CN104622870A - Gluconic acid chlorhexidine composite gargle and preparation method thereof - Google Patents
Gluconic acid chlorhexidine composite gargle and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a gluconic acid chlorhexidine composite gargle and a preparation method thereof. The gluconic acid chlorhexidine composite gargle is prepared from the following raw materials in parts by weight: 5.5-6 parts of polysorbate 80, 0.8-1.2 parts of metronidazole raw powder, 220-225 parts of ethyl alcohol, 310-315 parts of glycerinum, 275-300 parts of polyethylene glycol 400, 115-125 parts of gluconic acid chlorhexidine, 42.225-72.728 parts of auxiliary materials and a proper amount of purified water. The raw materials supplement one another and work together to play roles, and are capable of preventing and treating oral diseases in an assist manner and improving the oral nursing effect. According to the gluconic acid chlorhexidine composite gargle disclosed by the invention, the stability of the product is improved by adjusting the amount of auxiliary materials, the charging mode or even the charging order in the preparation process; the harmful substance parachloroaniline in the preparation process is greatly reduced; and the quality problems such as opacities and crystal separation easily generated by an existing gluconic acid chlorhexidine composite gargle in the preparation process are effectively solved.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of chlorhexidine gluconate Compound mouthwash and preparation method thereof.
Background technology
China's oral disease is a health problem having popularity and universality most, and sickness rate is high, very large to human health damage, but is not often valued by the people.For auxiliary prevention and therapy oral disease, improve mouth care effect, conventional gargarism carries out mouth care.Utilize medicine gargarism can anti-dental plaque effectively, improve gingivitis situation.
The effective ingredient of chlorhexidine gluconate Compound mouthwash is chlorhexidine and metronidazole.Existing chlorhexidine gluconate Compound mouthwash is in preparation process, and the impurity mainly harmful substance parachloroanilinum of generation, parachloroanilinum can absorb through harmless skin, very harmful to human body.In addition, the preparation process of existing chlorhexidine gluconate Compound mouthwash can cause unstable product quality, in storage process, occur precipitation.
Summary of the invention
Harmful substance parachloroanilinum can be produced in order to solve existing chlorhexidine gluconate Compound mouthwash in preparation process, unstable product quality can be caused and in storage process, occurring the technical problem of precipitation in preparation process, a kind of chlorhexidine gluconate Compound mouthwash and preparation method thereof is provided.
In order to achieve the above object, the present invention is by the following technical solutions: a kind of chlorhexidine gluconate Compound mouthwash, is made up of the raw material of following weight portion content: polyoxyethylene sorbitan monoleate is 5.5-6 part, metronidazole former powder 0.8-1.2 part, ethanol 220-225 part, glycerol 310-315 part, PEG400 are 275-300 part, Fructus Vitis viniferae acid saccharic acid chlorhexidine 115-125 part, adjuvant 42.225-72.728 part, Purified Water q. s.
Further, described adjuvant is flavoring banana essence 1.8-2.0 part, aqua methnae 40-70 part, saccharin sodium 0.4-0.7 part, lemon yellow pigment 0.025-0.028 part.
Further, a kind of chlorhexidine gluconate Compound mouthwash, is made up of the raw material of following weight portion content: polyoxyethylene sorbitan monoleate is 5.5 parts, 1 part, the former powder of metronidazole, ethanol 223 parts, flavoring banana essence 1.85 parts, aqua methnae 50 parts, saccharin sodium 0.5 part, lemon yellow pigment 0.0278 part, glycerol 312.5 parts, PEG400 are 275 parts, Fructus Vitis viniferae acid saccharic acid chlorhexidine 120 parts, Purified Water q. s.
Further, the mass fraction of described Fructus Vitis viniferae acid saccharic acid chlorhexidine is 5%.
