Preparation method of male health tablet for treating prostatitis

Abstract

The invention relates to the technical field of medical preparations, in particular to a preparation method of a male health tablet for treating prostatitis, composition and proportion of auxiliary materials except clean medicinal materials are optimized, and the preparation amount of each 2 million male health tablet is increased greatly. Only about 1.3 kg of silicon dioxide, 1.3 kg of magnesium stearate, 90 kg of corn starch, 18 kg of microcrystalline cellulose, 600 kg of ethyl alcohol and 15 kg of gastric soluble film coating premix are needed; an oil extraction treatment process is improved, the amount of water added is 0.4-0.6 time of the amount of medicinal materials instead of 6 times of the amount of the medicinal materials, the medicinal materials are also uniformly divided into 8 pots for oil extraction instead of being put into one pot for centralized oil extraction, and the quality of an oil extraction product is improved while the water consumption is greatly reduced through refined dispersion treatment; the procedure of additionally stirring alcohol precipitation liquid for 1 hour is added, so that the quality of supernate is improved; according to the present invention, the volatile ether extract determination results of the Mankang tablet produced by the preparation method show that the average value of the volatile ether extract is 0.53%, which is increased by about 60.6% compared to the average value of the volatile ether extract of 0.33% of the original process method, such that the significant technical progress is provided.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, and in particular to a method for preparing a male health tablet for treating prostatitis. Background Technology

[0002] The patent with publication number CN100469377C, entitled "A Soft Capsule for Treating Prostatitis", discloses the traditional Chinese medicine formula and preparation method for a soft capsule for treating prostatitis. This patented technology is the predecessor of Nankang tablets. Compared with soft capsules, Nankang tablets have different preparation methods and different methods for measuring the quality of preparation.

[0003] Volatile ether extract, a core marker for evaluating the quality of Nankang tablets, is mainly used for the quality analysis of traditional Chinese medicine preparations. It uses the content of medicinal extract as the determination method for its quality standard, and is particularly suitable for situations where the active ingredients or indicator ingredients are unclear, the content is very low, or there is no accurate quantitative method. The quality standard for Nankang tablets in the Chinese Pharmacopoeia is as follows: Take 20 tablets of this product, remove the coating, grind them into a fine powder, take about 2g, accurately weigh it, and except for heating under reflux for 3 hours, determine the remaining content according to the determination method for volatile ether extract (General Rule 2201). The volatile ether extract content of this product shall not be less than 0.25%.

[0004] Before the improvement of the preparation process and equipment of Nankang tablets, the average value of volatile ether extract of Nankang tablets was 0.33%, which met the pharmacopoeia standard (0.25%). However, with the development of technology and changes in the market, it is necessary to further improve the preparation quality of Nankang tablets. Summary of the Invention

[0005] The purpose of this invention is to provide a method for preparing male health tablets that significantly improves the quality of male health tablets, specifically by significantly increasing the percentage of volatile ether extracts in male health tablets.

[0006] To address the aforementioned technical problems, the present invention adopts the following technical solution: a method for preparing a male enhancement tablet for treating prostatitis, comprising the following steps: Step S1: Weigh and process the cleaned medicinal materials to obtain three different portions of medicinal materials; the first portion of medicinal materials includes half the amount of Astragalus membranaceus and half the amount of Paeonia lactiflora; the second portion of medicinal materials includes Hedyotis diffusa, half the amount of Paeonia lactiflora, Rehmannia glutinosa, Cistanche deserticola, Glycyrrhiza uralensis (processed), Taraxacum mongolicum, Pyrola rotundifolia, Phellodendron chinense, Carthamus tinctorius, Epimedium brevicornu, Rubus idaeus, half the amount of Astragalus membranaceus, Cuscuta chinensis, and Viola yedoensis; the third portion of medicinal materials includes Patrinia scabiosaefolia, Houttuynia cordata, Atractylodes macrocephala, Angelica sinensis, and Chrysanthemum indicum. Step S2: The first batch of medicinal materials is pulverized and sieved, and then sterilized to obtain Astragalus powder and Paeonia lactiflora powder; Step S3: Extract oil from the third portion of medicinal material to obtain residue, distillate, and volatile oil. Step S4: The second portion of medicinal material and the dregs are decocted together to obtain filtrate; the filtrate and distillate are mixed, concentrated under reduced pressure, and then precipitated with ethanol to obtain supernatant; the ethanol in the supernatant is recovered and the supernatant is further concentrated and then processed into a paste to obtain a thick paste. Step S5: Mix and stir the Astragalus powder, Red Peony powder and thick paste evenly, dry them, then pulverize and sieve them to obtain dry paste powder; mix the dry paste powder, internal excipients and 88% ethanol and granulate to obtain wet granules; dry and granulate the wet granules to obtain dry granules. Step S6: Ethanol, purified water and gastric-soluble film coating premix are pulped to obtain film coating solution; excipients, volatile oil and dry granules are mixed together, and the dry granules after mixing are compressed to obtain uncoated tablets, which are then coated with film coating solution. Step S7: The coated tablets are inner-packaged using inner packaging materials. After the inner packaging is completed, they are outer-packaged using outer packaging materials and then put into storage after passing inspection.

