CN101732244B - Nose drops taking fibrauretine as main medicine and preparation method - Google Patents
Nose drops taking fibrauretine as main medicine and preparation method Download PDFInfo
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- CN101732244B CN101732244B CN2009102182836A CN200910218283A CN101732244B CN 101732244 B CN101732244 B CN 101732244B CN 2009102182836 A CN2009102182836 A CN 2009102182836A CN 200910218283 A CN200910218283 A CN 200910218283A CN 101732244 B CN101732244 B CN 101732244B
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Abstract
The invention relates to nose drops taking fibrauretine as a main medicine and a preparation method thereof. The nose drops comprise the following components of raw materials by weight ratio: 0.1-2% of fibrauretine and the balance auxiliary materials. The preparation method comprises the following steps: dissolving the auxiliary materials by adopting a slushing method used for hydroxypropyl methylcellulose, enabling the auxiliary materials to form a uniform insoluble paste, then adding room-temperature water with the equivalent quantity and stirring until dissolving completely; adding physiological saline into fibrauretine powder, heating, dissolving and leaching to obtain supernatant liquid; and stirring and mixing a hydroxypropyl methylcellulose solution and the supernatant liquid of the fibrauretine evenly, then adding the physiological saline, fixing the volume to the required quantity, stirring evenly, regulating the pH value to 5.5-6.5, filtering and subpackaging. By the experimental verification, the nose drops do not have an irritative inflammatory reaction, have a better suppression function to inflammation and have better stability.
Description
Technical field:
This invention relates to the development of medical new product, and being specially a kind of is the nasal drop and the preparation method of principal agent with the fibrauretin.
Background technology
One, chronic rhinitis brief introduction
Chronic rhinitis (chronic rhinitis) is nasal membrane and submucosal chronic inflammatory disease.Show as the chronic congestion swelling of nasal mucosa, claim chronic simple rhinitis (chronic simple rhinitis).Develop into the hypertrophy plumpness of nasal mucosa and turbinates, claim chronic hypertrophic rhinitis (chronic hypertrophic rhinitis).
The deep artery of patient's nasal mucosa of chronic rhinitis, sinusitis is chronic expansion state, lose contractile function, the concha nasalis inferior spongy tissue also is chronic expansion, it is main inflammatory infiltration that lymphocyte and plasma cell are arranged around blood vessel and the body of gland, the mucous gland function is active, secretions increase, the proper mucous membrane edema, the modal pathogen that causes inflammation has hemophilus influenza, staphylococcus aureus, streptococcus pneumoniae, escherichia coli, pus bacillus etc.
Two, chronic simple rhinitis
Pathology: the chronic expansion of mucosa deep-level blood vessel changes the most obvious with the concha nasalis inferior cavernous sinusoids especially.The mucous gland function is active, secretion increasing.Turbinate mucosa swelling, but submucous tissue does not have obvious hypertrophy and sexually revises.
Three, chronic hypertrophic rhinitis
Chronic hypertrophic rhinitis (chronic hypertrophyc rhinitis) for the hypertrophy plumpness of nasal mucosa, tela submucosa and turbinates sexually revises, is generally developed by chronic simple rhinitis.
Pathology: the mucous epithelium cilium comes off, and becomes stratified cuboidal epithelium, and tela submucosa then proliferation of fibrous tissue takes place by edema and makes pachymucosa, and it can be Fructus Mori shape or polypoid to become for a long time, periosteum and osseous tissue hypertrophy, and the turbinates sclerotin also can be loose and change.
The medicine nasal drop that is used for the treatment of at present mostly is Western medicine preparation, clinical response weak curative effect and side reaction is arranged.Because Western medicine nasal drop Main Ingredients and Appearance is an ephedrine, its effect is shunk afterwards earlier often and is expanded, and easily produces " ephedrine sample " reaction, thereby makes nasal obstruction, nasal mucosa swelling can not get basic treatment, and life-time service easily causes the atrophic rhinitis.For pure Chinese medicinal preparation---fibrauretin nasal drop is adopted in this this test.
