Children Qingjiao granules and preparation method thereof

Abstract

The preparation method comprises the following steps: carrying out steam distillation on pogostemon cablin and fructus forsythiae, and extracting medicinal material volatile oil; taking gypsum, honeysuckle, cortex lycii radicis, indigo naturalis, cynanchum atratum and rehmannia, adding water, decocting, and concentrating to obtain an extract; adding the volatile oil into an ethyl cellulose aqueous solution, carrying out high-speed shearing, adding a stabilizer, carrying out secondary high-speed shearing, adding Tween, and carrying out high-pressure homogenization and spray drying to obtain volatile oil powder; and taking dextrin and cane sugar, adding the extract to prepare a soft material, granulating, drying, adding the volatile oil powder, and uniformly mixing the whole granules to obtain the granules. According to the preparation method of the oil-in-water type system volatile oil powder, the inclusion rate of volatile oil is high, the content of forsythin can be effectively increased, the infantile Qingjie granules are stable in quality and not prone to moisture absorption, deterioration and the like, meanwhile, the stability of the finished product is high, the loss amount of the content of forsythin after long-term storage can be reduced, the medicine effect can be maintained, and the preparation method is suitable for popularization and application. The production quality of finished products is improved.

Description

Technical Field

[0001] The invention relates to the technical field of drug preparation, and in particular to a pediatric Qingjie granule and a preparation method thereof. Background Art

[0002] Xiaoer Qingjie Granules is a Chinese patent medicine, mainly used to treat symptoms caused by exogenous wind-heat or epidemic colds in children. The ingredients are honeysuckle, forsythia, radix rehmanniae, indigo (packaged decoction), radix daphne, rehmanniae, patchouli and gypsum. The original preparation process of Xiaoer Qingjie Granules is to decoct and concentrate honeysuckle, radix rehmanniae, indigo (packaged decoction), radix daphne, rehmanniae and gypsum to obtain a clear paste, steam distill patchouli and forsythia to extract volatile oil, mix the volatile oil with the dried granules to obtain the finished product. However, the original process directly mixes the volatile oil with the granules, which is easy to cause the loss of volatile oil during the storage process, and ultimately affects the quality stability and efficacy of the finished product. Volatile oil is not only volatile, but also easy to oxidize and deteriorate. In severe cases, it will lead to the loss of efficacy, greatly reducing the efficacy and adding burden to the children. Summary of the invention

[0003] In view of this, the object of the present invention is to provide a pediatric Qingjie granule and a preparation method thereof.

[0004] The technical solution of the present invention is achieved in this way:

[0005] A method for preparing pediatric Qingjie granules comprises the following steps:

[0006] S1: Mix patchouli and forsythia suspensa, add water to soak, use steam distillation to extract volatile oil from the medicinal materials to obtain extracted oil, collect the distilled aqueous solution, filter it, and obtain a distilled aqueous solution;

[0007] S2: Take gypsum, add water to boil it, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia root to the boiled liquid, continue to add water to boil it, filter the boiled liquid, and obtain a boiled extract;

[0008] S3: Mix the decoction extract with the distilled water solution and concentrate to a relative density of 1.35-1.40 g / cm3 to obtain an extract;

[0009] S4: adding the extracted oil to the ethyl cellulose aqueous solution, homogenizing by high-speed shearing, adding a stabilizer for secondary high-speed shearing, and obtaining a primary emulsion;

[0010] S5: adding Tween to the primary emulsion and performing high pressure homogenization to obtain an oil-in-water emulsion;

[0011] S6: spray drying the oil-in-water emulsion to obtain volatile oil powder;

[0012] S7: taking dextrin and sucrose and stirring them, adding the extract while stirring, mixing, adding ethanol after mixing to make a soft material for granulation, drying, adding volatile oil powder, and mixing the whole granules to obtain the granules.

[0013] Furthermore, in step S1, the amount of water added is 5 to 7 times the total weight of the patchouli and forsythia medicinal materials, the steam pressure of the steam distillation is 0.1 to 0.3 MPa, and the steam passing time is 2 to 3 hours.

