CN109646394A - A kind of sucrose gel that treating bacterial vaginitis and its application - Google Patents
A kind of sucrose gel that treating bacterial vaginitis and its application Download PDFInfo
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Abstract
The invention discloses a kind of sucrose gel for treating bacterial vaginitis and its applications in treatment bacterial vaginitis, are prepared using following technique: deionized water preparation adjusts pH value, sucrose heating for dissolving, sizing material is added, and stirs evenly, obtains sucrose gel.Sizing material is xanthan gum, Arabic gum, Acritamer 940 and temperature sensitive hydrogel；Temperature sensitive hydrogel is poloxamer188.It has the beneficial effect that sucrose gel by the proliferation of the promotion intrinsic beneficial lactobacillus of intravaginal, enhances vagina acidity, adjusts vaginal flora, inhibits, removes vagina harmful bacteria, can achieve the effect that healing bacterial vaginosis BV.In order to preferably adapt to patient, temperature sensitive hydrogel is increased.
Description
Technical field
The present invention relates to field of medicine production, more particularly, to a kind of sucrose gel for treating bacterial vaginitis and its answer
With.
Background technique
Bacterial vaginosis BV (BV) is the common lower genital tract infection disease of Female in child bearing period, is since normal vagina is micro-
Ecological flora composition changes, i.e. the dominant bacteria Bacillus acidi lactici of maintenance normal vagina acidic environment is reduced, and other are a variety of micro-
Biological (predominantly anaerobic bacteria) increases the clinical syndrome of caused absence of vagina mucosal inflammation performance.Bacterial vaginosis BV and palace
The generation of neck inflammation, pelvic inflammatory disease, infertility, ectopic pregnancy, Sex transmitted pathogen etc. is related, the gestational period can increase spontaneous abortion, premature labor,
The complication such as premature rupture of fetal membranes, chorioamnionitis, infection of newborn, have seriously affected female reproductive health.
The gel preparation of bacterial vaginitis is treated mainly using the gel preparation of metronidazole as representative.There are more document reports
Metrogel treats vaginitis.This is vaginitis to be treated in a manner of antibiotic or antibacterial agent, thus side effect is to exist
Drug dependence has certain damage to vagina.
Clinical application metronidazole and clindamycin treat BV by standard scheme at present, and 3 months high recurrence rates are up in 30%, 1 year
Recurrence rate is more than 50%, and therefore, it is necessary to explore a kind of next substituted or supplemented current antibiotic treatment of new treatment method, application
Microecologic regulator has become the new direction of rear antibiotic epoch treatment BV, prevention BV recurrence.
With the gel that the sizing materials such as sucrose and xanthan gum are mixed with, referred to as sucrose gel.Be using sucrose as effective component,
Xanthan gum is prepared for excipient, is a kind of new Tiny ecosystem prebiotic preparation, and main component is sucrose, can only be by a small number of thin
Bacterium is decomposed, and sucrose itself does not inhibit the harmful bacteria of intravaginal, but the sizing material based on sucrose and xanthan gum is after becoming gel,
It can be provided with the superiority environment conducive to ability of Lactobacillus in human vagina growth, after Bacillus acidi lactici becomes dominant bacteria, various harmful bacterias
Growth is weakened, therefore has the function of selectively promoting ability of Lactobacillus in human vagina growth.Sizing material role be gel at
Type.This is the principle of the sucrose gel for treating bacterial vaginitis of the sizing materials such as sucrose and xanthan gum preparation.
Sucrose gel treats vaginitis not by the way of antibacterial agent, and there is no the negative of drug dependence.To vagina
Damage it is small.
Preferable trickling is presented in the sucrose gel of the proportion preparation of the sizing materials such as sucrose and xanthan gum selection optimization at room temperature
Property, convenient for being injected in human vagina with syringe, but the preferable common sucrose gel of trickling property at room temperature, entering human body
After intravaginal adapts to 36-37 DEG C of body temperature, it is swollen after encountering vaginal fluid, swelling effect is not necessarily optimal effect,
Cause not covered by sucrose gel swelling at topical vaginal inner part fold, influences therapeutic effect.
