CN100446774C - Clindamycin hydrochloride vaginal effervescent tablet and its preparing method - Google Patents
Clindamycin hydrochloride vaginal effervescent tablet and its preparing method Download PDFInfo
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- CN100446774C CN100446774C CNB2005100100551A CN200510010055A CN100446774C CN 100446774 C CN100446774 C CN 100446774C CN B2005100100551 A CNB2005100100551 A CN B2005100100551A CN 200510010055 A CN200510010055 A CN 200510010055A CN 100446774 C CN100446774 C CN 100446774C
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- Prior art keywords
- clindamycin hydrochloride
- acid
- effervescent tablet
- clindamycin
- vaginal effervescent
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- KDLRVYVGXIQJDK-AWPVFWJPSA-N clindamycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 KDLRVYVGXIQJDK-AWPVFWJPSA-N 0.000 title claims abstract description 45
- 229960001200 clindamycin hydrochloride Drugs 0.000 title claims abstract description 39
- 239000007938 effervescent tablet Substances 0.000 title claims abstract description 26
- 239000003814 drug Substances 0.000 claims abstract description 12
- 238000002360 preparation method Methods 0.000 claims abstract description 11
- 239000000314 lubricant Substances 0.000 claims abstract description 8
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 6
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- 239000002253 acid Substances 0.000 claims description 15
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 13
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 13
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 13
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 12
- 229920000053 polysorbate 80 Polymers 0.000 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 11
- 239000008187 granular material Substances 0.000 claims description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 10
- 150000001447 alkali salts Chemical class 0.000 claims description 10
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 10
- 235000002906 tartaric acid Nutrition 0.000 claims description 10
- 239000011975 tartaric acid Substances 0.000 claims description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims description 8
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 8
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 8
- 229960002227 clindamycin Drugs 0.000 claims description 7
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 6
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 6
- 239000004327 boric acid Substances 0.000 claims description 6
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical group [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 5
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- 239000007779 soft material Substances 0.000 claims description 5
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 4
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 4
- 239000011707 mineral Substances 0.000 claims description 4
- 235000010755 mineral Nutrition 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 150000007524 organic acids Chemical class 0.000 claims description 4
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 2
- 239000001530 fumaric acid Substances 0.000 claims description 2
- 235000011087 fumaric acid Nutrition 0.000 claims description 2
- 239000001630 malic acid Substances 0.000 claims description 2
- 235000011090 malic acid Nutrition 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims description 2
- 229940079593 drug Drugs 0.000 claims 2
- 210000001215 vagina Anatomy 0.000 abstract description 12
- 230000000694 effects Effects 0.000 abstract description 10
- 208000004926 Bacterial Vaginosis Diseases 0.000 abstract description 8
- 239000006260 foam Substances 0.000 abstract description 5
- 230000008901 benefit Effects 0.000 abstract description 4
- 230000001225 therapeutic effect Effects 0.000 abstract description 3
- 238000010579 first pass effect Methods 0.000 abstract description 2
- 210000004185 liver Anatomy 0.000 abstract description 2
- 210000004877 mucosa Anatomy 0.000 abstract description 2
- 230000002085 persistent effect Effects 0.000 abstract description 2
- 239000004094 surface-active agent Substances 0.000 abstract description 2
- 230000001988 toxicity Effects 0.000 abstract description 2
- 231100000419 toxicity Toxicity 0.000 abstract description 2
- 206010067484 Adverse reaction Diseases 0.000 abstract 1
- 206010067482 No adverse event Diseases 0.000 abstract 1
- 239000000853 adhesive Substances 0.000 abstract 1
- 230000001070 adhesive effect Effects 0.000 abstract 1
- 230000006838 adverse reaction Effects 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 229940126703 systemic medication Drugs 0.000 abstract 1
- 208000037009 Vaginitis bacterial Diseases 0.000 description 7
- 150000001412 amines Chemical class 0.000 description 4
- 230000000844 anti-bacterial effect Effects 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- 241000251468 Actinopterygii Species 0.000 description 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 2