[0014] Furthermore, in step S2, take gypsum, add water 8 to 10 times the weight of the gypsum and boil for 3 to 5 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia to the decoction, continue to add water and boil for 2 to 5 hours, filter the decoction to obtain a decoction extract.

[0015] Furthermore, the adding of honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia root also includes two decoctions. During the first decoction, the amount of water is supplemented to 8 to 10 times the weight of gypsum, and the decoction time is 1.5 to 2.5 hours; during the second decoction, the amount of water is supplemented to 6 to 8 times the weight of gypsum, and the decoction time is 0.5 to 1.5 hours.

[0016] Furthermore, in step S3, the concentrated steam pressure is 0.05-0.09 MPa, the temperature is 50-85° C., and the vacuum degree is 0.02-0.08 MPa.

[0017] Furthermore, in step S4, the mass ratio of the extracted oil to the ethyl cellulose aqueous solution is 1:2-4, and the mass concentration of the ethyl cellulose aqueous solution is 0.5%-2%; the high-speed shear rate is 8000-12000 r / min, and the time is 20-40s; the secondary high-speed shear rate is 6000-8000 r / min, and the time is 20-40s.

[0018] Furthermore, the stabilizer is hydroxypropyl methylcellulose, and based on the weight of the extracted oil, the added amount of the stabilizer is 0.8%wt-1.2%wt of the extracted oil, and the added amount of Tween is 0.4%wt-0.8%wt of the extracted oil.

[0019] Furthermore, in step S5, the pressure of the high-pressure homogenization is 80-100 MPa, and the cycle is repeated 2-3 times.

[0020] Furthermore, in parts by weight, there are 720-780 parts of honeysuckle, 720-780 parts of Chinese wolfberry bark, 220-280 parts of indigo, 720-780 parts of white mulberry, 720-780 parts of rehmannia root, 720-780 parts of patchouli, 720-780 parts of forsythia and 1220-1280 parts of gypsum; the mass ratio of dextrin, sucrose and extract is 1:3-4:1.

[0021] The present invention provides the Xiaoer Qingjie Granules prepared by the preparation method of the Xiaoer Qingjie Granules.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] The preparation method of the water-in-oil type system volatile oil powder provided by the present invention has a high inclusion rate of volatile oil, can effectively increase the content of forsythin, and when the granules prepared by mixing with honeysuckle, Chinese wolfberry bark, indigo naturalis (packaged decoction), white violet, rehmannia root and gypsum are mixed, there is less fine fragmentation and better fluidity, the prepared children's Qingjie granules have stable quality, are not prone to moisture absorption, deterioration and the like, and the finished product has high stability, can reduce the loss of forsythin content during long-term storage, is helpful to maintain the efficacy, and improves the production quality of the finished product.

[0024] The invention uses an ethyl cellulose aqueous solution to shear the volatile oil obtained by distilling patchouli and forsythia, so that the ethyl cellulose and the volatile oil form a composite system, the ethyl cellulose captures water, and high-pressure homogenization is performed through a stabilizer and Tween, so that the oil re-accumulates in the network system, thereby forming a stable water-in-oil type system, and drying to obtain the volatile oil powder; the preparation method of the volatile oil powder using the water-in-oil type system can effectively prevent the volatilization, oxidation and deterioration of the patchouli and forsythia volatile oils during the production process, and can ensure the quality and efficacy of the children's Qingjie granules. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0026] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0027] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0028] Example 1

[0029] The prescription of Xiaoer Qingjie Granules is as follows:

[0030] Honeysuckle 750g Forsythia suspensa 750g Lycium bark 750g

[0031] Indigo (decoction) 250g White Rhizoma 750g Rehmannia glutinosa 750g

[0032] Patchouli 750g Gypsum 1250g

[0033] The preparation method is as follows:

[0034] (1) Soak patchouli and forsythia in water, add 6 times the amount of water, and then use steam distillation to extract volatile oils for 2 hours. Filter the distilled water solution and collect the distilled water solution in another container for later use.

[0035] (2) Take gypsum and add 9 times the amount of water and boil it for 4 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry, and rehmannia root and boil it twice;

[0036] Steam pressure: 0.1-0.3MPa

[0037] Decoction for the first time for 2 hours, adding water until the volume is 9 times.

