Yinqiao detoxification tablet and preparation process thereof

Abstract

The invention provides a honeysuckle and fructus forsythiae detoxification tablet and a preparation process thereof, and belongs to the technical field of medicines. The preparation method comprises the following steps: S1, wet granulation: mixing fine powder of honeysuckle and platycodon grandiflorum with an adhesive, adding a wetting agent, and continuously stirring to prepare wet granules; s2, preparing an extract; s3, dry particle preparation: spraying the extract prepared in the step S2 to the wet particles prepared in the step S1, and spraying to dry the wet particles; s4, granulating: uniformly stirring the dry granules prepared in the step S3, additional auxiliary materials and volatile oil extracted from mint and herba schizonepetae, and sieving; and S5, mixing the granules obtained in the step S4, and tabletting. The disintegration time limit of the honeysuckle and fructus forsythiae detoxification tablet prepared by the process is obviously shortened. The added wet granulation process step does not influence the component change, does not influence the quality effect, and meets the compliance of the product.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medicine, and relates to a Yinqiao Jiedu tablet and a preparation process thereof, in particular to a Yinqiao Jiedu tablet with shortened disintegration time and a preparation process thereof. BACKGROUND

[0002] The Yinqiao Jiedu tablet is a variety recorded in the pharmacopoeia, and the prescription of the variety is recorded in the pharmacopoeia as follows: 200 g of honeysuckle, 200 g of forsythia, 120 g of mint, 80 g of schizonepeta, 100 g of soybean, 120 g of fried burdock seed, 120 g of platycodon, 80 g of lophatherum, and 100 g of licorice. The preparation method is as follows: the above nine kinds of materials are powdered into fine powder, and the honeysuckle and platycodon are sieved; the mint and schizonepeta are extracted to obtain volatile oil, and the water solution after distillation is collected in another container; the residues are boiled with forsythia, fried burdock seed, lophatherum, and licorice for two times, each for 2 hours, and the filtrate is combined; the soybean is boiled with water, and then is immersed at 80 DEG C for two times, each for 2 hours, and the immersion liquid is combined and filtered. The above liquids are combined, concentrated into thick paste, and then mixed with the honeysuckle and platycodon fine powder and starch or talc, uniformly mixed, dried, cooled, mixed with magnesium stearate, sprayed with the volatile oil of mint and schizonepeta, uniformly mixed, and compressed into 1000 tablets, or coated with film, to obtain the Yinqiao Jiedu tablet.

[0003] Due to the particularity of the variety process, the paste: base material (dry material) = 1:2.5 or so; which is contrary to the process of most one-step granulation varieties; in the existing situation, in the one-step granulation process, the atomization pressure is small in the initial stage, and the paste tablet or wire drawing is easily formed, the granules are uneven, and the product quality is affected; if the atomization pressure is large, the granule forming is slow, the product quality is uniform, but the fine powder and fine granules are more; in order to ensure the uniformity of the product quality, the granulation of the Yinqiao Jiedu tablet is difficult in the one-step granulation process, the paste amount is small, and the fine powder and fine granules are more after the production is completed; in addition, the added auxiliary materials are tablet granules, the overall particle size of the granules is small, the density of the raw tablets is large during tabletting, the water penetration is slow during disintegration, and thus the disintegration time is prolonged.

[0004] The disintegration time of the tablet prepared according to the current process is relatively long, and the disintegration time of the Yinqiao Jiedu tablet is unstable in the actual production process, but the disintegration time of the traditional Chinese medicine paste granulation variety needs to be <1 h to be qualified, and the disintegration time of the tablet after the current production is basically 50-55 min, which still has the risk of unqualified quality inspection, and the long disintegration time may cause the drug to be not released in time, affect the bioavailability of the drug, and reduce the therapeutic effect of the drug.

[0005] To improve this defect, first try to adjust the equipment control parameters, such as adjusting the atomization pressure, infusion frequency, air inlet frequency, drying temperature and other equipment control parameters, and in the process of one-step granulation, increase the particle size, reduce the proportion of fine powder to increase the particle size and looseness, increase the particle roundness, and reduce the proportion of fine powder. But through continuous data verification for many times, it is found that the disintegration time is not ideal.

