CN108014120A - A kind of drug release rate controllable azithromycin resin compound and its taste masking dry suspensoid agent - Google Patents

Abstract

The present invention provides a kind of drug release rate controllable azithromycin resin compound and its dry suspensoid agent, the controllable azithromycin resin compound of the drug release rate includes decorative material and azithromycin resin compound, and the controllable taste masking dry suspensoid agent of the drug release rate specifically includes azithromycin resin compound, suspending agent, flavouring and other pharmaceutically acceptable auxiliary materials after modification.Azithromycin for Suspension provided by the invention can realize that drug release rate is controllable while the bitterness problem of azithromycin is solved according to different treatment requirements, and particle is small, without grittiness in mouth, is particularly suitable for children taking.

Description

Azithromycin resin complex with controllable drug release rate and its taste-masking dry suspension

technical field

The invention belongs to the technical field of medicine, and relates to an azithromycin resin complex with controllable drug release rate and a taste-masking dry suspension.

Background technique

Ion exchange resin is a water-insoluble macromolecular polymer, which contains acidic or basic groups in the structure that can exchange ions with drugs, block the contact between drug molecules and bitter taste receptors, and mask the bitter taste. The exchangeable ions in the ion exchange resin structure undergo an ion exchange reaction with drug ions of the same electronic charge, and combine to form a drug resin. There are very few ions in the oral cavity, the drug will not be replaced, and almost no bitter taste will be produced. After entering the human body, the drug will be exchanged by the ions in the gastrointestinal tract to exert its curative effect. It can be administered orally or by other non-injection routes to achieve For taste masking purposes. Compared with other substances that regulate drug release, ion exchange resins have the following characteristics: drug release is not affected by intestinal pH, enzyme activity, and gastrointestinal fluid volume. Since the ion concentration in the gastrointestinal tract is relatively constant, the drug It can be released at a certain speed in the body.

Azithromycin is a second-generation macrolide broad-spectrum antibiotic derived from erythromycin A. Compared with erythromycin, azithromycin is more stable to acid than erythromycin and has a wider antibacterial spectrum. Azithromycin is a concentration-dependent antibiotic. The higher the peak concentration of the drug, the stronger the killing effect on pathogenic bacteria and the faster the killing speed. It has the following characteristics: (1) The antibacterial activity increases with the increase of the concentration of the antibacterial drug. When the blood drug concentration exceeds the minimum inhibitory concentration (MIC) of pathogenic bacteria by 8 to 10 times, the antibacterial activity is strong; (2) there is a significant post-antibiotic effect (PAE); (3) the blood drug concentration is lower than the MIC It still has a certain antibacterial effect on pathogenic bacteria. However, azithromycin has a very bitter taste, especially poor tolerance to pediatric patients. At the same time, traditional coated tablets and capsules are not suitable for children. It is of great significance to mask its bitter taste with appropriate taste-masking technology for children. The most common side effects of oral azithromycin are gastrointestinal reactions such as cramps, nausea, diarrhea, and vomiting. Wu Rongchu et al. investigated patients under the age of 16 in five major hospitals in Zhongshan City and found that the incidence of gastrointestinal adverse reactions caused by azithromycin was 9.2%. The gastrointestinal reactions of azithromycin are due to its bitter taste and irritation to the upper gastrointestinal tract (stomach and duodenum), so masking the bitter taste and reducing the release of azithromycin in the upper gastrointestinal tract are essential to reduce side effects and improve patient compliance.

The present invention can not only effectively mask the bitter taste of azithromycin, but also provides a high-dose azithromycin slow-release preparation (for example, 2g) compared with domestic commercially available dry suspension (100mg/bag). Azithromycin Sustained-release Microsphere Dry Suspension, a drug listed in the United States Clinical trials have shown that compared with taking azithromycin immediate-release preparations (once a day, 500mg once for three days), after taking high-dose azithromycin sustained-release preparations (2g), the levels of blood, monocytes, and neutrophils The drug concentration can reach the therapeutic concentration within 120 hours, and the fluctuation of the drug concentration of the slow-release preparation is smaller than that of the immediate-release preparation after 3 consecutive days. Azithromycin sustained-release preparations allow patients to take the drug only once in a course of treatment, which greatly improves the patient's compliance. The azithromycin controlled-release preparation provided by the present invention can realize slow release within 6 hours, compared with the drug listed in the United States (Azithromycin Sustained-release Dry Suspension) 3-hour sustained release, the release is more slow and stable, so that most of the drug is released in the lower gastrointestinal tract, reducing the stimulation of high-dose azithromycin on the stomach and duodenum, thereby alleviating gastrointestinal reactions .

