CN105687127A - Moxifloxacin hydrochloride chitosan injection for articular cavity and preparation method thereof - Google Patents
Moxifloxacin hydrochloride chitosan injection for articular cavity and preparation method thereof Download PDFInfo
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- CN105687127A CN105687127A CN201610068700.3A CN201610068700A CN105687127A CN 105687127 A CN105687127 A CN 105687127A CN 201610068700 A CN201610068700 A CN 201610068700A CN 105687127 A CN105687127 A CN 105687127A
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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
- A61K9/08—Solutions
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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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
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention belongs to the technological field of medicines and particularly relates to a moxifloxacin hydrochloride chitosan injection for articular cavity and a preparation method thereof. The moxifloxacin hydrochloride chitosan injection comprises the following components in percentage by weight: 0.3-0.8% of moxifloxacin hydrochloride, 0.1-0.8% of chitosan, 0.005-0.02% of surfactant, isoosmotic regulator and a pH regulator and the balance of injection water, wherein the addition of the isoosmotic regulator is proper when the osmotic pressure of the composition is 250-350 milliosmolarity per liter, and the addition of the pH regulator is proper when the pH of the composition is 6.5-7.5. By adopting the moxifloxacin hydrochloride chitosan injection for articular cavity prepared in the invention, the pain caused by arthritis can be effectively relieved and treated, and the treatment effect is remarkable.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to a kind of articular cavity moxifloxacin hydrochloride chitosan injection and preparation method thereof。
Background technology
Osteoarthritis is a kind of chronic joint diseases being characteristic with Articular cartilage degeneration and Secondary cases hyperosteogeny。Being more common in middle-aged and elderly people, women is more than male。It is mainly in the positions such as the bigger knee joint of heavy burden, hip joint, lumbosacral region joint of vertebral column and the first toe joint and the DIPJ of hand, proximal interphalangeal joint。This disease also becomes osteoarthritis, degenerative osteoarthritis, hypertrophy row arthritis, osteoarthritis, osteoarthritis, infective arthritis etc.。Along with the aging and fat ratio of population rises, the prevalence rate of osteoarthritis will improve。
Osteoarthritis can start morbidity from 20 years old, but most of asymptomatic, generally not easily finds。World Health Organization (WHO) adds up, and in more than 50 years old crowd, the sickness rate of osteoarthritis is 50%, and in the crowd of more than 55 years old, sickness rate is 80%。The incidence of China's osteoarthritis accounts for the 10% of total population, is about 100,000,000 people。Nineteen ninety, China only has ten thousand Human Osteoarthritis more than 4000, and 2000 have reached 80,000,000, and patient numbers has reached people more than 100,000,000, and China will become one of maximum country of world's osteoarthritis number of patients。
The cause of disease of osteoarthritis is owing to having lacked the synovial fluid of viscosity (joint fluid) in articular cavity, causes originally should serving as in osteoarthrosis as the abnormal friction of the cartilage of cushion, damages and degeneration。When, after cartilage degradation, just protecting bone surface, when walking or standing, body wt makes the joint degenerated more painful。Owing to fearing misery, naturally decreasing motion, then the muscle of there also follows atrophy, and ligament also can become more loose。
The main pathology of osteoarthritis changes into cartilage degeneration and disappearance, and joint margins ligament attachment place and subchondral bone qualitative response hypertrophy form hyperosteogeny, and thus causes arthralgia, stiff deformity and dysfunction。This disease clinically, can be divided into constitutional and Secondary cases two class。Spontaneous osteoarthritis means age ageing and the relevant arthropathy of other diseases of getting along well, and secondary osteoarthritis is then caused by damage, inflammation, heredity and the disease such as metabolism, endocrine。
Infective arthritis is the one of arthritis, refers to the arthritis caused in the microorganism such as antibacterial, virus invasion articular cavity。Patient mostly is the more weak child of passive protective physical fitness and old people。The modal reason of the infection of joint is septicemia, in addition, wound, operation, juxtra-articular soft tissue infection, also be morbidity major reason。Infective arthritis is divided into two classes according to the cause of disease:
1. acute infective arthritis
Can being caused by antibacterial or viral infection: (1) Neisseria gonorrhoeae arthritis, Neisser is gonococcal as pathogen, and it is from infecting mucous membrane surface (cervix uteri, rectum, pharynx) expand to some hands Minor articulus, elbow, knee joint and ankle joint, Axial sketelon joint is less to be involved；(2) Nongonococcal arthritis, how by staphylococcus aureus, streptococcus and gram-negative bacteria, as enterobacteria, bacillus pyocyaneus, serratia marcecens cause；(3) staphylococcus aureus and B group B streptococcus infect, and are more common in neonate and children more than 2 one full year of life；(4) infection of joint anaerobe, is often accompanied by facultative or aerobe infection (5%～10%), such as staphylococcus aureus, epidermis streptococcus and escherichia coli；(5) infection of joint caused after biting, how by gram-negative bacteria such as Type B streptococcus, oral cavity anaerobium (such as clostruidium, streptococcus, bacteroid) causes。The infection of joint caused after animal bite is often for staphylococcus aureus or mouth-flora；(6) infection of joint in HIV patient, by staphylococcus aureus, streptococcus, salmonella causes, and HIV patient can have reiter syndrome, relapsing arthritis, HIV dependency arthritis and arthralgia。HIV patient's survival is more of a specified duration, and mycobacteria, the infection chance of fungus and rare conditioned pathogen is also more many。
2. chronic infectional arthritis
Chronic arthritis can by mycobacteria, and fungus and some other pathogenic more weak antibacterial cause。Such as mycobacterium tuberculosis, Mycobacterium marinum, mycobacterium kansasii, Candida, coccidioides immitis genus, Histoplasma capsulatum, Cryptococcus histolyticus, the raw bacterium of dermatitis tooth, Sporothrix schenckii Pseudomonas, aspergillosis, actinomyces israelii and Brucella。The patient articular's replacement postoperative infection having 2/3 occurred within 1 year, and this is likely due to operation technique and introduces antibacterial or the infection of postoperative antibacterial such as skin infection, pneumonia, dentistry infection etc.。
Osteoarthritis is the performance that osteoarthrosis physiological is degenerated, and there is no the medicine reversing or stopping this disease progression。The purpose for the treatment of is to ease the pain, and relief of symptoms stops and delay advancing of disease, Saving cortilage function, in case maimed。Adopt Comprehensive Treatment, including patient education, Drug therapy, physical therapy and surgical operation therapy。
The Drug therapy of osteoarthritis common at present has following four kinds:
(1) medicine of symptom is improved: analgesics such as acetaminophen has analgesic activity, but antiinflammatory action is weak。NSAID (non-steroidal anti-inflammatory drug) has the feature of anti-inflammatory analgesic, can alleviate arthralgia, improve range of motion after medication。
(2) glucocorticoid: unsuitable systemic administration, only other treatment is invalid, there is acute inflammation outbreak performance in joint or has joint surrounding synovial membrane scorching, and skin inflammation etc. can give in articular cavity or diseased region local injection, unsuitable Reusability。Same position biphasic injection interval time is at least more than 3 months。
(3) use Chondroprotective agents: can relief of symptoms, maintain and recover function of joint, such as poly-glucosamine。
(4) viscosupplementation: be to the hyaluronate sodium of intraarticular injection macromolecule, chitosan solution, alleviates synovial membrane inflammation, cartilage destruction and improve function of joint, blocks the vicious cycle of local patholoic change。Viscoelasticity thing replacement therapy is the medical science new ideas proposed the seventies in last century, and namely intraarticular injection has a kind of clinical new method of viscoelastic Substance treatment osteoarthritis。Visco-elastic material used so far is mainly hyaluronate sodium, chitosan etc.。
Chitosan be mainly composed of glycosaminoglycan, having good biocompatibility and biodegradability, degradable is aminoglucose in vivo, and aminoglucose is the basis in articular cartilage, human chondrocytes synthetic proteins polysaccharide can be stimulated, it is possible to supplement knuckle synovia。In addition, chitosan has height viscoelasticity, similar to normal knuckle synovia, the physical action that can simulate knuckle synovia improves the lubrication state in joint, mitigation is in the pressure of articular cartilage face, and in covering cartilage surface or being filled into the cartilage crack of regression, in preventing and treating knuckle synovia, harmfulness cytokine contacts with cartilage matrix and chondrocyte, and articular cartilage degeneration is risen preventive effect。