[0007] Preferably, in step S1, the required dosage of various cleaned medicinal materials for preparing 1000 tablets of Nankang tablets is as follows: 240g of Hedyotis diffusa, 80g of Paeonia lactiflora, 96g of Rehmannia glutinosa, 96g of Cistanche deserticola, 48g of Glycyrrhiza uralensis, 240g of Taraxacum mongolicum, 160g of Pyrola rotundifolia, 160g of Patrinia scabiosaefolia, 80g of Phellodendron chinense, 32g of Carthamus tinctorius, 160g of Houttuynia cordata, 160g of Epimedium brevicornu, 160g of Rubus idaeus, 80g of Atractylodes macrocephala, 80g of Astragalus membranaceus, 80g of Cuscuta chinensis, 160g of Viola yedoensis, 96g of Chrysanthemum indicum, and 80g of Angelica sinensis. Each batch produces 2 million tablets of Nankang tablets, requiring a total weight of 4576 kg of various cleaned medicinal materials.

[0008] Preferably, in step S2, the first batch of medicinal materials is pulverized and sieved using a 100-mesh sieve made of nylon. Every half hour, 100g of the pulverized powder is taken and shaken by hand using a pharmacopoeia sieve. The passing rate of the powder through the No. 5 and No. 6 pharmacopoeia sieves is ≥96%. The Astragalus powder and Paeonia lactiflora powder obtained from each shift are placed in trays and put into a moist heat sterilizer. The sterilization temperature is set to 114℃ to 119℃, the sterilization time is set to 50min, and the thickness of the powder in the tray is ≤3.5cm. After moist heat sterilization, the sterilized powder is dried for 50min, and then the dried powder is pulverized. The pulverized powder must pass through an 80-mesh sieve.

[0009] Preferably, in step S3, drinking water is used as the solvent. The third portion of medicinal material is divided into 8 pots, and the amount of water added to each pot is 0.4 to 0.6 times the amount of medicinal material in the current pot. The mixture is soaked for 2 hours and the oil extraction time is 3 hours. The volatile oil is collected. The mixture in each pot is distilled, and the steam pressure is controlled at 0.01 MPa to 0.05 MPa to obtain the distillate. The remaining residue is reserved for later use.

[0010] Preferably, in step S4, the decoction process of the second portion of medicinal material and dregs is as follows: using drinking water as a solvent, the second portion of medicinal material and dregs are mixed evenly and divided into 8 pots, and each pot is decocted three times with water added; the first decoction is 1 hour, and the amount of water added in the first decoction is 8 times the amount of medicinal material; the second and third decoctions are each 0.5 hours, and the amount of water added in the second decoction is 6 times the amount of medicinal material, and the amount of water added in the third decoction is 4 times the amount of medicinal material; after the third decoction is completed, the decoctions obtained from the three decoctions and filtrations are combined to obtain filtrate, and the sieve used for filtration has a mesh size of 100 mesh; The requirements for vacuum concentration are: the steam pressure is set at 0.05 MPa to 0.1 MPa, and the concentration is carried out at a temperature of 90°C to 95°C until the concentrate has a relative density of 1.08. The alcohol precipitation process is as follows: the concentrate is transferred to the alcohol precipitation tank, the cooling water circulation and stirring paddle of the alcohol precipitation tank are turned on, and after the temperature of the concentrate is cooled to 40±0.2℃, ethanol is slowly added and stirred continuously until the ethanol concentration reaches 75% to obtain the alcohol precipitation liquid. The alcohol precipitation liquid is stirred for 1 hour, and the stirring is stopped when the temperature of the alcohol precipitation liquid is 30℃. After standing for 8 hours, the supernatant is obtained. The process of recovering ethanol from the supernatant is as follows: the supernatant is sent into a concentrator, the concentrator is set at a depressurization temperature of 50℃ to 60℃, a steam pressure of no more than 0.05MPa, and a vacuum degree of 0.06MPa to 0.08MPa to complete the depressurization recovery of ethanol. The paste collection process is as follows: the supernatant after ethanol recovery is sent into a spherical concentrator. The vacuum temperature of the spherical concentrator is set at 60℃ to 80℃, the steam pressure is set at 0.05MPa to 0.1MPa, and the vacuum degree is maintained at 0.04MPa to 0.08MPa. When the relative density of the supernatant reaches 1.20 to 1.24 at a temperature of 75℃, a thick paste is obtained.

[0011] Preferably, in step S5, the preparation process of the dry extract powder is as follows: Sterilized Astragalus powder and Paeonia lactiflora powder are added to a trough mixer in proportion and dry-mixed for 10 minutes. Then, a thick paste is added in proportion and wet-mixed for 5-10 minutes to obtain a paste-powder mixture. The paste-powder mixture is evenly spread on a drying tray and dried in an electric vacuum dryer to obtain a dry extract. During the drying process, the drying temperature does not exceed 80℃, the drying time is 2.5 to 3 hours, and the vacuum degree in the electric vacuum dryer is maintained at 0.06 MPa to 0.1 MPa. The dried product, the dry extract, is pulverized using a pulverizer and passed through an 80-mesh sieve to obtain the dry extract powder. 100g of the dry extract powder is randomly taken each shift and shaken by hand using a pharmacopoeia sieve. The passing rate of the powder through the No. 5 pharmacopoeia sieve is ≥96%. A two-dimensional mixer is used to perform total mixing of the dry extract powder. The rotation speed of the two-dimensional mixer is 8 r / min, the oscillation frequency is 3.5 times / minute, and the mixing time is 60 minutes.