Chinese patent 201610642510.8 discloses a taste-masking fine pellet of azithromycin, with a drug loading capacity of more than 30%. It is composed of a drug-containing fine pellet and a coating layer. First, the drug-containing solution is coated on the pill by a fluidized bed, and then an isolation layer is applied. and taste-masking layers. Although the taste-masking effect is better, the coating process is complex, with many process steps, more equipment requirements, and inconvenient operation.

Chinese patent 200910100956.8 discloses an enteric-coated dry suspension of azithromycin, which can dissolve, release, and absorb the drug in the intestinal tract through an enteric coating process without causing irritation to the stomach and reducing side effects. Compared with enteric-coated capsules, this preparation solves the problem of drug-capsule cross-linking, and is suitable for children. However, the isolation coating and enteric coating will have a certain impact on the dissolution of the drug, thereby affecting the bioavailability and efficacy in vivo. . Based on the combined design of different resin complexes and their compositions, the present invention can achieve the effect of releasing more than 80% of the drug within 10 minutes. Compared with gastric coating and enteric coating, the release speed is fast and will not reduce the drug bioavailability.

Chinese patent 200610157604.2 discloses azithromycin resin oral suspension and its preparation method. The ion exchange resin and flavoring agent are used to achieve better taste-masking effect, but the suspension is not conducive to transportation and storage, and azithromycin is hygroscopic. If the suspension contains part of free azithromycin or the azithromycin dissociates from the resin during storage, the stability of the preparation will be problematic. In addition, compared with this patent, the azithromycin drug release rate-controllable preparation provided by the present invention can not only effectively mask the bitter taste of the drug, but also can select drug resin complexes with different drug release behaviors or combinations thereof according to different treatment needs.

Among the resin complex products currently on the market, the drug molecules contained in them are small and the steric hindrance is small. As a macrolide antibiotic, azithromycin has a relatively large steric hindrance in its molecular structure, and azithromycin is a water-insoluble drug. Ion exchange resin drug loading is much more difficult than small molecule drugs. The present invention is based on the physical and chemical characteristics of azithromycin, and through prescription and process design and control (such as resin type, adjustment of acid dosage, control of hydrogen ion concentration and drug concentration, etc.), the maximum drug loading of azithromycin can reach 20%-25%, which greatly satisfies the Meet the needs of product development and improve its clinical application potential. At the same time, the present invention does not use organic solvents in the process of preparing the azithromycin drug resin compound and the surface modification process of the drug resin compound, and the production process is safe and environment-friendly. The ion exchange resin used in the present invention is powdery ion exchange resin, and its particle size is less than 0.075mm, and the product particle size of preparation is little, does not have gritty feeling in the mouth, and mouthfeel is compared with the azithromycin coated pellet (60 meshes) disclosed in Chinese patent 201510044338.1 ), the azithromycin granules (60-100 mesh) disclosed in Chinese patent 201610305581.9 are better and have better palatability. Different types of resins in the azithromycin oral taste-masking dry suspension provided by the present invention can obtain different release characteristics, and combined with different types of resins and drug-resin complex surface modification can achieve specific speed control characteristics such as rapid release or sustained release.

Compared with the coating and microencapsulation process, the surface modification method of the drug resin compound provided by the present invention is simpler, less time-consuming, easy to industrialized large-scale production, and can obtain a drug resin compound with good taste masking effect and drug release speed control effect. things.