The report for the sucrose gel for treating bacterial vaginitis for thering are the sizing materials such as sucrose and xanthan gum to prepare at present, but sucrose
When being retained in vagina fold with xanthan gum for the sucrose gel of main sizing material preparation, if the ingredient and ratio of gel,
Performance does not select to control, and is not necessarily optimal selection.
There is metronidazole that poloxamer188, CARBOPOL 971 is added as temperature sensitive hydrogel preparation for treating yin at present
The report of road inflammation.But metronidazole is still while treatment and has damage to vagina, increases the pain of patient.
Summary of the invention
The purpose of the present invention is to provide a kind of sucrose gel for treating bacterial vaginitis and its treating bacillary yin
Application in road inflammation.
When component design of the present invention, first condition for needing to meet is: keeping the enough dosages of sucrose, keeps treating
Effect.
When component design of the present invention, second condition for needing to meet is: viscosity about exists when 18 DEG C
2200mPa.s left and right.Viscosity is about in 2800mPa.s or so when 36 DEG C.Such design can satisfy sucrose gel normal
18 DEG C of importing human bodies of temperature are convenient.Also it can satisfy sucrose gel at 36 DEG C, temperature becomes apparent, and viscosity becomes larger, and preferably retains
To keep curative effect at vagina fold.
A kind of one of technical solution of the present invention are as follows: sucrose gel for treating bacterial vaginitis, in which: the preparation
Method the following steps are included:
A kind of sucrose gel for treating bacterial vaginitis, in which: the preparation method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, additive amount 10-20g/L in the step (4).
A kind of the two of technical solution of the present invention are as follows: sucrose gel for treating bacterial vaginitis, in which: the preparation
Method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, Arabic gum and Acritamer 940 in the step (4), and xanthan gum additive amount is 10-
20g/L；Arabic gum additive amount is 20-30g/L；Acritamer 940 additive amount is 5-10g/L.
A kind of the three of technical solution of the present invention are as follows: a sucrose gel for treating bacterial vaginitis, in which: the system
Preparation Method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940 and temperature sensitive hydrogel in the step (4)；Temperature
Degree sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 10-20g/L；Arabic gum additive amount is 20-30g/L；
Acritamer 940 additive amount is 5-10g/L；Poloxamer188 additive amount is 100-120g/L.
A kind of the four of technical solution of the present invention are as follows: the application of sucrose gel in treatment bacterial vaginitis.
Of particular note is that: it is recommended that it is solidifying to transport and save sucrose of the invention under the conditions of being lower than 20 DEG C of cool place
Glue.
The German BASF pharmaceutic adjuvant of the poloxamer188 Pluronic 407 of pharmacopeia grade, poloxamer188
(poloxamer 407, P407) is a kind of nonionic surface active agent, has unique reversed thermal gels property, safety
The features such as high, has a good application prospect and important economic value, as auxiliary material be widely used in food processing and
Pharmaceutical industry is included by the U.S. and British Pharmacopoeia.High concentration (20% ~ 30%) P407 aqueous solution is generally required with special
Reversed thermogelling matter, i.e., solution is in sol form under low temperature (4 ~ 5 DEG C), and changes gelled when temperature increases (body temperature)
State is cooled to and can return back to sol form.Temperature sensitive hydrogel be especially important a kind of environment-responsive vagina to
Medicinal gel system, such hydrogel have to temperature change stimuli responsive the performance of gelation.In general, at 25 DEG C to 37
The hydrogel that temperature-responsive can occur within the scope of DEG C is to be suitably applied vaginal jellies carried medicine sustained-release system.Due to temperature sensitive
Property, it is at room temperature the colloidal sol of free-flowing, drug is added in this condition, is formed with immediately under body temperature (36-37 DEG C)
Some strength cannot flow freely gel, can be using injection using the special sol-gel transition performance of this high polymer
Or method is sprayed into complete the placement of medicine-carried system, the discomfort or feeling of pain of patient will not be caused.
