Loratadine oral liquid and production process thereof

Abstract

The invention discloses a loratadine oral liquid and a production process thereof. Comprising the following raw materials in parts by weight: 0.5 to 0.6 part of loratadine, 5 to 6 parts of beta-cyclodextrin, 10 to 12 parts of polyethylene glycol 400, 8 to 10 parts of glycerol, 6 to 8 parts of propylene glycol, 0.3 to 0.4 part of sucralose, 0.2 to 0.3 part of stevioside, 15 to 18 parts of maltitol, 1 to 1.2 parts of citric acid, 0.5 to 0.6 part of malic acid, 0.1 to 0.15 part of disodium EDTA (Ethylene Diamine Tetraacetic Acid), 0.8 to 1 part of vitamin C, 0.3 to 0.4 part of xanthan gum, 0.5 to 0.6 part of sodium carboxymethyl cellulose and 0.4 to 0.5 part of lemon essence. The composition comprises the following components in parts by weight: 0.1-0.15 part of menthol, 2-3 parts of hawthorn extract, 1.2-1.5 parts of soya bean lecithin and the balance of purified water, totaling 100 parts. The loratadine is clathrated by the beta-cyclodextrin, the absorption promotion effect of the soya bean lecithin is combined, and the compound sweetening agent, the compound stabilizer and the natural flavor substance are matched, so that the problems of poor solubility and obvious bitter taste of the loratadine are solved, and the stability and bioavailability of the product are also improved.

Description

Technical Field

[0001] This invention relates to the field of loratadine oral solution technology, specifically to a loratadine oral solution and its manufacturing process. Background Technology

[0002] Loratadine is a long-acting, non-sedating antihistamine that selectively blocks histamine H1 receptors. It is widely used to relieve symptoms of allergic rhinitis, urticaria, and other allergic diseases. The oral liquid form is particularly suitable for children, the elderly, and those who have difficulty swallowing solid medications, making it highly sought after in both clinical and home use.

[0003] Existing loratadine oral solutions have several shortcomings: the excipient system is relatively simple, mostly consisting of simple solvents and sweeteners, resulting in limited solubility of the active ingredient and a tendency for precipitation and stratification during long-term storage; taste adjustment relies heavily on a single sweetener, leading to a monotonous flavor and residual bitterness in some products, affecting patient adherence; the production process lacks targeted optimization, failing to fully consider the stability and bioavailability of the active ingredient, and some process steps are vague, making it difficult to ensure batch-to-batch uniformity; furthermore, the excipients in existing formulations are mostly conventional types, lacking functional components that protect the active ingredient and promote its absorption, resulting in a need for further improvement in bioavailability.

[0004] Therefore, developing a loratadine oral solution and its production process has significant practical application value. Summary of the Invention

[0005] The purpose of this invention is to provide a loratadine oral solution and its manufacturing process to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a loratadine oral solution, comprising the following raw materials in parts by weight: loratadine 0.5-0.6 parts, β-cyclodextrin 5-6 parts, polyethylene glycol 400 10-12 parts, glycerin 8-10 parts, propylene glycol 6-8 parts, sucralose 0.3-0.4 parts, steviol glycosides 0.2-0.3 parts, maltitol 15-18 parts, citric acid 1-1.2 parts, malic acid 0.5-0.6 parts, disodium EDTA 0.1-0.15 parts, vitamin C 0.8-1 part, xanthan gum 0.3-0.4 parts, sodium carboxymethyl cellulose 0.5-0.6 parts, lemon flavoring 0.4-0.5 parts, menthol 0.1-0.15 parts, hawthorn extract 2-3 parts, soybean lecithin 1.2-1.5 parts, and purified water to 100 parts.

[0007] Loratadine, as the core active ingredient, can specifically block histamine H1 receptors, exert anti-allergic effects, and relieve allergy-related symptoms.

[0008] β-Cyclodextrin has a unique cavity structure that can form inclusion complexes with loratadine, improving the solubility and stability of loratadine while masking its inherent bitterness and improving the taste.

[0009] Polyethylene glycol 400, as a co-solvent, can increase the solubility of loratadine in aqueous systems, promote the dispersion of the active ingredient, and improve the uniformity of the formulation.

[0010] Glycerin has both moisturizing and sweetness-regulating functions, which can improve the smoothness of oral liquids and reduce moisture loss during storage, thus maintaining system stability.

[0011] Propylene glycol has solubilizing and stabilizing effects. It can work synergistically with other solvents to further improve the solubility of active ingredients and has a certain regulating effect on the viscosity of the formulation, preventing stratification.

[0012] Sucralose is a high-sweetness, low-calorie sweetener with a pure sweetness that does not affect blood sugar. When used in combination with steviol glycosides and maltitol, it can form a mild and natural sweetness system that masks the bitterness of drugs and the off-flavors of excipients.

[0013] Stevia glycosides are natural sweeteners with a refreshing taste. They work synergistically with sucralose and maltitol to enrich the sweetness and avoid the cloying sweetness of a single sweetener.

[0014] Maltitol not only provides a mild sweetness but also has moisturizing properties, which can enhance the smoothness of the formulation. It can also synergize with other stabilizers to improve the stability of the system.

[0015] Citric acid and malic acid, when combined as acidity modifiers, can regulate the pH environment of the formulation, enhance the perceived sweetness of sweeteners, improve taste, mask the bitterness of drugs, and improve medication adherence.

[0016] Disodium EDTA, as a chelating agent, can chelate metal ions that may be present in the system, avoiding the influence of metal ions on the stability of loratadine and extending the shelf life of the formulation.

[0017] Vitamin C has antioxidant properties, which can protect loratadine from oxidative damage. At the same time, its acidic properties can help regulate the pH of the preparation and work synergistically with other acid modifiers to improve the taste.

[0018] When xanthan gum is combined with sodium carboxymethyl cellulose as a stabilizer, it can increase the viscosity of the formulation, form a uniform and stable colloidal system, prevent the precipitation and stratification of effective components, and ensure the homogeneity of the formulation.

[0019] The combination of lemon flavoring and menthol can give the preparation a fresh and pleasant flavor, further masking the bitterness of the medicine and enhancing the user experience.

[0020] Hawthorn extract is a natural flavor substance. Its organic acids and flavor components can work synergistically with other acidity regulators and flavorings to enrich the taste. At the same time, its natural components enhance the safety of the formulation.

[0021] Soy lecithin, as an emulsifier and absorption enhancer, can improve the dispersibility of active ingredients in the gastrointestinal tract, promote the absorption of loratadine by the intestinal mucosa, enhance bioavailability, and at the same time enhance the emulsification stability of the formulation system.

