Preparation method of gynecological reconstitution pill film-coated pill

Abstract

According to the preparation method, coating powder and polishing powder are used for carrying out film coating on the gynecological reconstituted pill, so that the gynecological reconstituted pill has the advantages of moisture resistance, light resistance, taste masking, wear resistance, difficult generation of pill cracking, mildew spots and easy disintegration, the dissolution rate and bioavailability of the medicine are greatly improved, and the shelf life of the medicine is greatly prolonged. And the quality is stable, the pill shape is beautiful, the mark is clear, and counterfeiting is not easy.

Description

Technical Field

[0001] The invention relates to a preparation method of gynecological regeneration pills film-coated pills, belonging to the technical field of medicine preparation. Background Art

[0002] Fuke Zaizao Pills are formulated to nourish blood and regulate menstruation, tonify the liver and kidneys, warm the uterus, and relieve pain. They are used to treat irregular menstruation, prolonged menstruation, spotting, dysmenorrhea, and leucorrhea. The formula, created by renowned physician Wang Pinxian, consists of 42 herbs, including angelica sinensis (wine-cured), cyperus rotundus (vinegar-cured), white peony root, prepared rehmannia root, donkey-hide gelatin, and poria cocos. They combine nine key benefits: regulating menstruation, reducing inflammation, warming the uterus, relieving pain, nourishing blood, replenishing qi, soothing the liver, strengthening the spleen, and tonifying the kidneys. They not only treat various gynecological conditions, but also, through systemic conditioning, improve physical fitness, enhance immunity, remove freckles, enhance beauty, and delay aging. Fuke Zaizao Pills boast a century-long history and are the exclusive product of Guizhou Dechangxiang Pharmaceutical Co., Ltd. They adhere to the National Medical Products Standard, numbered WS-10051 (ZD-0051)-2002-2012Z.

[0003] The prescription consists of 42 medicinal ingredients: wine-soaked angelica, vinegar-soaked cyperus, white peony root, cooked rehmannia root, donkey-hide gelatin, poria, codonopsis, astragalus, yam, atractylodes, wine-soaked ligustrum lucidum fruit, tortoise shell (fried with vinegar), cornus officinalis, dipsaccharin, salt eucommia, cistanche deserticola, raspberry, antler frost, ligusticum chuanxiong, salvia miltiorrhiza, Achyranthes bidentata, motherwort, Corydalis yanhusuo, Panax notoginseng (fried with oil), mugwort (fried with vinegar), fennel, Ligusticum chuanxiong, cuttlebone, sanguisorba officinalis (fried with wine), alpinia oxyphylla, oriental medicine, lotus leaf (fried with vinegar), gentiana macrophylla, rehmannia root bark, white mulberry, toon bark, amber, wine-soaked scutellaria, jujube seed, processed polygala tenuifolia, tangerine peel, and licorice.

[0004] Conventional sugar-coated pills are made with a coating material to ensure the quality of the pills and facilitate their administration. This allows the pills to be isolated from the outside world, protecting them from moisture, light, and air oxidation, enhancing their storage stability, masking any unpleasant odors, and reducing drug irritation. This is why the pills need to be coated on their surface. Summary of the Invention

[0005] The purpose of the present invention is to disclose a preparation method of gynecological regeneration pill film-coated pills. According to the properties of the polymer materials of the coating powder and the polishing powder, the film-coated pills can be made into various film-coated materials such as gastric-soluble, enteric-soluble, sustained-release, and controlled-release targeted preparations, so as to meet the pathological needs of different patients and broaden the application range of the pill efficacy in medical technology.

