CN101007165A - A compound preparation for treating respiratory tract infection and its preparation method - Google Patents
A compound preparation for treating respiratory tract infection and its preparation method Download PDFInfo
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- CN101007165A CN101007165A CN 200610033066 CN200610033066A CN101007165A CN 101007165 A CN101007165 A CN 101007165A CN 200610033066 CN200610033066 CN 200610033066 CN 200610033066 A CN200610033066 A CN 200610033066A CN 101007165 A CN101007165 A CN 101007165A
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Abstract
The invention relates to a compound preparation for treating respiratory tract infection, which mainly comprises (by weight portions) amoxicillin 100-1250, mannosan peptide 1-30. The amoxicillin can be trihydrate of amoxicillin, waterless amoxicillin or the alkali metal salt of amoxicillin. The invention also provides a process for preparing the compound preparation.
Description
Technical field
The present invention relates to the pharmaceutical products field, particularly a kind of compound preparation that is used for the treatment of respiratory tract infection.
Background technology
Respiratory tract infectious disease is commonly encountered diseases, the frequently-occurring disease of hospital outpatient, worldwide is to cause a disease and lethal major reason.The WHO statistical result showed, the caused disease of respiratory tract infection accounts for 10% of total M ﹠ M.The antibiotic in the whole world 3/4 is used for the treatment of respiratory tract infection.The statistics of China's Ministry of Public Health shows that in the city, respiratory tract infection is the 4th the cause of death, comes after malignant tumor, cerebrovascular, the cardiovascular diseases.And in the rural area, the death that respiratory tract infection causes accounts for the 1st.Also have data to show that respiratory tract infection is one of modal cause of death of the child of developing country; Particularly (Recurrent respiratory infection is children's's commonly encountered diseases and frequently-occurring disease RRI) to recurrent respiratory tract infection, and sickness rate reaches about 30% in recent years.Studies show that immunologic hypofunction is the intrinsic factor that cause respiratory tract infectious disease, account for patient's 70%.Infant specificity and non-specific immunity are all unsound, and constitutional or Secondary cases immunodeficiency are the major reasons of RRI.Therefore on purpose use some immunostimulants, the elimination immunosuppressive condition, the unusual of immunologic function corrected in directed regulation and control immunoreation, and be significant to the morbidity of minimizing and control breathing road infectious disease.
Summary of the invention
The object of the present invention is to provide a kind of compound preparation that is used for the treatment of respiratory tract infection.
Another object of the present invention is to provide a kind of method for preparing above-mentioned compound preparation.
Technical scheme of the present invention realizes by the following technical solutions:
A kind of compound preparation that is used for the treatment of respiratory tract infection mainly is made up of amoxicillin and mannatide.
Described amoxicillin is the alkali metal salt of Utimox, anhydrous amoxicillin or amoxicillin.
Said components is pressed following weight portion proportioning raw materials: amoxicillin: 100-1250 mannatide: 1-30
A kind of method for preparing above-mentioned compound preparation, it comprises:
Take by weighing the amoxicillin according to quantity, add the adjuvant commonly used of 10%-200%, adopt marumerization to granulate; With the granule that the makes granulate that sieves;
Take by weighing mannatide according to quantity, add the adjuvant commonly used of 100%-1000%, adopt marumerization to granulate; With the granule that the makes granulate that sieves;
Amoxicillin (Amoxicillin) is the wide spectrum semisynthetic penicillin, and nineteen seventies just is used for clinical, and Gram-positive and negative bacterium are had broad-spectrum antibacterial activity.It brings into play bactericidal action by suppressing the synthetic of bacteria cell wall, can make antibacterial become spheroid rapidly and dissolves, breaks.For Hemolytic streptococcus, Streptococcus viridans, streptococcus pneumoniae, the responsive golden yellow staphylococcus of benzylpenicillin, gonococcus, hemophilus influenza, enterococcus, Salmonella, Bacillus typhi and Bacillus proteus etc. antibacterial action is arranged all.Behind the oral administration of amoxicillin, 75-90% is absorbed rapidly by gastrointestinal tract, and the existence of gastric food can not influence the absorption of medicine significantly.0.5g the peak time (t of oral blood drug level
Max) be about (1.28 ± 0.17) hour, blood drug level peak value (C
Max) be about (7.07 ± 1.26) μ g/ml.Cerebrospinal fluid, MEF, saliva, bronchus juice, tonsil, gonad, bile, bone marrow and amniotic fluid etc. can be infiltrated after absorbing well in the amoxicillin, and can be distributed to vitals such as kidney, lung, liver rapidly.Its concentration in organizing body fluid has substantially exceeded minimum inhibitory concentration.Mainly discharge in urine with original shape by glomerular filtration and tubular secretion the amoxicillin, drains in 8 hours urine to reach 50-70%, and other has 20% to drain in urine with penicilloic acid.The amoxicillin can be used for the following infection due to the sensitive organism:
1, upper respiratory tract infection such as otitis media, sinusitis, pharyngitis, tonsillitis due to Streptococcus hemolyticus, streptococcus pneumoniae, staphylococcus or the hemophilus influenza.