[0038] Decoction for the second time for 1 hour and add 7 times the amount of water.

[0039] (3) The decoction extract is centrifuged through a filter, poured into a liquid storage tank, and combined with the distilled aqueous solution. Concentrate at any time until the relative density is 1.35-1.40 g / cm 3 (50℃ hot test), the concentrated extract is transported to the extract collection room through pipelines.

[0040] Three-effect concentrator conditions: steam pressure 0.05-0.09Mpa

[0041] First effect: temperature 70-85℃, vacuum degree 0.02-0.03Mpa;

[0042] Second effect: temperature 60-75℃ vacuum degree 0.04-0.05Mpa;

[0043] Triple effect: temperature 50-65℃, vacuum degree 0.07-0.08Mpa.

[0044] (4) The volatile oil obtained by distillation is added with 3 times the mass concentration of 1% ethyl cellulose aqueous solution, dispersed once by a high-speed shear disperser, and then hydroxypropyl methylcellulose is added in an amount of volatile oil: hydroxypropyl methylcellulose: Tween = 100:1:0.5. The mixture is dispersed twice by a high-speed shear disperser, and Tween is added. After high-pressure homogenization, the homogenized water-in-oil type liquid is transported to a liquid storage tank through a pipeline.

[0045] First dispersion: shear rate 10000r / min, time 30s;

[0046] Second dispersion: shear rate 7000r / min, time 30s;

[0047] High-pressure homogenization conditions: pressure 100 MPa, two cycles.

[0048] (5) Each pot is fed with materials in the ratio of extract: sucrose: dextrin = 1:3:1: first, dextrin and sucrose powder are placed in a wet granulator (mixing blade speed 50-200 rpm, chopping knife speed 300-2800 rpm), mixed evenly (mixing frequency: 16 Hz; granulation frequency: 20 Hz), then the extract is added and stirred evenly, and an appropriate amount of ethanol is added to make a soft material, and then granulated on a swing granulator (42 rpm) with a 14-mesh nylon screen, and the integrity of the nylon screen is checked at any time. The wet granules are directly sent to the boiling drying bed through a pipeline.

[0049] (6) The wet particles are placed in a fluidized bed (air volume 2845 m / h, inlet temperature 80-110°C, box temperature 40-85°C, drying time 30-80 min), and the average box temperature is 80°C for fluidized drying, and the drying time is 60 min.

[0050] (7) The dried granules are sieved through a frequency modulated rotary sieve (sieve body speed 31-170 rpm), and the granules that cannot pass through a 12-mesh sieve and the powder that can pass through a 40-mesh sieve are removed, and the granules are weighed.

[0051] (8) The granules after granulation were sucked into a two-dimensional motion mixer (7 rpm, swing speed 6 rpm) by a vacuum feeder, and then the water-in-oil type volatile oil powder obtained after spray drying was added from the feed port. The feed port cover was locked and the mixer was started. The mixture was mixed for 45 minutes. After the mixture was evenly mixed, it was placed in a sealed container and weighed.

[0052] Example 2

[0053] The prescription of Xiaoer Qingjie Granules is as follows:

[0054] Honeysuckle 750g Forsythia suspensa 750g Lycium bark 750g

[0055] Indigo (decoction) 250g White Rhizoma 750g Rehmannia glutinosa 750g

[0056] Patchouli 750g Gypsum 1250g

[0057] The preparation method is as follows:

[0058] (1) Soak patchouli and forsythia in water, add 6 times the amount of water, and then use steam distillation to extract volatile oils for 2 hours. Filter the distilled water solution and collect the distilled water solution in another container for later use.

[0059] (2) Take gypsum and add 9 times the amount of water and boil it for 4 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry, and rehmannia root and boil it twice;

[0060] Steam pressure: 0.1-0.3MPa

[0061] Decoction for the first time for 2 hours, adding water until the volume is 9 times.

[0062] Decoction for the second time for 1 hour and add 7 times the amount of water.

[0063] (3) The decoction extract is centrifuged through a filter, poured into a liquid storage tank, and combined with the distilled aqueous solution. Concentrate at any time until the relative density is 1.35-1.40 g / cm 3 (50℃ hot test), the concentrated extract is transported to the extract collection room through pipelines.