A preparation method for chlorhexidine gluconate Compound mouthwash, comprises the following steps:
A, get polyoxyethylene sorbitan monoleate, the former powder of metronidazole being added in container A stirs, stir after 20-25 minute and continue to stir and get ethanol gradation to add, each 40-100 part, then stir 20-25 minute after adding flavoring banana essence, aqua methnae, obtain feed liquid A;
B, saccharin sodium 50-100 part purified water is dissolved in container B, obtains feed liquid B;
C, lemon yellow pigment 50-100 part purified water is dissolved in container C, obtains feed liquid C;
D, in container D, add 3700 parts of purified water, add glycerol, PEG400 successively while stirring, then add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of 5% content, continue to stir, obtain feed liquid D;
E, by feed liquid A, feed liquid B, feed liquid C and feed liquid D mix homogeneously, with purified water configuration, stir, obtain chlorhexidine gluconate Compound mouthwash.
Further, in described step a, mixing speed is 60 revs/min.
Further, in described steps d, mixing speed is 60 revs/min.
Hinge structure of the present invention has following beneficial effect:
1, chlorhexidine gluconate Compound mouthwash of the present invention is primarily of polyoxyethylene sorbitan monoleate, the former powder of metronidazole, ethanol, glycerol, PEG400, Fructus Vitis viniferae acid saccharic acid chlorhexidine composition, wherein chlorhexidine gluconate has broad-spectrum antibacterial bactericidal action, has stronger killing action to Gram-positive, negative bacterium and fungus; Metronidazole has the effect of obligate anaerobe specific antibacterial, has obvious bacteriostasis to borrelia buccale and gram-negative anaerobic bacteria; Glycerol, as solvent, has lubrication, increases medicinal liquid viscosity, with the local therapeutic effects of prolong drug at oral mucosa; Polyoxyethylene sorbitan monoleate is water-soluble nonionic surfactant, makes various composition emulsifying form clear transparent solutions; PEG400, as solvent, cosolvent, O/W type emulsifying agent and stabilizing agent, has enhancing osmosis to mucosa, and curative effect is strengthened; Ethanol is solvent, dissolves metronidazole in formula, also has bacteriostasis simultaneously.In addition, the present invention is equipped with the adjuvant improving mouthfeel and medicament appearance, and each raw material complements each other, and mutually works in coordination with and plays a role, can assist prevention and therapy oral disease, improve mouth care effect.
2, chlorhexidine gluconate Compound mouthwash of the present invention is in preparation process, the stability of product is improve by adjustment supplementary product consumption, feed way and even charging sequence, not only considerably reduce the generation of harmful substance parachloroanilinum in preparation process, and efficiently solve existing chlorhexidine gluconate Compound mouthwash easily produce the quality problems such as muddiness, crystallization in preparation process.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described.
Experimental example 1: the selection of polyoxyethylene sorbitan monoleate, PEG400 consumption
1. experiment purpose
Inquire into polyoxyethylene sorbitan monoleate, PEG400 consumption to the impact of chlorhexidine gluconate Compound mouthwash quality of the present invention.
2. equipment: dissolving tank (bucket), agitator, 1000ml beaker are some, 1000ml volumetric flask is some, weighing apparatus is some, pipet is some, one, 1000ml graduated cylinder, 200ml Compound mouthwash bottle are some.
3. material: configure the corresponding required supplementary material of chlorhexidine gluconate Compound mouthwash of the present invention.As table 1.
Table 1: configure the corresponding required supplementary material of chlorhexidine gluconate Compound mouthwash of the present invention
4. operating procedure:
4.1 polyoxyethylene sorbitan monoleate consumptions:
4.1.1 preparing experiment intermediate liquid: the intermediate liquid configuring 5 parts of 5000ml by technology preparation when not adding polyoxyethylene sorbitan monoleate, chlorhexidine gluconate and ethanol respectively, for subsequent use.Technology preparation is in table 2.
Table 2: 1000ml compojnd recipe
4.1.2 take 5 parts of polyoxyethylene sorbitan monoleates, weight is respectively 4g, 4.5g, 5g, 5.5g, 6g, is designated as T1, T2, T3, T4, T5.
