Preparation method of traditional Chinese medicine granular preparation

Abstract

The invention discloses a preparation method of a traditional Chinese medicine granular preparation, and relates to the technical field of pharmacy, in particular to an optimized spray granulation and volatile oil inclusion technology. According to the technology, the fan frequency, the air inlet temperature, the guniting speed, the atomization pressure and other parameters of the granulator are accurately controlled, and the inclusion process of the volatile oil is combined, so that efficient and stable granulation of materials and effective inclusion of the volatile oil are realized, and the product quality and the production efficiency are improved.

Description

[0001] The invention belongs to the technical field of production of traditional Chinese medicine granule preparations, and specifically relates to a spray granulation and volatile oil inclusion technology. Background Art

[0002] In the pharmaceutical industry, spray granulation and volatile oil inclusion are common production processes. Traditional granulation processes often have problems such as uneven granulation, long cycle and backward process, unstable volatile substances in particles, excessive material temperature leading to loss of active ingredients, hard particles, poor solubility, and defects in particle appearance. At the same time, the inclusion effect of volatile oil also directly affects the stability and efficacy of the product. Therefore, optimizing granulation and inclusion technology is of great significance to improving product quality. Summary of the invention

[0003] To solve the above problems, the present invention provides a method for preparing a Chinese medicine granule preparation, which solves the shortcomings of the prior art, such as uneven granulation, long cycle and backward process, unstable volatile substances in the granules, loss of effective ingredients due to excessive material temperature, hard granules, poor solubility, etc. The preparation method provided by the present invention improves the stability of the preparation and the utilization rate of the effective ingredients. At the same time, the preparation method is simple in process, safe and environmentally friendly, and has low energy consumption.

[0004] The technical solution provided by the present invention is:

[0005] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0006] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 10-48 parts: 15-72 parts: 15-72 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 2-4 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0007] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1-1.5 parts: 3-18 parts: 6-230 parts for inclusion, the inclusion temperature is 10-45° C., and the stirring time is 15-60 minutes to prepare a volatile oil inclusion compound;

[0008] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 14-350 parts: 7-175 parts: 3-60 parts: 1-20 parts, add the volatile oil inclusion compound prepared in step b, and inhale it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature ≤100℃, premixing;

[0009] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature ≤100℃, spraying speed 20±10Hz, atomization pressure 0.1-0.55MPa, make the material in boiling state, control the material temperature below 80℃ for granulation, after granulation, dry the material in boiling dryer for 60-90 minutes, and release the material.

[0010] Preferably, the weight ratio of mint, forsythia and patchouli in step a is 20-48 parts:15-70 parts:15-70 parts; more preferably, the weight ratio of mint, forsythia and patchouli is 45 parts:70 parts:70 parts.

[0011] Preferably, in step b, the weight ratio of volatile oil to β-cyclodextrin and water is 1 part: 3-15 parts: 6-180 parts; more preferably, the weight ratio of volatile oil to β-cyclodextrin and water is 1 part: 3-10 parts: 6-140 parts.

[0012] Preferably, the inclusion temperature in step b is 20-40° C. and the stirring time is 20-50 minutes.

[0013] Preferably, the air volume in step c is controlled to be 1400-3500m 3 / h, inlet air temperature ≤90℃.

[0014] More preferably, the air volume in step c is controlled to be 1500-3200m 3 / h, inlet air temperature ≤90℃.

[0015] Preferably, the air volume in step d is controlled to be 1500-4500m 3 / h, inlet air temperature ≤90℃.

[0016] Preferably, in step d, the spraying speed is 20±10 Hz and the atomization pressure is 0.15-0.45 MPa.

[0017] On the other hand, the preparation obtained by the method for preparing Chinese medicine granules provided by the present invention can be used to treat children's colds.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] 1. This method combines the inclusion of volatile oil with the optimal cyclodextrin process, effectively improving the inclusion rate of volatile oil and the stability of the product, turning the liquid oil into a solid powder inclusion compound, which is convenient for preparation, can not only improve the stability of volatile oil, but also cover up its own bad smell and reduce its irritation. After the volatile oil is included in the cyclodextrin, its solubility in water increases, has a sustained release effect, and greatly improves its bioavailability.

