CN102895177B - Metronidazole mucilage and preparation method thereof - Google Patents
Metronidazole mucilage and preparation method thereof Download PDFInfo
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- CN102895177B CN102895177B CN201210408765.XA CN201210408765A CN102895177B CN 102895177 B CN102895177 B CN 102895177B CN 201210408765 A CN201210408765 A CN 201210408765A CN 102895177 B CN102895177 B CN 102895177B
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Abstract
The invention discloses a metronidazole mucilage which is characterized by comprising the following components in parts by weight: 1000 parts of water, 1-10 parts of metronidazole, 10-300 parts of glycerol and/or propylene glycol, 0.1-10 parts of chlorhexidine, 1-100 parts of polyethylene oxide, 5-100 parts of polyoxyethylene polypropylene oxide copolymer and 0.05-0.5 parts of EDTA (Ethylene Diamine Tetraacetic Acid) disodium. The invention also discloses a preparation method of the metronidazole mucilage, comprising the steps of dissolving metronidazole by using water, adding other components, and fully and uniformly mixing to form a colloidal solution. The metronidazole mucilage disclosed by the invention has the due efficacy of metronidazole drugs and is capable of simulating cervix uteri, vagina mucus and moist local ecological environment of healthy women, suitable for the treatment and the rehabilitation protection of female reproductive tract infections, menopause vaginitis and reproductive tract infection after the uterus ovarian surgery and capable of overcoming the defect that the dispersion of traditional vaginal effervescent tablets, vaginal suppositories and lotions may be influenced due to insufficient environmental moisture.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, relate in particular to a kind of metronidazole mucilage; In addition the invention still further relates to, the preparation method of this metronidazole mucilage.
Background technology
Metronidazole is treatment climacteric women and the vaginitis of ovary and uterus hands postoperative patient and the common medicine of senile vaginitis, dosage form has vagina effervescence agent, vaginal suppository, and these dosage forms obviously have to be affected the moistening hydrophilic environment of vagina and make it have the defect of dry sensation.
The ultimate principle of vagina effervescence be under the acid-base material that contains in the tablet moisture existence condition in vaginal environment, occur neutralization reaction simultaneously carbon dioxide gas form band medicine foam medicine disperseed, vaginal suppository is from the solid-state process that is melted into liquid, except temperature factor, moisture is also essential condition, for patient and the middle and aged women of vaginal secretion liquid deficiency, women with the physiology congenital day after tomorrow of hyposecretion, above-mentioned dosage form may affect medicine and disperse because environment moisture content is not enough, obviously be inappropriate, the other drug of wishing clinically to overcome above-mentioned defect replaces.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of metronidazole mucilage; it can should have drug effect simultaneously in the performance of metronidazole medicine; simulation healthy women cervix uteri, vaginal mucus and moistening hydrophilic local ecological environment; be conducive to the treatment of female genital tract infection and rehabilitation protection, be particularly suitable for treating climacteric vaginitis and ovary and uterus operation after reproductive tract infection.
The crude drug that the present invention adopts and adjuvant all meet the regulation of < < Chinese Pharmacopoeia > > or < < British Pharmacopoeia > >, < < American Pharmacopeia > >.
For solving the problems of the technologies described above, the invention provides a kind of metronidazole mucilage, the component that contains following weight portion: 1000 parts, water, metronidazole 1-10 part, glycerol and/or 10 ~ 300 parts of propylene glycol, 0.1 ~ 10 part of chlorhexidine, 1 ~ 100 part of poly(ethylene oxide), 5 ~ 100 parts of poloxalkols, 0.05 ~ 0.5 part of EDETATE SODIUM.
Preferably, the molecular weight of described poly(ethylene oxide) is between 100 ~ 12000.
Preferably, described chlorhexidine is acetate, hydrochlorate or gluconate.
The present invention also provides the preparation method of above-mentioned metronidazole mucilage, comprises the steps:
Step 1: metronidazole is dissolved by suitable quantity of water, sneak into glycerol and/or propylene glycol, poloxalkol and poly(ethylene oxide), make to be fully mixed into colloid solution.
Step 2: just suitable quantity of water is dissolved chlorhexidine, EDETATE SODIUM.
Step 3: the solution that step 2 is obtained is sneaked in the colloid solution being obtained by step 1 again, makes fully to mix.
Preferably, in step 1, described blender is that container or the homogenizer class of conventional belt stirrer mixed apparatus.
Preferably, in step 3, described fully mix after, regulate PH at 6.0-7.0.
Metronidazole mucilage prepared by the inventive method meets China national drug standard.
The consumption of metronidazole mucilage of the present invention and the course for the treatment of can appropriately adjust according to the light and heavy degree of patient's age, disease, but are generally vagina administration 2 times every day, each 5ml, before getting up morning and evening just before going to bed respectively once, take 5-7 day as a course for the treatment of.