Fibrauretin has functions such as heat-clearing and toxic substances removing, antiinflammatory.With the Caulis Fibraureae is the fibrauretin of raw material production, composition has formed preparations such as fibrauretin sheet, capsule, injection based on palmatine (palmaine), has pharmacological actions such as broad-spectrum antiseptic, antiviral, to the urinary system infection determined curative effect, particularly remarkable to the gynecological infection curative effect especially.
Fibrauretin has another name called palmatine hydrochloride, is the alkaloids substance in a kind of Chinese medicine source, and extraction separation obtains in the middle of traditional Chinese medicine Caulis Fibraureae Fibraureatinctoria.Fibrauretin belongs to the proto-berberine in the Bian Ji Tetrahydroisoquinoli-beautiful jade Alkaloid, has biological action comparatively widely.Present studies show that, fibrauretin has significant anti-multiple pathogenic microorganism and protozoacide effect; Multiple Gram-positive and negative bacterium are had significant inhibitory effect, multiple fungus such as Candida albicans, achorion gypseum, Fonsecaea pedrosor etc. are also had stronger inhibitory action.In addition, discover that fibrauretin also has immunoregulation effect, strengthen body defence function thereby can strengthen leukocytic phagocytosis.Oral formulations, the injection of fibrauretin are widely used in gynecological inflammation, dysentery, enteritis, respiratory tract and urinary tract infection, surgical infection and conjunctivitis etc. clinically at present.But fibrauretin is not useful on research and the application that Rhinological diseases such as treatment rhinitis, sinusitis are used preparation as yet at present, only has oral formulations or injection to be useful on the treatment conjunctivitis.
Summary of the invention
The purpose of this invention is to provide a kind of fibrauretin nasal drop and preparation method with better effects treatment chronic rhinitis, sinusitis.
Technical scheme of the present invention is:
The weight proportion of the raw material components of the fibrauretin nasal drop of treatment chronic rhinitis, sinusitis is: fibrauretin 0.1%～2%, all the other are adjuvant.
The weight proportion of the raw material components of the fibrauretin nasal drop of treatment chronic rhinitis, sinusitis is: fibrauretin 0.7%, all the other are adjuvant.
The preparation method of the fibrauretin nasal drop of treatment chronic rhinitis, sinusitis is carried out according to the following steps:
Take by weighing fibrauretin powder and hydroxypropyl emthylcellulose according to quantity, the hydroxypropyl emthylcellulose hydroxypropyl emthylcellulose adopts and dissolves towards the slurry method, get hot water swelling, the dispersion of 80-90 ℃ of recipe quantity 1/5～1/3, the limit adds the hydroxypropyl emthylcellulose limit and stirs 15～25min, make it form uniform insoluble pastel, the room temperature water of equivalent stirs 15～25min then, i.e. dissolving fully; Fibrauretin powder, ethyl hydroxybenzoate are added normal saline, heating for dissolving, sucking filtration obtains supernatant while hot; With Gonak and fibrauretin supernatant stirring and evenly mixing, add normal saline and be settled to 1000mL, stir evenly, with the NaOH solution of an amount of 0.5mol/L its pH value is transferred to 5.5-6.5, packing gets final product.
Employing chronic sinusitis model is tested its rhinitis curative effect and is verified, and it is carried out extracorporeal bacteria inhibitor test, irritation test, antiinflammatory test and stability test.