2, lower respiratory infections such as acute bronchitis, pneumonia due to Streptococcus hemolyticus, streptococcus pneumoniae, staphylococcus or the hemophilus influenza.
Described in the present invention amoxicillin comprises free parent acid and its derivant (for example its alkali metal salt); The alkali metal salt that comprises Utimox, anhydrous amoxicillin or amoxicillin, metering method adopt the scale of parent compound amoxicillin to show.
Mannatide (Mannatide) is a kind of polysaccharose substance that extracts from alpha-Hemolytic streptococcus, and its chemical constitution is α-mannatide, is also referred to as mannan or polyactin (PolyactinA).It generally is that (α-hemolyticstreptococci) the 33# bacterial strain gets through ethanol extraction from culture fluid through submerged fermentation from the isolating alpha-Hemolytic streptococcus of healthy human mouth throat in utilization.Mannatide is the unformed powder of white or yellowish odorless, tasteless, mean molecule quantity is 71700, mainly contain polysaccharide (about 85-90%), wherein the ratio of mannose and a small amount of glucose is about 16: 1, and contain the about 4.5-6.2% of protein, and this mannatide has 15 seed amino acids approximately after hydrolysis, referring to national drug WS1-XG-053-2000.
Now work out mannatide and had following pharmacological action:
1, adjusts macrophage function
Mannatide is a kind of immunostimulant, and its mechanism of action is mainly realized by immunization route.Result of study shows that the mannan Toplink strengthens the phagocytic function that obtains the immunne response ability and express the mouse macrophage of phagocytic function under starch or sodium thioglycolate stimulation, and shows concentration dependent.Nearest research finds that also mannatide can produce nitric oxide (NO) by the inducing mouse macrophage.And NO has wide biological activity in body, except that central nervous system and cardiovascular system are played an important role, also all has important function in body each side functions such as immune system.Under the physiological status, the NO that macrophage produces can play immunoregulatory effect, and under some derivant effects, macrophage then can produce a large amount of NO, and exogenous antigen and tumor cell etc. is played lethal effect.
2, to the effect of the natural killer cell activity of people
Natural killer cell can suppress generation, development and the transfer of tumor in vivo, is the important effect cell that body is carried out immune surveillance function.Studies show that, the mannan Toplink strengthens obviously low combination rate and kill rate of esophageal carcinoma patient lymphocyte, though can not increase the combination rate of human peripheral lymphocytes and target cell, can obviously increase and the bonded lymphocytic kill rate of target cell.
3, to the influence of human lymphocyte immune function
After tumour patient was used the mannatide treatment, cellular immune function was improved rapidly,
3The H-thymidine reaches
14The C-uridnine participate in counting before treatment, show that mannatide improves and regulated the lymphocytic immunologic function of tumour patient.
4, to the killer cell propagation inhibition of lymphokineactivation and the influence of killing activity
The killer cell of lymphokineactivation (LAK)/IL-2 therapy is a kind of effective tumor biotherapy method, tumor to some type has good curative effect, but needs a considerable amount of effector lymphocytes to be aided with heavy dose of IL-2, costs dearly, erious adverse reaction, thereby its popularization is restricted.Mannatide acts on the LAK cell, and the expression of LAK cell surface IL-2R is strengthened, and LAK can be in conjunction with more IL-2, and its breeder reaction, the tumor effect just is further enhanced extremely.Mannatide can also strengthen the inductive lymphocyte killing activity of suboptimal dose IL-2, makes the inductive LAK activity of low dosage IL-2 reach the level of higher dosage IL-2, greatly reduces the consumption of IL-2.