[0006] The technical solution of the present invention is a preparation method of film-coated pills of gynecological regeneration pills, wherein the medicinal active ingredients of the gynecological regeneration pills are calculated by weight as follows: 65.14 parts of wine-soaked angelica, 66.14 parts of vinegar-soaked cyperus, 43.43 parts of white peony root, 21.71 parts of prepared rehmannia root, 10.86 parts of donkey-hide gelatin, 65.14 parts of poria, 21.71 parts of codonopsis pilosula, 21.71 parts of astragalus, 32.57 parts of yam, 16.28 parts of atractylodes macrocephala, 43.43 parts of wine-soaked privet fruit, 32.57 parts of vinegar-soaked tortoise shell, 21.71 parts of cornus officinalis, 21.71 parts of dipsacus root, 21.71 parts of salt eucommia, 10.86 parts of cistanche, 16.28 parts of raspberry, 5.43 parts of antler frost, 43.7 parts of chuanxiong. .43 parts, 21.71 parts of Salvia miltiorrhiza, 16.28 parts of Achyranthes bidentata, 21.71 parts of Leonurus japonicus, 16.28 parts of Corydalis yanhusuo, 5.43 parts of fried Panax notoginseng, 43.43 parts of vinegar-fried Artemisia argyi, 21.71 parts of fennel, 21.71 parts of Ligusticum chuanxiong, 32.57 parts of cuttlebone, 32.57 parts of wine-fried Sanguisorba officinalis, 10.86 parts of Alpinia oxyphylla, 21.71 parts of Alisma orientalis, 16.28 parts of vinegar-fried lotus leaf, 21.71 parts of Gentiana macrophylla, 21.71 parts of Lycium bark, 43.43 parts of Bletilla striata, 32.57 parts of Toona bark, 5.43 parts of amber, 32.57 parts of wine-fried Scutellaria baicalensis, 10.86 parts of Ziziphus jujuba seeds, 16.28 parts of processed Polygala tenuifolia, 32.57 parts of dried tangerine peel, and 21.71 parts of Glycyrrhiza uralensis; The preparation method comprises the following steps: (1) Extraction and concentration: according to the prescription ratio, weigh Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Lycium bark, add water and boil twice, each time for 2 hours, combine the two decoctions, filter, and concentrate the filtrate to obtain a concentrated solution; (2) Preparation of clear paste: Add the prescribed proportion of donkey-hide gelatin into boiling water, continue heating, and stir continuously until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin solution. Combine the melted donkey-hide gelatin solution with the concentrated solution prepared in step (1) and concentrate into a clear paste, i.e., the Fuke Zaizao Pill extract, which is set aside. (3) Grinding and mixing: After primary and secondary drying, the 33 ingredients including wine angelica root are ground into fine powder, and then mixed to obtain the mixed powder of Fuke Zaozao Pills; (4) Preparation of sucrose syrup: Take 3.5-3.6% of sucrose in the total mixed powder of Fuke Zaizao Pills, stir and dissolve sucrose and water in a weight ratio of 2-3:1 to obtain sucrose syrup; (5) Pill making: Mix the Fuke Zaizao Pill extract, the Fuke Zaizao Pill mixed powder and the sucrose syrup for 20-40 min, and refine the medicine 3-4 times to make wet pills weighing 3.4-3.7 g / 10 pills. Dry at 60-80°C until the moisture content of the pills is within the range of 3.0-6.0%, and the weight difference is controlled within 2.418-2.782 g / 10 pills. Thus, the Fuke Zaizao Pills are obtained. (6) First film coating: Divide the coating powder into 5-7 equal parts, add them into purified water in batches, stir and dissolve for 50-70 minutes to obtain a coating solution, the concentration of which is 12-13%; coat the Fuke Zaizao Wansu pills with the above coating solution for the first time, the mass ratio of the Fuke Zaizao Wansu pills to the coating solution is 1:0.25-0.30 kg, the coating solution spraying time is 100-170 minutes / pot, and the first coating is stopped after the weight gain is 1.50-3.00%, thereby obtaining film-coated pills with the first film coating; (7) Second film coating: Divide the polishing powder into 5-7 equal parts, add them into purified water in batches, stir and dissolve for 20-40 minutes to obtain a polishing liquid, the concentration of which is 7.0-9.0%; the film-coated pills that have been film-coated for the first time are coated with the above-mentioned polishing liquid for the second time, the mass ratio of the gynecological regeneration pills to the polishing liquid is 1:0.25-0.30 kg, the polishing liquid spraying time is 15-35 minutes, and the second coating is stopped after the weight gain is 2.00%-4.00%, the heating is turned off, and cold air is blown. After the pills are cooled, they are taken out to obtain the gynecological regeneration pills film-coated pills.