- 206010046914 Vaginal infection Diseases 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 235000010338 boric acid Nutrition 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- OJMMVQQUTAEWLP-KIDUDLJLSA-N lincomycin Chemical class CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@@H](C)O)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 OJMMVQQUTAEWLP-KIDUDLJLSA-N 0.000 description 2
- 206010025482 malaise Diseases 0.000 description 2
- 229960000282 metronidazole Drugs 0.000 description 2
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 description 2
- 231100000957 no side effect Toxicity 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 239000000829 suppository Substances 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 241000193738 Bacillus anthracis Species 0.000 description 1
- 241000606125 Bacteroides Species 0.000 description 1
- 241000606124 Bacteroides fragilis Species 0.000 description 1
- 241000193468 Clostridium perfringens Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000186216 Corynebacterium Species 0.000 description 1
- 208000004145 Endometritis Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 241000605909 Fusobacterium Species 0.000 description 1
- OJMMVQQUTAEWLP-UHFFFAOYSA-N Lincomycin Natural products CN1CC(CCC)CC1C(=O)NC(C(C)O)C1C(O)C(O)C(O)C(SC)O1 OJMMVQQUTAEWLP-UHFFFAOYSA-N 0.000 description 1
- 208000029082 Pelvic Inflammatory Disease Diseases 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
- 241000191992 Peptostreptococcus Species 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 208000007893 Salpingitis Diseases 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 201000008100 Vaginitis Diseases 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000003756 cervix mucus Anatomy 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 206010013023 diphtheria Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- DNJIEGIFACGWOD-UHFFFAOYSA-N ethanethiol Chemical compound CCS DNJIEGIFACGWOD-UHFFFAOYSA-N 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 229960005287 lincomycin Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 201000009442 piebaldism Diseases 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 238000001243 protein synthesis Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 238000007910 systemic administration Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a vaginal effervescent tablet made from clindamycin hydrochloride and a preparation method thereof. The clindamycin hydrochloride is applied to the vaginal effervescent tablet, and the clindamycin hydrochloride is used as a therapeutical agent. The vaginal effervescent tablet is composed of an effervescent disintegrating agent, a lubricating agent, an adhesive and a surfactant. After the vaginal effervescent tablet is locally applied, imperceptible and persistent foam can be generated in an effervescent disintegrating mode, and medicine is uniformly distributed in foam; thereby, the contact area of the medicine and vaginal mucosa is enlarged, and the medicine is fully absorbed. Because the medicine is applied to the vagina, the first pass effect of the liver is avoided, the adverse reaction caused by systemic medication is overcome, the toxicity is lowered, the effective concentration of the medicine on focus positions is enhanced, and the defects of other preparations for treating the bacterial vaginitis is overcome. The present invention has the advantages of scientific, reasonable and feasible formula, obvious treatment effect, no adverse reaction, and good economical and social benefits.
Description
Technical field
The present invention relates to a kind of effervescent tablet for the treatment of bacterial vaginosis, be specifically related to a kind of vagina effervescence by the Clindamycin Hydrochloride preparation.
Background technology
Clindamycin Hydrochloride belongs to lincomycin series antibiotics, antibacterial activity is high 4～8 times than lincomycin, gram positive bacteria such as staphylococcus (comprising the penicillin resistant strain), Streptococcus, diphtheria corynebacterium, anthrax bacillus etc. all there is higher antibacterial activity, the Grain-negative anaerobe is also had good antibacterial activity, and Bacteroides comprises that clinical common pathogenic anaerobe such as bacteroides fragilis, Fusobacterium, dyspepsiacoccus, peptostreptococcus, bacillus perfringens are extremely sensitive to this product mostly.And anaerobe is the main pathogens of pudendum, vaginitis, salpingitis, pelvic inflammatory disease, endometritis, pelvic cavity combined postoperative disease, and clindamycin can be brought into play important therapeutical effect to above-mentioned infection.
In China, the gynaecopathia sickness rate is up to more than 50%, and is higher at some outlying district sickness rate, especially suffers from gynaecopathia in the married woman mostly to some extent.Infectious disease is the most general in the gynaecopathia, and bacterial vaginosis is the modal vaginal infection disease of childbearing age women.Clindamycin is as a clinical line medicine of treatment bacterial vaginosis, and present domestic have only injection and capsule only have externally used paste and suppository abroad.