[0064] Double-effect energy-saving concentrator conditions: steam pressure 0.05-0.09Mpa

[0065] First effect: temperature 70-85℃, vacuum degree 0.04-0.05Mpa;

[0066] Second effect: temperature 50-65℃, vacuum degree 0.07-0.08Mpa.

[0067] (4) The volatile oil obtained by distillation is added with 3 times the mass concentration of 1% ethyl cellulose aqueous solution, dispersed once by a high-speed shear disperser, and then hydroxypropyl methylcellulose is added in an amount of volatile oil: hydroxypropyl methylcellulose: Tween = 100:1:0.5. The mixture is dispersed twice by a high-speed shear disperser, and Tween is added. After high-pressure homogenization, the homogenized water-in-oil type liquid is transported to a liquid storage tank through a pipeline.

[0068] First dispersion: shear rate 10000r / min, time 30s;

[0069] Second dispersion: shear rate 7000r / min, time 30s;

[0070] High-pressure homogenization conditions: pressure 100 MPa, two cycles.

[0071] (5) Each pot is fed with materials in the ratio of extract: sucrose: dextrin = 1:3:1: first, dextrin and sucrose powder are placed in a wet granulator (mixing blade speed 50-200 rpm, chopping knife speed 300-2800 rpm), mixed evenly (mixing frequency: 16 Hz; granulation frequency: 20 Hz), then the extract is added and stirred evenly, and an appropriate amount of ethanol is added to make a soft material, and then granulated on a swing granulator (42 rpm) with a 14-mesh nylon screen, and the integrity of the nylon screen is checked at any time. The wet granules are directly sent to the boiling drying bed through a pipeline.

[0072] (6) The wet particles are placed in a fluidized bed (air volume 2845 m / h, inlet temperature 80-110°C, box temperature 40-85°C, drying time 30-80 min), with an average box temperature of 75°C for fluidized drying and a drying time of 70 min.

[0073] (7) The dried granules are sieved through a frequency modulated rotary sieve (sieve body speed 31-170 rpm), and the granules that cannot pass through a 12-mesh sieve and the powder that can pass through a 40-mesh sieve are removed, and the granules are weighed.

[0074] (8) The granules after granulation were sucked into a two-dimensional motion mixer (7 rpm, swing speed 6 rpm) by a vacuum feeder, and then the water-in-oil type volatile oil powder obtained after spray drying was added from the feed port. The feed port cover was locked and the mixer was started. The mixture was mixed for 45 minutes. After the mixture was evenly mixed, it was placed in a sealed container and weighed.

[0075] Example 3

[0076] The prescription of Xiaoer Qingjie Granules is as follows:

[0077] Honeysuckle 750g Forsythia suspensa 750g Lycium bark 750g

[0078] Indigo (decoction) 250g White Rhizoma 750g Rehmannia glutinosa 750g

[0079] Patchouli 750g Gypsum 1250g

[0080] The preparation method is as follows:

[0081] (1) Soak patchouli and forsythia in water, add 6 times the amount of water, and then use steam distillation to extract volatile oils for 2 hours. Filter the distilled water solution and collect the distilled water solution in another container for later use.

[0082] (2) Take gypsum and add 9 times the amount of water and boil it for 4 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry, and rehmannia root and boil it twice;

[0083] Steam pressure: 0.1-0.3MPa

[0084] Decoction for the first time for 2 hours, adding water until the amount is 10 times.

[0085] Decoction for the second time for 1 hour and add 8 times more water.

[0086] (3) The decoction extract is centrifuged through a filter, poured into a liquid storage tank, and combined with the distilled aqueous solution. Concentrate at any time until the relative density is 1.35-1.40 g / cm 3 (50℃ hot test), the concentrated extract is transported to the extract collection room through pipelines.

[0087] Three-effect concentrator conditions: steam pressure 0.05-0.09Mpa

[0088] First effect: temperature 70-85℃, vacuum degree 0.02-0.03Mpa;

[0089] Second effect: temperature 60-75℃ vacuum degree 0.04-0.05Mpa;

[0090] Triple effect: temperature 50-65℃, vacuum degree 0.07-0.08Mpa.