[0022] Preferably, the ingredients include the following by weight: 0.5 parts loratadine, 5 parts β-cyclodextrin, 10 parts polyethylene glycol 400, 8 parts glycerin, 6 parts propylene glycol, 0.3 parts sucralose, 0.2 parts steviol glycosides, 15 parts maltitol, 1 part citric acid, 0.5 parts malic acid, 0.1 parts disodium EDTA, 0.8 parts vitamin C, 0.3 parts xanthan gum, 0.5 parts sodium carboxymethyl cellulose, 0.4 parts lemon flavoring, 0.1 parts menthol, 2 parts hawthorn extract, 1.2 parts soybean lecithin, and purified water to 100 parts.

[0023] Preferably, the ingredients include the following by weight: 0.6 parts loratadine, 6 parts β-cyclodextrin, 12 parts polyethylene glycol 400, 10 parts glycerin, 8 parts propylene glycol, 0.4 parts sucralose, 0.3 parts steviol glycosides, 18 parts maltitol, 1.2 parts citric acid, 0.6 parts malic acid, 0.15 parts disodium EDTA, 1 part vitamin C, 0.4 parts xanthan gum, 0.6 parts sodium carboxymethyl cellulose, 0.5 parts lemon flavoring, 0.15 parts menthol, 3 parts hawthorn extract, 1.5 parts soybean lecithin, and purified water to 100 parts.

[0024] Preferably, the ingredients include the following by weight: 0.55 parts loratadine, 5.5 parts β-cyclodextrin, 11 parts polyethylene glycol 400, 9 parts glycerin, 7 parts propylene glycol, 0.35 parts sucralose, 0.25 parts steviol glycosides, 16.5 parts maltitol, 1.1 parts citric acid, 0.55 parts malic acid, 0.12 parts disodium EDTA, 0.9 parts vitamin C, 0.35 parts xanthan gum, 0.55 parts sodium carboxymethyl cellulose, 0.45 parts lemon flavoring, 0.12 parts menthol, 2.5 parts hawthorn extract, 1.35 parts soybean lecithin, and purified water to 100 parts.

[0025] A manufacturing process for loratadine oral solution includes the following steps:

[0026] Step 1: Raw material pretreatment: Loratadine raw material is pulverized and passed through a 100-120 mesh sieve to obtain loratadine powder; β-cyclodextrin is dried and cooled to room temperature; soybean lecithin is dissolved in an appropriate amount of polyethylene glycol 400 to form a soybean lecithin emulsion pretreatment solution; hawthorn extract is dissolved in 5 times its weight of purified water and filtered through a 5μm filter membrane to obtain hawthorn extract for later use; xanthan gum and sodium carboxymethyl cellulose are passed through an 80 mesh sieve respectively.

[0027] Step 2: Preparation of loratadine-β-cyclodextrin inclusion complex: Take β-cyclodextrin, add 8-10 times its weight of purified water to dissolve it and obtain β-cyclodextrin aqueous solution; add loratadine powder, stir at a suitable temperature for 2-3 hours; refrigerate and stand for 12-18 hours, then dry under reduced pressure, pulverize the dried material and pass it through an 80-100 mesh sieve to obtain the inclusion complex;

[0028] Step 3: Preparation of excipient solution: Mix polyethylene glycol 400, glycerin, propylene glycol and 30% of the prescribed amount of purified water, then add sucralose, steviol glycosides and maltitol in sequence, stirring until dissolved; add citric acid and malic acid, stirring until dissolved; add disodium EDTA, vitamin C, xanthan gum and sodium carboxymethyl cellulose, stirring step by step until dissolved; add hawthorn extract (prepared solution) and stir evenly.

[0029] Step 4: Mixing and emulsification: Add the inclusion complex to the excipient solution and stir for 1-2 hours; add lemon flavor and menthol and stir for 30-40 minutes; add soybean lecithin emulsified pretreatment solution, stir, and then emulsify using a high-pressure homogenizing emulsifier;

[0030] Step 5, Volume Adjustment and pH Adjustment: Add purified water to near the total prescription volume and stir well; adjust the pH to a suitable range with 10% citric acid solution or 10% sodium hydroxide solution and stir for 15-20 minutes; add purified water to the total prescription volume and stir at high speed for 30-40 minutes.

[0031] Step 6, Filtration and Degassing: The solution is filtered through three stages of microporous membranes: 2.0μm, 0.8μm, and 0.45μm. After vacuum degassing, the filtrate is allowed to stand for 10 minutes.

[0032] Step 7, Filling and Sterilization: Fill the filtrate into brown oral liquid bottles using an automatic filling device; sterilize using an appropriate process and then cool to room temperature;

[0033] Step 8, Inspection and Packaging: Conduct a light inspection of the oral liquid and remove any unqualified products; after labeling, pack it into the packaging box according to specifications, add the instruction manual, and seal it.

[0034] Preferably, in step two, the vacuum drying of the inclusion complex should reduce the moisture content of the dried material to below 3%.

[0035] Preferably, the stepwise stirring of xanthan gum and sodium carboxymethyl cellulose in step three is as follows: first, stir at low speed for 15 minutes, and then increase the stirring speed for 30 minutes.

[0036] Preferably, in step eight, the light inspection should check the appearance and clarity of the oral liquid one by one to ensure that there is no turbidity, sediment, foreign matter, or leakage.

[0037] Compared with the prior art, the beneficial effects of the present invention are:

[0038] This invention encapsulates loratadine with β-cyclodextrin, combined with the absorption-promoting effect of soybean lecithin, and incorporates compound sweeteners, compound stabilizers, and natural flavor substances. This not only solves the problems of poor solubility and noticeable bitterness of loratadine but also improves the product's stability and bioavailability. The inclusion reaction significantly improves the physicochemical properties of the active ingredient. High-pressure homogenization emulsification ensures a uniform and stable system, preventing component stratification. Three-stage filtration and vacuum degassing effectively remove impurities and air bubbles, ensuring product clarity. Multi-step raw material pretreatment and stepwise mixing processes ensure full integration of components, improving batch-to-batch uniformity. The product exhibits excellent stability, with no precipitation or stratification during long-term storage. It has a mild and natural taste, no bitter residue, and a rich flavor profile, improving patient compliance. The active ingredient has good solubility and high bioavailability, allowing for better efficacy. Attached Figure Description

[0039] Figure 1 This is a process flow diagram of the present invention. Detailed Implementation

[0040] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0041] Please see Figure 1This invention provides a loratadine oral solution comprising the following raw materials in parts by weight: loratadine 0.5-0.6 parts, β-cyclodextrin 5-6 parts, polyethylene glycol 400 10-12 parts, glycerin 8-10 parts, propylene glycol 6-8 parts, sucralose 0.3-0.4 parts, steviol glycosides 0.2-0.3 parts, maltitol 15-18 parts, citric acid 1-1.2 parts, malic acid 0.5-0.6 parts, disodium EDTA 0.1-0.15 parts, vitamin C 0.8-1 part, xanthan gum 0.3-0.4 parts, sodium carboxymethyl cellulose 0.5-0.6 parts, lemon flavoring 0.4-0.5 parts, menthol 0.1-0.15 parts, hawthorn extract 2-3 parts, soybean lecithin 1.2-1.5 parts, and purified water to 100 parts.