4.1.3 get five beakers, all add the former powder of 1g metronidazole, then add T1, T2, T3, T4, T5 respectively, fully stir, divide five times respectively add 223g ethanol, front four each 40g, the 5th 63g, limit edged stirs.
4.1.4 configure five parts of intermediate liquids are added in above-mentioned five beakers respectively, post label.
4.1.5 the material 200ml Compound mouthwash bottle prepared above is distributed into five equal portions separately, and posts label.
4.1.6 keep sample and watch 6 months, observation index clarity (give a mark from muddiness to clear and bright according to 0-10, score value is more high more to be clarified).
4.1.7 experimental result: in table 3.
Table 3: the addition of polyoxyethylene sorbitan monoleate is on the impact of chlorhexidine gluconate Compound mouthwash product quality of the present invention
4.1.8 conclusion
The addition 5.5g-6g(of polyoxyethylene sorbitan monoleate and metronidazole weight ratio 5.5-6) suitable, economic angle 5.5g is optimum.
4.2 PEG400 consumptions:
4.2.1 preparing experiment intermediate liquid: configure 5 parts of 1000ml intermediate liquids respectively when not adding PEG400 and chlorhexidine gluconate by technology preparation, for subsequent use.Technology preparation is in table 2.
4.2.2 take 5 parts of PEG400s, weight is respectively 40g, 45g, 50g, 55g, 60g, is designated as J1, J2, J3, J4, J5.
4.2.3 get five beakers, all add 24g chlorhexidine gluconate (5%), then add J1, J2, J3, J4, J5 respectively, fully stir.
4.2.4 configure five parts of intermediate liquids are added in above-mentioned five beakers respectively, post label.
4.2.5 the material 200ml Compound mouthwash bottle prepared above is distributed into five equal portions separately, and posts label.
4.2.6 keep sample and watch 6 months, observation index clarity (give a mark from muddiness to clear and bright according to 0-10, score value is more high more to be clarified).
4.2.7 experimental result: in table 4.
Table 4: the addition of PEG400 is on the impact of chlorhexidine gluconate Compound mouthwash product quality of the present invention
4.2.8 conclusion
The addition 55g-60g of PEG400 is suitable, and economic angle 55g is optimum.
Experimental example 2: the feed postition of lemon yellow pigment
1. experiment purpose
Inquire into the feed postition of lemon yellow pigment to the impact of chlorhexidine gluconate Compound mouthwash product quality of the present invention.
2. equipment: with experimental example 1.
3. material: with experimental example 1.
4. operating procedure:
4.1 to configure the intermediate liquid of 4 parts of 5000ml respectively when not adding lemon yellow pigment by technology preparation in table 2 as follows:
4.1.1 5.5g polyoxyethylene sorbitan monoleate, the former powder of 1g metronidazole stirring under being added on the condition of low whipping speed 60 revs/min in container A is got, stir to continue to stir and get 223g ethanol after 20 minutes and divide five times to add, front four each 45g, 5th 43g, stir 20 minutes under adding the condition of low whipping speed 60 revs/min after 1.85g flavoring banana essence, 50g aqua methnae again, obtain feed liquid A;
4.1.2 0.5g saccharin sodium 50g purified water is dissolved in container B, obtains feed liquid B;
4.1.3 in container D, add 3700ml purified water, under the condition that low whipping speed is 60 revs/min, add 312.5g glycerol, 275g PEG400 while stirring successively, then add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of 120g5% content, continue to stir, obtain feed liquid D;
4.2 taking 4 parts of weight is the lemon yellow pigment of 0.0278g.
4. lemon yellow pigment adds in feed liquid by 3 respectively in the following manner:
Mode 1: lemon yellow pigment first fully dissolves by 50ml purified water, then mix homogeneously with feed liquid A, feed liquid B, feed liquid D;
Mode 2: lemon yellow pigment joins in feed liquid A, abundant mix homogeneously;
Mode 3: lemon yellow pigment joins in feed liquid B, abundant mix homogeneously;
Mode 4: lemon yellow pigment joins in feed liquid D, abundant mix homogeneously;
4. configure 4 parts of intermediate liquids add in four beakers by 4 respectively, are mixed with 5000ml, post label.