[0091] (4) The volatile oil obtained by distillation is added with 2.5 times the mass concentration of 1.5% ethyl cellulose aqueous solution, dispersed once by a high-speed shear disperser, and then hydroxypropyl methylcellulose is added in a ratio of volatile oil: hydroxypropyl methylcellulose: Tween = 100: 1.2: 0.6, dispersed twice by a high-speed shear disperser, and Tween is added, and high-pressure homogenization is performed, and the homogenized water-in-oil type liquid is transported to a liquid storage tank through a pipeline.

[0092] First dispersion: shear rate 10000r / min, time 30s;

[0093] Second dispersion: shear rate 7000r / min, time 30s;

[0094] High-pressure homogenization conditions: pressure 100 MPa, two cycles.

[0095] (5) Each pot is fed with materials in the ratio of extract: sucrose: dextrin = 1:3:1: first, dextrin and sucrose powder are placed in a wet granulator (mixing blade speed 50-200 rpm, chopping knife speed 300-2800 rpm), mixed evenly (mixing frequency: 16 Hz; granulation frequency: 20 Hz), then the extract is added and stirred evenly, and an appropriate amount of ethanol is added to make a soft material, and then granulated on a swing granulator (42 rpm) with a 14-mesh nylon screen, and the integrity of the nylon screen is checked at any time. The wet granules are directly sent to the boiling drying bed through a pipeline.

[0096] (6) The wet particles are placed in a fluidized bed (air volume 2845 m / h, inlet temperature 80-110°C, box temperature 40-85°C, drying time 30-80 min), and the average box temperature is 80°C for fluidized drying, and the drying time is 60 min.

[0097] (7) The dried granules are sieved through a frequency modulated rotary sieve (sieve body speed 31-170 rpm), and the granules that cannot pass through a 12-mesh sieve and the powder that can pass through a 40-mesh sieve are removed, and the granules are weighed.

[0098] (8) The granules after granulation were sucked into a two-dimensional motion mixer (7 rpm, swing speed 6 rpm) by a vacuum feeder, and then the water-in-oil type volatile oil powder obtained after spray drying was added from the feed port. The feed port cover was locked and the mixer was started. The mixture was mixed for 45 minutes. After the mixture was evenly mixed, it was placed in a sealed container and weighed.

[0099] The test results of the Xiaoer Qingjie Granules prepared in Examples 1 to 3 above are as follows:

[0100] Table 1 Test results of finished products of the validation batch of Pediatric Qingjie Granules

[0101]

[0102]

[0103] As shown in Table 1, the appearance of the Xiaoer Qingjie Granules prepared in Examples 1 to 3 of the present invention is brown granules with a slight fragrance, sweet taste and slightly bitter taste. The particle size, moisture, solubility and microbial limit meet the requirements. The content of forsythiaside is 0.972 to 0.987 mg / bag, and the production quality is stable.

[0104] Comparative Example 1

[0105] The difference between this comparative example and Example 1 is that no water-in-oil type liquid medicine is prepared, and the prescription of the children's Qingjie granules is the same as that of Example 1. The specific preparation method is as follows:

[0106] (1) Soak patchouli and forsythia in water, add 6 times the amount of water, and then use steam distillation to extract volatile oils for 2 hours. Filter the distilled water solution and collect the distilled water solution in another container for later use.

[0107] (2) Take gypsum and add 9 times the amount of water and boil it for 4 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry, and rehmannia root and boil it twice;

[0108] Steam pressure: 0.1-0.3MPa

[0109] Decoction for the first time for 2 hours, adding water until the volume is 9 times.

[0110] Decoction for the second time for 1 hour and add 7 times the amount of water.

[0111] (3) The decoction extract is centrifuged through a filter, poured into a liquid storage tank, and combined with the distilled aqueous solution. Concentrate at any time until the relative density is 1.35-1.40 g / cm 3 (50℃ hot test), the concentrated extract is transported to the extract collection room through pipelines.

[0112] Three-effect concentrator conditions: steam pressure 0.05-0.09Mpa

[0113] First effect: temperature 70-85℃, vacuum degree 0.02-0.03Mpa;

[0114] Second effect: temperature 60-75℃ vacuum degree 0.04-0.05Mpa;

[0115] Triple effect: temperature 50-65℃, vacuum degree 0.07-0.08Mpa.