Summary of the invention
The object of the present invention is to provide a kind of vagina tissue that directly acts on, increase the medicine local concentration, act on lasting, easy to use, short treating period, curative effect soon, the effervescent tablet-clindamycin hydrochloride vaginal effervescent tablet of the treatment bacterial vaginosis that has no side effect.
The invention provides a kind of preparation method of clindamycin hydrochloride vaginal effervescent tablet, before the preparation that raw material and main adjuvant is dry in advance, control moisture content strengthens stability of formulation.
Clindamycin hydrochloride vaginal effervescent tablet of the present invention, its composition comprises:
Clindamycin 30～35%
Acid 22～35%
Basic salt 24～39%
Polyvinylpyrrolidone 2～5%
Tween 80 4～8%
Lubricant 0.1～0.8%
Described acid is organic acid or mineral acid, and organic acid is tartaric acid, fumaric acid, malic acid, and mineral acid is a boric acid.Described basic salt is sodium carbonate, sodium bicarbonate.Described polyvinylpyrrolidone can replace with Polyethylene Glycol.Described lubricant is magnesium stearate, Pulvis Talci.
The preparation method of clindamycin hydrochloride vaginal effervescent tablet agent of the present invention may further comprise the steps:
(1) Clindamycin Hydrochloride, acid, basic salt are sieved drying respectively;
(2) polyvinylpyrrolidone, tween 80 are added dehydrated alcohol and make binding agent;
(3) Clindamycin Hydrochloride, acid, basic salt are mixed, add binding agent, make soft material;
(4) 12 mesh sieves are granulated, oven dry, 16 mesh sieve granulate;
(5) add lubricant, be mixed;
(6) measure granule content, it is heavy to calculate sheet, is pressed into special-shaped sheet.
Main feature of the present invention is first clindamycin to be applied to the vagina effervescence agent, can the effervescent disintegrate produce a large amount of trickle and persistent foams after the use, medicine is evenly distributed in the foam, has enlarged the contact area of medicine and vaginal mucosa, absorb fully, evident in efficacy, avoid the liver first-pass effect of oral formulations, overcome the untoward reaction that systemic administration causes, reduced toxicity, improve the lesions position concentration medicine, thereby improved curative effect.Simultaneously also overcome external preparation such as unguentum, suppository and need use skewness, the defective of pollution clothes by utensil.
Another characteristics of the present invention are to adopt reasonably combination and technology in Recipe.In prescription, add the tween 80 of about 4-8%, can make foam duration longer, improve curative effect as surfactant; It can make polyvinylpyrrolidone be dissolved in fast in the dehydrated alcohol as binding agent, has shortened preparation time.On technology, the hydrophilic supplementary material is carried out drying earlier, thereby realize that soda acid mixes one-step palletizing simultaneously, promptly guaranteed the blended uniformity of supplementary material, avoid occurring phenomenons such as piebaldism, simultaneously stability of drug products and the production efficiency that improves again.
The mechanism of action of Clindamycin Hydrochloride is to combine with bacterial ribosome 50S subunit, stops peptide elongation, thereby suppresses the protein synthesis of bacterial cell, belong to bacteriostatic, also have bactericidal action when higher concentration, every of the present invention contains clindamycin 0.2g, dosage is relatively large, and action effect is remarkable.
The present invention reasonably is applied to the vagina effervescence agent with Clindamycin Hydrochloride, and its prescription is reasonable, technology is reliable, easy operating.Remarkable through clinical practice treatment bacterial vaginosis effect, untoward reaction is few, and advantage is obvious, overcome the defective of existing clindamycin dosage form, be a kind of vagina local application for the treatment of bacterial vaginosis safely and effectively, can promote, will produce remarkable economic efficiency and social benefit.