1, the therapeutical effect of fibrauretin nasal drop chronic sinusitis
Get the healthy adult male New Zealand rabbit, adopt Dou Kou not exclusively to stop up and add the modeling method that cotton-wool is kept somewhere in the hole chamber, whole process must the sterile working.The hair of rabbit bridge of the nose center is cut short, scraped light.Chlore-ammonia ketone 50mg/kg intramuscular injection anesthesia, anaesthetize successfully after, routine disinfection, drape, 1% lignocaine art district infiltration anesthesia is cut a lengthwise otch along the bridge of the nose median line, sinus frontalis antetheca on picked at random one side, separation subcutaneous tissue and periosteum.Bore the hole of opening the about 1.5mm size of a diameter with micro-electric drill at last neck Dou Qianbi.With normal saline flushing hole chamber, the aperture that the cotton-wool that takes a morsel is bored by last sinus frontalis antetheca is seated in it in Dou Kou and the hole chamber, needn't stop up Dou Kou fully.With periosteum, skin layer-by-layer suture.Cause the chronic sinusitis animal model, the control drug of fibrauretin nasal drop is respectively normal saline, furan fiber crops nasal drop, animal subject is divided into: not administration blank group, normal saline negative control group, furan fiber crops nasal drop group, fibrauretin nasal drop 2mg/kg group, fibrauretin nasal drop 0.2mg/kg group, fibrauretin nasal drop 0.02mg/kg group, every group of 10 animals, after the animal subject modeling, except that the blank group, respectively with the medicinal liquid collunarium.
Observation tried each treated animal condition of illness sign and according under light microscopic observed pathological phenomenon be divided into semidefinite quantification gradation pathological examination (/ 1+2+).See Table 1
Table 1 fibrauretin nasal drop is infectd sinus frontalis mucosa treatment for diseases half quantification gradation result to rabbit
| Pathology sign | The blank group | Negative control group | Furan fiber crops nasal drop group | 2mg/kg fibrauretin nasal drop group | 0.2mg/kg fibrauretin nasal drop group | 0.02mg/kg fibrauretin nasal drop group |
| Epithelial proliferation (/+) | + | + | + | - | - | + |
| Glandular hyperplasia (/+) | + | + | + | - | + | + |
| Hyperosteogeny (/+) | - | - | - | - | - | - |
| Fibroplasia (/ 1+2+) | ++ | + | + | - | - | + |
| Ulcer level (/ 1+2+) | ++ | ++ | - | - | - | + |
| The inflammatory cell infiltration degree (/+) | + | + | - | - | - | - |
| Cilium come off (/ 1+2+) | ++ | ++ | - | - | - | + |
| Goblet cell increases situation (/+) | + | + | - | - | - | - |
2, the extracorporeal bacteria inhibitor test of fibrauretin nasal drop
The preparation of bacteria suspension is seeded to hemophilus influenza, staphylococcus aureus, streptococcus pneumoniae, escherichia coli, bacillus pyocyaneus, 6 kinds of lyophilizing bacterial strains of staphylococcus epidermidis in the serum broth respectively earlier, cultivate 18h for 37 ℃, picking one encircles microbionation to the 5mL serum broth respectively from each enrichment liquid, 37 ℃ of 18h, centrifugal (2000r/min, 10min), supernatant discarded; With physiological saline solution washing, recentrifuge; Each pipe precipitation is diluted with physiological saline solution.Adopt turbidimetry to make 5 kinds of bacteria suspension concentration be 1 * 105CFU/mL, standby.
Diluted sample adopts test tube serial dilution method, is that 0.7% fibrauretin phinamide sample is diluted to 6 different dilution factors with serum broth with mass percentage concentration, and promptly 1/2,1/4,1/8,1/16,1/32 and 1/64.
Microbionation will be than the bacterial suspension inoculation after turbid to pastille meat soup, and inoculum concentration is 50 μ L/ pipes.Set up the positive, feminine gender and blank group, wherein positive control simultaneously: not dosing adds bacterium; Negative control: add the ampicillin of 80 μ g/mL, add bacterium; Blank: dosing does not add bacterium.
After cultivating 24h in 37 ℃ of incubators of bacteria cultivation results, the situation of observing each bacterial growth.Least concentration with the finer contained drug is defined as minimum inhibitory concentration (MIC).Each picking one ring meat soup from finer, streak inoculation is to not containing on the flat board of medicine respectively.Cultivate 24h for 37 ℃, observation has or not bacterium colony to form to determine the minimum bactericidal concentration (MBC) of medicine.
The antibacterial action of table 2 fibrauretin nasal drop
By above bacteriostatic test as can be known, mass percentage concentration is that the antibiotic minimum produce effects dosage of 0.7% fibrauretin phinamide sample is 1/8 dilution factor, and this moment, sample concentration was 0.0875%.