[0116] (4) Each pot is fed with materials in the ratio of extract: sucrose: dextrin = 1:3:1: first, dextrin and sucrose powder are placed in a wet granulator (mixing blade speed 50-200 rpm, chopping knife speed 300-2800 rpm), mixed evenly (mixing frequency: 16 Hz; granulation frequency: 20 Hz), then the extract is added and stirred evenly, and an appropriate amount of ethanol is added to make a soft material, and then granulated on a swing granulator (42 rpm) with a 14-mesh nylon screen, and the integrity of the nylon screen is checked at any time. The wet granules are directly sent to the boiling drying bed through a pipeline.

[0117] (4) The wet particles are placed in a fluidized bed (air volume 2845 m / h, inlet temperature 80-110°C, box temperature 40-85°C, drying time 30-80 min), and the average box temperature is 80°C for fluidized drying, and the drying time is 60 min.

[0118] (6) The dried granules are sieved through a frequency modulation rotary sieve (sieve body speed 31-170 rpm), and the granules that cannot pass through the 12-mesh sieve and the powder that can pass through the 40-mesh sieve are removed, and then weighed.

[0119] (7) The granules after granulation were sucked into a two-dimensional motion mixer (7 rpm, swing speed 6 rpm) by a vacuum feeder, and then volatile oil was added from the feed port. The feed port cover was locked and the mixer was started. The mixture was mixed for 45 minutes. After the mixture was evenly mixed, it was put into a sealed container and weighed.

[0120] After testing the finished product, the average forsythin content of the Xiaoer Qingjie Granules prepared in Comparative Example 1 was 0.934 mg / bag.

[0121] Test Case

[0122] Appropriate amounts of the Xiaoer Qingjie Granules prepared in the above embodiments and comparative examples were taken respectively, and the granules were placed under conditions of relative humidity of 75±5% and temperature of 25±2°C to examine the effect of humidity on the quality stability of the granules. The results are shown in Table 2 below.

[0123] Table 2 Quality stability of Xiaoer Qingjie granules

[0124]

[0125] It can be seen from the moisture absorption and weight gain in Table 2 above that the Xiaoer Qingjie Granules prepared in Example 1 exhibit lower hygroscopicity and are not prone to deliquesce and mold in an environment with a relative humidity of 75±5%, indicating that their quality is stable and not prone to moisture absorption, deterioration, and the like.

[0126] Take appropriate amounts of the Xiaoer Qingjie Granules prepared in the above examples and comparative examples, place the granules in an open dry glass container, and place them in a 60°C thermostat to investigate the effect of high temperature on the quality stability of the granules. Compared with 0d, after being placed at 60°C for 15d, the appearance of the Xiaoer Qingjie Granules in Example 1 meets the requirements, with no obvious discoloration, agglomeration, or formation of color spots, the moisture content meets the requirements, and the loss of forsythin content is only 0.51%, indicating that its quality is stable under high temperature environment, while Comparative Example 1 shows slight discoloration and a loss of 2.57% of forsythin content.

[0127] Test example - process investigation

[0128] The prescription contains a large amount of volatile oil. In order to avoid the loss of effective ingredients, water-in-oil type volatile oil powder is prepared: the volatile oil obtained by distillation is added to an ethyl cellulose aqueous solution, dispersed once by a high-speed shear disperser, a stabilizer is added, dispersed twice by a high-speed shear disperser, Tween is added, high-pressure homogenization is performed, and spray drying is performed to obtain water-in-oil type volatile oil powder.

[0129] According to the method A of the volatile oil determination method in the "Chinese Pharmacopoeia", the oil content is determined and the inclusion rate of the volatile oil is calculated. The inclusion rate = (oil content of volatile oil powder / amount of volatile oil added) × 100%.

[0130] Table 3 Process investigation results of water-in-oil type volatile oil powder

[0131]

[0132] Note: The ratio of volatile oil: aqueous solution: stabilizer: Tween = 100:300:1:0.5; % indicates mass concentration; Process 3 is to directly homogenize after adding ethyl cellulose aqueous solution, hydroxypropyl methylcellulose and Tween.