Visco-elastic material as a kind of intraarticular injection, chitosan possesses following performance: (1) chitosan have selectively promote epithelial cell, endothelial cell growth and suppress the biological nature of fibroblastic growth, thus promoting the reparation of tissue physiology's property, suppress cicatrization, reduce tissue adhesion；(2) chitosan has local hemostasis effect and suppresses fibrin bundle to be formed, thus decreasing the tissue adhesion caused because of organization of hematoma；(3) chitosan has lubrication and biological barrier effect, can effectively stop adhesion to occur。The mechanism of chitosan Saving cortilage cartilage is in that chitosan is similar to intraarticular aminopolysaccharide in physicochemical property, has viscoelasticity, slow absorbability, and during aminopolysaccharide, cartilage and cartilage matrix constitute the basis with metabolism, and display is higher than natural joint liquid。
Moxifloxacin (Avelox, Avalox) for forth generation fluoroquinolone antibiotics, its Yuan Yan producer is Bayer A.G, three generations's quinolones is wider earlier above for antibiotics, commodity are called " visiing multiple pleasure ", list in Germany in JIUYUE, 1999, and the same year, December obtained FDA approval listing in the U.S., the market sales revenue of 2002 " visiing multiple pleasure ", more than 300,000,000 dollars, becomes the world ten one of situation of selling well antibiotic greatly。The product of Bayer A.G and Schering Plough company of the U.S. 2006 in world's market sales revenue up to 800,000,000 dollars, whole world situation of selling well prescription drugs ranking 129；Within 2007, its market sales revenue is up to 10.34 hundred million dollars, relatively within 2006, increases by 25.8%；Within 2008, its sales volume is more than 1,100,000,000 dollars。2002, Moxifloxacin sheet listed in China, Beyer Co., Ltd sell, and key market is the main hospital of China big and medium-sized cities。This medicine enters country's medical insurance catalogue for 2004, within hereafter 3 years, presents surprising rate of increase；Within 2003, the compound growth rate to Moxifloxacin in 2007 is 116%, and within 2007, city sample hospital money for drugs surpasses 2.16 hundred million yuan, relatively within 2006, increases by 75.1%；Within 2008, the sales volume in China surpasses 300,000,000 yuan。
Summary of the invention
Invention broadly provides a kind of articular cavity moxifloxacin hydrochloride chitosan injection and preparation method thereof, it is possible to effectively alleviating the pain that also treatment of arthritis causes, therapeutic effect is notable。Its technical scheme is as follows: a kind of articular cavity moxifloxacin hydrochloride chitosan injection, it includes following components: the moxifloxacin hydrochloride of 0.3-0.8wt%, the chitosan of 0.1-0.8wt%, the surfactant of 0.005-0.02wt%, isoosmotic adjusting agent and pH adjusting agent, surplus is water for injection, the addition of isoosmotic adjusting agent be make the osmotic pressure of compositions be 250-350 milliosmolarity/liter, the addition of pH adjusting agent is that to make the pH of compositions be 6.5-7.5。
Preferably, described articular cavity moxifloxacin hydrochloride chitosan injection, it includes following components: the moxifloxacin hydrochloride of 0.5wt%, the chitosan of 0.3wt%, the surfactant of 0.01wt%, isoosmotic adjusting agent and pH adjusting agent, surplus is water for injection, the addition of isoosmotic adjusting agent be make the osmotic pressure of compositions be 260-320 milliosmolarity/liter, the addition of pH adjusting agent is that to make the pH of compositions be 6.8-7.2。
Preferably, described isoosmotic adjusting agent is sodium chloride。
Preferably, described surfactant is tween 80。
Preferably, described pH adjusting agent is boric acid。
The preparation method of a kind of articular cavity moxifloxacin hydrochloride chitosan injection, comprises the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) pH adjusting agent of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and isoosmotic adjusting agent are added；
(4) water for injection adds to full dose, stirs；
(5) adopting poly (ether sulfone) film filtration sterilization, gained solution is moxifloxacin hydrochloride chitosan injection。
Preferably, in step (5), the aperture of poly (ether sulfone) film filtration sterilization is 0.22-0.45 μm。
Adopt above-mentioned articular cavity moxifloxacin hydrochloride chitosan injection and preparation method thereof, the invention have the advantages that