[0007] In the above step (1), extraction and concentration: according to the prescription ratio, Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Cortex Lycii are weighed and decocted twice with water. For the first time, 8 times of the net amount of water is added for 2 hours, and the decoction is filtered and the medicinal liquid is collected; water is added to the residue and the decoction is continued. For the second time, 5 times of the net amount of water is added for 2 hours, and the decoction is filtered and the medicinal liquid is collected. The residue is discarded, the two decoctions are combined, filtered, and the filtrate is concentrated to obtain a concentrated solution.

[0008] In the above step (2), a clear paste is prepared by adding 5 times the amount of boiling water to the prescribed proportion of donkey-hide gelatin, continuing to heat and stirring until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin liquid, combining the melted donkey-hide gelatin liquid with the concentrated liquid prepared in step (1), and concentrating them into a clear paste, i.e., the Fuke Zaizao Pill extract, which is set aside.

[0009] In the above step (3), crushing and mixing: the 33 clean ingredients including wine angelica are dried at 110°C for 20 minutes and at 80°C for 6 hours, crushed into fine powder, and then mixed to obtain the gynecological regeneration pill mixed powder.

[0010] In the aforementioned step (4), sucrose syrup is prepared by taking 3.57% sucrose from the total mixed powder of the gynecological regeneration pills, stirring and dissolving the sucrose and water in a weight ratio of 2.5:1 to obtain sucrose syrup.

[0011] In the aforementioned step (5), the pills are prepared by mixing the extract of Fuke Zaizao Pills, the total mixed powder of Fuke Zaizao Pills and sucrose syrup for 30 minutes, refining the medicine 3 to 4 times to prepare wet pills weighing 3.4 to 3.7 g / 10 pills, and drying them at 70°C until the moisture content of the pills is within the range of 3.0 to 6.0%, and the weight difference is controlled within the range of 2.418 to 2.782 g / 10 pills, thereby obtaining Fuke Zaizao Pills.

[0012] In the aforementioned step (6), the main component of the coating powder is hydroxypropyl methylcellulose, and the concentration of the coating solution is 12.5%.

[0013] In the aforementioned step (6), the hot air temperature for the first film coating is 100-115°C, the exhaust air temperature is 57-67°C, the tablet bed temperature is controlled at 38-44°C, the distance from the spray gun to the tablet bed is 20 cm, and the rotation speed is 4-9 r / m.

[0014] In the aforementioned step (7), the main component of the polishing powder is sodium carboxymethyl cellulose, and the concentration of the polishing liquid is 8.0%.

[0015] In the aforementioned step (7), the hot air temperature in the second film coating is 95-105°C, the exhaust air temperature is 53-63°C, the tablet bed temperature is controlled at 36-42°C, the distance from the spray gun to the tablet bed is 20 cm, and the rotation speed is 4-9 r / m.

[0016] Compared with the prior art, the present invention has the following beneficial effects: 1. The film coating material used in the present invention is composed of a polymer compound and is non-toxic and odorless. Depending on the properties of the polymer material, it can be made into a variety of film coating materials such as gastric-soluble, enteric-soluble, sustained-release, and controlled-release targeted formulations to meet the pathological needs of different patients and broaden the application range of pill efficacy in medical technology.