[0042] Loratadine, as the core active ingredient, can specifically block histamine H1 receptors, exert anti-allergic effects, and relieve allergy-related symptoms.

[0043] β-Cyclodextrin has a unique cavity structure that can form inclusion complexes with loratadine, improving the solubility and stability of loratadine while masking its inherent bitterness and improving the taste.

[0044] Polyethylene glycol 400, as a co-solvent, can increase the solubility of loratadine in aqueous systems, promote the dispersion of the active ingredient, and improve the uniformity of the formulation.

[0045] Glycerin has both moisturizing and sweetness-regulating functions, which can improve the smoothness of oral liquids and reduce moisture loss during storage, thus maintaining system stability.

[0046] Propylene glycol has solubilizing and stabilizing effects. It can work synergistically with other solvents to further improve the solubility of active ingredients and has a certain regulating effect on the viscosity of the formulation, preventing stratification.

[0047] Sucralose is a high-sweetness, low-calorie sweetener with a pure sweetness that does not affect blood sugar. When used in combination with steviol glycosides and maltitol, it can form a mild and natural sweetness system that masks the bitterness of drugs and the off-flavors of excipients.

[0048] Stevia glycosides are natural sweeteners with a refreshing taste. They work synergistically with sucralose and maltitol to enrich the sweetness and avoid the cloying sweetness of a single sweetener.

[0049] Maltitol not only provides a mild sweetness but also has moisturizing properties, which can enhance the smoothness of the formulation. It can also synergize with other stabilizers to improve the stability of the system.

[0050] Citric acid and malic acid, when combined as acidity modifiers, can regulate the pH environment of the formulation, enhance the perceived sweetness of sweeteners, improve taste, mask the bitterness of drugs, and improve medication adherence.

[0051] Disodium EDTA, as a chelating agent, can chelate metal ions that may be present in the system, avoiding the influence of metal ions on the stability of loratadine and extending the shelf life of the formulation.

[0052] Vitamin C has antioxidant properties, which can protect loratadine from oxidative damage. At the same time, its acidic properties can help regulate the pH of the preparation and work synergistically with other acid modifiers to improve the taste.

[0053] When xanthan gum is combined with sodium carboxymethyl cellulose as a stabilizer, it can increase the viscosity of the formulation, form a uniform and stable colloidal system, prevent the precipitation and stratification of effective components, and ensure the homogeneity of the formulation.

[0054] The combination of lemon flavoring and menthol can give the preparation a fresh and pleasant flavor, further masking the bitterness of the medicine and enhancing the user experience.

[0055] Hawthorn extract is a natural flavor substance. Its organic acids and flavor components can work synergistically with other acidity regulators and flavorings to enrich the taste. At the same time, its natural components enhance the safety of the formulation.

[0056] Soy lecithin, as an emulsifier and absorption enhancer, can improve the dispersibility of active ingredients in the gastrointestinal tract, promote the absorption of loratadine by the intestinal mucosa, enhance bioavailability, and at the same time enhance the emulsification stability of the formulation system.

[0057] A manufacturing process for loratadine oral solution includes the following steps:

[0058] Step 1: Raw material pretreatment

[0059] Loratadine raw material was pulverized in a clean pulverizing device and then sieved through a 100-120 mesh sieve to remove large particles and incompletely pulverized material, resulting in loratadine powder with uniform particle size, for later use. β-cyclodextrin was placed in a drying oven and dried at a suitable temperature to remove moisture from the raw material. After drying, it was removed and cooled to room temperature for later use. Soy lecithin was added to an appropriate amount of polyethylene glycol 400 and placed in a stirring container. It was continuously stirred at a suitable temperature until the soybean lecithin was completely dissolved, forming a uniform soybean lecithin emulsion pretreatment solution for later use. Hawthorn extract was added to 5 times its weight of purified water and dissolved under stirring. It was then filtered through a 5μm filter membrane to remove insoluble impurities, resulting in a hawthorn extract solution for later use. Xanthan gum and sodium carboxymethyl cellulose were sieved through an 80 mesh sieve to remove lumps and impurities, for later use.

[0060] Step 2: Preparation of loratadine-β-cyclodextrin inclusion complex

[0061] Take the prescribed amount of pretreated β-cyclodextrin, add 8-10 times its weight of purified water, place it in a reaction vessel equipped with a stirrer, and stir continuously at a suitable temperature until the β-cyclodextrin is completely dissolved to obtain a transparent β-cyclodextrin aqueous solution. Slowly add the pretreated loratadine powder to the β-cyclodextrin aqueous solution while stirring, and maintain a suitable temperature for 2-3 hours to allow loratadine and β-cyclodextrin to fully undergo an inclusion reaction. After stirring, transfer the mixture to a refrigeration device and let it stand at a low temperature for 12-18 hours to promote the full release of the inclusion complex. Then, place the refrigerated mixture in a vacuum drying device and dry it under a suitable pressure until the moisture content of the dried product drops below 3%. After drying, remove the dried product, place it in a pulverizer, and pulverize it through an 80-100 mesh sieve to obtain the loratadine-β-cyclodextrin inclusion complex for later use.

[0062] Step 3: Preparation of excipient solution

[0063] Take the prescribed amounts of polyethylene glycol 400, glycerin, and propylene glycol, add them to a mixing tank, then add 30% of the prescribed amount of purified water. Turn on the stirrer and stir until the three solvents are completely mixed and homogeneous to obtain a mixed solvent. Add the prescribed amounts of sucralose, steviol glycosides, and maltitol to the mixed solvent in sequence. After adding each sweetener, keep stirring until the sweetener is completely dissolved before adding the next one, ensuring that all sweeteners are fully dissolved and the system is homogeneous. Then add the prescribed amounts of citric acid and malic acid, and continue stirring until the two acidity levels are adjusted. The agent is completely dissolved, and the acidity of the system is initially adjusted to a suitable range. Then, the prescribed amount of pretreated disodium EDTA, vitamin C, xanthan gum, and sodium carboxymethyl cellulose are added. A stepwise stirring method is used. First, the mixture is stirred at a low speed for 15 minutes to evenly disperse the raw materials in the system. Then, the stirring speed is increased and the mixture is stirred for 30 minutes until all the stabilizers are completely dissolved, forming a uniform and viscous excipient solution. The prepared hawthorn extract stock solution is slowly added to the excipient solution and stirred for 20 minutes to ensure that the hawthorn extract and the excipient solution are fully mixed and homogeneous.

[0064] Step 4: Mixing and Emulsification

[0065] Slowly add the loratadine-β-cyclodextrin inclusion complex prepared in step two to the excipient solution prepared in step three while stirring continuously at a stable stirring speed for 1-2 hours to ensure that the inclusion complex is completely dispersed and dissolved in the excipient solution without obvious particles. Add the prescribed amount of lemon flavoring and menthol to the above mixture and continue stirring for 30-40 minutes to ensure that the flavor substances are evenly dispersed in the system and form a preliminary mixture. Add the soybean lecithin emulsion pretreatment solution prepared in step one to the preliminary mixture and stir for 15 minutes. Then, transfer the mixture to a high-pressure homogenizing emulsifier for emulsification to form a uniform and stable emulsion, ensuring that all components are fully integrated.