[0133] According to the results in Table 3 above, the volatile oil inclusion rate of process 1 reached 86.5%, and was repeated twice to 85.0% and 85.5% respectively. The inclusion rate was high and the process was stable, and the quality was controllable. It was also observed that the water-in-oil type volatile oil liquid had good stability at room temperature for 15 days, without stratification or mildew, and could be stored in liquid storage tanks.

[0134] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A method for preparing a pediatric Qingjie granule, It is characterized in that The steps include: S1: Mix patchouli and forsythia suspensa, add water to soak, use steam distillation to extract volatile oil from the medicinal materials to obtain extracted oil, collect the distilled aqueous solution, filter it, and obtain a distilled aqueous solution; S2: Take gypsum, add water to boil it, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia root to the boiled liquid, continue to add water to boil it, filter the boiled liquid, and obtain a boiled extract; S3: Mix the decoction extract with the distilled water solution and concentrate to a relative density of 1.35-1.40 g / cm 3 , get the extract; S4: adding the extracted oil to the ethyl cellulose aqueous solution, homogenizing by high-speed shearing, adding a stabilizer for secondary high-speed shearing, and obtaining a primary emulsion; S5: adding Tween to the primary emulsion and performing high pressure homogenization to obtain an oil-in-water emulsion; S6: spray drying the oil-in-water emulsion to obtain volatile oil powder; S7: taking dextrin and sucrose and stirring them, adding the extract while stirring, mixing, adding ethanol after mixing to make a soft material for granulation, drying, adding volatile oil powder, and mixing the whole granules to obtain the granules.

2. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In step S1, the amount of water added is 5 to 7 times the total weight of the patchouli and forsythia medicinal materials, the steam pressure of the steam distillation is 0.1 to 0.3 MPa, and the steam passing time is 2 to 3 hours.

3. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In step S2, take gypsum, add water 8 to 10 times the weight of the gypsum and boil for 3 to 5 hours, then add honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia to the decoction, continue to add water and boil for 2 to 5 hours, filter the decoction to obtain a decoction extract.

4. The preparation method of the Xiaoer Qingjie Granule according to claim 3, It is characterized in that The adding of honeysuckle, Chinese wolfberry bark, indigo, white mulberry and rehmannia root also includes two decoctions. During the first decoction, the amount of water is supplemented to 8 to 10 times the weight of the gypsum, and the decoction time is 1.5 to 2.5 hours; during the second decoction, the amount of water is supplemented to 6 to 8 times the weight of the gypsum, and the decoction time is 0.5 to 1.5 hours.

5. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In step S3, the concentrated steam pressure is 0.05-0.09 MPa, the temperature is 50-85° C., and the vacuum degree is 0.02-0.08 MPa.

6. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In step S4, the mass ratio of the extracted oil to the ethyl cellulose aqueous solution is 1:2-4, and the mass concentration of the ethyl cellulose aqueous solution is 0.5%-2%; the high-speed shear rate is 8000-12000 r / min, the time is 20-40s, and the secondary high-speed shear rate is 6000-8000 r / min, and the time is 20-40s.

7. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that The stabilizer is hydroxypropyl methylcellulose, and based on the weight of the extracted oil, the added amount of the stabilizer is 0.8%wt-1.2%wt of the extracted oil, and the added amount of Tween is 0.4%wt-0.8%wt of the extracted oil.

8. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In step S5, the pressure of the high-pressure homogenization is 80-100 MPa, and the process is repeated 2-3 times.

9. The preparation method of the Xiaoer Qingjie Granule according to claim 1, It is characterized in that In parts by weight, the ingredients include 720-780 parts of honeysuckle, 720-780 parts of Chinese wolfberry bark, 220-280 parts of indigo, 720-780 parts of white mulberry, 720-780 parts of rehmannia root, 720-780 parts of patchouli, 720-780 parts of forsythia and 1220-1280 parts of gypsum; the mass ratio of dextrin, sucrose and extract is 1:3-4:

1.

10. The Xiaoer Qingjie Granules prepared by the preparation method of Xiaoer Qingjie Granules according to any one of claims 1 to 9.

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