CN104856948A - Loratadine syrup and preparation method thereof - Google Patents
Loratadine syrup and preparation method thereof Download PDFInfo
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- CN104856948A CN104856948A CN201510291917.6A CN201510291917A CN104856948A CN 104856948 A CN104856948 A CN 104856948A CN 201510291917 A CN201510291917 A CN 201510291917A CN 104856948 A CN104856948 A CN 104856948A
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Abstract
The invention discloses loratadine syrup and a preparation method thereof. According to the syrup, with loratadine as a main medicine, beta-cyclodextrin or gamma-cyclodextrin as an inclusion agent, citrate or sodium citrate as a pH regulator, and a grapefruit essence or an orange essence as a corrective agent, on the basis of the parts by weight, each 100 parts of the main medicine is matched with 800-1200 parts of the inclusion agent, 150-250 parts of the pH regulator and 90-100 parts of the corrective agent. Through adjusting rational proportions of the components, the problem of the solubility of loratadine in a liquid preparation is solved; the stability of the physical property and the chemical property is ensured; the loratadine syrup is especially suitable for inpatient children and patients with dysphagia; the medication compliance and the bioavailability are improved.
Description
Technical field
The present invention relates to a kind of Lortadine syrup agent, belong to medical art, refer in particular to a kind of Lortadine syrup agent and preparation method thereof.
Background technology
Loratadine belongs to a long-acting tricyclic antidepressants antihistaminic, suppress histamine H1-receptor competitively, suppress the allergic symptom that histamine causes, low and not easily pass through blood-brain barrier to central nervous system H1 receptor affinity, without central inhibitory action, several without cholinolytic effect, on gastric acid secretion and cardiac function without impact.Loratadine is used for the treatment of allergic rhinitis and acute urticaria and other anaphylaxis dermatosis clinically, have rapid-action, curative effect is high, times for spraying is few, safety and the good feature of patient tolerability.
At present, for clinically have loratadine tablet, capsule, granule, syrup etc.Wherein, syrup is for child patient, and the dose ratio tablet, capsule etc. of medication more accurately, are more easily swallowed, and also allow child patient more take like a shot with fragrant and sweet mouthfeel, improves the compliance of medication.Therefore, constant in guarantee curative effect, under the consideration of convenient for children medication, Lortadine syrup agent can be clinical application provides one to select dosage form, simultaneously to improving our people's medicine quality, improving people's drug level and having good Social benefit and economic benefit.
But from the water solublity of loratadine, its water solublity is very poor, and all unstable under alkali, heat condition, so when prepared by Lortadine syrup, the steady dissolution of loratadine is a very crucial problem.Therefore, it is technical problem to be solved by this invention that the loratadine after how making dissolving has higher steady dissolution.
Summary of the invention
First object of the present invention is to overcome technical problem of the prior art, a kind of Lortadine syrup agent is provided, this syrup by adjustment component between rational proportion, solve loratadine deliquescent problem in liquid preparation, and ensure the stability of its physical property and chemical property, be specially adapted to child patient and dysphagia patients, compliance and bioavailability are provided.
Second object of the present invention is the preparation method providing above-mentioned Lortadine syrup agent.
In order to realize first object, the present invention realizes according to following technical scheme:
A kind of Lortadine syrup agent, it take loratadine as principal agent, with beta-schardinger dextrin-or gamma-cyclodextrin for inclusion agents, with citric acid or sodium citrate for PH regulator, with Citrua paradiai essence or fragrant citrus essence for correctives, wherein, with weight parts, every 100 parts of principal agent proportionings 800 ~ 1200 parts of inclusion agents, 150 ~ 250 parts of PH regulators and 90 ~ 100 parts of correctivess.
Further, described Lortadine syrup agent also includes preservative sodium benzoate or benzoic acid, adjuvant sucrose and etoh solvent and purified water.
Further, the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
Further, the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-11.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.5g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
Further, the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, gamma-cyclodextrin 10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, sodium citrate 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
Further, the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, benzoic acid 2.5g, 95% ethanol 3.95g, citric acid 1.9g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
Further, the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-9.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 1.8g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
Further, the pH value of described syrup is 3.0 ~ 5.0.
In order to realize second object, the present invention realizes according to following technical scheme:
A preparation method for Lortadine syrup agent, it includes following steps:
S1, get sucrose and add appropriate purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get inclusion agents and add appropriate purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent and add in ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add antiseptic, pH adjusting agent, correctives successively, add purified water to full dose, stir, filter and get final product.
Further, in described S3 step, the principal agent solution flow velocity added in inclusion agents solution is 30 milliliters ~ 60 ml/min, during enclose, speed of agitator is 2500 ~ 3000 revs/min, temperature controls at 60 ~ 70 DEG C, after principal agent solution adds, then continues stirring 30 ~ 60 minutes.