[0066] Step 5: Volume Adjustment and pH Adjustment

[0067] Transfer the emulsified mixture to a large-capacity mixing tank, add purified water to near the total weight specified in the prescription, turn on the stirrer, and stir for 20 minutes to ensure the system is uniformly mixed; slowly adjust the pH of the mixture with 10% citric acid solution or 10% sodium hydroxide solution, continuously stirring and monitoring the pH in real time during the adjustment process until the pH reaches the appropriate range, and continue stirring for 15-20 minutes after adjustment to ensure the pH of the system is uniform and stable; add purified water to the total weight specified in the prescription, turn on the stirrer and stir at high speed for 30-40 minutes to ensure all components are fully mixed to form a uniform oral liquid stock solution.

[0068] Step Six: Filtration and Degassing

[0069] The oral liquid concentrate was sequentially filtered through microporous membranes of 2.0μm, 0.8μm, and 0.45μm for three-stage filtration. During the filtration process, the filtration pressure was kept stable to remove insoluble impurities, air bubbles, and any fine particles that might be present in the system, ensuring that the filtrate was clear and transparent. The filtered filtrate was then transferred to a vacuum degassing device. The degassing device was turned on and degassed under suitable vacuum conditions to remove dissolved air from the filtrate, preventing the formation of air bubbles during subsequent storage and use that could affect product quality. After degassing was completed, the device was turned off and the mixture was allowed to stand for 10 minutes.

[0070] Step 7: Filling and Sterilization

[0071] After degassing, the qualified filtrate is transferred to the storage tank of the automatic filling equipment. Brown oral liquid bottles that meet pharmaceutical standards, along with matching rubber stoppers and aluminum caps, are selected. The automatic filling equipment is used for filling, and the filling volume of each bottle is strictly controlled to ensure accurate dosage. During the filling process, the bottle openings are kept tightly sealed, with no leakage or seepage. The filled oral liquid bottles are then neatly placed in the sterilization equipment and sterilized using an appropriate sterilization process. During sterilization, the sterilization conditions are strictly controlled to ensure thorough sterilization without affecting the stability of the active ingredients. After sterilization, the oral liquid bottles are quickly cooled to room temperature to avoid the continued impact of high temperatures on product quality.

[0072] Step 8: Light Inspection and Packaging

[0073] After cooling, the oral liquid undergoes light inspection. Each bottle of oral liquid is checked for appearance and clarity using light inspection equipment, and unqualified products with turbidity, sediment, foreign matter, leakage, etc. are rejected. The oral liquids that pass the light inspection are labeled with complete and clear label information, and then packaged into pharmaceutical packaging boxes according to the prescribed specifications. The instruction manual is added, the packaging boxes are sealed, and the finished product packaging is completed.

[0074] Example 1:

[0075] Formula composition (parts by weight):

[0076] Loratadine 0.5 parts, β-cyclodextrin 5 parts, polyethylene glycol 400 10 parts, glycerin 8 parts, propylene glycol 6 parts, sucralose 0.3 parts, steviol 0.2 parts, maltitol 15 parts, citric acid 1 part, malic acid 0.5 parts, disodium EDTA 0.1 parts, vitamin C 0.8 parts, xanthan gum 0.3 parts, sodium carboxymethyl cellulose 0.5 parts, lemon flavor 0.4 parts, menthol 0.1 parts, hawthorn extract 2 parts, soybean lecithin 1.2 parts, purified water to 100 parts.

[0077] Preparation method:

[0078] Step 1: Raw Material Pretreatment: Loratadine raw material is pulverized in a clean pulverizing device and then sieved through a 100-mesh sieve to obtain uniformly sized loratadine powder for later use. β-Cyclodextrin is placed in a drying oven and dried at a suitable temperature to remove moisture. After drying, it is removed and cooled to room temperature for later use. 1.2 parts of soybean lecithin are added to 3 parts of polyethylene glycol 400 in a stirring container and stirred continuously at a suitable temperature until the soybean lecithin is completely dissolved, forming a uniform soybean lecithin emulsion pretreatment solution for later use. 2 parts of hawthorn extract are added to 10 parts of purified water and dissolved under stirring. The solution is then filtered through a 5μm filter membrane to remove insoluble impurities, yielding a hawthorn extract solution for later use. 0.3 parts of xanthan gum and 0.5 parts of sodium carboxymethyl cellulose are passed through an 80-mesh sieve to remove lumps and impurities for later use.

[0079] Step 2: Preparation of the loratadine-β-cyclodextrin inclusion complex: Take 5 parts of pretreated β-cyclodextrin, add 40 parts of purified water, place in a reaction vessel equipped with a stirrer, and stir continuously at a suitable temperature until the β-cyclodextrin is completely dissolved to obtain a transparent β-cyclodextrin aqueous solution; slowly add 0.5 parts of pretreated loratadine powder to the β-cyclodextrin aqueous solution while stirring, and maintain a suitable temperature for 2 hours to allow loratadine and β-cyclodextrin to fully undergo the inclusion reaction; after stirring, transfer the mixture to a refrigeration device and let it stand at a low temperature for 12 hours to promote the full release of the inclusion complex; then place the refrigerated mixture in a vacuum drying device and dry it under a suitable pressure until the moisture content of the dried product drops below 3%. After drying, remove the dried product, pulverize it in a pulverizing device, and pass it through an 80-mesh sieve to obtain the loratadine-β-cyclodextrin inclusion complex for later use.

[0080] Step 3: Preparation of excipient solution: Take 10 parts polyethylene glycol 400, 8 parts glycerin, and 6 parts propylene glycol, add them to the mixing tank, then add 30 parts purified water. Turn on the stirrer and stir until the three solvents are completely mixed and homogeneous to obtain a mixed solvent. Add 0.3 parts sucralose, 0.2 parts steviol glycosides, and 15 parts maltitol to the mixed solvent in sequence. After adding each sweetener, keep stirring until the sweetener is completely dissolved before adding the next one, ensuring that all sweeteners are fully dissolved and the system is homogeneous. Then add 1 part citric acid and 0.5 parts malic acid, and continue stirring until the two acids are completely dissolved. The flavor regulator was completely dissolved to initially adjust the acidity of the system to a suitable range. Then, 0.1 parts of disodium EDTA, 0.8 parts of vitamin C, 0.3 parts of pretreated xanthan gum, and 0.5 parts of sodium carboxymethyl cellulose were added. A stepwise stirring method was adopted, first stirring at low speed for 15 minutes to evenly disperse the raw materials in the system, and then increasing the stirring speed and continuing to stir for 30 minutes until all stabilizers were completely dissolved to form a uniform and viscous excipient solution. The prepared hawthorn extract stock solution was slowly added to the excipient solution and stirred for 20 minutes to ensure that the hawthorn extract and excipient solution were fully mixed and homogeneous.

