Production method of Pudilan anti-inflammatory tablet

Abstract

The invention discloses a production method of Pudilan anti-inflammatory tablets. The production method comprises the following steps: step 1, preparing radix scutellariae raw medicinal powder; putting the weighed radix scutellariae into a crusher for crushing, sieving the crushed fine powder, and sterilizing to obtain radix scutellariae raw medicinal powder; step 2, preparing a scutellaria baicalensis extract; step 3, preparing dandelion, bunge corydalis herb and isatis root extract; step 4, preparing base powder; step 5, performing granulation; uniformly mixing the extractum in the step 2 and the extractum in the step 3, heating to 60-70 DEG C, transferring into a liquid spraying trolley matched with a spray drying granulator, and spraying extractum spray into the base powder through the liquid spraying trolley for granulating; drying is continued after liquid spraying is completed; step 6, size stabilization and total mixing; step 7, tabletting; and step 8, coating. The operation process is obviously simplified, the production cycle is shortened, the extract is sprayed out in a form of mist, particles are small, the particle size distribution of the obtained particles is more uniform, the retention rate of effective components of the medicine is higher, and the product quality and the production efficiency are improved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical manufacturing technology, specifically to a method for producing Pudilan anti-inflammatory tablets. Background Technology

[0002] Pudilan is a very common traditional Chinese medicine with the effects of clearing heat and detoxifying, anti-inflammatory and swelling-reducing. It is used to treat inflammation caused by "internal heat" accompanied by "redness, swelling, heat and pain". Currently, most Pudilan anti-inflammatory tablets are prepared using a wet granulation process: Scutellaria baicalensis, dandelion, Viola yedoensis and Isatis indigotica are extracted, concentrated and prepared into an extract. Scutellaria baicalensis powder and starch are added to the extract and mixed evenly, and then dried in a vacuum dryer for more than 10 hours. The material obtained from the above mixing and drying is then pulverized into a fine powder and sieved. The pulverized fine powder is then added to a wet granulator, stirred and cut, and then 95% ethanol is added. Stirring and cutting are continued until uniformly sized particles are formed. Finally, the particles are transferred to a spray dryer for drying, and after drying, they are granulated and mixed together.

[0003] This process requires mixing the extract with the raw medicinal powder, drying it in an oven, pulverizing it into a fine powder, then granulating it with starch using a wet method, drying it, mixing it all together, and finally compressing it into tablets. This process involves complex procedures, a long production cycle, and loss of effective ingredients. In particular, the production cycle of the product excluding the pre-processing of traditional Chinese medicine is about 11 days, and its final yield is only 85.0% to 90.0%, which is low. Summary of the Invention

[0004] This invention aims to solve the technical problems existing in the prior art, and innovatively proposes a production method for Pudilan anti-inflammatory tablets, which significantly simplifies the operation process, shortens the production cycle, and sprays the extract into small particles, resulting in a more uniform particle size distribution, higher retention rate of active pharmaceutical ingredients, and improved product quality and production efficiency.

[0005] To achieve the above-mentioned objectives of this invention, this invention provides a method for producing Puji Lan anti-inflammatory tablets, comprising the following steps:

[0006] Step 1: Prepare raw Scutellaria baicalensis powder; put the weighed Scutellaria baicalensis into a grinder for grinding, sieve the fine powder and sterilize it to obtain raw Scutellaria baicalensis powder;

[0007] Step 2: Prepare Scutellaria baicalensis extract;

[0008] Step 3: Prepare extracts of dandelion, bitter gourd, and isatis root;

[0009] Step 4: Prepare the base powder; Weigh out the starch and the raw Scutellaria baicalensis powder prepared in Step 1 as the base powder, and put them into a spray dryer granulator;

[0010] Step 5: Granulation;

[0011] Mix the extracts from steps 2 and 3 evenly, heat to 60℃~70℃, and transfer to the spray drying granulator's spray carriage. Spray the extract into the base powder through the spray carriage for granulation. Continue drying after spraying.

[0012] Step 6: Granulation and mixing; after drying, the granules are sieved and then placed in a mixer to be mixed with starch and magnesium stearate.

[0013] Step 7: Tableting; Place the mixed granules into a tablet press and compress them into tablets;

[0014] Step 8: Coating; Place the tablets into a coating pan for coating. After coating, cool until the temperature of the coated tablets is the same as the room temperature, and then discharge the material.

[0015] In the above scheme, step 2 also includes the following steps:

[0016] Step 2-1: Extract the Scutellaria baicalensis granules;

[0017] Weigh out the Scutellaria baicalensis granules and put them into the extraction tank. At the same time, put the tailings from the crushing and sieving in step 1 into the extraction tank, add ethanol to soak for 1 to 3 hours, then reflux for 1 to 2 hours and filter.

[0018] The filtered Scutellaria baicalensis residue was refluxed with ethanol for 1-2 hours, filtered again, and both filtrates were pumped into a storage tank for storage.