The present invention has following beneficial effect: the postoperative patient Yi Fasheng of the women in climacteric or menopause and ovary and uterus anaerobic infection; because secretion reduces; mucosa becomes dry and lacks lubricated and protected acidic; so many with the vaginovulvar puckery calcination excitement of itching; be difficult to stand, affect quality of life.Metronidazole mucilage of the present invention can be naturally equably affine, stick, be covered in reproductive tract mucomembranous surface; not only can make metronidazole performance anti-inflammation drug effect; and protect impaired reproductive tract mucosa; supplement due lubricated moisturizing simultaneously; maintain specific acid or alkali environment, for recovering preventing mechanism, provide condition.Metronidazole mucilage simulation healthy women cervix uteri/vaginal mucus of the present invention and moistening hydrophilic local ecological environment; be more conducive to the treatment of female genital tract infection and rehabilitation protection, overcome the defect (traditional vagina effervescence agent, vaginal suppository, lotion may affects because environment moisture content is not enough medicine dispersion) of vagina effervescence agent, vaginal suppository, lotion.Metronidazole mucilage of the present invention has retained above-mentioned enough advantages of dosage form property of medicine persistent period, it is a kind of homodisperse medicine aqueous solution, evolution process and relatively long onset time that need to be from solid to liquid, so onset time rapidly and keep enough durations, can with vaginal mucosa preferably compatible with contact, give with moistening-----this meeting of local environment necessity simultaneously and bring comparatively comfortable subjective feeling to user, unlikely generation is dried and foreign body sensation, visible, metronidazole mucilage of the present invention has solved traditional metronidazole agent (as vagina effervescence agent, vaginal suppository, lotion etc.) insurmountable technical problem, reached the unforeseeable technique effect of traditional metronidazole agent.The present invention is containing the mucilage of 37.5mg metronidazole and the contrast of the metronidazole suppository of 500mg, and curative effect is similar.
The specific embodiment
The present invention is described in further detail by the following examples:
Embodiment mono-:
By 7.5g metronidazole 800ml water dissolution, insert in container; 40g glycerol, 10g propylene glycol, 10g poloxalkol and 30g poly(ethylene oxide) 8000 are sneaked into, be stirred to material dissolution and become colloidal solution shape; In another container by 0.7g chlorhexidine acetate, 0.1gEDTA disodium with sneaking in above-mentioned colloid solution after 200ml water dissolution, fully stir evenly, regulate PH be 6.0, place subpackage after 12 hours, obtain metronidazole mucilage finished product.
Embodiment bis-:
By 75g metronidazole 8000ml water dissolution, insert in container; 300g glycerol, 200g propylene glycol, 100g poloxalkol and 300g poly(ethylene oxide) 8000 are sneaked into, put homogenizing to material dissolution in homogenizer and become colloidal solution shape; In another container by 7g chlorhexidine acetate, 1gEDTA disodium with sneaking in above-mentioned colloid solution after 2000ml water dissolution, fully stir evenly, regulate PH be 7.0, place subpackage after 10 hours, obtain metronidazole mucilage.
Embodiment tri-:
By 1g metronidazole 800ml water dissolution, insert in container; 50g glycerol, 100g poloxalkol and 1g poly(ethylene oxide) 6000 are sneaked into, be stirred to material dissolution and become colloidal solution shape; In another container by 10g Chlorhexidine hydrochloride, 0.5g EDETATE SODIUM with sneaking into after 200ml water dissolution in above-mentioned colloid solution, regulate PH be 6.5, fully stir evenly, obtain metronidazole mucilage.
Embodiment tetra-:
By 5g metronidazole 800ml water dissolution, insert in container; 10g glycerol, 20g poloxalkol and 100g poly(ethylene oxide) 6000 are sneaked into, be stirred to material dissolution and become colloidal solution shape; In another container by 10g chlorhexidine acetate, 0.1gEDTA disodium with sneaking in above-mentioned colloid solution after 200ml water dissolution, fully stir evenly, regulate PH be 7.0, obtain metronidazole mucilage.
Embodiment five:
By 10g metronidazole 800ml water dissolution, insert in container; 300g propylene glycol, 5g poloxalkol and 100g poly(ethylene oxide) 6000 are sneaked into, be stirred to material dissolution and become colloidal solution shape; In another container by 0.5g chlorhexidine gluconate, 0.05g EDETATE SODIUM with sneaking in above-mentioned colloid solution after 200ml water dissolution, fully stir evenly, regulate PH be 7.0, obtain metronidazole mucilage.
