A method for preparing a male health tablet for treating prostatitis

Abstract

This invention relates to the field of pharmaceutical preparation technology, and particularly to a method for preparing a male enhancement tablet for treating prostatitis. The method optimizes the composition and ratio of auxiliary materials other than the raw medicinal materials. To prepare 2 million tablets of this product, only approximately 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. The oil extraction process has also been improved, with the water addition reduced from 6 times the amount of raw materials to 0.4-0.6 kg. The method also changed the process of extracting oil from the medicinal materials by dividing them into eight separate pots for oil extraction. This refined dispersion process greatly saved water consumption and improved the quality of the extracted oil. An additional step of stirring the alcohol precipitation solution for one hour was added to improve the quality of the supernatant. The volatile ether extract of the male health tablets produced by the method of this invention was measured, and the average value of volatile ether extract was found to be 0.53%, which is about 60.6% higher than the 0.33% of the original process, demonstrating significant technological progress.

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:

[0007] 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.

[0008] Step S2: The first batch of medicinal materials is pulverized and sieved, and then sterilized to obtain Astragalus powder and Paeonia lactiflora powder;

[0009] Step S3: Extract oil from the third portion of medicinal material to obtain residue, distillate, and volatile oil.

[0010] Step S4: The second portion of medicinal material and the dregs are decocted together to obtain a filtrate; the filtrate and distillate are mixed, concentrated under reduced pressure, and then precipitated with ethanol to obtain a 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] Each batch produces 2 million tablets of Nankang tablets, requiring a total weight of 4576 kg of various cleaned medicinal materials.

[0016] 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.

[0017] 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.

[0018] 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;

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] The advantages of this invention compared to the prior art are:

[0029] (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

[0030] Figure 1 This is a flowchart illustrating the steps of the preparation method of the male enhancement tablets of the present invention;

[0031] Figure 2 This is a process flow diagram of the preparation method of the male enhancement tablets of the present invention. Detailed Implementation

[0032] 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.

[0033] Figure 1 and Figure 2 Preferred embodiments of the present invention are given.

[0034] like Figure 1 The method for preparing a male enhancement tablet for treating prostatitis, as shown, includes the following steps:

[0035] 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.

[0036] Each batch produces 2 million tablets of Nankang tablets, requiring a total weight of 4576 kg of various cleaned medicinal materials.

[0037] 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:

[0038] ;

[0039] The dried powder is then pulverized and passed through an 80-mesh sieve.

[0040] 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.

[0041] 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:

[0042] ;

[0043] 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.

[0044] 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:

[0045] ;

[0046] 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:

[0047] ;

[0048] 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:

[0049] ;

[0050] 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%.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] Table 1 Packaging Forms - Aluminum Composite Panels (Quantity for 100 Pieces)

[0055]

[0056] 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.

[0057] Table 2 Packaging Forms - Aluminum Composite Panel (Quantity for 100 Pieces)

[0058]

[0059] 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.

[0060] Table 3. List of outer packaging materials (for 100 pieces)

[0061]

[0062] In step S7, the list of required packing straps and tapes (for 100 pieces) for the outer packaging is shown in Table 4.

[0063] Table 4. List of Packing Straps and Adhesive Tape (Quantity for 100 Pieces)

[0064]

[0065] The packaging methods corresponding to Tables 1 to 4 are summarized as follows:

[0066] 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).

[0067] 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).

[0068] 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).

[0069] 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).

[0070] 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).

[0071] 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).

[0072] 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.

[0073] Table 5. Detection values ​​of volatile ether extracts

[0074] .

Claims

1. A method for preparing a male enhancement tablet for treating prostatitis, characterized in that, The following steps are required: Step S1: Weigh and process the cleaned medicinal materials to obtain three different portions; the first portion consists of half the amount of Astragalus membranaceus and half the amount of Paeonia lactiflora; the second portion consists of 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 consists of 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. Using drinking water as solvent, divide the third portion of medicinal material into 8 pots, adding water to each pot at a volume of 0.4 to 0.6 times the amount of medicinal material in the current pot. Soak for 2 hours, extract oil for 3 hours, and collect the volatile oil. Distill the mixture in each pot, controlling the steam pressure at 0.01 MPa to 0.05 MPa to obtain distillate. Reserve the remaining residue. 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, with the internal excipients being corn starch and microcrystalline cellulose. Step S6: Ethanol, purified water and gastric-soluble film coating premix are pulped to obtain film coating solution; external excipients, volatile oil and dry particles are mixed together, and the dry particles after mixing are compressed to obtain uncoated tablets. The uncoated tablets are then coated with film coating solution. The external excipients are silica and magnesium stearate. 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. 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.