[0006] Then, try to optimize the process parameters, adjust the type or proportion of excipients, increase the particle forming degree, and change the proportion or type of internal and external excipients for test, but changing the proportion of adhesive and disintegrant has little effect on disintegration, and cannot solve this problem.

[0007] Chinese patent application with publication number CN1742956A discloses a silver and unripe fruit of Chinese plum detoxification effervescent tablet, which can quickly disintegrate by using the preferred excipients and ring-shaped tablet shape. However, since its dosage form is not the same as the silver and unripe fruit of Chinese plum tablet specified in the pharmacopoeia, the excipients and tablet shape selected in this application cannot be used to solve the long disintegration time of the present application.

[0008] Chinese patent application with publication number CN114452356A discloses a silver and unripe fruit of Chinese plum tablet and its preparation method, which shortens the disintegration time by adding hydroxypropyl methylcellulose in two parts to make the material properties of granulation close to hydroxypropyl cellulose. But the preparation method is different from the method of pharmacopoeia, so the way of adding hydroxypropyl methylcellulose in two parts cannot be used to improve the existing process.

[0009] Therefore, it is necessary to develop a preparation process that can reduce the disintegration time of silver and unripe fruit of Chinese plum tablet. SUMMARY

[0010] Therefore, in view of the problem that the disintegration time of silver and unripe fruit of Chinese plum tablet is prone to exceed the limit in the prior art, the purpose of the present application is to provide a preparation process that can reduce the disintegration time of silver and unripe fruit of Chinese plum tablet and the silver and unripe fruit of Chinese plum tablet prepared by the process.

[0011] To achieve the above-mentioned purpose of the application, the first aspect of the present application provides a preparation process of silver and unripe fruit of Chinese plum tablet, comprising the following steps: S1, wet granulation: mixing the fine powder of honeysuckle and platycodon grandiflorum with the binder, then adding the wetting agent and continuing to stir to obtain wet granules; S2, extract preparation: boiling and then warm soaking the soybean sprouts with water to obtain filtrate B; combining the filtrate A and the filtrate B, and concentrating to obtain the extract; S3, dry granule preparation: spraying the extract prepared in step S2 on the wet granules prepared in step S1, and drying after spraying to obtain dry granules; S4, whole grain: the dry granules prepared in step S3 are stirred uniformly with additional excipients and volatile oil extracted from mint and catnip, and then sieved; S5, total mixing of the granules obtained in step S4, and then tabletting, to obtain the product.

[0012] Further, in the preparation process of the present application, the formula amount of each traditional Chinese medicine component is 150-250 parts of honeysuckle, 150-250 parts of forsythia, 100-150 parts of mint, 60-100 parts of catnip, 80-120 parts of weak soybean, 100-150 parts of fried burdock seed, 100-150 parts of platycodon, 60-100 parts of lophatherum gracile, and 80-120 parts of licorice.

[0013] In a specific embodiment of the present application, the formula amount of each traditional Chinese medicine component is 200 parts of honeysuckle, 200 parts of forsythia, 120 parts of mint, 80 parts of catnip, 100 parts of weak soybean, 120 parts of fried burdock seed, 120 parts of platycodon, 80 parts of lophatherum gracile, and 100 parts of licorice.

[0014] Further, in the preparation process of the present application, the binder in step S1 is starch, and the wetting agent is ethanol; the additional excipients in step S4 are talc, magnesium stearate, sodium carboxymethyl starch, and silicon dioxide.

[0015] Further, in step S1, the wetting agent is an ethanol solution with a volume fraction of 70%-80%.

[0016] Further, in the preparation process of the present application, the amounts of each material of Yinqiao Jiedu Tablets are as follows: .

[0017] In a specific embodiment of the present application, the binder is corn starch. Further, in step S1, the mixing time is 60s-100s, and the stirring time after adding the wetting agent is 60s-100s.

[0018] In a specific embodiment of the present application, in step S1, the mixing time is 80s, and the stirring time after adding the wetting agent is 80s.

[0019] Further, in the preparation process of the present application, the honeysuckle and platycodon in step S1 are made into fine powder according to the preparation method of Yinqiao Jiedu Tablets in Chinese Pharmacopoeia (2020 edition) (Part I), and the mesh number of the fine powder complies with the provisions in the general rules of Chinese Pharmacopoeia (2020 edition) (Part I). In step S4, the method for extracting volatile oil from mint and catnip is as follows: catnip and mint are put into a hanging basket extraction tank, and volatile oil is extracted by steam distillation, complying with the provisions in the volatile oil determination method in Chinese Pharmacopoeia 2020 edition (General Rules).