The invention provides a preparation method of azithromycin resin complex and taste-masking dry suspension thereof. While solving the problem of azithromycin's bitter taste, it does not affect the dissolution of the drug, and the particles are small, and there is no gritty feeling in the mouth, and it is especially suitable for children. It can be taken; and high drug loading capacity can be obtained by the green and environmentally friendly water-based system preparation process, the drug release rate can be flexibly adjusted through different combination designs, and the dissolution conditions are systematically screened to better simulate the release behavior. The preparation process of the invention is simple, the requirements for equipment are relatively low, the dry suspension is convenient for transportation and storage, and the drug stability is good.

Contents of the invention

The purpose of the present invention is to provide a method for drug resin surface modification and azithromycin taste-masking dry suspension with controllable drug release rate, while improving the bitter taste of azithromycin, reduce the drug's effect on the gastrointestinal tract by adjusting the release rate of azithromycin. Stimulation to improve the compliance of patients with dysphagia and children taking medicine.

In addition to using the resin to mask the taste, the present invention further modifies the surface of the drug-resin complex through charge action or physical adsorption, which not only enhances the taste-masking effect, but also regulates the release of the drug. Different modification materials have different effects on the drug release of the drug resin complex, the modified material selected by the present invention does not affect its release to the surface modification of the immediate release drug resin complex, and for the sustained release drug resin complex, the present invention provides Another modification material and ratio can further adjust the drug release. The present invention also provides a composition with specific drug release characteristics, the composition is composed of an immediate-release drug resin complex and a sustained-release drug resin compound, and the ratio of the composition can be designed according to the needs of clinical drug efficacy, both The effective dose can be achieved in a short time, and the drug can be released at a slow rate in the later stage, reducing the stimulation of azithromycin to the stomach and duodenum, thereby reducing gastrointestinal side effects and enhancing patient compliance.

Through research on the release of the azithromycin drug resin complex, the present invention finds that the complex formed by the azithromycin and the weakly acidic ion exchange resin can release more than 75% of the drug within 10 minutes, and can be used as an immediate release preparation. The complex formed by azithromycin and strongly acidic ion exchange resin can achieve a sustained release effect of 3 hours, which can be used as a sustained release preparation, and the sustained release drug resin complex with further surface modification can achieve a slow release of 6 hours.

Azithromycin has a long biological half-life and a strong post-antibiotic effect. After being made into a sustained-release preparation, it can be administered only once in a course of treatment. Compared with the immediate-release preparation, the sustained-release preparation has less gastrointestinal effects and patients’ compliance. strong sex. Sodium polystyrene sulfonate is a strongly acidic ion exchange resin, and the complex composed of azithromycin can achieve a sustained release effect of 3 hours. However, the sudden release of the compound is serious, so the present invention further simply modifies it after the drug resin compound is prepared, which can not only enhance the taste-masking effect, but also enable the drug to be released more stably, within 10 minutes About 15%-25% of azithromycin is released; about 30%-40% of azithromycin is released in 1 hour; about 60%-70% of azithromycin is released in 3 hours; no less than 85% of azithromycin is released in 6 hours.

When azithromycin is used clinically, the first dose needs to be doubled and the dosage for different diseases is different. The present invention provides a composition with specific drug release characteristics, which is combined in a specific ratio by using an immediate-release ion exchange resin and a slow-release ion exchange resin. , it can not only reach the effective concentration within 10 minutes to quickly exert the curative effect, but also can release the drug smoothly in the later period of 6 hours, and the ratio can be adjusted according to different treatment needs. The invention provides an azithromycin sustained-release preparation and a new combination thereof. The key to the efficacy of antibiotics is to quickly reach the minimum inhibitory concentration, so the design of the composition can quickly reach the minimum inhibitory concentration in a short time, and azithromycin is very irritating to the stomach and duodenum, so the slow release in the later stage Helps relieve gastrointestinal side effects.

The azithromycin taste-masking dry suspension with controllable drug release speed involved in the present invention combines the ion-exchange resin taste-masking technology and the surface modification method of drug-resin complexes. Firstly, the drug is loaded on the ion-exchange resin by using the ion-exchange principle, and then Block the drug from directly contacting the oral cavity, and then modify the surface of the drug-resin complex to mask the bitter taste of a small amount of free drug that may exist and achieve some specific required release characteristics.