Compared with prior art, its beneficial effect is in the present invention:
1, Lortadine syrup preparation of the present invention, by rationally arranging the content of the components such as principal agent loratadine, inclusion agents and PH regulator, by the synergism between each component, there is provided stable dissolving enclose to principal agent loratadine and be beneficial to its pH value environment stored, thus make loratadine can stabilizing dissolved enclose, overcome its shortcoming in alkali, heat condition instability, make the product prepared have high stability, and also can storage-stable;
2, Lortadine syrup preparation of the present invention, adopt citric acid or sodium citrate as pH value regulator, and further by selecting weight part ratio suitable between itself and loratadine, improve the dissolubility of loratadine, the Simultaneous Stabilization content of loratadine, makes product have better quality stability;
3, Lortadine syrup preparation of the present invention, is made by the suitable proportion of various correctives the mouthfeel of the Lortadine syrup formulation products prepared more mellow soft, easy to patients, is subject to the welcome of old man or child especially.
In order to the present invention can be understood more clearly, below the specific embodiment of the present invention will be elaborated.
Detailed description of the invention
Embodiment 1
An every 1000ml of Lortadine syrup agent includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of an above-mentioned Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 2
No. two every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-11.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.5g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. two Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 140ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, fragrant citrus essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 3
No. three every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, gamma-cyclodextrin 10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, sodium citrate 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. three Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get gamma-cyclodextrin and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, sodium citrate, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 4
No. four every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, benzoic acid 2.5g, 95% ethanol 3.95g, citric acid 1.9g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. four Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add benzoic acid, citric acid, fragrant citrus essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 5
No. five every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-9.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 1.8g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. five Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 6
No. six every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, alpha-cyclodextrin 10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. six Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get alpha-cyclodextrin and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 7
No. seven every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, hydrochloric acid 1.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. seven Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, hydrochloric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 8
No. eight every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-7.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. eight Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 100ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 9
No. nine every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, beta-schardinger dextrin-13.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. nine Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 160ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 10
No. ten every 1000ml of Lortadine syrup agent include the component of following weight: loratadine 1.0g, β-ring essence 10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 3.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned No. ten Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Embodiment 11
The every 1000ml of ride on Bus No. 11 Lortadine syrup agent includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 1.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
The preparation method of above-mentioned ride on Bus No. 11 Lortadine syrup agent comprises the following steps:
S1, get sucrose and add 250ml purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get beta-schardinger dextrin-and add 120ml purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent loratadine and add in 95% ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add sodium benzoate, citric acid, Citrua paradiai essence successively, add purified water to full dose, stir, filter and get final product.
Experimental comparison
In order to more all right the stability that Lortadine syrup agent of the present invention is described, it is as a comparison sample that the present invention chooses now commercially available Lortadine syrup preparation, contrast experiment is carried out with the 11 clock syrups of above-described embodiment 1 to 11, all syrups carry out temperatures involved and accelerated test at identical conditions, and acquired results is shown in following table 1.
Table 1
Can be learnt by the experimental result of above-mentioned table 1: the content of the character of the Lortadine syrup agent that the embodiment of the present invention 1 to 5 prepares, pH value, related substance, loratadine all keeps stable, and find after changing Lortadine syrup proportioning in the embodiment of the present invention 6 to 11, product after Acceleration study, related substance, assay result and the embodiment of the present invention 1 to 5 are carried out contrast and are found, product all significantly decreases from mouthfeel, appearance character and quality stability.Meanwhile, the Lortadine syrup agent that the embodiment of the present invention 1 to 5 prepares is compared with existing commercially available Lortadine syrup, and Lortadine syrup agent content of the present invention is more stable.Therefore reach a conclusion, the stability of the Lortadine syrup agent that the embodiment of the present invention 1 to 5 prepares obviously is better than embodiment 6 to 11 and comparative sample.
Syrup prepared by the embodiment of the present invention 1 to 5 is the rational proportion by adjusting between component, solve loratadine deliquescent problem in liquid preparation, and ensure the stability of its physics and chemical property, be specially adapted to child patient and dysphagia patients, compliance and bioavailability are provided.
The human bioavailability of syrup product of the present invention and Bioequivalence Test.