5, strengthen specific cytotoxic T cytoactive
In vitro study is found, educates the cytotoxicity that PERIPHERAL BLOOD MONONUCLEAR CELL can strengthen its NK cell sexual cell activity and macrophage altogether with mannatide, and behind these cell activations, it suppresses and enhancing can be further amplified in the killing tumor cells effect.
6, to animal erythrocyte degeneration ability and Immune Effects
Experiment showed, that mannatide can make the tumor-bearing mice hematid immunity function rise comprehensively.Show as: 1. erythrocyte-C3b receptor rosette rate, erythrocyte-IC (immune complex) rosette rate obviously rise; 2. erythrocyte in the serum-C3b receptor garland promotes factor active to rise, and inhibitive factor is active to descend, and impels rate and suppression ratio ratio to rise.The prompting mannatide can make the tumor animal hematid immunity function recover and improve, and suppresses the propagation and the diffusion of tumor cell.
The mannatide safety is good, non-carcinogenesis, genotoxicity and genetoxic.Adopt the intravenous injection of Bliss method in Kunming kind white mice, single administration, dosage are 675.3-4018.0mg/kg, observe seven days, and recording LD50 is 1707.0mg/kg; Lumbar injection is in Kunming kind white mice, and single administration, dosage are 6097.5-11687.5mg/kg, observes seven days, and recording LD50 is 8041.2mg/kg.
Clinically mannatide can be used for stimulating bone marrow hematogenesis, regulate autoimmune, enhancing body phylactic power defensive power, opposing pathogenic microorganism etc. (referring to Wang Zhao etc., the pharmacological research progress of polyactin, Chinese Pharmacological circular, 2002 Aug; 18 (4): 374-8; Wang Yunsheng etc., the pharmacological action and the clinical practice of mannatide (polyactin), Chinese pharmacist, 2004, Vol.7, No.4,302-5).
By the applicant the long-term and unremitting research of amoxicillin and mannatide characteristic and the clinical data of compound preparation are shown that what amoxicillin and mannatide compound recipe were used the reasons are as follows:
1, both pharmacological actions are clear and definite, and through long-term clinical application, confirm safe and effectively, all are used for the control of infectious disease.
2, has the pharmacology synergism.Pathogen can directly be killed in the amoxicillin, and mannatide recovers and corrects the low state of immune level, helps body to remove pathogen, and using both at anti-infective is a kind of complementary relationship.
3, both safeties are all good, and are little to liver function influence, make the compound preparation application and can not produce antagonism or other untoward reaction.
4, the compound preparation treatment can be shortened the course of treatment and reduce recurrence, has drug effect economics advantage, also helps to reduce the bacterial resistance odds.
5, this compound preparation determined curative effect is safe and reliable, and oral administration, and method is simple, makes the patient avoid the suffering of flesh of drug administration by injection.
Further specify effect of the present invention below by the curative effect report.
(1) the curative effect report of amoxicillin mannatide compound preparation treatment respiratory tract infectious disease
1 purpose
Observe and compare respiratory tract infection patient list and zero difference is arranged with the clinical efficacy between amoxicillin group and the use compound preparation treatment group of the present invention.
2 methods
2.1 case is selected
42 routine patients are upper and lower respiratory tract infection after diagnosing, comprise tonsillitis, tracheitis, pneumonia, asthma concurrent infection; Treat in preceding 48 hours and do not accept antibacterial drug therapy.All there are not the Beta-lactam medicine allergies, no hepatic and renal function injure or nerve and psychosis history, no gastritis and gastric ulcer case history, and get rid of anemia of pregnant woman and nursing women.Male's 26 examples wherein, women's 16 examples, age 16-70 year, average 49.8 years old.Be divided into two groups at random, 22 people are organized in treatment, matched group 20 people.