The specific embodiment
Embodiment 1
Clindamycin Hydrochloride 200g
Tartaric acid 150g
Sodium bicarbonate 170g
Boric acid 50g
Polyvinylpyrrolidone 15g
Tween 80 35g
Dehydrated alcohol 150ml
Magnesium stearate 2g
Pulvis Talci 2g
Clindamycin Hydrochloride, tartaric acid, sodium bicarbonate, boric acid are sieved dry control moisture＜2% respectively; Polyvinylpyrrolidone, tween 80 are added dehydrated alcohol make binding agent; Clindamycin Hydrochloride, tartaric acid, sodium bicarbonate, boric acid are mixed, add binding agent and make soft material; 12 mesh sieves are granulated, oven dry, 16 mesh sieve granulate; Add magnesium stearate and Pulvis Talci, be mixed; Pressing cost invention clindamycin hydrochloride vaginal effervescent tablet abnormity sheet is 1000 behind the mensuration granule content.
Embodiment 2
Clindamycin Hydrochloride 200g
Tartaric acid 170g
Sodium bicarbonate 192g
Polyvinylpyrrolidone 20g
Tween 80 40g
Dehydrated alcohol 150ml
Magnesium stearate 2g
With Clindamycin Hydrochloride, tartaric acid, sodium bicarbonate sieve respectively, drying, control moisture content＜2%;
Polyvinylpyrrolidone, tween 80, dehydrated alcohol are mixed with binding agent; With Clindamycin Hydrochloride, tartaric acid, sodium bicarbonate mixing, add binding agent, the system soft material; Granulate oven dry, 16 mesh sieve granulate with 12 mesh sieves.Add magnesium stearate, be mixed, pressing cost invention Clindamycin Hydrochloride effervescent tablet abnormity sheet is 1000 behind the mensuration granule content.
Use clindamycin hydrochloride vaginal effervescent tablet treatment bacterial vaginosis clinical effectiveness of the present invention and observe, and compare with the metronidazole effervescent tablet.
Physical data: non-anemia of pregnant woman woman 120 examples more than 18 years old, test group 60 examples, matched group 60 examples
Diagnostic criteria: vaginal secretions increases or distinguishes the flavor of for sparing the matter shape or having to smell as of rotten fish; The linear element cell accounts for more than 20% in wet sheet of vagina or the staining section; And meet in following 3 indexs at least 2: the vagina discharge opeing of (1) uniformity, (2) vagina PH＞4.7, (3) amine test positive.
Therapeutic Method: use clindamycin hydrochloride vaginal effervescent tablet of the present invention, behind the pudendum cleaning, with finger tablet is pushed the vagina deep before sleeping, 1 slice/day, 7 days is a course of treatment.The same test group of matched group Metronidazole Tablet usage and dosage.
Curative effect determinate standard: (1) cures: the symptom complete obiteration, and the leucorrhea outward appearance is normal, the stench flavor of no fish; Clues cell is less than 20%; Vagina PH＜4.7; Amine test is turned out cloudy.(2) produce effects: symptom and Signs alleviate; Clues cell is less than 20%; Binomial index vagina PH＜4.7, amine test is turned out cloudy and is met one.(3) invalid: symptom does not have improvement; Clues cell is more than more than 20%; Binomial index vagina PH＜4.7, amine test is turned out cloudy and is not all met.
Therapeutic outcome:
7 days effects relatively after test group and the treatment of control group
Group recovery from illness produce effects is invalid
Test group (N=60) 54 33
Matched group (N=60) 45 4 11
The test group cure rate is 90%, and effective percentage reaches 95%, and the matched group cure rate is 75%, and effective percentage reaches 82%.Clindamycin Hydrochloride effervescent tablet relapse rate of the present invention is extremely low, and untoward reaction is rare, has no side effect.
Claims (7)
1, a kind of clindamycin hydrochloride vaginal effervescent tablet is characterized in that composition comprises:
Clindamycin 30～35%
Acid 22～35%
Basic salt 24～39%
Polyvinylpyrrolidone 2～5%
Tween 80 4～8%
Lubricant 0.1～0.8%;
Its preparation method is:
(1) Clindamycin Hydrochloride, acid, basic salt are sieved drying respectively;
(2) polyvinylpyrrolidone, tween 80 are added dehydrated alcohol and make binding agent;
(3) Clindamycin Hydrochloride, acid, basic salt are mixed, add binding agent, make soft material;
(4) 12 mesh sieves are granulated, oven dry, 16 mesh sieve granulate;
(5) add lubricant, be mixed;
(6) measure granule content, it is heavy to calculate sheet, is pressed into special-shaped sheet.