[0019] Step 2-2: Concentrate the Scutellaria baicalensis extract;

[0020] The Scutellaria baicalensis extract was added to a concentration tank and concentrated to a relative density of 1.1–1.5 to form Scutellaria baicalensis extract.

[0021] In the above scheme, the concentration of ethanol is 60%.

[0022] In the above scheme, step 3 also includes the following steps:

[0023] Step 3-1: Extract dandelion and bitter violet;

[0024] Weigh out dandelion and bitter violet, add dandelion and bitter violet to an extraction tank, add water and boil to extract twice, each time for 1 to 2 hours, filter the decoction, and combine the two filtrates to obtain dandelion and bitter violet extract;

[0025] Step 3-2: Extraction of Isatis root;

[0026] Weigh out the Isatis root and put it into an extraction tank. Add water and boil twice to extract. After each decoction, stop heating and let it soak for 1 to 2 hours. Filter and combine the filtrates to obtain the Isatis root extract.

[0027] Step 3-3: Combine the dandelion and bitter gourd extracts from Step 3-1 and the isatis root extract from Step 3-2 and concentrate them to form an aqueous extract paste.

[0028] In the above scheme: the relative density of the extract is 1.1 to 1.5, and the yield is not less than 35%.

[0029] In the above scheme: In step 4, each shaking of the bag lasts for 15 to 20 seconds, and the interval between shaking the bag is about 180 to 210 seconds.

[0030] In the above scheme: in step 5, the drying temperature is 70℃~80℃, and the drying time is 20~30min.

[0031] In summary, due to the adoption of the above technical solution, the beneficial effects of this invention are as follows: The aqueous extracts of dandelion, bitter gourd, and isatis root, along with scutellaria baicalensis extract, are mixed and heated to 60-70°C to maintain the fluidity of the extracts. Then, a spray-drying granulator is used to directly spray the extracts onto a base powder formed by mixing starch and raw scutellaria baicalensis powder. This eliminates the need for the steps of mixing, drying, and pulverizing the extracts with the raw scutellaria baicalensis powder, significantly simplifying the operation process. The production cycle for the product, excluding pretreatment of traditional Chinese medicine, is approximately 9 days, shortening the production cycle. Furthermore, the spray-dried extracts result in smaller particles with a more uniform particle size distribution, higher retention of active pharmaceutical ingredients, and a finished product yield of 90%–100%, improving product quality and production efficiency. Attached Figure Description

[0032] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0033] Figure 1 This is a flowchart illustrating the present invention. Detailed Implementation

[0034] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0035] Example 1

[0036] like Figure 1 As shown, a method for producing Puji Blue Anti-inflammatory Tablets includes the following steps:

[0037] Step 1: Prepare raw Scutellaria baicalensis powder as raw Scutellaria baicalensis powder;

[0038] Weigh 58 kg of Scutellaria baicalensis and put it into a pulverizer for pulverization. Pass the pulverized fine powder through a 100-mesh sieve. After sieving, put the powder into a sterilization room for sterilization. The yield of raw Scutellaria baicalensis powder is not less than 90%.

[0039] Step 2: Prepare Scutellaria baicalensis extract;

[0040] Step 2-1: Extract the Scutellaria baicalensis granules;

[0041] Weigh 46.4 kg of Scutellaria baicalensis granules and put them into the extraction tank. At the same time, put the tailings from the crushing and sieving in step 1 into the extraction tank as well. Add 232 kg of 60% ethanol and soak for 1 to 3 hours. Then reflux and extract for 1 to 2 hours and filter.

[0042] The filtered Scutellaria baicalensis residue was refluxed with 60% ethanol for 1-2 hours, filtered, and both filtrates were pumped into a storage tank for storage.

[0043] Step 2-2: Concentrate the Scutellaria baicalensis extract;

[0044] The Scutellaria baicalensis extract was added to a concentration tank and concentrated to a relative density of 1.1–1.5 (measured at 60°C) to form Scutellaria baicalensis extract.

[0045] Step 3: Prepare extracts of dandelion, bitter gourd, and isatis root;

[0046] Step 3-1: Extract dandelion and bitter violet;

[0047] Weigh 135 kg of dandelion and 33.8 kg of bitter dandelion, add the dandelion and bitter dandelion to the extraction tank, add 1700 kg of drinking water, boil and extract twice, each time for 1 to 2 hours, filter the decoction after boiling, and combine the two filtrates to obtain dandelion and bitter dandelion extract.

[0048] Water should be added each time the decoction is prepared, and the decoction should be boiled at a constant temperature for 1 to 2 hours before filtering.

[0049] Step 3-2: Extraction of Isatis root;

[0050] Weigh 101.5 kg of Isatis root and put it into an extraction tank. Add 1700 kg of drinking water and boil twice. After each decoction, stop heating and let it soak for 1-2 hours. Filter and combine the filtrates to obtain Isatis root extract.