2.2 Therapeutic Method
The treatment group gives amoxicillin and mannatide compound preparation (wherein containing amoxicillin 500mg, mannatide 5mg), tid, and oral, 7-14 days is a course of treatment.Patient's consumption cuts down according to the circumstance more than 60 years old.Matched group only gives the amoxicillin of corresponding dosage.Do not use other antibiotic during the treatment.
All have a blood test in all patient's medications front and back, routine urinalysis, and suppurative tonsillitis patient does throat swab and cultivates, and pneumonia patient does X line chest and takes the photograph sheet.Variation and the record of observing patient temperature, symptom and sign every day carry out efficacy evaluation.
2.3 curative effect is judged and observation index
2.3.1 3 days endosome temperature drops of produce effects are to normal, symptom and sign disappear, and blood leukocytes, routine urinalysis recover normal, and throat swab is cultivated and turned out cloudy.
2.3.2 effectively medication 4-7 days, body temperature was normal, symptom and sign disappear substantially, and it is normal that blood leukocytes or routine urinalysis recover, rabat pneumonia basic absorption.
2.3.3 invalid medication 3 days, symptom and sign do not have obvious change.Need to change other antibacterials.
2.4 statistical procedures
Enumeration data x
2Check, ranked data are analyzed with Ridit.
3 results
3.1 two groups of therapeutic effect see Table 1.Treatment group total effective rate 90.9%, matched group total effective rate 70% has tangible significant difference (P＜0.01)
Table 1 liang group curative effect comparative example (%)
| Group | n | Produce effects | Effectively | Invalid |
| The treatment group | 22 | 13(59.1) | 7(31.8) | 2(9.1) |
| Matched group | 20 | 9(45) | 5(25) | 6(30) |
4 conclusions
Obviously be better than independent anti-infective therapy with this compound preparation treatment respiratory tract infection effect.
(2) the clinical efficacy report of amoxicillin and mannatide compound preparation treatment repeated respiratory tract infections in children
1 purpose
Observe and compare recurrent respiratory tract infection infant list and zero difference is arranged with the clinical efficacy between amoxicillin group and the use compound preparation treatment group of the present invention.
2 methods
2.1 case is selected:
58 routine RRI infant diagnosis all meet the recurrent respiratory tract infection diagnostic criteria, treatment the first half interior every monthly have upper and lower respiratory tract infection generation, the each course of disease 〉=7d.Age＜1 year old 5 examples, 1-3 year 28 examples, 3-5 year 22 examples, 6-9 year 3 examples.Boys and girls's ratio is 1.15: 1.Be divided into two groups at random: 30 examples are organized in treatment, matched group 28 examples.And get rid of diseases such as malnutrition, rickets active stage, congenital heart disease, anemia, treat in preceding 3 months and do not accept immunostimulant or immunosuppressant therapy.
2.2 the mensuration of immune indexes:
Measure the serum immune globulin and the T cell subsets of administration front and back.
Go into the group standard: 1. IgA≤2s; 2. CD3 and CD4 all≤2s; 3. CD3≤2s and CD4/CD8＜1.5 meet 1 in above-mentioned 3 at least.
2.3 Therapeutic Method:
The treatment group gives amoxicillin and mannatide compound preparation, wherein＜gave compound preparation (containing amoxicillin 125mg, mannatide 2.5 mg), each 0.5 bag, every day 3 times in 1 years old; 1-3 year gives each 1 bag of this compound preparation, every day 3 times; 3-5 year gives each 1.5 bags of this compound preparation, every day 3 times; 6-9 year gives each 2 bags of this compound preparation, every day 3 times.Matched group only gives the amoxicillin of corresponding dosage.Two groups all are administered to the symptom complete obiteration.
2.4 evaluation of clinical curative effect:
Followed up a case by regular visits to 1 time statistics after 1 year after taking medicine in per 3 months.Curative effect is judged: produce effects: respiratory tract infection did not take place in individual month or only infected 1 time in drug withdrawal 3-6, and symptom obviously alleviates, and the course of disease shortens, and it is normal that immune indexes recovers substantially; Effectively: the respiratory tract infection number of times reduces to some extent, sx, and the course of disease shortens, and immune indexes is become a full member normal or the same; Invalid: morbidity number of times, the course of disease all do not change, and immune indexes is the same.