2, clindamycin hydrochloride vaginal effervescent tablet according to claim 1 is characterized in that: described acid is organic acid or mineral acid, and organic acid is tartaric acid, fumaric acid or malic acid, and mineral acid is a boric acid.
3, clindamycin hydrochloride vaginal effervescent tablet according to claim 1 is characterized in that: described basic salt is sodium carbonate or sodium bicarbonate.
4, clindamycin hydrochloride vaginal effervescent tablet according to claim 1 is characterized in that: described lubricant is magnesium stearate or Pulvis Talci.
5, clindamycin hydrochloride vaginal effervescent tablet according to claim 1 is characterized in that: the weight of making 1000 each crude drug of effervescent tablet is:
Clindamycin Hydrochloride 200g
Tartaric acid 150g
Sodium bicarbonate 170g
Boric acid 50g
Polyvinylpyrrolidone 15g
Tween 80 35g
Dehydrated alcohol 150ml
Magnesium stearate 2g
Pulvis Talci 2g.
6, clindamycin hydrochloride vaginal effervescent tablet according to claim 1 is characterized in that: the weight of making 1000 each crude drug of effervescent tablet is:
Clindamycin Hydrochloride 200g
Tartaric acid 170g
Sodium bicarbonate 192g
Polyvinylpyrrolidone 20g
Tween 80 40g
Dehydrated alcohol 150ml
Magnesium stearate 2g.
7, the preparation method of the described clindamycin hydrochloride vaginal effervescent tablet agent of claim 1 is characterized in that may further comprise the steps:
(1) Clindamycin Hydrochloride, acid, basic salt are sieved drying respectively;
(2) polyvinylpyrrolidone, tween 80 are added dehydrated alcohol and make binding agent;
(3) Clindamycin Hydrochloride, acid, basic salt are mixed, add binding agent, make soft material;
(4) 12 mesh sieves are granulated, oven dry, 16 mesh sieve granulate;
(5) add lubricant, be mixed;
(6) measure granule content, it is heavy to calculate sheet, is pressed into special-shaped sheet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100100551A CN100446774C (en) | 2005-05-31 | 2005-05-31 | Clindamycin hydrochloride vaginal effervescent tablet and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100100551A CN100446774C (en) | 2005-05-31 | 2005-05-31 | Clindamycin hydrochloride vaginal effervescent tablet and its preparing method |
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| Publication Number | Publication Date |
|---|---|
| CN1748708A CN1748708A (en) | 2006-03-22 |
| CN100446774C true CN100446774C (en) | 2008-12-31 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101744833B (en) * | 2008-12-02 | 2012-05-23 | 济南宏瑞创博医药科技开发有限公司 | Pharmaceutical composition for treating bacterial vaginitis |
| CN102335151B (en) * | 2010-07-20 | 2015-07-08 | 杭州赛利药物研究所有限公司 | Clindamycin phosphate vaginal mucosa tablet and preparation method thereof |
| CN116059177A (en) * | 2022-12-14 | 2023-05-05 | 迪沙药业集团有限公司 | Clindamycin phosphate composition and preparation method thereof |
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|---|---|---|---|---|
| WO2002003896A1 (en) * | 2000-07-11 | 2002-01-17 | Umd, Inc. | Device and method for intravaginal or transvaginal treatment of fungal, bacterial, viral or parasitic infections |
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| WO2003020736A1 (en) * | 2001-08-28 | 2003-03-13 | Pharmacia Corporation | Crystaline clindamycin free base |
| CN1586497A (en) * | 2004-08-02 | 2005-03-02 | 程月发 | Clindamycin metronidazole vagina effervescent tablet and its preparing method and use |
-
2005
- 2005-05-31 CN CNB2005100100551A patent/CN100446774C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1360495A (en) * | 1999-08-06 | 2002-07-24 | 法玛西雅厄普约翰美国公司 | Intravaginal clindamycin ovule composition |
| WO2002003896A1 (en) * | 2000-07-11 | 2002-01-17 | Umd, Inc. | Device and method for intravaginal or transvaginal treatment of fungal, bacterial, viral or parasitic infections |
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