[0012] Preferably, the added excipients include corn starch and microcrystalline cellulose. The dry powder and added excipients are fed into a wet mixing granulator and dry-mixed for 3-5 minutes. Then, 88% ethanol is added and stirred for 2-3 minutes to mix evenly, forming a soft material. The amounts of dry powder, added excipients, and 88% ethanol used in the soft material preparation process are: 58.5 kg / batch of dry powder, 9 kg / batch of corn starch, 1.8 kg / batch of microcrystalline cellulose, and 10 kg / batch of 88% ethanol. The soft material is then processed into wet granules in a gyratory granulator. The granulation screen for the wet granules is an 18-mesh stainless steel screen. The wet granules are then loaded into a dryer for drying to obtain dry granules. The inlet air temperature of the dryer is 75℃±5℃, and the drying time is 10-15 minutes. The dry granules are then granulated to obtain dry granules. The granulation screen is an 18-mesh stainless steel screen.

[0013] Preferably, in step S6, the film coating solution is prepared in units of per batch. The preparation materials include 12 kg of 95% ethanol, 20 kg of purified water, and 3.5 kg of gastric-soluble film coating premix. The preparation method is to use a pulping process. First, 95% ethanol and purified water are added to a mixer, the mixer is started to form a vortex on the liquid surface, and then the gastric-soluble film coating premix is ​​slowly added. The mixture is stirred for 50 minutes to obtain the film coating solution.

[0014] Preferably, the added excipients include silica and magnesium stearate; for every 2 million tablets of Nankang prepared, the amount of silica used is 1.3±0.1 kg, and the amount of magnesium stearate used is 1.3±0.1 kg; in step S6, the extracted volatile oil and silica are mixed and passed through a 100-mesh sieve, mixed evenly, and divided into 3 equal parts, and the dry particles to be mixed are divided into 3 equal parts. The dry granules are added in portions to a two-dimensional mixer. Each time, one portion of dry granules is added, followed by one portion of a mixture of volatile oil and silica. The mixture is then thoroughly mixed. 0.2% (by weight of the dry granules) of magnesium stearate is added, the feed inlet of the two-dimensional mixer is sealed, and the mixer is turned on for final mixing. The mixer speed is 8 rpm, the oscillation frequency is 6 times / minute, and the mixing time is 40 minutes. The dry granules after final mixing are then fed into a tablet press for tableting. The tablet press uses a 10mm diameter tableting die and operates at a speed of 15-20 rpm. The resulting tablets are unprocessed tablets of Nan Kang tablets. The standard weight of each unprocessed tablet is 0.325g, with an allowable weight variation within ±4%, i.e., 0.312g to 0.338g.

[0015] Preferably, in step S6, the uncoated tablets are coated using the coating pan of the coating machine. 100kg of uncoated tablets and 32kg of film coating solution are added to each pan. The rotation speed of the coating pan is 1-4 revolutions per minute, and the coating time is 3 hours per pan. The uncoated tablets after coating are the final male health tablets. The standard weight of each male health tablet is 0.33g, and the allowable weight difference is within ±4%, rounded to three decimal places from 0.317g to 0.343g.

[0016] The advantages of this invention compared to the prior art are: (1) The composition and ratio of auxiliary materials other than the raw medicinal materials were optimized. For every 2 million tablets of Nankang tablets prepared, only about 1.3 kg of silica, 1.3 kg of magnesium stearate, 90 kg of corn starch, 18 kg of microcrystalline cellulose, 600 kg of ethanol and 15 kg of gastric-soluble film coating premix are required; (2) The oil extraction process was improved. The amount of water added was changed from 6 times the amount of medicinal materials to 0.4-0.6 times. The medicinal materials were also changed from being put into one pot for concentrated oil extraction to being divided into 8 pots for dispersed extraction. The oil, through fine dispersion treatment, greatly saves water consumption and improves the quality of the oil product; (3) an additional stirring process of 1 hour for the alcohol precipitation liquid is added to improve the quality of the supernatant; (4) the volatile ether extract of the male health tablets produced by the preparation method of this invention is measured, and the average value of volatile ether extract is 0.53%, which is about 60.6% higher than the original process method of 0.33%, achieving unexpected technical effects and significant technical progress. Attached Figure Description

[0017] Figure 1 This is a flowchart illustrating the steps of the preparation method of the male enhancement tablets of the present invention; Figure 2 This is a process flow diagram of the preparation method of the male enhancement tablets of the present invention. Detailed Implementation

[0018] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments. The accompanying drawings are for illustrative purposes only and are schematic diagrams, not actual pictures, and should not be construed as limiting the present invention. In order to better illustrate the embodiments of the present invention, some parts in the drawings may be omitted, enlarged or reduced, and do not represent the actual product size. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0019] Figure 1 and Figure 2 Preferred embodiments of the present invention are given.