[0020] Further, in step S3, the drying is specifically: spraying and then blowing air to dry and cool the wet particles.

[0021] Further, in step S3, the drying is specifically: adjusting the inlet air temperature to 60-80℃, keeping the material temperature at 60℃ or below, drying for 10-20min, and blowing cold air to keep the material temperature below 40℃.

[0022] In one specific embodiment of the present application, the drying is specifically: adjusting the inlet air temperature to 70℃, keeping the material temperature at 50℃, drying for 15min, and blowing cold air to keep the material temperature the same as the room temperature.

[0023] Further, in step S4, the screen mesh size of the sieving is 1.5-2.0mm.

[0024] In one specific embodiment of the present application, in step S4, the screen mesh size of the sieving is 1.5 or 2.0mm.

[0025] Further, in step S5, the total mixing time is not more than 30min.

[0026] In one specific embodiment of the present application, when the total mixing amount in step S5 is ≤200kg, the total mixing time is 15min.

[0027] Further, in step S5, the total mixing is until the particle moisture is 6.0%-8.0%.

[0028] In one specific embodiment of the present application, in step S5, the total mixing is until the particle moisture is 7.0%.

[0029] Further, in step S5, the tabletting is specifically: adjusting the pressure to make the hardness of the obtained raw tablets ≥5kg, and measuring the disintegration time ≤50min.

[0030] Further, in step S5, after the tabletting, a coating step is further included, and the coating material is Opadry 85G66600, and the weight fraction is 13.0-15.6.

[0031] Further, in step S5, the weight fraction of the coating material is 14.

[0032] The second aspect of the present application provides a Yiqiu Jiedu tablet prepared according to the above preparation process.

[0033] Compared with the prior art, the present application has the following beneficial effects: 1. The present application increases wet granulation before preparing dry granules, and then performs spray coating on the granules, which greatly retains the granule forming degree, increases the dispersion speed, and reduces the disintegration time limit after tabletting. In addition, the increased wet granulation process step does not affect the ingredient change and does not affect the quality effect, has good stability, and meets the compliance of the product.

[0034] 2. The preparation process of the present application can significantly reduce the disintegration time limit and improve the product quality by adding the adhesive corn starch and reducing the amount of corn starch. This method has great adaptability in the production process of traditional Chinese medicine tablet thick paste granulation, and can also be referenced and cited on other varieties. DETAILED DESCRIPTION

[0035] Terms and statements of the present application: 1. The articles "a", "an", and "the": unless otherwise indicated, include plural references.

[0036] 2. Numerical ranges: unless otherwise expressly specified, all ranges or ratios disclosed herein are to be understood to be inclusive of any and all sub-ranges or sub-ratios subsumed therein. For example, a stated range or ratio of 1 to 30 should be considered to include any and all sub-ranges or sub-ratios between the minimum value of 1 and the maximum value of 30, including by way of example only, 10 to 20, and including by way of example only, integer, decimal, or sub-ranges or sub-ratios consisting of an integer or decimal.

[0037] The following non-limiting examples can enable those of ordinary skill in the art to more fully understand the present application, but in no way limit the present application. The following is only an exemplary description of the scope of the present application, and those skilled in the art can make various changes and modifications to the present application based on the disclosed content, and it should also belong to the scope of the present application.

[0038] The present application is further described below in the form of specific examples. The various chemical reagents used in the examples of the present application are obtained by conventional commercial routes unless otherwise specified. If not otherwise specified, the contents described below are mass contents. If not otherwise specified, it is understood to be carried out at room temperature.

[0039] In the following examples, some reagents are obtained as follows in Table 1: Table 1

[0040] Basic example The prescription of traditional Chinese medicine components is: honeysuckle 200 kg, forsythia 200 kg, mint 120 kg, schizonepeta 80 kg, soybean 100 kg, burdock seed (fried) 120 kg, platycodon 120 kg, lophatherum 80 kg, and licorice 100 kg.