[0020] 2. This method adopts a one-step granulation method, integrating multiple steps such as mixing, granulation, and drying into a continuous production process. It is easy to operate, significantly shortens the production cycle, reduces production costs, and improves economic benefits.

[0021] 3. This preparation method achieves efficient and stable granulation of materials by accurately controlling various parameters of the granulator, avoiding the loss of effective ingredients caused by excessively high material temperature.

[0022] 4. This method reduces quality risks during the preparation process, effectively avoiding the risks of contamination and cross-contamination that may occur during multiple transfers and transportations of materials; on the other hand, it helps pharmaceutical companies achieve green manufacturing and sustainable development goals by reducing waste generation and energy consumption. DETAILED DESCRIPTION

[0023] The following is a preferred embodiment of the present invention. It should be noted that a person skilled in the art may 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.

[0024] Embodiment 1:

[0025] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0026] Step a: taking mint, forsythia and patchouli in a weight ratio of 10 parts: 15 parts: 15 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 2 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0027] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1 part:3 parts:6 parts for inclusion, the inclusion temperature is 10° C., and the stirring time is 15 minutes to prepare a volatile oil inclusion compound;

[0028] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 14 parts: 7 parts: 3 parts: 1 part, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 70℃, premixing;

[0029] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature of 70℃, spraying speed of 10Hz, atomization pressure of 0.1MPa, make the material in boiling state, control the material temperature at 70℃ for granulation, dry the material in boiling dryer for 60 minutes after granulation, and release the material.

[0030] Embodiment 2:

[0031] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0032] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 48 parts:72 parts:72 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 4 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0033] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1.5 parts: 18 parts: 230 parts for inclusion, the inclusion temperature is 45° C., the stirring time is 60 minutes, and the volatile oil inclusion compound is prepared;

[0034] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 350 parts: 175 parts: 60 parts: 20 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 100℃, premixing;

[0035] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature of 100℃, spraying speed of 30Hz, atomization pressure of 0.55MPa, make the material in boiling state, control the material temperature at 80℃ for granulation, dry the material in boiling dryer for 90 minutes after granulation, and release the material.

[0036] Embodiment 3:

[0037] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0038] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 10 parts:35 parts:35 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 3 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0039] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1 part:15 parts:180 parts for inclusion, the inclusion temperature is 35° C., the stirring time is 40 minutes, and the volatile oil inclusion compound is prepared;

[0040] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 40 parts: 20 parts: 10 parts: 5 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 80℃, premixing;

[0041] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, inlet air temperature 60℃, spraying speed 15Hz, atomization pressure 0.2MPa, make the material in boiling state, material temperature controlled at 70℃ for granulation, after granulation, the material is dried in boiling dryer for 70 minutes, and then the material is discharged.

[0042] Embodiment 4:

[0043] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0044] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 40 parts:55 parts:55 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4 between the medicinal materials and water, steam distilling, extracting volatile oil for 3 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0045] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1 part:10 parts:140 parts for inclusion, the inclusion temperature is 30° C., and the stirring time is 50 minutes to prepare a volatile oil inclusion compound;

[0046] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 150 parts: 80 parts: 40 parts: 15 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 90℃, premixing;

[0047] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, inlet air temperature is 90℃, spraying speed is 25Hz, atomization pressure is 0.45MPa, so that the material is in boiling state, the material temperature is controlled at 70℃ for granulation, and after granulation, the material is dried in a boiling dryer for 80 minutes and then discharged.

[0048] Embodiment 5:

[0049] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0050] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 20 parts: 50 parts: 50 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 3 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0051] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1.2 parts: 16 parts: 150 parts for inclusion, the inclusion temperature is 25° C., the stirring time is 45 minutes, and the volatile oil inclusion compound is prepared;

[0052] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 180 parts: 160 parts: 40 parts: 15 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 85℃, premixing;

[0053] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature ≤80℃, spraying speed 25Hz, atomization pressure 0.45MPa, make the material in boiling state, control the material temperature below 70℃ for granulation, after granulation, dry the material in boiling dryer for 80 minutes, and release the material.