[0020] like Figure 1 The method for preparing a male enhancement tablet for treating prostatitis, as shown, includes the following steps: Step S1: Weigh and prepare the cleaned medicinal materials to obtain three different portions; the first portion includes half the amount of Astragalus membranaceus and half the amount of Paeonia lactiflora; the second portion includes Hedyotis diffusa, half the amount of Paeonia lactiflora, Rehmannia glutinosa, Cistanche deserticola, Glycyrrhiza uralensis (processed), Taraxacum mongolicum, Pyrola rotundifolia, Phellodendron chinense, Carthamus tinctorius, Epimedium brevicornu, Rubus idaeus, half the amount of Astragalus membranaceus, Cuscuta chinensis, and Viola yedoensis; the third portion includes Patrinia scabiosaefolia, Houttuynia cordata, Atractylodes macrocephala, Angelica sinensis, and Chrysanthemum indicum; for every 1000 tablets of Nan Kang tablets prepared, the... The required dosage of various cleaned medicinal materials is as follows: 240g of Oldenlandia diffusa, 80g of Paeonia lactiflora, 96g of Rehmannia glutinosa (processed), 96g of Cistanche deserticola, 48g of Glycyrrhiza uralensis (processed), 240g of Taraxacum mongolicum, 160g of Pyrola rotundifolia, 160g of Patrinia scabiosaefolia, 80g of Phellodendron chinense, 32g of Carthamus tinctorius, 160g of Houttuynia cordata, 160g of Epimedium brevicornu, 160g of Rubus idaeus, 80g of Atractylodes macrocephala, 80g of Astragalus membranaceus, 80g of Cuscuta chinensis, 160g of Viola yedoensis, 96g of Chrysanthemum indicum, and 80g of Angelica sinensis. Each batch produces 2 million tablets of Nankang tablets, requiring a total weight of 4576 kg of various cleaned medicinal materials.

[0021] Step S2: The first batch of medicinal materials is pulverized and sieved, and then sterilized to obtain Astragalus powder and Paeonia lactiflora powder. The sieve used for pulverizing and sieving the first batch of medicinal materials is 100 mesh and made of nylon. Every half hour, 100g of the pulverized powder is taken and shaken by hand using a pharmacopoeia sieve. The passing rate of the powder through the No. 5 and No. 6 pharmacopoeia sieves is ≥96%. The Astragalus powder and Paeonia lactiflora powder obtained from each shift are placed in trays and put into a moist heat sterilizer. The sterilization temperature is set to 114℃ to 119℃, the sterilization time is set to 50min, and the thickness of the powder in the tray is ≤3.5cm. After moist heat sterilization, the sterilized powder is dried for 50min, and the following conditions must be met: ; The dried powder is then pulverized and passed through an 80-mesh sieve.

[0022] Step S3: Extract oil from the third portion of medicinal material to obtain residue, distillate, and volatile oil. Specifically, using drinking water as a solvent, the third portion of medicinal material is divided into 8 pots, with the amount of water added to each pot being 0.4 to 0.6 times the amount of medicinal material in the current pot. The mixture is soaked for 2 hours, and the oil extraction time is 3 hours. The volatile oil is collected. The mixture in each pot is distilled, with the steam pressure controlled at 0.01 MPa to 0.05 MPa, to obtain the distillate. The remaining residue is reserved for later use.

[0023] Step S4: Combine the second portion of medicinal materials with the dregs and decoct to obtain a filtrate. The decoction process is as follows: using drinking water as the solvent, mix the second portion of medicinal materials and dregs evenly and divide the mixture into 8 pots. Each pot is decocted three times with water. The first decoction is for 1 hour, and the amount of water added for the first decoction is 8 times the amount of medicinal materials. The second and third decoctions are each for 0.5 hours, with the amount of water added for the second decoction being 6 times the amount of medicinal materials and the amount of water added for the third decoction being 4 times the amount of medicinal materials. After the third decoction is completed, filter the three decoctions to obtain the filtrate. The decoctions were combined to obtain a filtrate, which was filtered through a 100-mesh sieve. Further, the filtrate and distillate were mixed and concentrated under reduced pressure. The requirements for reduced pressure concentration were: a steam pressure of 0.05 MPa to 0.1 MPa, a temperature of 90°C to 95°C, and concentration to a relative density of 1.08. The concentrate was then subjected to alcohol precipitation with ethanol to obtain a supernatant. The alcohol precipitation process involved transferring the concentrate to an alcohol precipitation tank, activating the cooling water circulation and stirring paddle, and allowing the concentrate to concentrate... After the temperature of the precipitate is lowered to 40±0.2℃, ethanol is slowly added while continuously stirring until the ethanol concentration reaches 75%, resulting in an alcohol precipitate. The precipitate is stirred for 1 hour, and stirring is stopped when the temperature of the precipitate reaches 30℃. After standing for 8 hours, the supernatant is obtained. The ethanol in the supernatant is recovered and further concentrated, followed by paste collection to obtain a thick paste. The ethanol recovery process in the supernatant is as follows: the supernatant is sent to a concentrator, and the concentrator's reduced pressure temperature is set at 50℃ to 60℃, and the steam pressure does not exceed 0.05 MPa. a. The vacuum degree is maintained at 0.06MPa to 0.08MPa to complete the reduced pressure recovery of ethanol. The paste collection process is as follows: the supernatant after ethanol recovery is sent to a spherical concentrator. The reduced pressure temperature of the spherical concentrator is set at 60℃ to 80℃, the steam pressure is set at 0.05MPa to 0.1MPa, and the vacuum degree is maintained at 0.04MPa to 0.08MPa. When the relative density of the supernatant reaches 1.20 to 1.24 at a temperature of 75℃, a thick paste is obtained. The amount of the thick paste should satisfy the following formula: ; The equipment used in steps S3 and S4 specifically includes: a 1000L extraction tank, a 6m... 3 Conical extraction tank, TQWV6-00 multi-functional extraction tank, alcohol precipitation tank, TCS-300 electronic platform scale, double-effect vacuum concentrator, WZF2-2000-00 double-effect evaporator, multi-functional ethanol recovery concentrator, spherical concentration tank, TCS-150 electronic platform scale.