[0041] The volatile oil, fine powder and extract are prepared according to the contents under the item of Yinqiao Jiedu Tablet in Chinese Pharmacopoeia 2020 edition: 1. Preparation of volatile oil: put Schizonepeta and Mentha into the hanging basket extraction tank, and extract the volatile oil by water vapor distillation method, in accordance with the provisions in the volatile oil determination method of Chinese Pharmacopoeia 2020 edition (general rules).

[0042] 2. Preparation of fine powder of medicinal materials: grind honeysuckle and platycodon into fine powder in accordance with the fine powder in Chinese Pharmacopoeia 2020 edition (general rules).

[0043] 3. Preparation of extract: extract the residues of Mentha and Schizonepeta after volatile oil extraction with forsythia, milk vetch (fried), lophatherum gracile and licorice root by decoction twice, 2 hours each time, filter, combine the filtrates to obtain filtrate A; boil the soybean sprouts with water, then warm soak at 80℃ twice, 2 hours each time, combine the soaking liquids, filter to obtain filtrate B. Combine the above filtrate A and filtrate B, concentrate to obtain the extract.

[0044] The volatile oil, fine powder and extract prepared above are used in the preparation of the following examples and comparative examples.

[0045] Examples 1-3 1. Formulation of Yinqiao Jiedu Tablet and prescription of traditional Chinese medicine components The components are shown in Table 2 by weight.

[0046] Table 2

[0047] 2. Process steps S1, wet granulation According to the formulation amount, 95% (v / v) ethanol is added with an appropriate amount of purified water to prepare 75% (v / v) ethanol as a wetting agent. The fine powder of medicinal materials prepared in the base example and the binder are evenly divided and put into a high-efficiency wet granulator. After mixing for 80s with stirring and chopping, the wetting agent prepared above is added and stirred for 80s. The soft material has stickiness, can be kneaded into a ball, and scatters immediately when touched, with uniform color and small needle-like particles.

[0048] S2, preparation of extract: the steps are the same as those in the preparation of extract in the base example.

[0049] S3, preparation of dry granules After the wet granules are prepared, they are put into a boiling drying pan. After drying, the air pressure valve of the infusion trolley is opened (not more than 0.6 Mpa), the inlet air frequency is set to 40 HZ, the atomization pressure is 0.3 Mpa, the inlet air temperature is 80℃, and the infusion of the extract is started. First, the infusion is carried out at a frequency of 20 r / min for 75 min, then at a frequency of 28 r / min for 40 min, and finally the infusion frequency is set to 22 r / min for 50 min. After the infusion of the extract is completed, the inlet air temperature is adjusted to 70℃, the material temperature is maintained at 50℃, and the drying is carried out for 15 min until the moisture content is qualified. The material is cooled to room temperature by blowing cold air, and then the main air blower is turned off and the material is discharged.

[0050] S4, whole granulation The fixed lifting whole granulation material transfer machine is equipped with a screen with a diameter of 1.5 mm. The additional excipients and the volatile oil prepared in the basic example are placed on the dry granules, and after stirring, the material trolley is connected to the whole granulation machine. The material is sieved through the fixed lifting whole granulation material transfer machine, and the obtained granules have moderate particle size, uniform color, and no small pieces of excipients.

[0051] S5, total mixing and tabletting Total mixing: the granules obtained in step S3 are sucked into the mixer through the vacuum feeder, the power is turned on and mixed for 30 min, and then the material is divided and packed in double-layer plastic bags or stainless steel transfer barrels. The weight is measured and the material label is attached. The obtained granules have a moisture content of 7.0%, no white spots of excipients, and good flowability.

[0052] Tabletting: the tablet press is equipped with a φ11 mm shallow punch die. The upper punch is coated with lubricating oil, and the lower punch is coated with a lubricating oil. The tablet press is turned on, the lower punch is lifted flexibly, the granules are added to the hopper, the tablet press is started, the pressure is appropriately increased to form the tablets, the filling amount is adjusted to meet the requirements of the tablet weight, and the pressure is adjusted to make the hardness of the obtained tablets ≥5 kg, and the disintegration time is measured to be ≤50 min.