2.5 statistical method
(x ± s) expression relatively adopts the t check between group in the measurement data employing; The relatively employing x of rate
2Check.Inspection level α=0.05.
3 results
3.1 treatment group and treatment of control group result are relatively
Treatment group clinical cure rate, obvious effective rate and effective percentage are apparently higher than matched group, and inefficiency also has obvious reduction than matched group, and difference all has statistical significance (P＜0.01), sees Table 2.
Table 2 treatment group and the comparison of matched group clinical efficacy (example, %)
| Group | n | Produce effects | Effectively | Invalid |
| The treatment group | 30 | 16(53.3) | 9(30.0) | 5(16.7) |
| Matched group | 28 | 9(32.1) | 4(14.3) | 15(53.6) |
3.2 the variation of two groups of treatment front and back immune indexes
Treatment group and matched group have all been checked immune indexes.Compare changing before and after two groups of treatments, this compound preparation is treated back 6 immune indexes and is improved as a result, raises significantly with IgA, CD3, CD4, and these 3 index differences have statistical significance before and after the treatment, see Table 3.Immune indexes difference has statistical significance before and after the treatment of control group, shows that compound preparation of the present invention obviously improves CD3, CD4 and the effect that improves IgG is arranged.
The variation of immune indexes before and after the treatment of table 3 treatment group RRI infant compound preparation (x ± s)
| The treatment situation | IgG(g/L) | IgA(mg/L) | IgM(mg/L) | CD3(％) | CD4(％) | CD8(％) |
| Before the treatment | 62.80±0.13 | 5.21±0.30 | 9.81±0.11 | 40.4±1.6 | 26.1±1.8 | 20.8±1.3 |
| After the treatment | 75.00±0.09 | 9.34±0.18 | 10.45±0.09 | 57.1±1.0 | 33.6±1.4 | 25.9±1.5 |
| The t value | 1.64 | 3.48 | 0.81 | 4.87 | 3.07 | 1.95 |
| The P value | ＞0.05 | ＜0.01 | ＞0.05 | ＜0.01 | ＜0.01 | ＞0.05 |
3.3 symptom and sign changes before and after the treatment
After compound preparation treatment of the present invention, rale all obviously alleviates in cough, heating, antiadoncus and the lung, learns by statistics and handles, and difference has statistical significance (the P value all＜0.01) before and after the treatment.Sings and symptoms does not all have obvious improvement the (the P value all＞0.05) before and after the matched group medication.
4 conclusions
Through the infant RRI produce effects 53.3% of compound preparation of the present invention treatment, effective 30.0%, invalid only have 16.7%, with matched group relatively, this compound preparation curative effect obviously is better than general anti-infective therapy.This compound preparation of discovery is treated back 6 immune indexes in the observation all raising in various degree, and especially to IgG, IgA, CD3, CD4, CD8 effect obviously, with the matched group ratio, the effect highly significant that it improves CD3, CD4 also can significantly improve the IgA value.According to clinical observation, not only immune indexes improves, and the morbidity number of times reduces, and has shortened the course of disease, and rale etc. all has and alleviates in cough with asthma, heating, antiadoncus and the lung.
Studies confirm that in a large number in the past that infection can cause immune function depression, immune function depression can increase the weight of to infect or infection is shown effect repeatedly.Our result of study shows: amoxicillin and mannatide compound preparation can obviously improve the clinical symptoms of RRI infant, and mitigate the disease, the shortening course of disease do not have serious adverse reaction simultaneously and take place.Has long-term effect preferably with this compound preparation treatment RRI infant.
The specific embodiment
Further specify the present invention below by specific embodiment, but therefore do not limit the present invention among the described scope of embodiments.
Embodiment one
Take by weighing amoxicillin 125g, add adjuvant commonly used (disintegrating agent, adhesive, diluent, correctives, the lubricant etc. of 10%-200%.As: the plain sodium of carboxymethyl starch, HPMC, polyvidone, pregelatinized Starch, aspartame, saccharin sodium, stevioside, Fructus Citri Limoniae essence, lemon yellow, stearate etc.), adopt marumerization to granulate.The granule that makes is crossed 16 mesh sieves earlier after 60 mesh sieve granulate, and the above part of following 60 mesh sieves of 16 mesh sieves is prepared granule.