Acritamer 940,971P or 974P can be used as thickener, suspending agent, gel-type vehicle bio-adhesive in pharmaceuticals industry
Material, viscosity is high, can be formed with the full-bodied gel of bioadhesive at very low concentrations.Carbomer hydrogel
Most sticky between pH6~11, such as pH < 3 or pH > 12, viscosity is reduced, and strong electrolyte presence can also reduce viscosity.
Compared with prior art, one of beneficial effect are as follows:
The present invention uses sizing material for xanthan gum, Arabic gum, Acritamer 940 and temperature sensitive hydrogel；Temperature sensitivity water
Gel is poloxamer188；Xanthan gum additive amount is 10-20g/L；Arabic gum additive amount is 20-30g/L；Acritamer 940
Additive amount is 5-10g/L；Poloxamer188 additive amount is 100-120g/L.
Viscosity is smaller at room temperature for sucrose gel, and suitable syringe pushes in vagina.In vivo in the case of 36-37 DEG C,
Under the action of temperature sensitive hydrogel poloxamer188, because viscosity becomes larger, trickling property decline occurs with gel form,
It is more suitable among infiltration vagina, wall built-up can be preferably swollen at vaginal walls fold, it is not easy to which trickling, which comes out, to be influenced to treat
Effect.
Compared with prior art, the two of beneficial effect are as follows:
Sucrose addition is 180-200g/L, and faintly acid is presented in the final pH value of gel, this is conducive to keep the growth of vagina beneficial bacterium
Environment.The Comprehensive Clinical curative effect that the present invention treats bacterial vaginosis BV is better than Metrogel in the recent period (treatment the 7th ~ 10 day), far
Phase cure rate (treatment the 21st ~ 30 day) is suitable with Metrogel, and is substantially better than first nitre in terms of restoring patient's vaginal flora
The sucrose gel of azoles gel.
The report for the sucrose gel for treating bacterial vaginitis for thering are the sizing materials such as sucrose and xanthan gum to prepare at present, but sucrose
When being retained in vagina fold with xanthan gum for the sucrose gel of main sizing material preparation, if the ingredient and ratio of gel,
Performance does not select to control, and is not necessarily optimal selection.
The preferred sizing material of the invention patent, xanthan gum, Arabic gum, Acritamer 940 and temperature sensitive hydrogel；Temperature
Sensitive aqueous gel is poloxamer188；By preferred xanthan gum, Arabic gum, Acritamer 940 and its dosage, temperature is reduced
Spend sensitive aqueous gel poloxamer188 dosage.
Specific embodiment
Embodiment 1,
A kind of sucrose gel for treating bacterial vaginitis, in which: the preparation method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180g/L；
Wherein: sizing material is xanthan gum, additive amount 20g/L in the step (4).
Embodiment 2
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 190g/L；
Wherein: sizing material is xanthan gum, additive amount 15g/L in the step (4).Remaining is the same as embodiment 1.
Embodiment 3
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 200g/L；
Wherein: sizing material is xanthan gum, additive amount 10g/L in the step (4).Remaining is the same as embodiment 1.
Embodiment 4
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 190g/L；
Wherein: sizing material is xanthan gum and Arabic gum in the step (4), and xanthan gum additive amount is 15g/L；Arabic gum adds
Dosage is 20g/L；Acritamer 940 additive amount is 5g/L.Remaining is the same as embodiment 1.
Embodiment 5
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 200g/L；
Wherein: sizing material is xanthan gum and Arabic gum in the step (4), and xanthan gum additive amount is 10g/L；Arabic gum adds
Dosage is 30g/L；Acritamer 940 additive amount is 5g/L.Remaining is the same as embodiment 1.