[0024] Step S5: Mix and stir the Astragalus powder, Paeonia lactiflora powder, and thick paste evenly. After drying, pulverize and sieve to obtain dry extract powder. The specific preparation process of dry extract powder is as follows: Add sterilized Astragalus powder and Paeonia lactiflora powder to a trough mixer in proportion and dry mix for 10 minutes. Then add thick paste in proportion and wet mix for 5-10 minutes to obtain a paste-powder mixture. Spread the paste-powder mixture evenly on a drying tray and dry it in an electric vacuum dryer to obtain a dry extract. During the drying process, the drying temperature should not exceed 80℃, the drying time should be 2.5h to 3h, and the vacuum degree in the electric vacuum dryer should be maintained at 0.06MPa to 0.1MPa. Pulverize the dried product dry extract using a pulverizer and pass it through an 80-mesh sieve to obtain dry extract powder. Randomly take 100g of dry extract powder each shift and shake it with both hands using a pharmacopoeia sieve. The passing rate of the powder through a No. 5 pharmacopoeia sieve should be ≥96%. The amount of dry extract powder should meet the following formula: ; The dry powder was mixed using an EYH-4000 two-dimensional mixer. The EYH-4000 two-dimensional mixer had a rotation speed of 8 r / min, an oscillation frequency of 3.5 times / min, and a mixing time of 60 minutes. The amount of dry powder after mixing should meet the following formula: ; The dry extract powder, added excipients, and 88% ethanol are mixed and granulated. The added excipients include corn starch and microcrystalline cellulose. The 88% ethanol solution is prepared by taking approximately 92.6 kg of 95% ethanol and diluting it with purified water to 100 kg. The dry extract powder and added excipients are fed into a wet mixing granulator and dry-mixed for 3-5 minutes. Then, 88% ethanol is added and stirred for 2-3 minutes to ensure uniform mixing, thus forming a soft mass. The amounts of dry extract powder, added excipients, and 88% ethanol used in the soft mass preparation process are as follows: 58.5 kg / batch of dry extract powder, 9 kg / batch of corn starch, 1.8 kg / batch of microcrystalline cellulose, and 10 kg / batch of 88% ethanol. The resulting soft mass is then granulated into wet granules in a gyratory granulator with a granulation sieve mesh size of 18. The wet granules are fed into a dryer to obtain dried granules. The inlet air temperature of the dryer is 75℃±5℃, and the drying time is 10-15 minutes. The dried granules are then sized to obtain dry granules. The sizing screen is an 18-mesh stainless steel screen. The total weight of the dry granules should meet the following formula: ; In step S5, the equipment used specifically includes: CH-200 trough mixer, WBZ-80 intelligent electric vacuum dryer, ZKF-3-200 automatic pulverizer unit, TCS-150 electronic platform scale, EYH-4000 two-dimensional mixer, GHL-250 high-efficiency wet mixer, YK-160 swing granulator, and GFG-150 high-efficiency fluidized bed dryer; such as Figure 2 As shown, the above equipment operates in a Class D clean area, with the ambient temperature controlled between 18°C ​​and 26°C and the relative humidity controlled between 45% and 65%.

[0025] Step S6: Ethanol, purified water, and gastric-soluble film-coating premix are pulped to obtain a film-coating solution. Specifically, the film-coating solution is prepared per batch, and the preparation materials include 12 kg of 95% ethanol, 20 kg of purified water, and 3.5 kg of gastric-soluble film-coating premix. The preparation method is pulping. First, 95% ethanol and purified water are added to a mixer, and the mixer is started to form a vortex. Then, the gastric-soluble film-coating premix is ​​slowly added, and the mixture is stirred for 50 minutes to obtain the film-coating solution. The excipients, volatile oil, and dry granules are then mixed. Specifically, the excipients include silica and magnesium stearate. For every 2 million tablets of Nankang prepared, the amount of silica is 1.3 ± 0.1 kg, and the amount of magnesium stearate is 1.3 ± 0.1 kg. The extracted volatile oil is mixed with silica and passed through a 100-mesh sieve, mixed thoroughly, and then divided into 3 equal portions. Divide the dry granules to be mixed into 3 equal parts and add them to the two-dimensional mixer in batches. After adding one part of dry granules, add one part of the mixture of volatile oil and silica, mix well, and then add 0.2% magnesium stearate by weight of the dry granules. Tighten the feed port of the two-dimensional mixer and start the two-dimensional mixer for overall mixing. The speed of the two-dimensional mixer is 8 r / min, the oscillation frequency is 6 times / min, and the mixing time is 40 minutes. After overall mixing, feed the dry granules into a tablet press for tableting. The tablet press uses a 10mm diameter tableting die with shallow concave lettering. The specific tablet press is a ZP-35D. A rotary tablet press with a speed of 15-20 rpm is used to compress the raw tablets of Nan Kang tablets. The standard weight of each raw tablet is 0.325g, with an allowable weight difference within ±4%, i.e., 0.312g to 0.338g. The raw tablets are then coated in the coating pan of a coating machine. 100kg of raw tablets and 32kg of film coating solution are added to each pan. The coating pan speed is 1-4 rpm, and the coating time is 3 hours per pan. The raw tablets after coating are the final Nan Kang tablets. The standard weight of each Nan Kang tablet is 0.33g, with an allowable weight difference within ±4%, rounded to three decimal places, from 0.317g to 0.343g. The two-dimensional mixer in step S6 is an EYH-2500 two-dimensional motion mixer, and the coating machine is an LDB150 high-efficiency flow layer coating machine.