Take by weighing mannatide 2.5g, add adjuvant commonly used (disintegrating agent, adhesive, diluent, correctives, the lubricant etc. of 100%-1000%.As: the plain sodium of carboxymethyl starch, HPMC, polyvidone, pregelatinized Starch, aspartame, saccharin sodium, stevioside, Fructus Citri Limoniae essence, lemon yellow, stearate etc.), adopt marumerization to granulate.The granule that makes is crossed 16 mesh sieves earlier after 60 mesh sieve granulate, and the above part of following 60 mesh sieves of 16 mesh sieves is prepared granule.
With above-mentioned two kinds of granule mix homogeneously, be distributed into 1000 bags promptly.
Embodiment two
Take by weighing amoxicillin 125g, mannatide 5g, adjuvant commonly used (disintegrating agent, adhesive, diluent, correctives, the lubricant etc. of adding 100%-1000%.As: dried starch, the plain sodium of carboxymethyl starch, HPMC, polyvidone, pregelatinized Starch, hard acid ester salt etc.),, be pressed into 1000 promptly with tablet machine through granulation, granulate.
Embodiment three
Take by weighing amoxicillin 1250g, mannatide 3g, adjuvant commonly used (disintegrating agent, adhesive, diluent, correctives, the lubricant etc. of adding 100%-1000%.As: dried starch, the plain sodium of carboxymethyl starch, HPMC, polyvidone, pregelatinized Starch, hard acid ester salt etc.), through granulation, granulate, filled capsules makes every capsules contain amoxicillin 1250mg, mannatide 30mg.
The proportion relation of amoxicillin and mannatide sees the following form among the later embodiment of embodiment two:
Claims (10)
1, a kind of compound preparation for the treatment of respiratory tract infection mainly is made up of amoxicillin and mannatide.
According to claim 1 compound preparation for the treatment of respiratory tract infection, it is characterized in that 2, described amoxicillin is the alkali metal salt of Utimox, anhydrous amoxicillin or amoxicillin.
3, a kind of compound preparation for the treatment of respiratory tract infection according to claim 1 and 2 is characterized in that, said components is pressed following weight portion proportioning raw materials: amoxicillin: 100-1250 mannatide: 1-30.
4, a kind of compound preparation for the treatment of respiratory tract infection according to claim 1 and 2 is characterized in that it also comprises adjuvant, and described adjuvant is that in disintegrating agent, adhesive, diluent, correctives, the lubricant one or several are united use.
5, a kind of compound preparation for the treatment of respiratory tract infection according to claim 4 is characterized in that, described respiratory tract infection is a repeated respiratory tract infections in children.
6, a kind of compound preparation for the treatment of repeated respiratory tract infections in children according to claim 1 and 2 is characterized in that described compound preparation can be made the solid preparation on any pharmaceutics.
7, a kind of method for preparing any one described treatment respiratory tract infection compound preparation among the claim 1-6, it comprises following process:
Take by weighing the amoxicillin according to quantity, add the adjuvant commonly used of 10%-200%, adopt marumerization to granulate; With the granule that the makes granulate that sieves;
Take by weighing mannatide according to quantity, add the adjuvant commonly used of 100%-1000%, adopt marumerization to granulate; With the granule that the makes granulate that sieves.
According to the described preparation method of claim 7, it is characterized in that 8, the amount of described amoxicillin and mannatide is the amoxicillin: 100-1250 weight portion mannatide: 1-30 weight portion.
According to claim 7 or 8 described preparation methoies, it is characterized in that 9, described granule sieves granulate for crossing 16 mesh sieves earlier after 60 mesh sieve granulate, the above part of following 60 mesh sieves of 16 mesh sieves is prepared granule.
According to claim 7 or 8 described preparation methoies, it is characterized in that 10, described adjuvant is that in disintegrating agent, adhesive, diluent, correctives, the lubricant one or several are united use.
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