Embodiment six:
By 5g metronidazole 800ml water dissolution, insert in container; 100g glycerol, 5g poloxalkol and 100g poly(ethylene oxide) 4000 are sneaked into, be stirred to material dissolution and become colloidal solution shape; In another container by 0.1g chlorhexidine acetate, 0.05g EDETATE SODIUM with sneaking in above-mentioned colloid solution after 200ml water dissolution, fully stir evenly, regulate PH be 7.0, obtain metronidazole mucilage.
By clinical verification, beneficial effect of the present invention is described in further detail below:
The bacterial vaginosis case and the trichomonal vaginitis case that meet clinical criteria are divided into two groups at random: tested group of 101 examples, 38.33 ± 5.12 years old mean age, wherein treat trichomonal vaginitis 81 examples, treatment bacterial vaginosis 20 examples.Matched group 53 examples, 36.36 ± 4.9 years old mean age, wherein treat trichomonal vaginitis 43 examples, treatment bacterial vaginosis 10 examples.
Take metronidazole mucilage of the present invention as tested group of medicine, commercially available metronidazole suppository (500mg/ grain bolt) is matched group medicine.Medication is in Table 1:
Table 1: medication
MAIN OUTCOME MEASURES result and analysis in table 2, table 3, table 4:
Table 2: treat trichomonal vaginitis symptom, sign efficacy analysis for two groups
Table 3: treat bacterial vaginosis symptom, sign efficacy analysis for two groups
Table 4: two groups for the treatment of total effectses analysis
Clinical verification conclusion (of pressure testing): treat after 14 days, tested group 101 example and matched group 53 examples in effective percentage be respectively 88.12% and 92.46%, P > 0.05(in Table 4), show the two curative effect there was no significant difference.There is untoward reaction in tested group of none example of 101 routine patients.Metronidazole mucilage of the present invention has the feature that diffuses into rapidly medicinal liquid film in intravaginal, and more easily arrive solid drugs and be difficult to the affected part arriving, vagina fold place, and easily maintain reservation.Contain the mucilage of 37.5mg metronidazole and the metronidazole suppository curative effect of 500mg without significant difference, this property of medicine shape is similar to normal secretion, and patient's foreign body sensation is light, without bad sensation, is easy to psychological endurance.
Claims (6)
1. a metronidazole mucilage, it is characterized in that, comprise the component of following weight portion: 1000 parts, water, metronidazole 1-10 part, glycerol and/or 10～300 parts of propylene glycol, 0.1～10 part of chlorhexidine, 1～100 part of poly(ethylene oxide), 5～100 parts of poloxalkols, 0.05～0.5 part of EDETATE SODIUM.
2. metronidazole mucilage as claimed in claim 1, is characterized in that, the molecular weight of described poly(ethylene oxide) is between 100～12000.
3. metronidazole mucilage as claimed in claim 1, is characterized in that, described chlorhexidine is acetate, hydrochlorate or gluconate.
4. a preparation method for metronidazole mucilage as claimed in claim 1, is characterized in that, in turn includes the following steps:
Step 1: metronidazole is dissolved by suitable quantity of water, sneak into glycerol and/or propylene glycol, poloxalkol and poly(ethylene oxide), make to be fully mixed into colloid solution in blender;
Step 2: suitable quantity of water is dissolved to chlorhexidine, EDETATE SODIUM;
Step 3: the solution that step 2 is obtained is sneaked in the colloid solution being obtained by step 1, makes fully to mix.
5. the preparation method of metronidazole mucilage as claimed in claim 4, is characterized in that, in step 1, described blender is that container or the homogenizer class of conventional belt stirrer mixed apparatus.
6. the preparation method of metronidazole mucilage as claimed in claim 4, is characterized in that, in step 3, described fully mix after, regulate pH at 6.0-7.0.
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| CN102552114A (en) * | 2012-03-19 | 2012-07-11 | 段亚东 | Metronidazole ophthalmic gel and preparation method and application thereof |
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| CN102552114A (en) * | 2012-03-19 | 2012-07-11 | 段亚东 | Metronidazole ophthalmic gel and preparation method and application thereof |
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Effective date of registration: 20200908 Address after: 588 Longchang Road, Yangpu District, Shanghai, 201499_ Room 2301-2303, No.2 (centralized registration place) Patentee after: Shanghai ruixiao Medical Technology Co., Ltd Address before: 200434 room 57, No. 289, Lane 202, Memorial Road, Shanghai, Yangpu District Patentee before: Wang Xiaoming |
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Effective date of registration: 20201231 Address after: Room 101, building 763, 2865-2 Zhoujiazui Road, Yangpu District, Shanghai 200082 Patentee after: Shanghai Rui Rui Biomedical Technology Co.,Ltd. Address before: 201499 588 Longchang Road, Yangpu District, Shanghai_ Room 2301-2303, No.2 (centralized registration place) Patentee before: Shanghai ruixiao Medical Technology Co., Ltd |