4. 5 the material 200ml Compound mouthwash bottle prepared above is distributed into 4 equal portions respectively, and posts label.
4. 6 keep sample and watch 6 months, observation index clarity (give a mark from muddiness to clear and bright according to 0-10, score value is more high more to be clarified).
4. 7 experimental results: in table 5.
Table 5: the feed postition of lemon yellow pigment is on the impact of chlorhexidine gluconate Compound mouthwash product quality of the present invention
4. 8 conclusions
Lemon yellow pigment needs configuration separately, otherwise occurs crystallization.
Experimental example 3: saccharin sodium, aqua methnae concentration affect chlorhexidine gluconate Compound mouthwash mouthfeel of the present invention
1. experiment purpose
1) discussion saccharin sodium, aqua methnae concentration affect situation to chlorhexidine gluconate Compound mouthwash mouthfeel of the present invention, find best mouthfeel saccharin sodium, aqua methnae formula.
2) discussion saccharin sodium, aqua methnae concentration affect situation to chlorhexidine gluconate Compound mouthwash quality aspect of the present invention.
2. equipment: with experimental example 1.
3. material: with experimental example 1.
4. operating procedure:
4.1 change the experiment of saccharin sodium dosage:
4.1.1 preparing experiment intermediate liquid: configure 5000ml intermediate liquid when not adding saccharin sodium by table 2 technology preparation, for subsequent use.
4.1.2 take saccharin sodium 5 parts, weight is respectively 0.06g, 0.08g, 0.10g, 0.12g, 0.14g, is designated as A1, A2, A3, A4, A5.
4.1.3 measure experiment intermediate liquid five parts, every part of 1000ml by graduated cylinder equivalent, be loaded on respectively in five beakers.
4.1.4 A1, A2, A3, A4, A5 are added in above five beakers respectively, proper good label, stirs evenly.
4.1.5 the material 200ml Compound mouthwash bottle prepared above is distributed into five equal portions separately, and posts label.
4.1.6 often kind of formula 3 bottles is used for keeping sample and watches; 2 bottles for testing mouthfeel.
4.1.7 experimental result:
4.1.7.1 sensory test result: in table 6.
Table 6: test mouthfeel result
4.1.7.2 keep sample the situation of watching: in table 7.
Table 7: keep sample and watch outcome record table
4.2 change the experiment of aqua methnae dosage:
4.2.1 preparing experiment intermediate liquid: configure five parts of 980ml intermediate liquids respectively when not adding aqua methnae by table 2 technology preparation, for subsequent use.
4.2.2 get aqua methnae 5 parts, weight is respectively 6g, 8g, 10g, 12g, 14g, is designated as B1, B2, B3, B4, B5.
4.2.3 B1, B2, B3, B4, B5 being added respectively five is equipped with in the 1000ml volumetric flask of intermediate liquid, standardize solution 1000ml.
4.2.4 post label, shake up.
4.2.5 the material 200ml Compound mouthwash bottle prepared above is distributed into five equal portions separately, and posts label.
4.2.6 often kind of formula 3 bottles is used for keeping sample and watches; 2 bottles for testing mouthfeel.
4.2.7 experimental result:
4.2.7.1 keep sample the situation of watching: in table 8.
Table 8: test mouthfeel result
4.2.7.2 keep sample the situation of watching: in table 9.
Table 9: keep sample and watch outcome record table
4.3 change saccharin sodium, the experiment of aqua methnae dosage simultaneously: (two factor four horizontal quadrature experiments)
4.3.1 preparing experiment intermediate liquid: configure 16 parts of 980ml intermediate liquids respectively when not adding saccharin sodium, aqua methnae by table 2 technology preparation, for subsequent use.
4.3.2 take saccharin sodium 4 parts, weight is respectively 0.08g, 0.10g, 0.12g, 0.14g, is designated as A2, A3, A4, A5, each 4 parts of often kind of specification, and fills in A water-glass, in table 10.