[0053] S6, coating, including the following sub-steps: S61, coating liquid preparation: 56.36 L of purified water is weighed and poured into an electric heating stirring and heat preservation cylinder. The stirrer is turned on and starts stirring. The amount of coating excipients required by the formula is added and stirred for 30-40 min. Sieve for use; S62, put in the tablet core: the tablet core prepared in step S5 is put into the coating drum, the main machine is turned on to make the coating drum run, the hot air and exhaust air are turned on to preheat the tablet core, and when the temperature reaches above 35℃, the atomization is turned on and the spray gun is turned on to start coating; S63, after the coating liquid is sprayed, the quality of the coated tablets meets the process requirements, the coating layer is complete, the color is not transparent, and the color is uniform. Then the hot air, spray gun and atomizer are turned off, and then the exhaust air is turned on to cool the film-coated tablets. After cooling to below 35℃, the equipment is turned off.

[0054] Example 4 Compared with Example 1, the difference is that in step S1, the mixing time of stirring and chopping is 60 s, and the stirring time after adding the wetting agent is 60 s; in step S3, the infusion frequency is set at 18 r / min for 90 min, then at 27 r / min for 50 min, and finally at 20 r / min for 60 min. The rest is the same.

[0055] Example 5 Compared with Example 1, the difference is that in step S1, the mixing time of stirring and chopping is 100 s, and the stirring time after adding the wetting agent is 100 s; in step S3, the infusion frequency is set at 22 r / min for 60 min, then at 30 r / min for 30 min, and finally at 24 r / min for 40 min. The rest is the same.

[0056] Example 6 Compared with Example 1, the difference is that in step S1, the wetting agent is 70% (v / v) ethanol solution, and the stirring time after adding the wetting agent is 80 s. The rest is the same.

[0057] Example 7 Compared with Example 1, the difference is that in step S1, the wetting agent is 80% (v / v) ethanol solution, and the stirring time after adding the wetting agent is 80 s. The rest is the same.

[0058] Example 8 Compared with Example 1, the difference is that in step S4, the mesh size of the screen fixed on the lifting whole-grain conveyor is 2.0 mm. The rest is the same.

[0059] Example 9 Compared with Example 1, the difference is that in step S3, after the extract is sprayed, the inlet air temperature is adjusted to 60℃, the material temperature is maintained at 60℃ or below, and dried for about 20 min until the moisture content is qualified. Then, the material temperature is cooled to below 40℃, the main air blower is turned off, and the material is discharged. In step S5, the moisture content of the obtained granules is 8.0%. The rest is the same.

[0060] Example 10 Compared with Example 1, the difference is that in step S3, after the extract is sprayed, the inlet air temperature is adjusted to 80℃, the material temperature is maintained at 60℃ or below, and dried for about 10 min until the moisture content is qualified. Then, the material temperature is cooled to below 40℃, the main air blower is turned off, and the material is discharged. In step S5, the moisture content of the obtained granules is 6.0%. The rest is the same.

[0061] Comparative Example 1 In this comparative example, the traditional process was used to prepare Yinqiao Jiedu Tablets.

[0062] The traditional preparation process of Yinqiao Jiedu Tablets is different from that of Example 1 in that there is no step S1, and in the preparation of dry granules in S3, the fine powder of honeysuckle and balloonflower is directly added into the boiling drying equipment together with the internal excipients, and the extract prepared by spraying step S2 is sprayed and dried to obtain dry granules; the subsequent steps are the same.

[0063] Comparative Example 2 Based on Example 1, the difference is that in step S1, the amount of corn starch added is 70 kg, and the rest is the same.

[0064] Comparative Example 3 Compared with Example 1, the difference is that in step S1, the amount of wetting agent edible ethanol (volume fraction 75%) added is 90 kg, and the rest is the same.

[0065] Comparative Example 4 Compared with Comparative Example 1, the equipment parameters are adjusted: reduce the air intake, increase the atomization pressure, increase the infusion frequency, and reduce the temperature. The rest is the same as Comparative Example 1, and multiple data verifications are continuously carried out, and the process parameters are shown in Table 3: Table 3

[0066] Comparative Example 5 Compared with Comparative Example 1, the ratio of the binding agent and carboxymethyl starch sodium as the disintegrating agent is adjusted, and the rest is the same as Comparative Example 1. Multiple data verifications are continuously carried out, and the amount of excipients is shown in Table 4: Table 4

