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 PDF

Info

Publication number
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
Authority
CN
China
Prior art keywords
cellulose
capsule
cefixime
plant hollow
hollow capsule
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
Application number
CN201810000896.1A
Other languages
Chinese (zh)
Inventor
马雪华
张宇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Qi Yu Biological Technology Co Ltd
Original Assignee
Shanghai Qi Yu Biological Technology Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Shanghai Qi Yu Biological Technology Co Ltd filed Critical Shanghai Qi Yu Biological Technology Co Ltd
Priority to CN201810000896.1A priority Critical patent/CN108042505A/en
Publication of CN108042505A publication Critical patent/CN108042505A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54Heterocyclic 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
    • A61K31/542Heterocyclic 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
    • A61K31/545Compounds 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
    • A61K31/546Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; 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)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

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

A kind of plant hollow capsule for being exclusively used in Cefixime
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.
CN201810000896.1A 2018-01-02 2018-01-02 A kind of plant hollow capsule for being exclusively used in Cefixime Pending CN108042505A (en)

Priority Applications (1)

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

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
CN108042505A true CN108042505A (en) 2018-05-18

Family

ID=62126151

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201810000896.1A Pending CN108042505A (en) 2018-01-02 2018-01-02 A kind of plant hollow capsule for being exclusively used in Cefixime

Country Status (1)

Country Link
CN (1) CN108042505A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111388443A (en) * 2020-05-14 2020-07-10 上海祺宇生物科技有限公司 Cellulose empty capsule and capsule thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101889987A (en) * 2009-11-16 2010-11-24 江苏亚邦强生药业有限公司 Method for preparing novel cefixime tablets and cefixime capsules
CN102119026A (en) * 2008-06-13 2011-07-06 葛兰素集团有限公司 Hydroxypropyl cellulose capsule shell
CN103110607A (en) * 2013-03-01 2013-05-22 浙江华立南湖制药有限公司 Cefixime capsule and preparation method thereof
CN105496984A (en) * 2015-12-18 2016-04-20 石药集团欧意药业有限公司 Cefixime capsule stable in quality and preparation method thereof
CN103536578B (en) * 2013-11-05 2016-06-15 天津医药集团津康制药有限公司 A kind of Cefixime Capsules and preparation method thereof
CN105997931A (en) * 2016-07-19 2016-10-12 南京正宽医药科技有限公司 Cefixime capsules and preparation method thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102119026A (en) * 2008-06-13 2011-07-06 葛兰素集团有限公司 Hydroxypropyl cellulose capsule shell
CN101889987A (en) * 2009-11-16 2010-11-24 江苏亚邦强生药业有限公司 Method for preparing novel cefixime tablets and cefixime capsules
CN103110607A (en) * 2013-03-01 2013-05-22 浙江华立南湖制药有限公司 Cefixime capsule and preparation method thereof
CN103536578B (en) * 2013-11-05 2016-06-15 天津医药集团津康制药有限公司 A kind of Cefixime Capsules and preparation method thereof
CN105496984A (en) * 2015-12-18 2016-04-20 石药集团欧意药业有限公司 Cefixime capsule stable in quality and preparation method thereof
CN105997931A (en) * 2016-07-19 2016-10-12 南京正宽医药科技有限公司 Cefixime capsules and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111388443A (en) * 2020-05-14 2020-07-10 上海祺宇生物科技有限公司 Cellulose empty capsule and capsule thereof
CN111388443B (en) * 2020-05-14 2021-12-31 上海祺宇生物科技有限公司 Cellulose empty capsule and capsule thereof

Similar Documents

Publication Publication Date Title
EP1057862B1 (en) Polymer film compositions for capsules
EP1117736B2 (en) Modified starch film compositions
EP1045000B1 (en) Cellulose ether films
AU2010358565B2 (en) Film-forming composition for soft capsules
US20070254024A1 (en) Process for manufacturing films
US6635275B1 (en) Modified starch film compositions
EP1748763A1 (en) Improved pullulan capsules
EP1580229A1 (en) Biopolymer compositons and products thereof
EP1072633A1 (en) Pullulan film compositions
CN108113974A (en) A kind of preparation method of porous hollow capsule and the capsule thus prepared
CN107929258A (en) A kind of plant hollow capsule
CN108042505A (en) A kind of plant hollow capsule for being exclusively used in Cefixime
CN115429771B (en) Composite glue for capsules and preparation method and application thereof
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
WO2022244713A1 (en) Non-gelatin hard capsule and method for producing same
CN116196289A (en) Medical capsule composite adhesive and raw material proportion and preparation method thereof

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
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20180518

WD01 Invention patent application deemed withdrawn after publication