[0081] Step 4, Mixing and Emulsification: Slowly add the loratadine-β-cyclodextrin inclusion complex prepared in Step 2 to the excipient solution prepared in Step 3 while stirring continuously at a stable stirring speed for 1 hour to ensure that the inclusion complex is completely dispersed and dissolved in the excipient solution without obvious particles; add 0.4 parts lemon flavoring and 0.1 parts menthol to the above mixture and continue stirring for 30 minutes to evenly disperse the flavor substances in the system and form a preliminary mixture; add the soybean lecithin emulsion pretreatment solution prepared in Step 1 to the preliminary mixture and stir for 15 minutes. Then transfer the mixture to a high-pressure homogenizing emulsifier for emulsification to form a uniform and stable emulsion, ensuring that all components are fully integrated.

[0082] Step 5, Volume Adjustment and pH Adjustment: Transfer the emulsified mixture to a large-capacity mixing tank, add purified water to 95 parts, turn on the stirrer, and stir for 20 minutes to ensure the system is evenly mixed; slowly adjust the pH of the mixture with 10% citric acid solution or 10% sodium hydroxide solution, continuously stirring and monitoring the pH in real time until the pH reaches the appropriate range. After adjustment, continue stirring for 15 minutes to ensure the pH of the system is uniform and stable; add purified water to 100 parts, turn on the stirrer and stir at high speed for 30 minutes to ensure all components are fully mixed and form a uniform oral liquid stock solution.

[0083] Step Six: Filtration and Degassing: The oral liquid concentrate is sequentially filtered through microporous membranes of 2.0μm, 0.8μm, and 0.45μm for three-stage filtration. During the filtration process, the filtration pressure is kept stable to remove insoluble impurities, air bubbles, and any fine particles that may be present in the system, ensuring that the filtrate is clear and transparent. The filtered filtrate is then transferred to a vacuum degassing device. The degassing device is turned on and degassing is performed under suitable vacuum conditions to remove dissolved air from the filtrate, preventing air bubbles from affecting product quality during subsequent storage and use. After degassing is completed, the device is turned off and the mixture is allowed to stand for 10 minutes.

[0084] Step 7, Filling and Sterilization: Transfer the degassed, qualified filtrate to the storage tank of the automatic filling equipment. Select pharmaceutical-grade brown oral liquid bottles with matching rubber stoppers and aluminum caps. Perform the filling operation using the automatic filling equipment, strictly controlling the filling volume of each bottle to 10 ml to ensure accurate dosage. During the filling process, ensure the bottle opening is tightly sealed without leakage or seepage. Neatly place the filled oral liquid bottles into the sterilization equipment and sterilize them using an appropriate sterilization process. Strictly control the sterilization conditions during the sterilization process to ensure thorough sterilization without affecting the stability of the active ingredients. After sterilization, quickly cool the oral liquid bottles to room temperature to avoid the continued impact of high temperatures on product quality.

[0085] Step 8, Inspection and Packaging: After cooling, the oral liquid is inspected by light. Each bottle of oral liquid is checked for appearance and clarity using light inspection equipment. Unqualified products with turbidity, sediment, foreign matter, leakage, etc. are rejected. The oral liquid that passes the light inspection is labeled with complete and clear label information. Then, it is packed into a pharmaceutical packaging box with 10 bottles per box, the instruction manual is added, the packaging box is sealed, and the finished product packaging is completed.

[0086] Example 2:

[0087] Formula composition (parts by weight):

[0088] Loratadine 0.6 parts, β-cyclodextrin 6 parts, polyethylene glycol 400 12 parts, glycerin 10 parts, propylene glycol 8 parts, sucralose 0.4 parts, steviol 0.3 parts, maltitol 18 parts, citric acid 1.2 parts, malic acid 0.6 parts, disodium EDTA 0.15 parts, vitamin C 1 part, xanthan gum 0.4 parts, sodium carboxymethyl cellulose 0.6 parts, lemon flavor 0.5 parts, menthol 0.15 parts, hawthorn extract 3 parts, soybean lecithin 1.5 parts, purified water to 100 parts.

[0089] Preparation method:

[0090] Step 1: Raw Material Pretreatment: Loratadine raw material is pulverized in a clean pulverizing device and then sieved through a 120-mesh sieve to obtain uniformly sized loratadine powder for later use. β-Cyclodextrin is placed in a drying oven and dried at a suitable temperature to remove moisture. After drying, it is removed and cooled to room temperature for later use. 1.5 parts of soybean lecithin are added to 4 parts of polyethylene glycol 400 in a stirring container and stirred continuously at a suitable temperature until the soybean lecithin is completely dissolved, forming a uniform soybean lecithin emulsion pretreatment solution for later use. 3 parts of hawthorn extract are added to 15 parts of purified water and dissolved under stirring. The solution is then filtered through a 5μm filter membrane to remove insoluble impurities, yielding a hawthorn extract solution for later use. 0.4 parts of xanthan gum and 0.6 parts of sodium carboxymethyl cellulose are passed through an 80-mesh sieve to remove lumps and impurities for later use.

[0091] Step 2: Preparation of the loratadine-β-cyclodextrin inclusion complex: Take 6 parts of pretreated β-cyclodextrin, add 60 parts of purified water, place in a reaction vessel equipped with a stirrer, and stir continuously at a suitable temperature until the β-cyclodextrin is completely dissolved to obtain a transparent β-cyclodextrin aqueous solution; slowly add 0.6 parts of pretreated loratadine powder to the β-cyclodextrin aqueous solution while stirring, and maintain a suitable temperature for 3 hours to allow loratadine and β-cyclodextrin to fully undergo the inclusion reaction; after stirring, transfer the mixture to a refrigeration device and let it stand at a low temperature for 18 hours to promote the full release of the inclusion complex; then place the refrigerated mixture in a vacuum drying device and dry it under a suitable pressure until the moisture content of the dried product drops below 3%. After drying, remove the dried product, pulverize it in a pulverizing device, and pass it through a 100-mesh sieve to obtain the loratadine-β-cyclodextrin inclusion complex for later use.