Table 10:A water-glass
4.3.3 get aqua methnae 4 parts, weight is respectively 8.0g, 10.0g, 12.0g, 14.0g, is designated as B2, B3, B4, B5, each 4 parts of often kind of specification, and fills in B water-glass, in table 11.
Table 11:B water-glass
4.3.4 measure experiment intermediate liquid 16 parts, every part of 980ml by graduated cylinder equivalent, be loaded on respectively in 16 beakers.
4.3.5 by factor level table (see table 12), by A2B2 (namely adding A2 and B2 successively in beaker), A2B3 ... A5B5 adds in above 16 beakers respectively, and proper good label, stirs evenly.
Table 12: empirical factor water-glass
4.3.5 the material 200ml Compound mouthwash bottle prepared above is distributed into five equal portions separately, and posts label.
4.3.6 often kind of formula 3 bottles is used for keeping sample and watches; 2 bottles for testing mouthfeel.
4.3.7 experimental result:
4.3.7.1 keep sample the situation of watching: in table 13.
Table 13: test mouthfeel result
4.3.7.2 keep sample the situation of watching: in table 14.
Table 14: keep sample and watch outcome record table
4.3.8 conclusion:
1. the saccharin sodium of different recipe quantity and aqua methnae form impact to product characteristics.
2. the saccharin sodium of different recipe quantity and the impact of aqua methnae on gluconic acid content not obvious.
3. best with 6,7,8,10 these four samples from the angle reference of mouthfeel, because No. 6 sample inventorys are minimum, the most economical, therefore fixed No. 6 (A3B3) is final prescription, when namely configuring 1000ml, adds saccharin sodium 0.1g, aqua methnae 10g is the most suitable.
Experimental example 4: different charging sequence is on the impact of chlorhexidine gluconate Compound mouthwash product quality of the present invention
1. prescription: configure 5000 milliliters by table 2.
2. reagent, instrument: with experimental example 1.
3. method: for investigating the impact of different charging sequence on its related substances in test, carry out the experimental implementation of following 3 different process, wherein first three step is identical, for:
(1) measure polyoxyethylene sorbitan monoleate by formula, the former powder of metronidazole being added in container A stirs, stir under the condition that low whipping speed is 60 revs/min after 25 minutes and continue to stir and get ethanol gradation to add, after adding flavoring banana essence, aqua methnae again low whipping speed 60 revs/min condition under stir 20-25 minute, obtain feed liquid A;
(2) the saccharin sodium 100ml purified water of formula ratio is dissolved in container B, obtains feed liquid B;
(3) the lemon yellow pigment 100ml purified water of formula ratio is dissolved in container C, obtains feed liquid C;
Step (4)-step (5) relates to different charging sequence, and concrete operations are as follows:
Technique 1: order 1
(4) in container D, add 3700ml purified water, add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of formula ratio under the condition of low whipping speed 60r/min while stirring, and then add glycerol, PEG400 successively, continue to stir, feed liquid D.The feed liquid A, the feed liquid B that are prepared to step (3) with above-mentioned steps (1) by feed liquid D, feed liquid C are mixed homogeneously, and add purified water and are configured to 5000ml, stir, obtain fill liquid.
(5) fill liquid after filtration, inspection, fill, obtained finished product.
Technique 2: order 2
(4) in container D, add 3700ml purified water, under the condition of low whipping speed 60r/min, add the glycerol of formula ratio, PEG400 while stirring successively, and then add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of formula ratio, continue to stir, feed liquid D.The feed liquid A, the feed liquid B that are prepared to step (3) with above-mentioned steps (1) by feed liquid D, feed liquid C are mixed homogeneously, and add purified water and are configured to 5000ml, stir, obtain fill liquid.
(5) fill liquid after filtration, inspection, fill, obtained finished product.