[0051] Step 3-3: Concentrate the dandelion and bitter violet extracts from Step 3-1 and the isatis root extract from Step 3-2 to a relative density of 1.1 to 1.5 to form an aqueous extract paste.

[0052] Step 4: Prepare the base powder; Weigh 20 kg of starch and the raw Scutellaria baicalensis powder prepared in Step 1 as the base powder, and put them into a spray drying granulator; When spraying the liquid, shake the bag intermittently, each shaking lasting 15-20 seconds, with an interval of about 180-210 seconds between shaking.

[0053] Step 5: Granulation;

[0054] Mix the extracts from steps 2 and 3 evenly and heat them to 60℃~70℃ while maintaining their fluidity. Transfer them to the spray trolley of the spray dryer granulator and spray the extract into the base powder through the spray trolley for granulation. After spraying, continue drying at a temperature of 70℃~80℃ for 20~30 minutes.

[0055] Step 6: Granulation and mixing; After drying, the granules are sieved and then placed in a mixer with 15.1 kg of starch and 0.9 kg of magnesium stearate in a certain proportion and mixed for 20-35 minutes.

[0056] Step 7: Tableting; After the granules have been mixed, they are placed into a tablet press for tableting.

[0057] Step 8: Coating; Place the tablets into a coating pan for coating. After coating, cool until the temperature of the coated tablets is the same as the room temperature, and then discharge the material.

Claims

1. A method for producing Puji Lan anti-inflammatory tablets, characterized in that: Includes the following steps: Step 1: Prepare raw Scutellaria baicalensis powder; put the weighed Scutellaria baicalensis into a grinder for grinding, sieve the fine powder and sterilize it to obtain raw Scutellaria baicalensis powder; Step 2: Prepare Scutellaria baicalensis extract; Step 3: Prepare extracts of dandelion, bitter gourd, and isatis root; Step 4: Prepare the base powder; Weigh out the starch and the raw Scutellaria baicalensis powder prepared in Step 1 as the base powder, and put them into a spray dryer granulator; Step 5: Granulation; Mix the extracts from steps 2 and 3 evenly, heat to 60℃~70℃, and transfer to the spray drying granulator's spray carriage. Spray the extract into the base powder through the spray carriage for granulation. Continue drying after spraying. Step 6: Granulation and mixing; after drying, the granules are sieved and then placed in a mixer to be mixed with starch and magnesium stearate. Step 7: Tableting; Place the mixed granules into a tablet press and compress them into tablets; Step 8: Coating; Place the tablets into a coating pan for coating. After coating, cool until the temperature of the coated tablets is the same as the room temperature, and then discharge the material.

2. The method for producing Puji Blue Anti-inflammatory Tablets according to claim 1, characterized in that: Step 2 also includes the following steps: Step 2-1: Extract the Scutellaria baicalensis granules; Weigh out the Scutellaria baicalensis granules and put them into the extraction tank. At the same time, put the tailings from the crushing and sieving in step 1 into the extraction tank, add ethanol to soak for 1 to 3 hours, then reflux for 1 to 2 hours and filter. The filtered Scutellaria baicalensis residue was refluxed with ethanol for 1-2 hours, filtered again, and both filtrates were pumped into a storage tank for storage. Step 2-2: Concentrate the Scutellaria baicalensis extract; The Scutellaria baicalensis extract was added to a concentration tank and concentrated to a relative density of 1.1–1.5 to form Scutellaria baicalensis extract.

3. The method for producing Puji Blue Anti-inflammatory Tablets according to claim 2, characterized in that: The concentration of the ethanol is 60%.

4. The method for producing Puji Blue Anti-inflammatory Tablets according to claim 1, characterized in that: Step 3 also includes the following steps: Step 3-1: Extract dandelion and bitter violet; Weigh out dandelion and bitter violet, add dandelion and bitter violet to an extraction tank, add water and boil to extract twice, each time for 1 to 2 hours, filter the decoction, and combine the two filtrates to obtain dandelion and bitter violet extract; Step 3-2: Extraction of Isatis root; Weigh out the Isatis root and put it into an extraction tank. Add water and boil twice to extract. After each decoction, stop heating and let it soak for 1 to 2 hours. Filter and combine the filtrates to obtain the Isatis root extract. Step 3-3: Combine the dandelion and bitter gourd extracts from Step 3-1 and the isatis root extract from Step 3-2 and concentrate them to form an aqueous extract paste.

5. The method for producing Puji Blue Anti-inflammatory Tablets according to claim 4, characterized in that: The relative density of the extract is 1.1 to 1.

5.

6. The method for producing Puji Blue Anti-inflammatory Tablets according to claim 1, characterized in that: In step 4, each shaking of the bag lasts 15 to 20 seconds, and the interval between shaking the bag is 180 to 210 seconds.

7. The method for producing Puji Lan anti-inflammatory tablets according to claim 1, characterized in that: In step 5, the drying temperature is 70℃~80℃ and the drying time is 20~30min.

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