[0092] Step 3: Preparation of excipient solution: Take 12 parts of polyethylene glycol 400, 10 parts of glycerin, and 8 parts of propylene glycol, add them to the mixing tank, then add 30 parts of purified water. Turn on the stirrer and stir until the three solvents are completely mixed and homogeneous to obtain a mixed solvent. Add 0.4 parts of sucralose, 0.3 parts of steviol glycosides, and 18 parts of maltitol to the mixed solvent in sequence. After adding each sweetener, keep stirring until the sweetener is completely dissolved before adding the next one, ensuring that all sweeteners are fully dissolved and the system is homogeneous. Then add 1.2 parts of citric acid and 0.6 parts of malic acid, and continue stirring until the mixture is completely dissolved and homogeneous. The acidity regulator was completely dissolved to initially adjust the acidity of the system to a suitable range. Then, 0.15 parts of disodium EDTA, 1 part of vitamin C, 0.4 parts of pretreated xanthan gum, and 0.6 parts of sodium carboxymethyl cellulose were added. A stepwise stirring method was adopted, first stirring at low speed for 15 minutes to evenly disperse the raw materials in the system, and then increasing the stirring speed and continuing to stir for 30 minutes until all stabilizers were completely dissolved to form a uniform and viscous excipient solution. The prepared hawthorn extract stock solution was slowly added to the excipient solution and stirred for 20 minutes to ensure that the hawthorn extract and excipient solution were fully mixed and uniform.

[0093] Step 4, Mixing and Emulsification: Slowly add the loratadine-β-cyclodextrin inclusion complex prepared in Step 2 to the excipient solution prepared in Step 3 while stirring continuously at a stable stirring speed for 2 hours to ensure that the inclusion complex is completely dispersed and dissolved in the excipient solution without obvious particles; add 0.5 parts lemon flavoring and 0.15 parts menthol to the above mixture and continue stirring for 40 minutes to evenly disperse the flavor substances in the system and form a preliminary mixture; add the soybean lecithin emulsion pretreatment solution prepared in Step 1 to the preliminary mixture and stir for 15 minutes. Then transfer the mixture to a high-pressure homogenizing emulsifier for emulsification to form a uniform and stable emulsion, ensuring that all components are fully integrated.

[0094] Step 5, Volume Adjustment and pH Adjustment: Transfer the emulsified mixture to a large-capacity mixing tank, add purified water to 95 parts, turn on the stirrer, and stir for 20 minutes to ensure the system is evenly mixed; slowly adjust the pH of the mixture with 10% citric acid solution or 10% sodium hydroxide solution, continuously stirring and monitoring the pH in real time until the pH reaches the appropriate range. After adjustment, continue stirring for 20 minutes to ensure the pH of the system is uniform and stable; add purified water to 100 parts, turn on the stirrer and stir at high speed for 40 minutes to ensure all components are fully mixed and form a uniform oral liquid stock solution.

[0095] Step Six: Filtration and Degassing: The oral liquid concentrate is sequentially filtered through microporous membranes of 2.0μm, 0.8μm, and 0.45μm for three-stage filtration. During the filtration process, the filtration pressure is kept stable to remove insoluble impurities, air bubbles, and any fine particles that may be present in the system, ensuring that the filtrate is clear and transparent. The filtered filtrate is then transferred to a vacuum degassing device. The degassing device is turned on and degassing is performed under suitable vacuum conditions to remove dissolved air from the filtrate, preventing air bubbles from affecting product quality during subsequent storage and use. After degassing is completed, the device is turned off and the mixture is allowed to stand for 10 minutes.

[0096] Step 7, Filling and Sterilization: Transfer the degassed, qualified filtrate to the storage tank of the automatic filling equipment. Select pharmaceutical-grade brown oral liquid bottles with matching rubber stoppers and aluminum caps. Perform the filling operation using the automatic filling equipment, strictly controlling the filling volume of each bottle to 10 ml to ensure accurate dosage. During the filling process, ensure the bottle opening is tightly sealed without leakage or seepage. Neatly place the filled oral liquid bottles into the sterilization equipment and sterilize them using an appropriate sterilization process. Strictly control the sterilization conditions during the sterilization process to ensure thorough sterilization without affecting the stability of the active ingredients. After sterilization, quickly cool the oral liquid bottles to room temperature to avoid the continued impact of high temperatures on product quality.

[0097] Step 8, Inspection and Packaging: After cooling, the oral liquid is inspected by light. Each bottle of oral liquid is checked for appearance and clarity using light inspection equipment. Unqualified products with turbidity, sediment, foreign matter, leakage, etc. are rejected. The oral liquid that passes the light inspection is labeled with complete and clear label information. Then, it is packed into a pharmaceutical packaging box with 10 bottles per box, the instruction manual is added, the packaging box is sealed, and the finished product packaging is completed.

[0098] Comparative Example 1:

[0099] Formula composition (parts by weight):

[0100] Loratadine 0.5 parts, polyethylene glycol 400 10 parts, glycerin 8 parts, propylene glycol 6 parts, sucralose 0.3 parts, steviol glycosides 0.2 parts, maltitol 15 parts, citric acid 1 part, malic acid 0.5 parts, disodium EDTA 0.1 parts, vitamin C 0.8 parts, xanthan gum 0.3 parts, sodium carboxymethyl cellulose 0.5 parts, lemon flavor 0.4 parts, menthol 0.1 parts, hawthorn extract 2 parts, purified water to 100 parts.

[0101] Preparation method:

[0102] Step 1: Raw material pretreatment: Place loratadine raw material in a clean pulverizing device for pulverization. After pulverization, sieve through a 100-mesh sieve to obtain loratadine powder with uniform particle size, and set aside. Add 2 parts of hawthorn extract to 10 parts of purified water and dissolve under stirring. Then filter through a 5μm filter membrane to remove insoluble impurities and obtain hawthorn extract solution for later use. Pass 0.3 parts of xanthan gum and 0.5 parts of sodium carboxymethyl cellulose through an 80-mesh sieve to remove lumps and impurities, and set aside.

[0103] Step 2: Preparation of excipient solution: Take 10 parts polyethylene glycol 400, 8 parts glycerin, and 6 parts propylene glycol, add them to the mixing tank, then add 30 parts purified water. Turn on the stirrer and stir until the three solvents are completely mixed and homogeneous to obtain a mixed solvent. Add 0.3 parts sucralose, 0.2 parts steviol glycosides, and 15 parts maltitol to the mixed solvent in sequence. After adding each sweetener, keep stirring until the sweetener is completely dissolved before adding the next one, ensuring that all sweeteners are fully dissolved and the system is homogeneous. Then add 1 part citric acid and 0.5 parts malic acid, and continue stirring until the two acids are completely dissolved. The flavor regulator was completely dissolved to initially adjust the acidity of the system to a suitable range. Then, 0.1 parts of disodium EDTA, 0.8 parts of vitamin C, 0.3 parts of pretreated xanthan gum, and 0.5 parts of sodium carboxymethyl cellulose were added. A stepwise stirring method was adopted, first stirring at low speed for 15 minutes to evenly disperse the raw materials in the system, and then increasing the stirring speed and continuing to stir for 30 minutes until all stabilizers were completely dissolved to form a uniform and viscous excipient solution. The prepared hawthorn extract stock solution was slowly added to the excipient solution and stirred for 20 minutes to ensure that the hawthorn extract and excipient solution were fully mixed and homogeneous.