For realizing the technical measure that the object of the present invention takes:

A method for modifying an azithromycin resin complex, comprising the following steps: dissolving a modifying material in a corresponding solvent or swelling it in water to obtain a modifying material solution, adding the azithromycin resin complex to the modifying material solution, filtering, washing the product, and drying to obtain The modified azithromycin resin complex, wherein the concentration of the modified material is 0.1%-10% (g/mL); the mass volume ratio (g/mL) of the azithromycin resin complex to the modified material solution is 1:4-1:60 ; The stirring temperature is 5-80°C; the stirring time is 0.1-12 hours.

A taste-masking dry suspension of azithromycin with controllable drug release rate, comprising the following components: a modified azithromycin resin complex or a composition thereof, a flavoring agent, a suspending agent, and other pharmaceutically acceptable excipients, Wherein the modified azithromycin resin complex is selected from the immediate-release modified azithromycin resin complex, the sustained-release modified azithromycin complex or a combination of the two; the modified azithromycin resin complex is released in the composition The ratio of the type and the slow-release type is 1:1-1:20.

The modified azithromycin resin complex includes a modification material, azithromycin resin complex, and the modification material is selected from the copolymer formed by acrylate or methacrylate and methacrylic acid, methyl cellulose, hydroxypropyl cellulose, One or more of hypromellose, carboxymethyl chitosan, and hydroxypropylmethylcellulose acetate succinate.

The azithromycin resin complex is selected from ion exchange resins selected from weakly acidic acrylic cation exchange resins and strongly acidic styrene cation exchange resins, preferably ^AmberliteTM IRP69, 254、 344, Amberlite ^™ IRP88, 294、 339、 414, Amberlite ^™ IRP64, One or more of 335

The preparation process of the azithromycin resin complex is as follows: dissolve the drug in an organic acid solution, then add an ion exchange resin, react at a certain temperature for a certain period of time, filter, wash, and dry to obtain the azithromycin resin complex, wherein azithromycin and ion The mass ratio of the exchange resin is 1:20-1:1, the stirring temperature is 5°C-60°C, and the stirring time is 0.1-12 hours.

Specifically, the azithromycin taste-masked dry suspension with controllable drug release rate provided by the present invention has a preparation process as follows:

(1) Dissolving the drug in an organic acid solution, adding an ion exchange resin, reacting at 5°C-60°C for 0.1-12 hours, filtering, washing, and drying to obtain the azithromycin resin complex.

(2) Dissolve the modification material in the corresponding solvent or swell it in water to obtain a modification material solution, add the azithromycin resin complex to the modification material solution, react at 5-80°C for 0.1-12 hours, filter, wash, and dry to obtain a modification After the azithromycin resin complex.

(3) Mixing the modified azithromycin resin complex or its composition with flavoring agents, suspending agents and other pharmaceutically acceptable adjuvants to obtain a taste-masking dry suspension of azithromycin with controllable drug release rate.

The amount of the organic acid described in the step (1) of the present invention is determined according to the amount of azithromycin to be added, and the amount can ensure the complete dissolution of the azithromycin without affecting the drug loading. The present invention can make the drug-loading capacity of the resin reach about 20-25% by screening acid types and controlling the quantity of hydrogen ions in the reaction solution.

The modified azithromycin resin complexes of the present invention are classified into immediate-release and sustained-release modified azithromycin resin complexes.

The quick-release modified azithromycin resin complex provided by the invention can not only further effectively mask the taste, but also does not affect the release of azithromycin.

The sustained-release modified azithromycin resin complex provided by the present invention can also release the drug more stably after further taste-masking, releasing about 10%-25% of azithromycin within 10 minutes; about 30%-25% in 1 hour. 40% azithromycin; release about 60%-70% azithromycin in 3 hours; release no less than 85% azithromycin in 6 hours.

