsule is to the effect unobvious of the sensibility of dissolution medium during to reducing dissolution rate test；More than 5
Parts by weight can reduce the dissolution rate of Cefixime Capsules instead.Preferably 2~4 parts by weight.
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, preferably, the plant hollow capsule of the present invention, is tested according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method
Cefixime Capsules dissolution rate be all higher 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 ethylene pyrrole network alkanone and vinyl acetate copolymerized
One or more in object.
The PH conditioning agents are used to adjust the pH value of 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, the plant hollow capsule of the present invention also has 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 disintegrations leach or the limit into particle and the time required to passing through 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, and content is got over
It is low, it is smaller to the harm of human body.
More than performance can be measured according to the method that Chinese Pharmacopoeia is recorded.
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.
Further, the present invention also provides a kind of capsule, the capsule using the plant hollow capsule of the present invention as shell,
The content formed comprising one or more compositions in the derivative containing Cefixime or Cefixime.The present invention's
Capsule is suitable for treatment and infectious diseases, capsule caused by the bacterium of Cefixime sensitivity is entirely swallowed, in good taste, nothing
Peculiar smell, dissolution rate is high in vivo, there is better 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 drug easily discharges and absorbs, is quick in capsule；Plant is empty
The content of beary metal of heart-soothing capsule is low, low to the harm of human body.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein are not precluded from one or more
A other materials, ingredient, performance, state, element or the presence or addition of its combination；" being more than ", " being less than " all include numerical value sheet
Body.
Specific embodiment
It is further illustrated the present invention 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 field
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, each test all at 25 DEG C into
Row.
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
Content in the tolerant Cefixime Capsules using the production of Shanghai marine rainbow company, 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/.
Japanese Pharmacopoeia test method：
It presses《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：It is measured with dark type viscometer at 20 DEG C.
7th, water content：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 8.3%, the viscosity for the aqueous solution that concentration is 8wt% is 113mPa
s；
A2：The carefree production of South Korea, hydroxypropoxy content 9.4%, the viscosity for the aqueous solution that concentration is 8wt% is 282mPa
s。
Second of cellulose
B1：The carefree production of South Korea, hydroxypropoxy content 9.4%, the viscosity for the aqueous solution that concentration is 8wt% is 42mPa
s；
B2：The carefree production of South Korea, hydroxypropoxy content 9.0%, the viscosity for the aqueous solution that concentration is 8wt% is 71mPa
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 653mPa
s；
C2：The carefree production of South Korea, hydroxypropoxy content 6.2%, the viscosity for the aqueous solution that concentration is 8wt% is 875mPa
s。
Embodiment 1~13
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, by the cellulose in table 1, (Examples 1 to 6 includes the first and second of cellulose, and embodiment 7~13 is also wrapped
Containing the third cellulose) and water mixing, the liquid that cellulose mass percentage is 25% is configured to, it is mixed to be heated to 90 DEG C of stirrings
It closes uniform；
2nd, mixed solution is cooled to 40~50 DEG C, stands 5h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out with 0# molds after dipping in glue, shaping, is sent into drying baker, baking oven temperature
70 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/.
Table 1
Remarks："/" is represented without using the third cellulose.
Embodiment 14~18
According to the composition of raw materials shown in table 2, plant hollow capsule of the invention is prepared according to following preparation method.
1st, by table 1 cellulose (including the first, second and the third cellulose) and water mix, be configured to fiber
Plain mass percentage is 25% liquid, is heated to 90 DEG C and is uniformly mixed；
2nd, mixed solution is cooled to 40~50 DEG C, stands 5h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out with 0# molds after dipping in glue, shaping, is sent into drying baker, baking oven temperature
70 DEG C of degree dries certain time, after making the water content of Capsules for the value shown in table 2, takes out cutting, body cap sleeve obtains after closing
Plant hollow capsule finished product.Finished product is 0# Capsuleses, and weight is 98 ± 7mg/.