[0026] Step S7: The coated tablets are inner-packaged using inner packaging materials. After the inner packaging is completed, they are outer-packaged using outer packaging materials and then put into storage after passing inspection.

[0027] In step S7, for the inner packaging, when the packaging form is aluminum-plastic composite board, each board contains 12 pieces. The list of required packaging materials (for 100 pieces) is shown in Table 1.

[0028] Table 1 Packaging Forms - Aluminum Composite Panels (Quantity for 100 Pieces)

[0029] In step S7, for the inner packaging, when the packaging form is aluminum-plastic aluminum sheet, each sheet contains 12 pieces. The list of required packaging materials (for 100 pieces) is shown in Table 2.

[0030] Table 2 Packaging Forms - Aluminum Composite Panel (Quantity for 100 Pieces)

[0031] In step S7, the outer packaging is divided into three specifications: 36 pieces × 300 boxes / carton, 36 pieces / small box × 3 small boxes / medium box × 60 medium boxes / carton, and 24 pieces × 200 boxes / carton; the list of required packaging materials (for 100 pieces) is shown in Table 3.

[0032] Table 3. List of outer packaging materials (for 100 pieces)

[0033] In step S7, the list of required packing straps and tapes (for 100 pieces) for the outer packaging is shown in Table 4.

[0034] Table 4. List of Packing Straps and Adhesive Tape (Quantity for 100 Pieces)

[0035] The packaging methods corresponding to Tables 1 to 4 are summarized as follows: 36 tablets × 300 boxes / carton (aluminum-plastic): Every 3 blister packs are packaged into a moisture-proof package on a pillow packaging machine. Each box contains 1 moisture-proof unit, and every 10 boxes form a plastic-sealed unit. Each carton contains 30 plastic-sealed units. One pad is placed on the bottom of the carton. One carton label is affixed to the upper middle of the narrow side of each of the two outer sides of the carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0036] 36 tablets / small box × 3 small boxes / medium boxes × 60 medium boxes / carton (aluminum-plastic): Every 3 blister packs are packaged into a moisture-proof package on a pillow packaging machine. Each small box contains 1 moisture-proof unit, every 3 small boxes contain 1 medium box, every 5 medium boxes form a heat-sealed unit, and each carton contains 12 plastic-sealed units. One pad is placed on the bottom of the carton, and one carton label is affixed to the upper middle of the narrow side of each of the two outer sides of the carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0037] 24 tablets x 200 boxes / carton (aluminum-plastic): Two blister packs are packaged into a moisture-proof package on a pillow packaging machine. Each box contains one moisture-proof unit, and 10 boxes form one plastic-sealed unit. Each carton contains 20 plastic-sealed units. One pad is placed on the bottom of the carton. One carton label is affixed to the upper middle of the narrow side of each side of the carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0038] 36 tablets × 300 boxes / carton (aluminum-plastic-aluminum): Each box contains 3 blister packs, 10 boxes are sealed per unit, and each carton contains 30 sealed units. Place one pad on the bottom of the carton, and attach one carton label to the upper middle of the narrow side of each side of the carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0039] 36 tablets / small box × 3 small boxes / medium boxes × 60 medium boxes / carton (aluminum-plastic-aluminum): Each small box contains 3 blister packs, every three small boxes contain 1 medium box, every 5 medium boxes constitute a heat-sealed unit, and each carton contains 12 heat-sealed units. Place one pad on the bottom of the carton, and affix one carton label to the upper middle of each of the narrow sides of the outer carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0040] 24 tablets x 200 boxes / carton (aluminum-plastic-aluminum): Each box contains 2 blister packs, 10 boxes are sealed per unit, and each carton contains 20 sealed units. Place one pad on the bottom of the carton, and attach one carton label to the upper middle of each of the narrow sides of the outer carton (indicating: product name, approval number, dosage form, specifications, packaging specifications, storage, product batch number, production date, and expiration date).

[0041] Before the process and equipment improvements, the average volatile ether extract of Nankang tablets was 0.33%, which met the pharmacopoeia standard (0.25%). After the improvements, namely the use of the technology of this invention, the extract reached 0.53%, an improvement of 60.6%. The quality standard of Nankang tablets has been significantly improved. The values ​​of volatile ether extracts detected at different times are shown in Table 5.

[0042] Table 5. Detection values ​​of volatile ether extracts .