3, irritation test
Get 6 of 18-22g mices, be divided into 2 groups at random.One group is blank group (distilled water), one group is that mass percentage concentration is 2% fibrauretin nasal drop medicine group, every 2h drips 1 time, each 2-3 drips, and observation animal activity situation, put to death mice and get the nasopharynx part mucosa with the air tap inserting method behind the 24h, embathe with 10% formaldehyde immediately and send pathological biopsy.
The irritation test result: observe the mice behavior, nasal mucosa, nasopharynx part mucosa matched group and medicine group inorganization morphological change, the result shows the inflammatory reaction of fibrauretin nasal drop nonirritant.
4, antiinflammatory test
By the animal inflammatory model, observe the inhibitory action of fibrauretin nasal drop to inflammation.
(1) the fibrauretin nasal drop is to the influence of rat paw edema due to the agar
Adopt the concentrated solution of fibrauretin nasal drop, it is divided into 3 dosage groups, every group contains the crude drug amount and is respectively 2mg/kg, 0.2mg/kg, 0.02mg/kg; Select 50 of healthy Wister rats for use.Body weight 130～190g, male and female are not limit, and divide physiology saline control group, furan fiber crops nasal drop group, fibrauretin nasal drop 2mg/kg group, fibrauretin nasal drop 0.2mg/kg group, fibrauretin nasal drop 0.02mg/kg group at random.Smear the following position of rat paw and joint repeatedly with medicine before the Yu Zhiyan.Every day 5 times, 3d continuously.30min causes inflammation at rat paw subcutaneous injection 1% agar solution 0.05mL after the last administration, measures to cause the following change in volume in rat paw joint, scorching front and back.Subsequently respectively at 1,3,5,24h each survey 1 right hind ankle joint girth, the record result is calculated as follows the swelling degree:
Girth * 100% before swelling degree (%)=(cause scorching back girth-cause scorching before girth)/cause is scorching
Table 3 fibrauretin nasal drop is to the influence of rat paw edema due to the agar (x ± s)
Fibrauretin nasal drop therapeutic effect is remarkable, compares with matched group, and P＜0.01, difference has statistical significance.There is not significant difference between fibrauretin nasal drop treatment group and the furan fiber crops nasal drop group.
(2) the bullate influence of fibrauretin nasal drop xylol induced mice ear
Adopt the concentrated solution of fibrauretin nasal drop, it is divided into 3 dosage groups.Select 50 of body weight 18～22g Kunming mouses for use, male and female are not limit.Be divided into 5 groups at random, i.e. normal saline matched group, furan fiber crops nasal drop group, fibrauretin nasal drop 2mg/kg group, fibrauretin nasal drop 0.2mg/kg group, fibrauretin nasal drop 0.02mg/kg group.Smear the mice left and right sides ear every day 5 times, continuously 3d.30min after the last administration drips dimethylbenzene in mouse right ear, puts to death animal behind the 15min, and along the punching of left and right sides auricle same area, the both sides auricle is weighed respectively with the 6mm card punch, with two weight differences as the swelling level index.The difference of comparative drug group and matched group.Fibrauretin nasal drop xylol induced mice ear is the bullate result of influence weigh respectively to mice both sides auricle, with two weight differences as the swelling level index, and the difference by comparative drug group and matched group, obtain the antiinflammatory action that inhibitory rate of intumesce is judged the fibrauretin nasal drop.Suppression ratio=(model group swelling degree average-medication group swelling degree average)/model group swelling degree average * 100%.