[0104] Step 3, Mixing: Slowly add 0.5 parts of pretreated loratadine powder to the excipient solution while stirring, maintaining a stable stirring speed, and continue stirring for 1 hour to ensure that the loratadine powder is completely dispersed and dissolved in the excipient solution; add 0.4 parts of lemon flavoring and 0.1 parts of menthol to the above mixture, and continue stirring for 30 minutes to evenly disperse the flavor substances in the system, forming the oral liquid stock solution.

[0105] Step 4: Volume Adjustment and pH Adjustment: Transfer the oral liquid stock solution to a large-capacity mixing tank, add purified water to 95 parts, turn on the stirrer, and stir for 20 minutes to ensure the system is evenly mixed; slowly adjust the pH value of the mixture with 10% citric acid solution or 10% sodium hydroxide solution, continuously stirring and monitoring the pH value in real time during the adjustment process until the pH reaches the appropriate range. After adjustment, continue stirring for 15 minutes to ensure the pH of the system is uniform and stable; add purified water to 100 parts, turn on the stirrer and stir at high speed for 30 minutes to ensure all components are fully mixed.

[0106] Step 5, Filtration and Degassing: The oral liquid concentrate is sequentially filtered through microporous membranes of 2.0μm, 0.8μm, and 0.45μm for three-stage filtration. During the filtration process, the filtration pressure is kept stable to remove insoluble impurities, air bubbles, and any fine particles that may be present in the system. The filtered liquid is then transferred to a vacuum degassing device. The degassing device is turned on and degassed under suitable vacuum conditions. After degassing is completed, the device is turned off and the mixture is allowed to stand for 10 minutes.

[0107] Step Six: Filling and Sterilization: Transfer the degassed and qualified filtrate to the storage tank of the automatic filling equipment. Select brown oral liquid bottles that meet pharmaceutical standards and use matching rubber stoppers and aluminum caps. Perform the filling operation using the automatic filling equipment, strictly controlling the filling volume of each bottle to 10 ml to ensure accurate dosage. Ensure the bottle opening is tightly sealed during the filling process. Place the filled oral liquid bottles neatly into the sterilization equipment and sterilize them using an appropriate sterilization process. After sterilization, quickly cool the oral liquid bottles to room temperature.

[0108] Step 7, Inspection and Packaging: The cooled oral liquid is inspected by light. Each bottle of oral liquid is checked for appearance and clarity using light inspection equipment. Unqualified products with turbidity, sediment, foreign matter, leakage, etc. are rejected. The oral liquid that passes the light inspection is labeled with complete and clear label information. Then, it is packed into a pharmaceutical packaging box with 10 bottles per box, the instruction manual is added, the packaging box is sealed, and the finished product packaging is completed.

[0109] Comparative Example 2:

[0110] Formula composition (parts by weight):

[0111] Loratadine 0.5 parts, polyethylene glycol 400 10 parts, glycerin 8 parts, propylene glycol 6 parts, sucrose 5 parts, citric acid 1 part, malic acid 0.5 parts, disodium EDTA 0.1 parts, lemon flavor 0.4 parts, menthol 0.1 parts, hawthorn extract 2 parts, soybean lecithin 1.2 parts, purified water to 100 parts.

[0112] Preparation method:

[0113] Step 1: Raw material pretreatment: Place loratadine raw material in a clean pulverizing device for pulverization. After pulverization, sieve through a 100-mesh sieve to obtain loratadine powder with uniform particle size, and set aside. Add 1.2 parts of soybean lecithin to 3 parts of polyethylene glycol 400 in a stirring container and stir continuously at a suitable temperature until the soybean lecithin is completely dissolved to form a uniform soybean lecithin emulsion pretreatment solution, and set aside. Add 2 parts of hawthorn extract to 10 parts of purified water and dissolve while stirring. Then filter through a 5μm filter membrane to remove insoluble impurities to obtain hawthorn extract reserve solution, and set aside.

[0114] Step 2: Preparation of excipient solution: Take 10 parts of polyethylene glycol 400, 8 parts of glycerin, and 6 parts of propylene glycol, add them to the mixing tank, then add 30 parts of purified water, turn on the stirrer, and stir until the three solvents are completely mixed and homogeneous to obtain a mixed solvent; add 5 parts of sucrose to the mixed solvent and stir until the sucrose is completely dissolved; then add 1 part of citric acid and 0.5 parts of malic acid, and continue stirring until the two acidity regulators are completely dissolved, so that the acidity of the system is initially adjusted to a suitable range; then add 0.1 parts of disodium EDTA and stir until completely dissolved; slowly add the prepared hawthorn extract stock solution to the excipient solution and stir for 20 minutes to ensure that the hawthorn extract and excipient solution are fully mixed and homogeneous.

[0115] Step 3, Mixing and Emulsification: Slowly add 0.5 parts of pretreated loratadine powder to the excipient solution while stirring, maintaining a stable stirring speed, and continue stirring for 1 hour to ensure that the loratadine powder is completely dispersed and dissolved in the excipient solution; add 0.4 parts of lemon flavoring and 0.1 parts of menthol to the above mixture, and continue stirring for 30 minutes to evenly disperse the flavor substances in the system and form a preliminary mixture; add the soybean lecithin emulsion pretreated solution prepared in Step 1 to the preliminary mixture, stir for 15 minutes, and then transfer the mixture to a high-pressure homogenizing emulsifier for emulsification to form an emulsion.

[0116] Step 4: Volume Adjustment and pH Adjustment: Transfer the emulsified mixture to a large-capacity mixing tank, add purified water to 95 parts, turn on the stirrer, and stir for 20 minutes to ensure the system is evenly mixed; slowly adjust the pH of the mixture with 10% citric acid solution or 10% sodium hydroxide solution, continuously stirring and monitoring the pH in real time until the pH reaches the appropriate range. After adjustment, continue stirring for 15 minutes to ensure the pH of the system is uniform and stable; add purified water to 100 parts, turn on the stirrer and stir at high speed for 30 minutes to ensure all components are fully mixed and form a uniform oral liquid stock solution.

[0117] Step 5, Filtration and Degassing: The oral liquid concentrate is sequentially filtered through microporous membranes of 2.0μm, 0.8μm, and 0.45μm for three-stage filtration. During the filtration process, the filtration pressure is kept stable to remove insoluble impurities, air bubbles, and any fine particles that may be present in the system. The filtered liquid is then transferred to a vacuum degassing device. The degassing device is turned on and degassed under suitable vacuum conditions. After degassing is completed, the device is turned off and the mixture is allowed to stand for 10 minutes.

[0118] Step Six: Filling and Sterilization: Transfer the degassed and qualified filtrate to the storage tank of the automatic filling equipment. Select brown oral liquid bottles that meet pharmaceutical standards and use matching rubber stoppers and aluminum caps. Perform the filling operation using the automatic filling equipment, strictly controlling the filling volume of each bottle to 10 ml to ensure accurate dosage. Ensure the bottle opening is tightly sealed during the filling process. Place the filled oral liquid bottles neatly into the sterilization equipment and sterilize them using an appropriate sterilization process. After sterilization, quickly cool the oral liquid bottles to room temperature.