2. The method for preparing a male health tablet for treating prostatitis as described in claim 1, characterized in that: 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.

3. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 2, characterized in that: In step S4, the combined decoction process of the second portion of medicinal materials and dregs is as follows: using drinking water as the solvent, the second portion of medicinal materials and dregs are mixed evenly and divided into 8 pots. Each pot is decocted three times with water added. The first decoction is 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 0.5 hours. The amount of water added for the second decoction is 6 times the amount of medicinal materials, and the amount of water added for the third decoction is 4 times the amount of medicinal materials. After the third decoction is completed, the decoctions obtained from the three decoctions and filtrations are combined to obtain the filtrate. The sieve used for filtration has a mesh size of 100. 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.

4. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 3, characterized in that: 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 thick paste is added in proportion and wet-mixed for 5-10 minutes to obtain an extract powder mixture. The extract 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 2.5h to 3h, and the vacuum degree in the electric vacuum dryer is maintained at 0.06MPa to 0.1MPa. The dried product 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 from 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 8r / min, the oscillation frequency is 3.5 times / min, and the mixing time is 60 minutes.

5. The method for preparing a male health tablet for treating prostatitis as described in claim 4, characterized in that: 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 mass. The amounts of dry powder, added excipients, and 88% ethanol used in the soft mass preparation process are as follows: 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 mass is then processed into wet granules in a gyratory granulator. The wet granules are granulated using an 18-mesh stainless steel sieve. 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 using an 18-mesh stainless steel sieve.

6. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 5, characterized in that: In step S6, the film coating solution is prepared in units of per batch. The preparation materials are 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, add 95% ethanol and purified water into a mixer, start the mixer to form a vortex on the liquid surface, and then slowly add the gastric-soluble film coating premix. Stir the mixture for 50 minutes to obtain the film coating solution.

7. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 6, characterized in that: For every 2 million tablets of Nankang Tablets prepared, the dosage of silicon dioxide is 1.3 ± 0.1 kg, and the dosage of magnesium stearate is 1.3 ± 0.1 kg; in step S6, the extracted volatile oil is mixed with silicon dioxide and passed through a 100-mesh sieve, then evenly mixed and divided into 3 equal parts. The dry granules to be granulated are also divided into 3 equal parts and added to the two-dimensional mixer in batches. After adding one part of the dry granules each time, one part of the mixture of volatile oil and silicon dioxide is added and evenly mixed. Then, magnesium stearate accounting for 0.2% of the dry granule amount is added. The feeding port of the two-dimensional mixer is tightly covered, and the two-dimensional mixer is started for overall mixing. The rotation speed of the two-dimensional mixer is 8 r / min, the swing frequency is 6 times / minute, and the mixing time is 40 minutes; the dry granules after overall mixing are put into a tablet press for tableting. The tablet press uses a tablet mold with a diameter of 10 mm and a rotation speed of 15 - 20 revolutions / minute. The material after tableting is the plain tablets of Nankang Tablets. The standard weight of each plain tablet is 0.325 g, and the allowable weight difference is within ±4%, that is, 0.312 g to 0.338 g.

8. The method for preparing a male enhancement tablet for treating prostatitis as described in claim 7, characterized in that: In step S6, the plain tablets are coated by the coating pan of the coating machine. 100 kg of plain tablets and 32 kg of film coating solution are added to each pan. The rotation speed of the coating pan is 1 - 4 r / min, and the coating time is 3 h / pan. The plain tablets after coating are the final Nankang Tablets. The standard weight of each Nankang Tablet is 0.33 g, and the allowable weight difference is within ±4%. After retaining three decimal places, it is 0.317 g to 0.343 g.

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