Claims

1. A method for preparing Nankang tablets for treating prostatitis, characterized in that, The method comprises the following steps: Step S1: The net medicinal materials are weighed and prepared, and three different medicinal materials are obtained; the first medicinal material comprises half of the amount of Astragalus membranaceus and half of the amount of Red Root; the second medicinal material comprises Yellowish Flower Snakeweed, half of the amount of Red Root, Prepared Rehmannia Root, Cistanche, Fried Licorice, Dandelion, Lianthus Herb, Cork Tree, Red Flower, Herba Epimedii, Raspberry, half of the amount of Astragalus membranaceus, Semen Falcatum and Purple Violet; and the third medicinal material comprises Herba Descurainiae, Houttuynia Cordata, Atractylodes Macrocephala, Angelica Sinensis and Wild Chrysanthemum; Step S2: The first medicinal material is crushed and sieved, and is sterilized respectively to obtain Astragalus membranaceus powder and Red Root powder; Step S3: The third medicinal material is subjected to oil extraction treatment, and residue, distillation liquid and volatile oil are obtained respectively; Step S4: The second medicinal material is subjected to joint decocting treatment with the residue to obtain filtrate; the filtrate and the distillation liquid are mixed, and are subjected to vacuum concentration, and then are subjected to alcohol precipitation treatment with ethanol to obtain supernatant; the ethanol in the supernatant is recovered, and the supernatant is further concentrated, and is subjected to paste collection treatment to obtain thick paste; Step S5: The Astragalus membranaceus powder, the Red Root powder and the thick paste are mixed and stirred uniformly, are subjected to drying treatment, are crushed and sieved to obtain dry paste powder; the dry paste powder, the internal auxiliary material and 88% ethanol are mixed to obtain wet granules; the wet granules are dried and are subjected to whole granule treatment to obtain dry granules; Step S6: The ethanol, purified water and gastric soluble film coating premix are subjected to beating treatment to obtain film coating liquid; the external auxiliary material, the volatile oil and the dry granules are subjected to total mixing treatment, the dry granules subjected to the total mixing treatment are subjected to tabletting treatment to obtain blank tablets, and the blank tablets are subjected to coating treatment in combination with the film coating liquid; Step S7: The tablets subjected to the coating treatment are subjected to internal packaging treatment by the internal packaging material, are subjected to external packaging treatment by the external packaging material after the internal packaging is completed, and are stored in the warehouse after being qualified in inspection.

2. The preparation method of the male health tablet for treating prostatitis according to claim 1, characterized in that: In step S1, the amount of each type of net medicinal material required for preparing 1000 male health tablets is as follows: 240g of Yellowish Flower Snakeweed, 80g of Red Root, 96g of Prepared Rehmannia Root, 96g of Cistanche, 48g of Fried Licorice, 240g of Dandelion, 160g of Lianthus Herb, 160g of Herba Descurainiae, 80g of Cork Tree, 32g of Red Flower, 160g of Houttuynia Cordata, 160g of Herba Epimedii, 160g of Raspberry, 80g of Atractylodes Macrocephala, 80g of Astragalus membranaceus, 80g of Semen Falcatum, 160g of Purple Violet, 96g of Wild Chrysanthemum, 80g of Angelica Sinensis; The total weight of each type of net medicinal material required for preparing 2 million male health tablets in each batch is 4576kg.

3. The preparation method of the male health tablet for treating prostatitis according to claim 2, characterized in that: In step S2, the mesh size of the screen used for crushing and sieving the first medicinal material is 100, and the screen material is nylon; 100g of the crushed medicinal powder is taken every half an hour, and the medicinal powder is shaken by two hands according to the pharmacopoeia screen, and the passing rate of the medicinal powder through the No.5 pharmacopoeia screen and the No.6 pharmacopoeia screen is greater than or equal to 96%; the Astragalus membranaceus powder and the Red Root powder obtained in each shift are placed in a wet heat sterilization cabinet, the sterilization temperature is set to 114-119℃, the sterilization time is set to 50min, and the thickness of the medicinal powder placed in the cabinet is less than or equal to 3.5cm; after the wet heat sterilization is completed, the wet heat sterilized medicinal powder is dried for 50min, and then the dried medicinal powder is crushed, and the crushed medicinal powder needs to pass through a screen with a mesh size of 80.

4. The preparation method of the male health tablet for treating prostatitis according to claim 3, characterized in that: In step S3, the third batch of medicinal materials is evenly divided into 8 pots using drinking water as the solvent, the water added in each pot is 0.4 to 0.6 times the amount of the medicinal materials in the current pot, the mixture is soaked for 2 hours, and the oil is extracted for 3 hours to collect the volatile oil; the mixture in each pot is distilled, the steam pressure is controlled at 0.01 MPa to 0.05 MPa, and the distillate is obtained, and the remaining residue is reserved.

5. The preparation method of the male health tablet for treating prostatitis according to claim 4, characterized in that: In step S4, the second batch of medicinal materials and the residue are mixed and processed as follows: the second batch of medicinal materials and the residue are mixed evenly using drinking water as the solvent, and then divided into 8 pots, and each pot is boiled three times with water added; the first boiling is performed for 1 hour, the water added in the first boiling is 8 times the amount of the medicinal materials; the second and third boilings are each performed for 0.5 hour, the water added in the second boiling is 6 times the amount of the medicinal materials, and the water added in the third boiling is 4 times the amount of the medicinal materials; after the third boiling is completed, the decoction obtained by filtering the three times of boiling is combined to obtain the filtrate, and the mesh size of the filter used for filtering is 100 mesh; The requirement for vacuum concentration is that the steam pressure is set at 0.05 MPa to 0.1 MPa, and the concentration is performed at a temperature of 90°C to 95°C until the relative density of the concentrated liquid reaches 1.08; The process of alcohol precipitation is as follows: the concentrated liquid is transferred to an alcohol precipitation tank, the cooling water circulation and stirring paddle of the alcohol precipitation tank are turned on, after the temperature of the concentrated liquid is lowered to 40±0.2°C, ethanol is slowly added while continuously stirring until the concentration of ethanol reaches 75% to obtain the alcohol precipitation liquid, the alcohol precipitation liquid is stirred for 1 hour, the stirring is stopped when the temperature of the alcohol precipitation liquid is 30°C, and the supernatant is obtained after standing for 8 hours; The process of recovering ethanol from the supernatant is as follows: the supernatant is sent to a concentrator, the vacuum concentration temperature of the concentrator is set at 50°C to 60°C, the steam pressure does not exceed 0.05 MPa, and the vacuum degree is maintained at 0.06 MPa to 0.08 MPa to complete the vacuum recovery of ethanol; The process of collecting the paste is as follows: the supernatant after recovering ethanol is sent to a spherical concentration tank, the vacuum concentration temperature of the spherical concentration tank is set at 60°C to 80°C, the steam pressure is set at 0.05 MPa to 0.1 MPa, and the vacuum degree is maintained at 0.04 MPa to 0.08 MPa; under the condition of a temperature of 75°C, the relative density of the supernatant reaches 1.20 to 1.24 to obtain the thick paste.