In the composition of the modified azithromycin resin complex provided by the present invention, the quick-release modified azithromycin complex and the sustained-release modified azithromycin complex are mixed in a certain ratio to achieve a specific release characteristic, which can be It reaches the minimum inhibitory concentration in the shortest time (5-10 minutes) to achieve the drug effect, and can be released slowly in the later stage to reduce the stimulation of azithromycin to the gastrointestinal tract.

The present invention utilizes the composition of the modified azithromycin resin complex to provide a high-dose azithromycin slow-release agent (for example, 2g), which allows patients to take the medicine only once in a course of treatment. (Azithromycin Sustained-release Dry Suspension) 3-hour sustained release, the release is more slow and stable, so that most of the drug is released in the lower gastrointestinal tract, reducing the stimulation of high-dose azithromycin on the stomach and duodenum, thereby alleviating gastrointestinal reactions .

The preparation process of the invention is simple, no organic solvent is used in the drug loading process and the quick-release type modification process, only part of the slow-release material may use low-concentration ethanol, and the production process is safe and environmentally friendly.

Detailed ways

The following examples further illustrate the invention without limiting its scope.

Example 1: Dissolve 2g of tartaric acid in 1000mL of pure water, add 10g of azithromycin, stir until dissolved, then add 150g of ion exchange resin ( ^AmberliteTM IRP64), the reaction temperature is 40 ° C, the reaction time is 0.1 hour, filter, wash, dry, Azithromycin resin complex was obtained. It was determined that the drug loading was 6.12%.

Embodiment 2: get 3g citric acid and be dissolved in 1000mL pure water, add 10g azithromycin, stir until dissolving, then add 60g ion exchange resin ( 335), the reaction temperature is 5° C., the reaction time is 2 hours, filtered, washed, and dried to obtain the azithromycin resin complex. Take 1000 mL of carboxymethyl chitosan solution with a concentration of 4%, add 60 g of azithromycin resin complex, modify the temperature at 80°C, and modify for 2 hours, filter, wash, and dry to obtain the immediate-release modified azithromycin resin complex . It was determined that the drug loading was 10.30%.

Example 3: Dissolve 2.5 g of tartaric acid in 1000 mL of pure water, add 15 g of azithromycin, stir until dissolved, then add 100 g of ion exchange resin (Amberlite ^TM IRP88), the reaction temperature is 30 ° C, the reaction time is 3 hours, filter, wash, and dry , to obtain azithromycin resin complex. Take 1000 mL of 10% hydroxypropyl cellulose solution, add 100 g of azithromycin resin complex, modify the temperature at 40°C, and modify for 0.1 hour, filter, wash, and dry to obtain the immediate-release modified azithromycin resin complex. It was determined that the drug loading was 9.30%.

Embodiment 4: get 5g succinic acid and dissolve in 1000mL pure water, add 20g azithromycin, stir until dissolving, then add 80g ion exchange resin ( 214: 204 (1:1), the reaction temperature was 20°C, the reaction time was 6 hours, filtered, washed, and dried to obtain the azithromycin resin complex. Take 1000 mL of 0.5% hydroxypropyl methylcellulose solution, add 30 g of azithromycin resin complex, modify the temperature at 30°C, and modify for 4 hours, filter, wash, and dry to obtain the immediate-release modified azithromycin resin complex . It was determined that the drug loading was 10.65%.

Example 5: Dissolve 4.3g of succinic acid in 1000mL of pure water, add 18g of azithromycin, stir until dissolved, then add 90g of ion exchange resin ( ^AmberliteTM IRP64: ^AmberliteTM IRP88 is 3:1), the reaction temperature is 37 ° C, the reaction The time is 4 hours, filtered, washed, and dried to obtain the azithromycin resin complex. Take 1000 mL of a 4% methylcellulose solution, add 45 g of azithromycin resin complex, modify the temperature at 5°C, and modify for 2.5 hours, filter, wash, and dry to obtain the immediate-release modified azithromycin resin complex. The drug loading was determined to be 8.34%.

Example 6: Dissolve 3 g of citric acid in 1000 mL of pure water, add 30 g of azithromycin, stir until dissolved, then add 60 g of ion exchange resin (Amberlite ^TM IRP69), the reaction temperature is 50 ° C, the reaction time is 10 hours, filter and wash and drying to obtain the azithromycin resin complex. The drug loading was determined to be 23.86%.