Technique 3: order 3
(4) in container D, 3700ml purified water is added, glycerol, the PEG400 of formula ratio is added while stirring successively under the condition of low whipping speed 60r/min, and then add feed liquid A, feed liquid B, the feed liquid C that above-mentioned steps (1) prepares to step (3), add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of formula ratio again, continue to stir, add purified water and be configured to 5000ml, stir, obtain fill liquid.
(5) fill liquid after filtration, inspection, fill, obtained finished product.
The manufactured goods obtained by technique 1-3 detect, and the assay method of content and related substance is with reference to USP35 version chlorhexidine gluconate assay method.
4. result conclusion
Accelerated stability test result is as table 15:
Table 15: the accelerated stability test result of different charging sequence products obtained therefrom
5. conclusion: in the preparation technology of chlorhexidine gluconate Compound mouthwash of the present invention, chlorhexidine gluconate add sequencing, to test result have a great impact.The chlorhexidine gluconate Compound mouthwash that the chlorhexidine gluconate Compound mouthwash that preparation technology 3 obtains obtains than technique 1 and technique 2 in accelerated test 0,1,3, June the clarity that records and impurity parachloroanilinum and other related substance all few, therefore, charging sequence has a great impact chlorhexidine gluconate Compound mouthwash product quality of the present invention, and technique 3 is best.
Embodiment 1
A kind of chlorhexidine gluconate Compound mouthwash, is made up of following raw material: polyoxyethylene sorbitan monoleate is 5.5g, the former powder 1.2g of metronidazole, ethanol 220g, flavoring banana essence 2.0g, aqua methnae 40g, saccharin sodium 0.7g, lemon yellow pigment 0.025g, glycerol 315g, PEG400 are 275g, Fructus Vitis viniferae acid saccharic acid chlorhexidine (mass fraction is 5%) 125g, Purified Water q. s.
The preparation method of this chlorhexidine gluconate Compound mouthwash, comprise the following steps: a, get polyoxyethylene sorbitan monoleate, the former powder of metronidazole being added in container A stirs, low whipping speed is stir under the condition of 60 revs/min to continue to stir after 20 minutes and get ethanol to divide five times to add, front four each 40g, 5th 60g, after adding flavoring banana essence, aqua methnae again, low whipping speed is stir 20 minutes under the condition of 60 revs/min, obtains feed liquid A; B, saccharin sodium 50ml purified water is dissolved in container B, obtains feed liquid B; C, lemon yellow pigment 50ml purified water is dissolved in container C, obtains feed liquid C; D, in container D, add 3700ml purified water, low whipping speed is add glycerol, PEG400 successively while stirring under the condition of 60 revs/min, then adds the Fructus Vitis viniferae acid saccharic acid chlorhexidine that mass fraction is 5%, continues stirring and stirs for 5 minutes, obtain feed liquid D; E, by feed liquid A, feed liquid B, feed liquid C and feed liquid D mix homogeneously, be configured to 5000ml by purified water, stir, obtain chlorhexidine gluconate Compound mouthwash.
Embodiment 2
A kind of chlorhexidine gluconate Compound mouthwash, is made up of following raw material: polyoxyethylene sorbitan monoleate is 6g, the former powder 0.8g of metronidazole, ethanol 225g, flavoring banana essence 1.8g, aqua methnae 70g, saccharin sodium 0.4g, lemon yellow pigment 0.028g, glycerol 310g, PEG400 are 300g, Fructus Vitis viniferae acid saccharic acid chlorhexidine (mass fraction is 5%) 115g, Purified Water q. s.