[0119] Step 7, Inspection and Packaging: The cooled oral liquid is inspected by light. Each bottle of oral liquid is checked for appearance and clarity using light inspection equipment. Unqualified products with turbidity, sediment, foreign matter, leakage, etc. are rejected. The oral liquid that passes the light inspection is labeled with complete and clear label information. Then, it is packed into a pharmaceutical packaging box with 10 bottles per box, the instruction manual is added, the packaging box is sealed, and the finished product packaging is completed.

[0120] The following table compares the above Examples 1 and 2 with Comparative Examples 1 and 2:

[0121]

[0122]

[0123] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. Loratadine oral solution, characterized in that, The product contains the following ingredients by weight: 0.5-0.6 parts loratadine, 5-6 parts β-cyclodextrin, 10-12 parts polyethylene glycol 400, 8-10 parts glycerin, 6-8 parts propylene glycol, 0.3-0.4 parts sucralose, 0.2-0.3 parts steviol glycosides, 15-18 parts maltitol, 1-1.2 parts citric acid, 0.5-0.6 parts malic acid, 0.1-0.15 parts disodium EDTA, 0.8-1 part vitamin C, 0.3-0.4 parts xanthan gum, 0.5-0.6 parts sodium carboxymethyl cellulose, 0.4-0.5 parts lemon flavoring, 0.1-0.15 parts menthol, 2-3 parts hawthorn extract, 1.2-1.5 parts soybean lecithin, and purified water to 100 parts.

2. The loratadine oral solution of claim 1, wherein, The ingredients include the following by weight: 0.5 parts loratadine, 5 parts β-cyclodextrin, 10 parts polyethylene glycol 400, 8 parts glycerin, 6 parts propylene glycol, 0.3 parts sucralose, 0.2 parts steviol glycosides, 15 parts maltitol, 1 part citric acid, 0.5 parts malic acid, 0.1 parts disodium EDTA, 0.8 parts vitamin C, 0.3 parts xanthan gum, 0.5 parts sodium carboxymethyl cellulose, 0.4 parts lemon flavor, 0.1 parts menthol, 2 parts hawthorn extract, 1.2 parts soybean lecithin, and purified water to 100 parts.

3. The loratadine oral solution of claim 1, wherein, The ingredients include the following by weight: 0.6 parts loratadine, 6 parts β-cyclodextrin, 12 parts polyethylene glycol 400, 10 parts glycerin, 8 parts propylene glycol, 0.4 parts sucralose, 0.3 parts steviol glycosides, 18 parts maltitol, 1.2 parts citric acid, 0.6 parts malic acid, 0.15 parts disodium EDTA, 1 part vitamin C, 0.4 parts xanthan gum, 0.6 parts sodium carboxymethyl cellulose, 0.5 parts lemon flavoring, 0.15 parts menthol, 3 parts hawthorn extract, 1.5 parts soybean lecithin, and purified water to 100 parts.

4. The loratadine oral solution of claim 1, wherein, The ingredients include the following by weight: 0.55 parts loratadine, 5.5 parts β-cyclodextrin, 11 parts polyethylene glycol 400, 9 parts glycerin, 7 parts propylene glycol, 0.35 parts sucralose, 0.25 parts steviol glycosides, 16.5 parts maltitol, 1.1 parts citric acid, 0.55 parts malic acid, 0.12 parts disodium EDTA, 0.9 parts vitamin C, 0.35 parts xanthan gum, 0.55 parts sodium carboxymethyl cellulose, 0.45 parts lemon flavoring, 0.12 parts menthol, 2.5 parts hawthorn extract, 1.35 parts soybean lecithin, and purified water to 100 parts.

5. The production process of loratadine oral solution according to any one of claims 1-4, characterized in that, Includes the following steps: Step 1: Raw material pretreatment: Loratadine raw material is pulverized and passed through a 100-120 mesh sieve to obtain loratadine powder; β-cyclodextrin is dried and cooled to room temperature; soybean lecithin is dissolved in an appropriate amount of polyethylene glycol 400 to form a soybean lecithin emulsion pretreatment solution; hawthorn extract is dissolved in 5 times its weight of purified water and filtered through a 5μm filter membrane to obtain hawthorn extract for later use; xanthan gum and sodium carboxymethyl cellulose are passed through an 80 mesh sieve respectively. Step 2: Preparation of loratadine-β-cyclodextrin inclusion complex: Take β-cyclodextrin, add 8-10 times its weight of purified water to dissolve it and obtain β-cyclodextrin aqueous solution; add loratadine powder, stir at a suitable temperature for 2-3 hours; refrigerate and stand for 12-18 hours, then dry under reduced pressure, pulverize the dried material and pass it through an 80-100 mesh sieve to obtain the inclusion complex; Step 3, preparation of excipient solution: Mix polyethylene glycol 400, glycerin, propylene glycol and 30% of the prescribed amount of purified water, then add sucralose, steviol glycosides and maltitol in sequence, and stir until dissolved; Add citric acid and malic acid, and stir until dissolved; add disodium EDTA, vitamin C, xanthan gum, and sodium carboxymethyl cellulose, and stir step by step until dissolved; add hawthorn extract (prepared solution) and stir well. Step 4: Mixing and emulsification: Add the inclusion complex to the excipient solution and stir for 1-2 hours; add lemon flavor and menthol and stir for 30-40 minutes; add soybean lecithin emulsified pretreatment solution, stir, and then emulsify using a high-pressure homogenizing emulsifier; Step 5, Volume Adjustment and pH Adjustment: Add purified water to near the total prescription volume and stir well; adjust the pH to a suitable range with 10% citric acid solution or 10% sodium hydroxide solution and stir for 15-20 minutes; add purified water to the total prescription volume and stir at high speed for 30-40 minutes. Step 6, Filtration and Degassing: The solution is filtered through three stages of microporous membranes: 2.0μm, 0.8μm, and 0.45μm. After vacuum degassing, the filtrate is allowed to stand for 10 minutes. Step 7, Filling and Sterilization: Fill the filtrate into brown oral liquid bottles using an automatic filling device; sterilize using an appropriate process and then cool to room temperature; Step 8, Inspection and Packaging: Conduct a light inspection of the oral liquid and remove any unqualified products; after labeling, pack it into the packaging box according to specifications, add the instruction manual, and seal it.

6. The process for the production of loratadine oral solution as claimed in claim 5 wherein, In step two, the vacuum drying of the inclusion complex must reduce the moisture content of the dried material to below 3%.

7. The process for the production of loratadine oral solution as claimed in claim 5 wherein, In step three, the xanthan gum and sodium carboxymethyl cellulose are stirred in stages: first at low speed for 15 minutes, then at increased speed for 30 minutes.

8. The process for the production of loratadine oral solution as claimed in claim 5 wherein, In step eight, the light inspection requires checking the appearance and clarity of each oral liquid to ensure there is no turbidity, sediment, foreign matter, or leakage.

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