Embodiment 7: get 5g citric acid and be dissolved in 1000mL pure water, add 50g azithromycin, stir until dissolving, then add 50g ion exchange resin ( 254), the reaction temperature is 60° C., the reaction time is 12 hours, filtered, washed, and dried to obtain the azithromycin resin complex. Take 1000 mL of Eudragit RS100 solution with a concentration of 5%, add 20 g of azithromycin resin complex, modify the temperature at 10°C, and modify for 10 hours, filter, wash, and dry to obtain a modified azithromycin resin complex of sustained release type. The drug loading was determined to be 24.38%.

Example 8: Dissolve 1.5 g of tartaric acid in 1000 mL of pure water, add 10 g of azithromycin, stir until dissolved, then add 30 g of ion exchange resin (Amberlite ^TM IRP64), the reaction temperature is 45 ° C, the reaction time is 3 hours, filter, wash, and dry , to obtain azithromycin resin complex. Take 1000 mL of 7% hydroxypropyl cellulose solution, add 17 g of azithromycin resin complex, modify the temperature at 50°C, and modify for 2 hours, filter, wash, and dry to obtain the immediate-release modified azithromycin resin complex. The measured drug loading was 9.86%. Dissolve 3g of citric acid in 1000mL of pure water, add 20g of azithromycin, stir until dissolved, then add 75g of ion exchange resin ( 344), the reaction temperature is 45° C., the reaction time is 6 hours, filtered, washed, and dried to obtain the azithromycin resin complex. Take 1000 mL of Eudragit RS100 solution with a concentration of 6%, add 60 g of azithromycin resin complex, modify the temperature at 45°C, and modify for 3 hours, filter, wash, and dry to obtain a modified azithromycin resin complex of sustained release type. The measured drug loading was 19.83%. The quick-release modified azithromycin resin complex and the sustained-release modified azithromycin complex are mixed at a ratio of 1:10 of the azithromycin amount to obtain the azithromycin complex with controllable drug release rate.

Example 9: Mix the immediate-release modified azithromycin resin complex and the sustained-release modified azithromycin complex in the ratio of 1:1 in the amount of azithromycin in Example 7 to obtain an azithromycin complex with controllable drug release rate things.

Example 10: Mix the immediate-release modified azithromycin resin complex and the sustained-release modified azithromycin complex in Example 7 at a ratio of 1:20 to obtain a drug-releasing rate-controllable azithromycin complex things.

Example 11: Immediate-release azithromycin taste-masked dry suspension

Preparation process: Mix the immediate-release modified azithromycin resin complex in Example 2 evenly with other excipients in the prescription to obtain an immediate-release azithromycin taste-masked dry suspension.

Example 12: Sustained-release azithromycin taste-masked dry suspension

Preparation process: uniformly mix the sustained-release modified azithromycin resin complex in Example 6 with other excipients in the prescription to obtain a slow-release azithromycin taste-masked dry suspension.

Example 13: Azithromycin taste-masked dry suspension with controllable release rate

Preparation process: Mix the immediate-release modified azithromycin resin complex in Example 8 evenly with other excipients in the prescription to obtain an immediate-release azithromycin taste-masked dry suspension.

Embodiment 14: Azithromycin release test

The drug release behavior of azithromycin resin complexes with immediate release type, sustained release type and controlled drug release rate was explored experimentally, and the release medium was phosphate buffer solution with pH 6.0. Table 1 shows the drug release data of the immediate-release azithromycin resin complex, and Table 2 shows the drug release data of the sustained-release and controllable drug release rate azithromycin resin complex.

Table 1 Drug release of release-type azithromycin resin complex

From the data in Table 1, it can be concluded that the modification has no effect on the release of the immediate-release azithromycin resin complex.