The bullate influence of table 4 fibrauretin nasal drop xylol induced mice ear
| Group | Dosage (mg/kg) | Number of animals (only) | Swelling degree (mg) | Suppression ratio % |
| The normal saline group | 10 | 6.9±3.26 | / | |
| Furan fiber crops nasal drop group | 10 | 3.3±2.69 | 52％ | |
| Fibrauretin nasal drop group | 2mg/kg | 10 | 2.2±1.63 | 68％ |
| Fibrauretin nasal drop group | 0.2mg/kg | 10 | 3.9±2.73 | 43％ |
| Fibrauretin nasal drop group | 0.02mg/kg | 10 | 5.1±2.45 | 26％ |
Fibrauretin nasal drop therapeutic effect is remarkable, compares with matched group, and P＜0.01, difference has statistical significance.There is not significant difference between fibrauretin nasal drop treatment group and the furan fiber crops nasal drop group.
Rhinitis curative effect checking result and extracorporeal bacteria inhibitor test, irritation test, antiinflammatory test experimental result by the fibrauretin nasal drop can infer that the produce effects dosage of fibrauretin nasal drop is 0.1%～2%.
5, stability test
(1) accelerated test
Sample is placed on 40 ℃ ± 2 ℃ of temperature, in the incubator of relative humidity 75% ± 5%, by 1,2,3, check June.
The result: the color of sample, clarity and pH value, content does not all change.
The stable case of table 5 sample in accelerated test three months
| Sample standing time | The color of sample | The clarity of sample | The pH value of sample | The labelled amount of sample |
| 0 month | Faint yellow | Clarification | 6.0 | 100％ |
| January | Faint yellow | Clarification | 6.0 | 100％ |
| February | Faint yellow | Clarification | 6.0 | 98％ |
| March | Faint yellow | Clarification | 5.9 | 94％ |
| June | Faint yellow | Clarification | 5.9 | 93％ |
This product microbial limit test of drugs meets the microbial limit standard of nasal administration preparation in the version pharmacopeia in 2005, and product indicia thing content all in acceptability limit, shows that product is stable.
(2) investigation that keeps sample for a long time
This product embedding is sealed in the 10mL bottle, put 25 ℃ ± 2 ℃ of temperature, the following reserved sample observing of doing of relative humidity 60% ± 10% during respectively at 0,3,6,9,12 month, is observed mensuration to its color, clarity, pH value, precipitation etc.
Labelled amount is respectively as a result: 100%, 100%, 98%, 97%, 95%.Its outward appearance and pH and content do not have significant change.
The stable case of table 6 sample in 12 months
| Sample standing time | The color of sample | The clarity of sample | The pH value of sample | The labelled amount of sample |
| 0 month | Faint yellow | Clarification | 6.0 | 100％ |
| March | Faint yellow | Clarification | 6.0 | 100％ |
| June | Faint yellow | Clarification | 5.9 | 98％ |
| JIUYUE | Faint yellow | Clarification | 5.9 | 97％ |
| December | Faint yellow | Clarification | 5.9 | 95％ |
This product medicine sanitary inspection meets the microbial limit standard of nasal administration preparation in the version pharmacopeia in 2005, and product indicia thing content all in acceptability limit, shows that product is stable.
The specific embodiment
Embodiment 1:
Pharmaceutical formulation:
Fibrauretin 7mg hydroxypropyl emthylcellulose 10g
0.5mol/L NaOH solution ethyl hydroxybenzoate 0.3g
Mass percentage concentration is 0.9% normal saline 1000mL
Preparation method:
Take by weighing fibrauretin powder 7mg, hydroxypropyl emthylcellulose 10g; Hydroxypropyl emthylcellulose adopts towards the dissolving of slurry method, gets 250ml 80-90 ℃ hot water swelling, dispersion, and the limit adds the hydroxypropyl emthylcellulose limit and stirs 15min, make it form uniform insoluble pastel, the room temperature water of equivalent stirs 15min then, i.e. dissolving fully; Fibrauretin powder, ethyl hydroxybenzoate are added normal saline 600mL, heating for dissolving, sucking filtration obtains supernatant while hot.With Gonak and fibrauretin supernatant stirring and evenly mixing, add normal saline again and be settled to 1000mL, stir evenly, with the NaOH solution of an amount of 0.5mol/L its pH value is transferred to 6.0, packing gets final product.