6. The preparation method of the male health tablet for treating prostatitis according to claim 5, characterized in that: In step S5, the preparation process of the dry extract powder is as follows: the sterilized Huangqi powder and Chishao powder are put into a slot mixer in proportion and dry-mixed for 10 minutes, then put into the slot mixer in proportion and wet-mixed for 5-10 minutes to obtain a mixture of extract powder, which is evenly spread on a drying tray and dried in an electric vacuum drying machine to obtain dry extract, wherein the drying temperature is not higher than 80℃, the drying time is 2.5-3 hours, and the vacuum degree in the electric vacuum drying machine is maintained at 0.06-0.1 MPa. The dry extract obtained after drying is crushed by a crusher and sieved through an 80-mesh sieve to obtain the dry extract powder. 100 g of the dry extract powder is taken randomly in each shift, and the powder is passed through a 5# pharmacopoeia sieve by double-hand shaking, and the passing rate of the powder through the 5# pharmacopoeia sieve is ≥96%. The dry extract powder is subjected to total mixing treatment by a two-dimensional mixer, the rotating speed of the two-dimensional mixer is 8 r / min, the swinging frequency is 3.5 times / min, and the mixing time is 60 minutes.

7. The preparation method of the male health tablet for treating prostatitis according to claim 6, characterized in that: The inner added excipients include corn starch and microcrystalline cellulose. The dry extract powder and the inner added excipients are fed into a wet granulation machine, dry-mixed for 3-5 minutes, 88% ethanol is added, and the mixture is stirred for 2-3 minutes to obtain soft material. In the preparation process of the soft material, the amounts of the dry extract powder, the inner added excipients and 88% ethanol are as follows: 58.5 kg of dry extract powder, 9 kg of corn starch, 1.8 kg of microcrystalline cellulose and 10 kg of 88% ethanol per pot. The prepared soft material is granulated in a swing granulator to obtain wet granules, and the mesh size of the stainless steel screen of the wet granules is 18 meshes. The wet granules are dried in a drying machine to obtain dry granules, and the inlet air temperature of the drying machine is 75℃±5℃, and the drying time is 10-15 minutes. The dry granules are sieved to obtain dry granules, and the mesh size of the stainless steel screen is 18 meshes.

8. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 7, characterized in that: In step S6, the film coating liquid is prepared in units of per pot, and the preparation materials include 12 kg of 95% ethanol, 20 kg of purified water and 3.5 kg of gastric soluble film coating premix, and the preparation method is beating treatment. First, 95% ethanol and purified water are added to a mixer, the mixer is started to form a vortex on the liquid surface, and then the gastric soluble film coating premix is slowly added, and the mixture is stirred for 50 minutes to obtain the film coating liquid.

9. The preparation method of the male health tablet for treating prostatitis according to claim 8, characterized in that: The additional excipients include silicon dioxide and magnesium stearate; for the preparation of 2 million male health tablets, the amount of silicon dioxide is 1.3±0.1 kg, and the amount of magnesium stearate is 1.3±0.1 kg; in step S6, the extracted volatile oil is mixed with silicon dioxide through a 100-mesh sieve, mixed uniformly, and divided into 3 equal parts, and the dry granules to be mixed in total are also divided into 3 equal parts, and then added to a two-dimensional mixer, one part of dry granules is added each time, and then one part of the mixture of volatile oil and silicon dioxide is added, mixed uniformly, 0.2% of magnesium stearate based on the amount of dry granules is added, the feeding port of the two-dimensional mixer is tightly covered, the two-dimensional mixer is started for total mixing treatment, the rotating speed of the two-dimensional mixer is 8 r / min, the swing frequency is 6 times / min, and the mixing time is 40 minutes; the dry granules after total mixing treatment are put into a tablet press for tablet pressing treatment, the tablet press uses a tablet press die with a diameter of 10 mm, the rotating speed is 15-20 r / min, and the material after tablet pressing treatment is the male health tablet blank, the standard weight of each blank tablet is 0.325 g, and the allowable weight difference is within ±4%, i.e. 0.312 g to 0.338 g.

10. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 9, characterized in that: In step S6, the blank tablets are coated by a coating pot of a coating machine, 100 kg of blank tablets and 32 kg of film coating liquid are added to each pot, the rotating speed of the coating pot is 1-4 r / min, the coating time is 3 h / pot, and the blank tablets after coating treatment are the final male health tablets, the standard weight of each male health tablet is 0.33 g, the allowable weight difference is within ±4%, and the weight is 0.317 g to 0.343 g when the third digit after the decimal point is retained.

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