Moxifloxacin treatment infective arthritis, mainly plays the effect of potent antibacterial antiinflammatory to bacterial acute and chronic arthritis。Chitosan is coordinated to be injected in articular cavity, it is possible to play effect of antiinflammatory and pain relieving。The injection of the present invention uses moxifloxacin hydrochloride and chitosan, and good stability, curative effect are good, resistant rate is low, untoward reaction is few, it is possible to effectively alleviating the pain that also treatment of arthritis causes, therapeutic effect is notable。
Detailed description of the invention
1, injection formula
The moxifloxacin hydrochloride of 0.3-0.8wt%, the chitosan of 0.1-0.8wt%, the surfactant of 0.005-0.02wt%, isoosmotic adjusting agent and pH adjusting agent, surplus is water for injection, the addition of isoosmotic adjusting agent be make the osmotic pressure of compositions be 250-350 milliosmolarity/liter, the addition of pH adjusting agent is that to make the pH of compositions be 6.5-7.5。
2, injection preparation
Comprise the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) pH adjusting agent of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and isoosmotic adjusting agent are added；
(4) water for injection adds to full dose, stirs；
(5) adopting poly (ether sulfone) film filtration sterilization, gained solution is moxifloxacin hydrochloride chitosan injection。
One, specific embodiment
Embodiment 1
1, injection formula
The moxifloxacin hydrochloride of 0.5wt%, the chitosan of 0.3wt%, the tween 80 of 0.01wt%, sodium chloride and boric acid, surplus is water for injection, the addition of sodium chloride be make the osmotic pressure of compositions be 260 milliosmolaritys/liter, the addition of boric acid is that to make the pH of compositions be 6.8。
2, injection preparation
Comprise the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) boric acid of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and sodium chloride are added；
(4) water for injection adds to full dose, stirs；
(5) the poly (ether sulfone) film filtration sterilization adopting aperture to be 0.22 μm, gained solution is moxifloxacin hydrochloride chitosan injection。
Embodiment 2
1, injection formula
The moxifloxacin hydrochloride of 0.8wt%, the chitosan of 0.1wt%, the tween 80 of 0.02wt%, sodium chloride and boric acid, surplus is water for injection, the addition of sodium chloride be make the osmotic pressure of compositions be 320 milliosmolaritys/liter, the addition of boric acid is that to make the pH of compositions be 7.2。
2, injection preparation
Comprise the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) boric acid of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and sodium chloride are added；
(4) water for injection adds to full dose, stirs；
(5) the poly (ether sulfone) film filtration sterilization adopting aperture to be 0.45 μm, gained solution is moxifloxacin hydrochloride chitosan injection。
Embodiment 3
1, injection formula
The moxifloxacin hydrochloride of 0.3wt%, the chitosan of 0.8wt%, the tween 80 of 0.005wt%, sodium chloride and boric acid, surplus is water for injection, the addition of sodium chloride be make the osmotic pressure of compositions be 320 milliosmolaritys/liter, the addition of boric acid is that to make the pH of compositions be 7.5。
2, injection preparation
Comprise the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) boric acid of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and sodium chloride are added；
(4) water for injection adds to full dose, stirs；
(5) the poly (ether sulfone) film filtration sterilization adopting aperture to be 0.35 μm, gained solution is moxifloxacin hydrochloride chitosan injection。
Two, adjuvant Study on Compatibility
For studying moxifloxacin hydrochloride, chitosan and adjuvant consistency problem, do following experiment:
Experiment 1: moxifloxacin hydrochloride 0.5g, chitosan 2g, injection water 100mL；
Experiment 2: moxifloxacin hydrochloride 0.5g, chitosan 2g, boric acid 0.6g, injection water 100mL；
Experiment 3: moxifloxacin hydrochloride 0.5g, chitosan 2g, sodium chloride 0.5g, injection water 100mL；
Experiment 4: moxifloxacin hydrochloride 0.5g, chitosan 2g, boric acid 0.6g, sodium chloride 0.5g, injection water 100mL。
Prepare above-mentioned prescription to measure afterwards and had related substance, be described in table 1 below。
Table 1 related substances measurement result
As shown in Table 1, in experiment 1-4, related substances difference under influence factor is little, illustrates that adjuvant is little on there being related substance impact, and the adjuvant compatibility is good。
Three, Experiment of Zoology
This experiment mainly research articular cavity, specifically comprises the following steps that traumatic arthritis Rabbit Model observation of curative effect with moxifloxacin hydrochloride chitosan injection
(1) choosing 8～15 monthly age 2.0～3.0kg (♀) rabbit 40,30 are served only for modeling, and 10 is normal control；