Syrup product of the present invention has also obtained the New Drug Certificate (traditional Chinese medicines card word H20050215) of State Food and Drug Administration's approval by new drug declaration and has produced official written reply number: the accurate word H20050329 of traditional Chinese medicines.By Clinical Trials requirement, entrust Zhongshan Medical Univ. clinical pharmacology institute to product of the present invention: Lortadine syrup is be that the loratadine tablet (trade name: clarityne) produced with Shanghai Schering Plough pharmaceutical Co. Ltd carries out Bioequivalence research for reference preparation by test preparation, whether has identical drug effect to investigate it.Test the routine Young adult healthy male subjects of employing 20 with dividing into groups mutually, own control for this, intersection single oral medicine, twice interval time (cleaning phase) is 7d, and the dosage of each preparation of all experimenters is 40mg; Solid-Phase Extraction reverse hplc method measures loratadine blood plasma concentration, and gained blood plasma concentration v. time data determines Cmax, T max, AUC0-t, AUC0-∞.
Clinical trial statistical result: reference preparation is respectively 71.6 ± 41.7ng/ml and 68.8 ± 37.2ng/ml with the Cmax by test preparation; T max is respectively 0.92 ± 0.36h and 0.89 ± 0.31h; T1/2 is respectively 3.85 ± 2.35h and 3.77 ± 2.18h; AUC0-t is respectively 145.9 ± 118.6ng.ml-1.h and 173.8 ± 152.9ng.ml-1.h; AUC0-∞ is respectively 163.1 ± 119.5ng.ml-1.h and 184.4 ± 157.2ng.ml-1.h; Be 112.9 ± 26.4% by test preparation relative to reference preparation bioavailability F.Variance analysis shows, by Cmax, AUC0-t, AUC0-∞ of test preparation and reference preparation there are no significant difference.Bioequivalence test shows, and the 90% fiducial limit Cmax by test preparation and each parameter of reference preparation is 84.0 ~ 119.3%; AUC0-t is 98.2 ~ 122.9%; AUC0-∞ is 99.0 ~ 124.1%, points out this two kinds of preparation bioequivalences.
The present invention is not limited to above-mentioned embodiment, if do not depart from the spirit and scope of the present invention to various change of the present invention or modification, if these are changed and modification belongs within claim of the present invention and equivalent technologies scope, then the present invention is also intended to comprise these change and modification.
Claims (10)
1. a Lortadine syrup agent, it is characterized in that: take loratadine as principal agent, with beta-schardinger dextrin-or gamma-cyclodextrin for inclusion agents, with citric acid or sodium citrate for PH regulator, with Citrua paradiai essence or fragrant citrus essence for correctives, wherein, with weight parts, every 100 parts of principal agent proportionings 800 ~ 1200 parts of inclusion agents, 150 ~ 250 parts of PH regulators and 90 ~ 100 parts of correctivess.
2. a kind of Lortadine syrup agent according to claim 1, is characterized in that: also include preservative sodium benzoate or benzoic acid, adjuvant sucrose and etoh solvent and purified water.
3. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
4. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-11.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 2.5g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
5. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, gamma-cyclodextrin 10.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, sodium citrate 2.0g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
6. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-10.0g, benzoic acid 2.5g, 95% ethanol 3.95g, citric acid 1.9g, fragrant citrus essence 1.0g, sucrose 650g, surplus are purified water.
7. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the agent of described 1000ml Lortadine syrup includes the component of following weight: loratadine 1.0g, beta-schardinger dextrin-9.0g, sodium benzoate 2.5g, 95% ethanol 3.95g, citric acid 1.8g, Citrua paradiai essence 1.0g, sucrose 650g, surplus are purified water.
8. a kind of Lortadine syrup agent according to claim 2, is characterized in that: the pH value of described syrup is 3.0 ~ 5.0.
9. the preparation method of a kind of Lortadine syrup agent as claimed in claim 2, is characterized in that including following steps:
S1, get sucrose and add appropriate purified water, heating makes to be dissolved into syrup, is cooled to less than 60 DEG C;
S2, get inclusion agents and add appropriate purified water, heated and stirred is dissolved, for subsequent use;
S3, get principal agent and add in ethanol, after stirring and dissolving, adding in the inclusion agents solution of S2 step with thread, dissolving completely with being stirred to adding, for subsequent use;
S4, the solution of S3 step to be added in the syrup of S1 step, then add antiseptic, pH adjusting agent, correctives successively, add purified water to full dose, stir, filter and get final product.
10. the preparation method of a kind of Lortadine syrup agent according to claim 9, it is characterized in that: in described S3 step, the principal agent solution flow velocity added in inclusion agents solution is 30 milliliters ~ 60 ml/min, during enclose, speed of agitator is 2500 ~ 3000 revs/min, temperature controls at 60 ~ 70 DEG C, after principal agent solution adds, then continue stirring 30 ~ 60 minutes.
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| CN113730336A (en) * | 2021-09-27 | 2021-12-03 | 浙江核力欣健药业有限公司 | Loratadine syrup and preparation method thereof |
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| CN104856948B (en) | 2018-10-19 |
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