Table 2 Drug release of azithromycin resin complexes with sustained release and controlled release rate

As can be seen from Table 2, the modification has an impact on the sustained-release azithromycin resin complex (Example 6 and 7), which can make the drug release of the sustained-release azithromycin resin complex slower; Azithromycin resin complex with controllable drug speed, it can be seen that different combination ratio designs can release the drug at different speeds

Embodiment 15: Oral taste experiment

The azithromycin resin complexes or dry suspensions prepared in Examples 1 to 13 were made into mouth-tasting samples containing azithromycin 10 mg/ml, and the azithromycin bulk drug was used as the bitterness standard. Choose 12 healthy volunteers (6 males and 6 females) aged 22-28, rinse your mouth with water 3 times before tasting, drop 1ml of the sample on the center of the tongue, stay in the mouth for about 30 seconds, and record the degree of bitterness and grit feeling, then rinse your mouth. The bitterness scale ranges from 0-4, with 0 being no bitterness, 1 being slightly bitter, 2 being acceptable bitterness, 3 being moderately bitter, and 4 being strongly bitter.

Table 1 Results of mouth-tasting experiment

Claims (7)

1. A kind of 1. controllable azithromycin resin compound of drug release rate, it is characterised in that：Archie after being modified comprising quick-releasing type The composition of one or both of azithromycin compound after mycin resin complexes, slow-release modification, two of which are repaiied The ratio of the composition of azithromycin resin compound after decorations is 1: 1-1: 20.
2. 2. according to the azithromycin resin compound after the modification described in claim 1, it is characterised in that：Including decorative material With azithromycin resin compound, wherein decorative material is selected from what acrylate or methacrylate were formed with methacrylic acid Copolymer, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl chitosan, acetic acid butanedioic acid hydroxypropyl methyl One or more in cellulose.
3. 3. according to the azithromycin resin compound after the modification described in claim 1, it is characterised in that：Method of modifying is will Decorative material is dissolved in coordinative solvent or is swollen in water to obtain decorative material solution, then by azithromycin resin compound add to Stirred in decorative material solution, filtering, cleaning product, drying, the azithromycin resin compound after must modifying, wherein modifying material The concentration of material is 0.1%-10% (g/mL)；The mass volume ratio (g/mL) of azithromycin resin compound and decorative material solution For 1: 4-1: 60；It is 5-80 DEG C to modify temperature；When the modification time is 0.1-12 small.
4. 4. according to the azithromycin resin compound described in Claims 2 or 3, it is characterised in that：Ion exchange resin is selected from Acidulous acrylic acid's cation exchanger resin and strongly acidic styrene type cation exchange resin, preferably Amberlite^TM IRP69、254、344、Amberlite^TM IRP88、204、335、214、 Amberlite^TMOne or more in IRP64.
5. 5. according to the azithromycin resin compound described in Claims 2 or 3, it is characterised in that preparation process is as follows：By medicine Thing is dissolved in organic acid or inorganic acid solution, is added ion exchange resin, is reacted certain time under certain temperature, filters, washes Wash, is dry, obtaining azithromycin resin compound, the wherein mass ratio of azithromycin and ion exchange resin is 1: 1-1: 20, instead It is 5-60 DEG C to answer temperature, when reaction time 0.1-12 is small.
6. 6. the controllable azithromycin resin compound of drug release rate according to claim 1, it is characterised in that：After modification Drug release speed can be further made in azithromycin resin compound with flavouring, suspending agent and other pharmaceutically acceptable auxiliary materials Spend controllable azithromycin taste masking dry suspensoid agent.
7. 7. the controllable azithromycin taste masking dry suspensoid agent of drug release rate according to claim 6, it is characterised in that：Quick-releasing type Azithromycin resin compound after modification further mixes system with flavouring, suspending agent and other pharmaceutically acceptable auxiliary materials Into azithromycin quick-release taste masking dry suspensoid agent；Slow-release modification after azithromycin resin compound further with flavouring, help Suspension and other pharmaceutically acceptable auxiliary materials are mixed and made into Azithromycin slow-release taste masking dry suspensoid agent；Quick-releasing type, slow-release are repaiied Azithromycin resin composite compositions after decorations are further mixed with flavouring, suspending agent and other pharmaceutically acceptable auxiliary materials Close the azithromycin taste masking dry suspensoid agent that specific drug release behavior is made.