Embodiment 6
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180g/L；
Wherein: sizing material is xanthan gum and Arabic gum in the step (4), and xanthan gum additive amount is 20g/L；Arabic gum adds
Dosage is 30g/L；Acritamer 940 additive amount is 10g/L.Remaining is the same as embodiment 1.
Embodiment 7
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 20g/L；Arabic gum additive amount is 20g/L；Carbomer
940 additive amounts are 5g/L；Poloxamer188 additive amount is 100g/L.Remaining is the same as embodiment 1.
Embodiment 8
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 190g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 15g/L；Arabic gum additive amount is 25g/L；Carbomer
940 additive amounts are 8g/L；Poloxamer188 additive amount is 110g/L.Remaining is the same as embodiment 1.
Embodiment 9
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 200g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 10g/L；Arabic gum additive amount is 30g/L；Carbomer
940 additive amounts are 10g/L；Poloxamer188 additive amount is 120g/L.Remaining is the same as embodiment 1.
Comparative example 1
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 300g/L；
Wherein: sizing material is xanthan gum, temperature sensitive hydrogel in the step (4)；Temperature sensitive hydrogel is pool Lip river
Husky nurse 407；Xanthan gum additive amount is 15g/L；Poloxamer188 additive amount is 130g/L.Remaining is the same as embodiment 1.
Sucrose addition is very big, and by normal preferable curative effect, but temperature sensitive hydrogel dosage is to 130g/L, but phase
Sucrose addition is still not enough to enough temperature is caused to become.Still cause viscosity when 36 DEG C not sticky enough.In vagina
Retention at fold is ineffective, and therapeutic effect is not so good as metronidazole.Under the premise of keeping good temperature to become, other is selected to assist
Sizing material reduces the performance that poloxamer188 additive amount is the invention.The present invention has found this in embodiment 7,8,9
The good selection of kind.
Comparative example 2
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 190g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 50g/L；Arabic gum additive amount is 25g/L；Carbomer
940 additive amounts are 8g/L；Poloxamer188 additive amount is 95g/L.Remaining is the same as embodiment 1.
Sucrose addition is moderate, but xanthan gum is too many, causes viscosity when 18 DEG C larger, imports human body in room temperature
When, push-in viscosity is big, imports difficulty, inconvenient to use.Poloxamer188 additive amount is that 95g/L cooperates matching for other sizing materials
Than causing viscosity when 36 DEG C to increase few, undesirable, the less effective of temperature change.
Comparative example 3
Heating temperature is 45 DEG C in the step (3), sucrose addition 50g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 15g/L；Arabic gum additive amount is 25g/L；Carbomer
940 additive amounts are 10g/L；Poloxamer188 additive amount is 120g/L.Remaining is the same as embodiment 1.
Sucrose is very little, and effect is not so good as metronidazole.
Comparative example 4
Heating temperature is 45 DEG C in the step (3), sucrose addition 300g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940, temperature sensitive hydrogel in the step (4)；Temperature
Sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 15g/L；Arabic gum additive amount is 30g/L；Carbomer
940 additive amounts are 6g/L；Poloxamer188 additive amount is 60g/L.Remaining is the same as embodiment 1.
Although sucrose addition is big, poloxamer188 additive amount is very little, and 36 DEG C of viscosity does not rise, in vaginal rugae
Retention at wrinkle is ineffective, and therapeutic effect is not so good as metronidazole.
Test result is as follows:
1, it takes sucrose gel 20ml obtained by above-described embodiment 1-9 and comparative example 1-4 in 30ml test tube, sets electric heating constant temperature water
In bath, bath temperature gradually rises to 36 DEG C by 18 DEG C of speed with l DEG C/min, with the choked flow stick of rotational viscometer
With the rotation of 12r/min speed, viscosity number (mPa.s) of the measurement each sample in two temperature ranges.