The preparation method of this chlorhexidine gluconate Compound mouthwash, comprise the following steps: a, get polyoxyethylene sorbitan monoleate, the former powder of metronidazole being added in container A stirs, low whipping speed is stir under the condition of 60 revs/min to continue to stir after 25 minutes and get ethanol to divide three times to add, first time 100g, second time 60g, third time 65g, then after adding flavoring banana essence, aqua methnae, low whipping speed is stir 25 minutes under the condition of 60 revs/min, obtains feed liquid A; B, saccharin sodium 100ml purified water is dissolved in container B, obtains feed liquid B; C, lemon yellow pigment 100ml purified water is dissolved in container C, obtains feed liquid C; D, in container D, add 3700ml purified water, low whipping speed is add glycerol, PEG400 successively while stirring under the condition of 60 revs/min, then adds the Fructus Vitis viniferae acid saccharic acid chlorhexidine that mass fraction is 5%, continues stirring and stirs for 5 minutes, obtain feed liquid D; E, by feed liquid A, feed liquid B, feed liquid C and feed liquid D mix homogeneously, be configured to 5000ml by purified water, stir, obtain chlorhexidine gluconate Compound mouthwash.
Embodiment 3
A kind of chlorhexidine gluconate Compound mouthwash, is made up of following raw material: polyoxyethylene sorbitan monoleate is 5.5g, the former powder 1g of metronidazole, ethanol 223g, flavoring banana essence 1.85g, aqua methnae 50g, saccharin sodium 0.5g, lemon yellow pigment 0.0278g, glycerol 312.5g, PEG400 are 275g, Fructus Vitis viniferae acid saccharic acid chlorhexidine (mass fraction is 5%) 120g, Purified Water q. s.
The preparation method of this chlorhexidine gluconate Compound mouthwash, comprise the following steps: a, get polyoxyethylene sorbitan monoleate, the former powder of metronidazole being added in container A stirs, low whipping speed is stir under the condition of 60 revs/min to continue to stir after 20 minutes and get ethanol to divide four times to add, front twice each 50g, third time 60g, 4th 63g, then after adding flavoring banana essence, aqua methnae, low whipping speed is stir 20 minutes under the condition of 60 revs/min, obtains feed liquid A; B, saccharin sodium 50ml purified water is dissolved in container B, obtains feed liquid B; C, lemon yellow pigment 100ml purified water is dissolved in container C, obtains feed liquid C; D, in container D, add 3700ml purified water, low whipping speed is add glycerol, PEG400 successively while stirring under the condition of 60 revs/min, then adds the Fructus Vitis viniferae acid saccharic acid chlorhexidine that mass fraction is 5%, continues stirring and stirs for 5 minutes, obtain feed liquid D; E, by feed liquid A, feed liquid B, feed liquid C and feed liquid D mix homogeneously, be configured to 5000ml by purified water, stir, obtain chlorhexidine gluconate Compound mouthwash.
Clinical trial
1, object: tested by double blind control, observes chlorhexidine gluconate Compound mouthwash of the present invention and commercially available Chlorhexidine Compound Mouthrinse Solution curative effect, indication and untoward reaction situation.
2, study subject:
(1) main suit has gingiva (or mucosa) to swell and ache, and flows any one in tooth blood (bleeding when comprising spontaneity or brush teeth) and halitosis three.
(2) clinical manifestation is diagnosed as a. gingivitis; B. periodontitis; C. pericoronitis; D. oral mucositis.
Patient have at least 20 teeth be natural teeth tooth example.
(4) whole body health, did not use any antibacterials in one month.
3, test method: patient's random packet, totally 150 examples, be wherein divided into again test group 50 example; Positive controls 50 example; Negative control group 50 example.Every group gingivitis 25 example, periodontitis 10 example, pericoronitis 10 example, oral mucositis 5 example.
4, content of the test
:
(1) medicine: a. test group: chlorhexidine gluconate Compound mouthwash of the present invention; B. positive controls: Chlorhexidine Compound Mouthrinse Solution on market
; c. negative control group: the invention formulation not containing chlorhexidine gluconate and metronidazole composition.
(2) method: a. double blind control; B., after patient brushes teeth sooner or later, with medicinal liquid 10 ml rinsing the mouth 1min, need not gargle after spuing.
5, result of the test: in table 16.
Table 16: comparitive study after medication
6, conclusion:
Test group curative effect is better than positive controls, illustrates that chlorhexidine gluconate Compound mouthwash of the present invention is better than like product on the market.