(2), after the rabbit of 30 modelings being anaesthetized with pentobarbital sodium, select knee joint sterilization on the right side of animal, carry out meniscectomy by the method for document, then by skin closure, proceeded by penicillin intramuscular injection the same day, totally 7 days；
(3) rabbit of 30 modelings being randomly divided into A, B, C tri-groups, often group 10, A group rabbit injection prepared by embodiment 1 gives each 2ml treatment, and injection in 7 days once, is injected for continuous 5 weeks；B group rabbit chitosan injection gives each 2ml treatment, and injection in 7 days once, is injected for continuous 5 weeks；C group is treatment not；10 matched groups are D group, and the rabbit of D group is normal not injured；
(4) TNF-α content in an animal blood Samples detection blood sample is respectively taken after postoperative 12,14,16 weeks。By TNF-α standard substance with buffer 1mL, regulate concentration respectively 0.3,0.9,2.7,8.1,24.3 μ g/L, respectively take 100 μ L and add in test tube, sequentially add 125I-TNF and anti-tnf-alpha serum 100 μ L to standard pipe, fully 24h is placed in latter 40 DEG C of mixing, adds PR separating medium 500 μ L mixing, places 20min, 4 DEG C are centrifuged, and 3500r/min is centrifuged 25min。Supernatant is abandoned in suction, measures precipitation number on automatic gamma counter, and drawing standard curve also calculates sample concentration, and statistical variance analyzes group difference。
(5) result: four groups of rabbit articular conditions are C group < B group < A group < D group。After modeling 12 weeks, A group, B group, C group blood plasma and joint irrigation TNF-α content are obviously higher than D group (p < 0.01), and the TNF-α content of 12,14,16,18 weeks each time points, C group is significantly higher than B group, A group, D group, the TNF-α content of each time point of A group all relatively B group low (p < 0.05), in Table 2。
TNF-α content results in table 2 rabbit different time points blood plasma, joint fluid
It follows that infective arthritis is had good healing effect by moxifloxacin hydrochloride chitosan injection prepared by the present invention。
It will be apparent to those skilled in the art that can technical scheme as described above and design, make other various corresponding changes and deformation, and all these change and deformation all should belong within the protection domain of the claims in the present invention。
Claims (7)
1. an articular cavity moxifloxacin hydrochloride chitosan injection, it includes following components: the moxifloxacin hydrochloride of 0.3-0.8wt%, the chitosan of 0.1-0.8wt%, the surfactant of 0.005-0.02wt%, isoosmotic adjusting agent and pH adjusting agent, surplus is water for injection, the addition of isoosmotic adjusting agent be make the osmotic pressure of compositions be 250-350 milliosmolarity/liter, the addition of pH adjusting agent is that to make the pH of compositions be 6.5-7.5。
2. articular cavity moxifloxacin hydrochloride chitosan injection according to claim 1, it includes following components: the moxifloxacin hydrochloride of 0.5wt%, the chitosan of 0.3wt%, the surfactant of 0.01wt%, isoosmotic adjusting agent and pH adjusting agent, surplus is water for injection, the addition of isoosmotic adjusting agent be make the osmotic pressure of compositions be 260-320 milliosmolarity/liter, the addition of pH adjusting agent is that to make the pH of compositions be 6.8-7.2。
3. articular cavity moxifloxacin hydrochloride chitosan injection according to claim 1, it is characterised in that: isoosmotic adjusting agent is sodium chloride。
4. articular cavity moxifloxacin hydrochloride chitosan injection according to claim 1, it is characterised in that: surfactant is tween 80。
5. the moxifloxacin hydrochloride chitosan injection of the articular cavity according to any one of claim 1-4, it is characterised in that: pH adjusting agent is boric acid。
6. the preparation method of an articular cavity moxifloxacin hydrochloride chitosan injection as claimed in claim 1, it is characterised in that: comprise the following steps:
(1) chitosan weighing formula ratio is dissolved in the water for injection of 95% volume, stirs；
(2) pH adjusting agent of formula ratio is added in chitosan solution, stir；
(3) in the solution of step (2), moxifloxacin hydrochloride and isoosmotic adjusting agent are added；
(4) water for injection adds to full dose, stirs；
(5) adopting poly (ether sulfone) film filtration sterilization, gained solution is moxifloxacin hydrochloride chitosan injection。
7. the preparation method of articular cavity moxifloxacin hydrochloride chitosan injection according to claim 6, it is characterised in that: in step (5), the aperture of poly (ether sulfone) film filtration sterilization is 0.22-0.45 μm。
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