1 viscosity of table
| Project | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 | Embodiment 8 | Embodiment 9 | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 |
| Viscosity (mPa.s) at 18 DEG C | 1865 | 1723 | 1706 | 2206 | 2276 | 2309 | 2256 | 2287 | 2245 | 2276 | 2498 | 2189 | 2267 |
| Viscosity (mPa.s) at 36 DEG C | 1765 | 1678 | 1656 | 2167 | 2201 | 2198 | 2789 | 2880 | 2910 | 2405 | 2587 | 2798 | 2343 |
2, the present invention prepares product sucrose gelling agent to the therapeutic effect effect of bacterial vaginitis
Sucrose gelling agent made of Example 9, comparative example 1,3,4 and metronidazole vagina gelling agent carry out therapeutic effect comparison
(1) Validity Index uses complete analysis collection
Investigational agent: sucrose gelling agent, 5.0 g of specification.Positive control drug: metronidazole vagina gelling agent, 5.0 g of specification.Use SAS
8.0 statistical softwares are analyzed.Validity Index uses complete analysis collection (full analysis set, FAS).
Table 2 treats the 7th ~ 10 day Comprehensive Clinical efficacy result
| Clinical effectiveness | Metrogel | Sucrose gel (embodiment 9) | Sucrose gel (comparative example 1) | Sucrose gel (comparative example 3) | Sucrose gel (comparative example 4) |
| In vain | 61(29.47) | 60(19.17) | 128(58.18) | 58(54.72) | 38(52.05) |
| It cures | 146(70.53) | 253(80.83) | 92(41.82) | 48(45.28) | 35(47.94) |
| It amounts to | 207 | 313 | 220 | 106 | 73 |
Remarks: the accounting that sucrose gel (comparative example 1), sucrose gel (comparative example 3) and sucrose gel (comparative example 4) are cured is inclined
It is low, Metrogel cure accounting be 70.53%, sucrose gel (embodiment 9) cure accounting be 80.83%, P=0.010 <
0.05, there is statistical difference, sucrose gel (embodiment 9) group is better than Metrogel group.
Table 3 treats the 21st ~ 30 day Comprehensive Clinical efficacy result
| Clinical effectiveness | Metrogel | Sucrose gel (embodiment 9) |
| In vain | 76(36.71) | 119(38.02) |
| It cures | 131(63.29) | 194(61.98) |
| It amounts to | 207 | 313 |
Remarks: Metrogel cure accounting be 63.29%, sucrose gel (embodiment 9) cure accounting be 61.98%, P=
0.578 > 0.05, no difference of science of statistics.
(2) Validity Index, which uses, meets scheme collection
Investigational agent: sucrose gelling agent, 5.0 g of specification.Positive control drug: metronidazole vagina gelling agent, 5.0 g of specification.Use SAS
8.0 statistical softwares are analyzed.Validity Index, which uses, meets scheme collection (pre-protocal, PP).
Table 4 treats the 7th ~ 10 day Comprehensive Clinical efficacy result
| Clinical effectiveness | Metrogel | Sucrose gel (embodiment 9) |
| In vain | 61(29.47) | 60(19.17) |
| It cures | 146(70.53) | 253(80.83) |
| It amounts to | 207 | 313 |
The remarks of P=0.010: the accounting that Metrogel is cured is 70.53%, and the accounting that sucrose gel (embodiment 9) is cured is
, there is statistical difference in 80.83%, P < 0.05, and sucrose gel group is better than Metrogel group.
Table 5 treats the 21st ~ 30 day Comprehensive Clinical efficacy result
| Clinical effectiveness | Metrogel | Sucrose gel (embodiment 9) |
| In vain | 75(36.41) | 118(38.19) |
| It cures | 131(63.59) | 191(61.81) |
| It amounts to | 206 | 309 |
Remarks: Metrogel cure accounting be 63.59%, sucrose gel (embodiment 9) cure accounting be 61.81%, P=
0.682 > 0.05, no difference of science of statistics.