Model case
Case 1 Zhang, female, 46 one full year of life, gingivitis is with periodontal abscess, and hurt like hell before medication, periodontal local swelling, hyperemia is serious.Use chlorhexidine gluconate Compound mouthwash of the present invention after five days pain disappear completely, local swelling obviously improves, congestive symptom disappear.
Case 2 Chen, man, 35 one full year of life, pericoronitis of the wisdom tooth, local swelling before medication, gingival hemorrhage, lymphadenectasis.Use chlorhexidine gluconate Compound mouthwash of the present invention after five days local swelling obviously improve, gingival hemorrhage transference cure, swollen lymph node disappears completely.
Case 3 king so-and-so, man, 19 one full year of life, exodontia after reaction, cause local swelling, hyperemia, laboratory rodent chow difficulty.Use chlorhexidine gluconate Compound mouthwash of the present invention after five days local swelling obviously improve, congestive symptom makes moderate progress, can normal laboratory rodent chow.
Claims (7)
1. a chlorhexidine gluconate Compound mouthwash, is characterized in that: be made up of the raw material of following weight portion content: polyoxyethylene sorbitan monoleate is 5.5-6 part, metronidazole former powder 0.8-1.2 part, ethanol 220-225 part, glycerol 310-315 part, PEG400 are 275-300 part, Fructus Vitis viniferae acid saccharic acid chlorhexidine 115-125 part, adjuvant 42.225-72.728 part, Purified Water q. s.
2. a kind of chlorhexidine gluconate Compound mouthwash according to claim 1, is characterized in that: described adjuvant is flavoring banana essence 1.8-2.0 part, aqua methnae 40-70 part, saccharin sodium 0.4-0.7 part, lemon yellow pigment 0.025-0.028 part.
3. a kind of chlorhexidine gluconate Compound mouthwash according to claim 2, is characterized in that: be made up of the raw material of following weight portion content: polyoxyethylene sorbitan monoleate is 5.5 parts, 1 part, the former powder of metronidazole, ethanol 223 parts, flavoring banana essence 1.85 parts, aqua methnae 50 parts, saccharin sodium 0.5 part, lemon yellow pigment 0.0278 part, glycerol 312.5 parts, PEG400 are 275 parts, Fructus Vitis viniferae acid saccharic acid chlorhexidine 120 parts, Purified Water q. s.
4. a kind of chlorhexidine gluconate Compound mouthwash according to Claims 2 or 3, is characterized in that: the mass fraction of described Fructus Vitis viniferae acid saccharic acid chlorhexidine is 5%.
5. the preparation method of a kind of chlorhexidine gluconate Compound mouthwash according to claim 4, is characterized in that: comprise the following steps:
A, get polyoxyethylene sorbitan monoleate, the former powder of metronidazole being added in container A stirs, stir after 20-25 minute and continue to stir and get ethanol gradation to add, each 40-100 part, then stir 20-25 minute after adding flavoring banana essence, aqua methnae, obtain feed liquid A;
B, saccharin sodium 50-100 part purified water is dissolved in container B, obtains feed liquid B;
C, lemon yellow pigment 50-100 part purified water is dissolved in container C, obtains feed liquid C;
D, in container D, add 3700 parts of purified water, add glycerol, PEG400 successively while stirring, then add the Fructus Vitis viniferae acid saccharic acid chlorhexidine of 5% content, continue to stir, obtain feed liquid D;
E, by feed liquid A, feed liquid B, feed liquid C and feed liquid D mix homogeneously, with purified water configuration, stir, obtain chlorhexidine gluconate Compound mouthwash.
6. the preparation method of a kind of chlorhexidine gluconate Compound mouthwash according to claim 5, is characterized in that: in described step a, mixing speed is 60 revs/min.
7. the preparation method of a kind of chlorhexidine gluconate Compound mouthwash according to claim 5, is characterized in that: in described steps d, mixing speed is 60 revs/min.
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| CN114680128A (en) * | 2022-04-22 | 2022-07-01 | 广东国得科技发展有限公司 | Antimicrobial aqueous solution and preparation method and application thereof |
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