Embodiment 2:
Pharmaceutical formulation:
Fibrauretin 20mg hydroxypropyl emthylcellulose 5g
0.5mol/L NaOH solution ethyl hydroxybenzoate 0.3g
Mass percentage concentration is 0.9% normal saline 1000mL
Preparation method:
Take by weighing fibrauretin powder 20mg, hydroxypropyl emthylcellulose 5g; Hydroxypropyl emthylcellulose adopts towards the dissolving of slurry method, gets 200ml 80-90 ℃ hot water swelling, dispersion, and the limit adds the hydroxypropyl emthylcellulose limit and stirs 20min, make it form uniform insoluble pastel, the room temperature water of equivalent stirs 20min then, i.e. dissolving fully; Fibrauretin powder, ethyl hydroxybenzoate are added normal saline 600mL, heating for dissolving, sucking filtration obtains supernatant while hot.With Gonak and fibrauretin supernatant stirring and evenly mixing, add normal saline again and be settled to 1000mL, stir evenly, with the NaOH solution of an amount of 0.5mol/L its pH value is transferred to 6.5, packing gets final product.
Embodiment 3
Pharmaceutical formulation:
Fibrauretin 1mg hydroxypropyl emthylcellulose 15g
0.5mol/L NaOH solution ethyl hydroxybenzoate 0.3g
Mass percentage concentration is 0.9% normal saline 1000mL
Preparation method:
Take by weighing fibrauretin powder 1mg, hydroxypropyl emthylcellulose 15g; Hydroxypropyl emthylcellulose adopts towards the dissolving of slurry method, gets 300ml 80-90 ℃ hot water swelling, dispersion, and the limit adds the hydroxypropyl emthylcellulose limit and stirs 25min, make it form uniform insoluble pastel, the room temperature water of equivalent stirs 25min then, i.e. dissolving fully; Fibrauretin powder, ethyl hydroxybenzoate are added normal saline 600mL, heating for dissolving, sucking filtration obtains supernatant while hot.With Gonak and fibrauretin supernatant stirring and evenly mixing, add normal saline again and be settled to 1000mL, stir evenly, with the NaOH solution of an amount of 0.5mol/L its pH value is transferred to 5.5, packing gets final product.
Claims (1)
1. one kind is the nasal drop of principal agent with the fibrauretin, it is characterized in that the weight proportion of raw material components is: fibrauretin 0.1%～2%, and all the other are adjuvant; Preparation by the following method:
Take by weighing fibrauretin powder and hydroxypropyl emthylcellulose according to quantity, hydroxypropyl emthylcellulose adopts and dissolves towards the slurry method, get hot water swelling, the dispersion of 80-90 ℃ of recipe quantity 1/5～1/3, the limit adds the hydroxypropyl emthylcellulose limit and stirs 15～25min, make it form uniform insoluble pastel, the room temperature water that adds equivalent then stirs 15～25min, i.e. dissolving fully; Fibrauretin powder, ethyl hydroxybenzoate are added normal saline, heating for dissolving, sucking filtration obtains supernatant while hot; With Gonak and fibrauretin supernatant stirring and evenly mixing, add normal saline again and be settled to aequum, stir evenly, with the NaOH solution of an amount of 0.5mol/L its pH value is transferred to 5.5～6.5, to filter, packing gets final product.
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| CN104606137A (en) * | 2015-01-07 | 2015-05-13 | 江苏迪沃生物制品有限公司 | Antimicrobial repair-type nasal spray |
| CN104546690B (en) * | 2015-01-07 | 2017-07-14 | 北京紫光制药有限公司 | A kind of pharmaceutical composition containing fibrauretine |
| CN108578406A (en) * | 2018-04-18 | 2018-09-28 | 曹建华 | A kind of composition for allergic rhinitis treatment |
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Effective date of registration: 20171018 Address after: High tech Zone Jinpu Ma Cheng Road 650503 Yunnan city of Kunming province No. 2899 Patentee after: Yunnan Plant Pharmaceutical Industry Co., Ltd. Address before: 650034 Wang Jia dam 22, Yunnan, Kunming Patentee before: Kunming Zhenhua Pharmacy Co., Ltd. |