Table 2
Comparative example 1
1st, the first cellulose A1 and water are mixed, is configured to the liquid that cellulose mass percentage is 25%, heating
It is uniformly mixed to 90 DEG C；
2nd, mixed solution is cooled to 40~50 DEG C, stands 5h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out with 0# molds after dipping in glue, shaping, is sent into drying baker, baking oven temperature
70 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 and water are mixed, is configured to the liquid that cellulose percentage composition is 25%, is heated to 90
It DEG C is uniformly mixed；
2nd, mixed solution is cooled to 40~50 DEG C, stands 5h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out with 0# molds after dipping in glue, shaping, is sent into drying baker, baking oven temperature
70 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 mixed, is configured to the liquid that cellulose mass percentage is 25%, heating
It is uniformly mixed to 90 DEG C；
2nd, mixed solution is cooled to 40~50 DEG C, stands 5h, be sent into capsule production line；
3rd, the preparation solution that will be fed into capsule production line is carried out with 0# molds after dipping in glue, shaping, is sent into drying baker, baking oven temperature
70 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/.
With regard to the plant hollow capsule that embodiment and comparative example are prepared, corresponding performance survey is carried out to plant hollow capsule
Examination, test result are as shown in table 3 below.
Table 3
Capsule prepared by embodiment 1~18, 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 10~13,17~18, friability do not have to test in 50
There is capsule to crush, disintegration time limited<4min, content of beary metal<5ppm.
Friability, disintegration time limited of plant hollow capsule etc. of the present invention has excellent performance, and content of beary metal is few, and from table
As can be seen that the Cefixime Capsules dissolution rate of these embodiments is both greater than according to the test of the test method of Chinese Pharmacopoeia in 3
80%.The Cefixime Capsules dissolution rate for implementing 7~18 is both greater than 80% according to Chinese Pharmacopoeia method and the test of Japanese Pharmacopoeia method, very
To more than 90%.In addition, the difference of plant hollow capsule water content (weight ratio), plant hollow capsule water content (weight ratio) is right
There are different in friability, dissolution rate and the disintegration time limited of capsule, and plant hollow capsule water content (weight ratio) is in preferred model
Friability, dissolution rate and the disintegration time limited of embodiment 13,17~18 in enclosing all are better than embodiment 14~16.
And the plant hollow capsule being prepared by comparative example, no matter Cefixime Capsules dissolution rate is according to Chinese Pharmacopoeia method
Or the test of Japanese Pharmacopoeia method, dissolution rate are both less than 80%, influence the rate of release and therapeutic effect of Cefixime.
Claims (10)
1. a kind of plant hollow capsule, which is characterized in that there is following performance：The Cefixime glue tested according to Chinese Pharmacopoeia method
Capsule dissolution rate is more than 80%.
2. plant hollow capsule according to claim 1, which is characterized in that the Cefixime tested according to Japanese Pharmacopoeia method
Capsule dissolubility is more than 80%.
3. plant hollow capsule according to claim 1, which is characterized in that surveyed according to Chinese Pharmacopoeia method and Japanese Pharmacopoeia method
The Cefixime Capsules dissolution rate of examination is all higher than 90%.
4. plant hollow capsule according to claim 1, which is characterized in that 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.
5. plant hollow capsule according to claim 1, which is characterized in that including the first cellulose, second of fiber
Element and water, for the first described cellulose at 20 DEG C, the aqueous solution that concentration is 8wt% is viscous with 100~500mPas
Degree；For second of cellulose at 20 DEG C, concentration is that the aqueous solution of 8wt% has the viscosity of 10~99mPas；It is aqueous
It measures as the 1~30% of Capsules weight.
6. plant hollow capsule according to claim 5, which is characterized in that the first described cellulose and second of fibre
Dimension element is the one or more in hypromellose or derivatives thereof respectively.
7. plant hollow capsule according to claim 5, which is characterized in that the first described cellulose and second of fibre
The weight ratio of dimension element is 99/1~60/40, preferably 90/10~80/20.
8. plant hollow capsule according to claim 5, which is characterized in that with the first cellulose and second of cellulose
Total 100 parts by weight meters, also containing the third 1~5 parts by weight of cellulose, the third described cellulose is at 20 DEG C, concentration
There is the viscosity of 501~1000mPas for the aqueous solution of 8wt%.
9. plant hollow capsule according to claim 8, which is characterized 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%.
10. a kind of capsule has used the plant hollow capsule described in claim 1~9.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810000896.1A CN108042505A (en) | 2018-01-02 | 2018-01-02 | A kind of plant hollow capsule for being exclusively used in Cefixime |
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| CN201810000896.1A CN108042505A (en) | 2018-01-02 | 2018-01-02 | A kind of plant hollow capsule for being exclusively used in Cefixime |
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