[0054] Embodiment 6:

[0055] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0056] Step a: taking mint, forsythia and patchouli in a weight ratio of 15 parts:45 parts:45 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4 between the medicinal materials and water, steam distilling, extracting volatile oil for 3 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0057] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1.5 parts:7 parts:80 parts for inclusion, the inclusion temperature is 30° C., and the stirring time is 50 minutes to prepare a volatile oil inclusion compound;

[0058] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 150 parts: 75 parts: 30 parts: 10 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 90℃, premixing;

[0059] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature 85℃, spraying speed 15Hz, atomization pressure 0.35MPa, make the material in boiling state, material temperature controlled at 60℃ for granulation, after granulation, the material is dried in boiling dryer for 90 minutes, and then the material is discharged.

[0060] Embodiment 7:

[0061] A method for preparing a Chinese medicine granule preparation comprises the following steps:

[0062] Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 16 parts: 28 parts: 28 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 2.5 hours, and storing the volatile oil in a container after the oil extraction is completed;

[0063] Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1 part:15 parts:180 parts for inclusion, the inclusion temperature is 30° C., and the stirring time is 55 minutes to prepare a volatile oil inclusion compound;

[0064] Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 170 parts: 70 parts: 25 parts: 15 parts, add the volatile oil inclusion compound prepared in step b, and suck it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature 70℃, premixing;

[0065] Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature 80℃, spraying speed 18Hz, atomization pressure 0.25MPa, make the material in boiling state, material temperature controlled at 60℃ for granulation, after granulation, the material is dried in boiling dryer for 90 minutes, and then the material is discharged.

[0066] It should be noted that although the present invention is disclosed as above in terms of a preferred embodiment, it is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made by anyone familiar with this technology without departing from the spirit and scope of the present invention should be included in the scope of protection of the present invention.

Claims

1. A method for preparing a Chinese medicine granule preparation, characterized in that The following steps are involved: Step a: taking mint, forsythia suspensa and patchouli in a weight ratio of 10-48 parts: 15-72 parts: 15-72 parts, sequentially putting them into an extraction tank, adding water in a weight ratio of 1:4, steam distilling, extracting volatile oil for 2-4 hours, and storing the volatile oil in a container after the oil extraction is completed; Step b: taking the volatile oil in step a and β-cyclodextrin and water in a mass ratio of 1-1.5 parts: 3-18 parts: 6-230 parts for inclusion, the inclusion temperature is 10-45° C., and the stirring time is 15-60 minutes to prepare a volatile oil inclusion compound; Step c: Take sugar powder, dextrin, isatis root powder, gypsum powder in a mass ratio of 14-350 parts: 7-175 parts: 3-60 parts: 1-20 parts, add the volatile oil inclusion compound prepared in step b, and inhale it into the granulator, and control the air intake volume to 1400-3500m 3 / h, inlet air temperature ≤100℃, premixing; Step d: After the material is preheated, start spraying and control the air volume to 1500-4500m 3 / h, air inlet temperature ≤100℃, spraying speed 20±10Hz, atomization pressure 0.1-0.55MPa, make the material in boiling state, control the material temperature below 80℃ for granulation, after granulation, dry the material in boiling dryer for 60-90 minutes, and release the material.

2. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step b, the weight ratio of volatile oil, beta-cyclodextrin and water is 1 part: 3-15 parts: 6-180 parts.

3. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step b, the weight ratio of volatile oil, beta-cyclodextrin and water is 1 part: 3-10 parts: 6-140 parts.

4. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step b, the inclusion temperature is 20-40° C. and the stirring time is 20-50 minutes.

5. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step c, control the air volume to 1400-3500m 3 / h, inlet air temperature ≤90℃.

6. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step d, control the air volume to 1500-4500m 3 / h, inlet air temperature ≤90℃.

7. The method for preparing a Chinese medicine granule preparation according to claim 1, characterized in that In step d, the spraying speed is 20±10 Hz and the atomization pressure is 0.15-0.45 MPa.

8. A Chinese medicine granule preparation obtained by the preparation method according to claims 1-7, characterized in that The preparation can be used to treat colds in children.