[0067] Disintegration time test Yinqiao Jiedu Tablets prepared in Examples 1-10 and Comparative Examples 1-5 were tested for disintegration time according to the Disintegration Time Limit Test Method of Chinese Pharmacopoeia (2020 Edition), and the results are shown in Table 5 below: Table 5

[0068] From the results in Table 5 above, it can be seen that by changing the process route, the material is first wet granulated before dry granulation, and the granules are top-sprayed, which can significantly reduce the disintegration time limit of traditional Chinese medicine extract tablets. The change in process route has a significant effect on improving the disintegration time limit, and at the same time, increasing the air intake temperature to 60-80°C can speed up the production progress and shorten the production cycle. In addition, from the disintegration time limit of Example 6, it can be seen that reducing the amount of binding agent can also significantly reduce the disintegration time limit, improve the quality of the product, and other varieties can also learn from this way.

[0069] Stability test Example 2-10 is an adjustment of process parameters based on the new process improved in Example 1, and the disintegration time experiment results are not much different; the disintegration time of Comparative Example 2-5 is prolonged. The sample of Example 1 is tested for stability according to the accelerated test in General Test 9001 of the fourth part of Chinese Pharmacopoeia (2020 edition) Guiding Principles for Stability Test of Raw Materials and Preparations and the disintegration time test according to General Test 0921 Disintegration Time Test Method, and the results are shown in Table 6 below: Table 6

[0070] From the results in Table 6 above, it can be seen that the sample of Example 1 meets the requirements in each index in the accelerated test for 6 months, and the disintegration time changes little. Therefore, the method of the present application also achieves good stability on the basis of improving the disintegration time, and has application value in the actual production of products.

[0071] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A preparation process of Yinqiao Jiedu tablet, characterized in that, The preparation process comprises the following steps: S1, wet granulation: fine powder of honeysuckle and platycodon grandiflorum is mixed with a binder, and then a wetting agent is added and stirred continuously to prepare wet granules; S2, extract preparation: residue of mint and schizonepeta after extraction of volatile oil is boiled with water, and then warm soaked to obtain filtrate B; filtrate A and filtrate B are combined and concentrated to obtain extract; S3, dry granule preparation: the wet granules prepared in step S1 are sprayed with the extract prepared in step S2, and then dried to obtain dry granules; S4, whole granulation: the dry granules prepared in step S3 are stirred uniformly with additional excipients and volatile oil extracted from mint and schizonepeta, and then sieved; S5, total mixing of the granules obtained in step S4, and then tabletting, to obtain the product.

2. The manufacturing process according to claim 1, characterized in that, The formula of each traditional Chinese medicine component is as follows: honeysuckle 150-250 parts, forsythia 150-250 parts, mint 100-150 parts, schizonepeta 60-100 parts, soybean sprouts 80-120 parts, fried burdock 100-150 parts, platycodon grandiflorum 100-150 parts, lophatherum gracile 60-100 parts, and licorice 80-120 parts.

3. The manufacturing process of claim 1, wherein, The binder in step S1 is starch; the wetting agent is ethanol, and the wetting agent is preferably an ethanol solution with a volume fraction of 70%-80%; the additional excipients in step S4 are talc, magnesium stearate, sodium carboxymethyl starch, and silicon dioxide.

4. The manufacturing process of claim 3, wherein, The amount of each material in the Yinqiao Jiedu tablet is as follows: 。 5. The manufacturing process of claim 1, wherein, In step S1, the mixing time is 60s-100s, and the stirring time after adding the wetting agent is 60s-100s.

6. The manufacturing process of claim 1, wherein, In step S3, the drying is specifically as follows: the wet granules are dried and cooled by air blowing after spraying.

7. The manufacturing process of claim 1, wherein, In step S4, the mesh size of the sieve is 1.5-2.0mm.

8. The manufacturing process of claim 1, wherein, In step S5, the total mixing time is not more than 30min; the tabletting is specifically as follows: the hardness of the obtained tablets is adjusted to ≥5kg, and the disintegration time is measured to be ≤50min.

9. The manufacturing process of claim 1, wherein, In step S5, the tabletting is followed by a coating step, and the coating material is Opadry 85G66600, with a weight fraction of 13.0-15.

6.

10. The Yinqiao Jiedu tablet prepared by the preparation process of any one of claims 1-9.

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