As seen from the above table, middle through the embodiment of the present invention to test the results show that treating the 7th ~ 10 day, sucrose gel group is faced
Bed comprehensive therapeutic effect cure rate is substantially better than Metrogel group.In treatment the 21st ~ 30 day, Metrogel group and sucrose gel group
Comprehensive Clinical curative effect cure rate it is suitable, no significant difference, but declined for the 7th ~ 10 day than treatment.
Routine operation in operation of the present invention step is well known to those skilled in the art, herein without repeating.More than
Technical solution of the present invention is described in detail in the embodiment described, it should be understood that the foregoing is merely tools of the invention
Body embodiment, is not intended to restrict the invention, all any modifications made in spirit of the invention, supplement or similar side
Formula substitution etc., should all be included in the protection scope of the present invention.
Claims (4)
1. a kind of sucrose gel for treating bacterial vaginitis, in which: the preparation method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, additive amount 10-20g/L in the step (4).
2. a kind of sucrose gel for treating bacterial vaginitis, in which: the preparation method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, Arabic gum and Acritamer 940 in the step (4), and xanthan gum additive amount is 10-
20g/L；Arabic gum additive amount is 20-30g/L；Acritamer 940 additive amount is 5-10g/L.
3. a kind of sucrose gel for treating bacterial vaginitis, in which: the preparation method the following steps are included:
(1) prepared by deionized water: producing deionized water with equipment of De-ionized Water；
(2) it adjusts pH value: adjusting pH value with hydrochloric acid；
(3) sucrose dissolves by heating: sucrose is added and heating stirring dissolution is complete；
(4) sizing material is added, stirs evenly, obtains sucrose gel；
Wherein: pH value is to 4.0-5.2 in the step (2)；
Wherein: heating temperature is 45 DEG C in the step (3), sucrose addition 180-200g/L；
Wherein: sizing material is xanthan gum, Arabic gum, Acritamer 940 and temperature sensitive hydrogel in the step (4)；Temperature
Degree sensitive aqueous gel is poloxamer188；Xanthan gum additive amount is 10-20g/L；Arabic gum additive amount is 20-30g/L；
Acritamer 940 additive amount is 5-10g/L；Poloxamer188 additive amount is 100-120g/L.
4. application of any one the sucrose gel described in claim 1,2,3 in treatment bacterial vaginitis.
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| CN201910039095.0A CN109646394A (en) | 2019-01-16 | 2019-01-16 | A kind of sucrose gel that treating bacterial vaginitis and its application |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593386A (en) * | 2004-06-30 | 2005-03-16 | 上海复康医药科技发展有限公司 | Temperature sensitive gel formulation for in situ vagina uses |
| US20080193428A1 (en) * | 2005-04-27 | 2008-08-14 | Shenzhen Phlora Biotechnology Limited | Composition and Method for Modulating and Maintaining Vaginal Bacterial Flora and Vaginal Acidity |
| CN101695473A (en) * | 2009-10-28 | 2010-04-21 | 武汉华纳联合药业有限公司 | Use and preparation method of vaginal thermosensitive gel |
-
2019
- 2019-01-16 CN CN201910039095.0A patent/CN109646394A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593386A (en) * | 2004-06-30 | 2005-03-16 | 上海复康医药科技发展有限公司 | Temperature sensitive gel formulation for in situ vagina uses |
| US20080193428A1 (en) * | 2005-04-27 | 2008-08-14 | Shenzhen Phlora Biotechnology Limited | Composition and Method for Modulating and Maintaining Vaginal Bacterial Flora and Vaginal Acidity |
| CN101695473A (en) * | 2009-10-28 | 2010-04-21 | 武汉华纳联合药业有限公司 | Use and preparation method of vaginal thermosensitive gel |
Non-Patent Citations (1)
| Title |
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| 肖冰冰 等: "蔗糖凝胶治疗细菌性阴道病的多中心、随机、双盲、平行对照Ⅲ期临床试验", 《北京大学学报( 医学版)》 * |
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