[0017] 2. Film-coated pills are not only moisture-proof, light-proof, odor-masking, and wear-resistant, but also not prone to cracking, spotting, and mold, and are easy to disintegrate, greatly improving the solubility, bioavailability, and shelf life of the drug.

[0018] 3. The weight gain of excipients in film-coated pills is only 2-4% of the original pill weight. Due to their small size and smooth shape, film-coated pills are easier and more convenient for children and women to swallow. Each batch of Fuke Zaizao Wan sugar-coated pills requires approximately 326.80 kg of sucrose for the sugar coating syrup and 66.50 kg for the color coating syrup, for a total of approximately 393.3 kg of sucrose. Fuke Zaizao Wan film-coated pills are coated with coating powder 21M05093-1 (SNWR-1004) and polishing powder 22M03049-1 (SMWT-1003). The coating powder is primarily composed of hydroxypropyl methylcellulose, and the polishing powder is primarily composed of sodium carboxymethylcellulose. Both are sucrose-free. Therefore, film-coated pills are suitable for diabetics and those avoiding sugar, expanding their applicability to a wider range of patients.

[0019] 4. Short production time and automated operation. Since the coating pan maintains negative pressure during the coating process, dust generation is minimal, preventing environmental pollution. The entire production process is under both equipment and manual control, complying with GMP production management standards. After coating, pellets can proceed directly to packaging without requiring a drying step, significantly shortening the production cycle. However, the production process requires high core hardness and surface finish; otherwise, loose and rough pellets will be produced during the coating process, affecting their shape and aesthetics. Furthermore, the attractively shaped pellets, clearly labeled, and difficult to counterfeit. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 : Comparison of moisture test results of Fuke Zaizao Pills film-coated pills and Fuke Zaizao Pills sugar-coated pills; Figure 2 : Comparison of dissolution time test results of Fuke Zaizao Pills film-coated pills and Fuke Zaizao Pills sugar-coated pills; Figure 3 : Comparison of content determination results of Fuke Zaizao Wan film-coated pills and Fuke Zaizao Wan sugar-coated pills; Figure 4 : Actual comparison picture of Fuke Zaizao Wan film-coated pills and Fuke Zaizao Wan sugar-coated pills. DETAILED DESCRIPTION

[0021] The following will clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. It should be noted that all raw materials involved in the present invention are purchased from Shanghai Xinfeier Biopharmaceutical Engineering Technology Co., Ltd., the coating powder is model 21M05093-1 coating powder (SNWR-1004), and the polishing powder is model 22M03049-1 polishing powder (SMWT-1003).

[0022] Both coating powder and polishing powder are gastric-soluble film coating premixes. The main component of coating powder is hydroxypropyl methylcellulose, and the main component of polishing powder is sodium carboxymethylcellulose.

[0023] Example 1: Preparation of Fuke Zaozao Pills Prescription: Wine-soaked Angelica 65.14g, Vinegar-soaked Cyperus 66.14g, White Peony Root 43.43g, Rehmannia Glutinosa 21.71g, Donkey-hide Gelatin 10.86g, Poria 65.14g, Codonopsis pilosula 21.71g, Astragalus 21.71g, Chinese Yam 32.57g, Atractylodes macrocephala 16.28g, Wine-soaked Ligustrum lucidum 43.43g, Vinegar-soaked Tortoise Shell 32.57g, Cornus officinalis 21.71g, Dipsacus asper 21.71g, Salt-soaked Eucommia ulmoides 21.71g, Cistanche deserticola 10.86g, Rubus idaeus 16.28g, Deer Antler Powder 5.43g, Chuanxiong 43.43g, Salvia miltiorrhiza 21.71g, Achyranthes bidentata 16.28g, Motherwort 21.71g, Corydalis 16.28g, Panax notoginseng 5.43g, vinegar-fried mugwort 43.43g, fennel 21.71g, Ligusticum 21.71g, cuttlebone 32.57g, wine-fried Sanguisorba officinalis 32.57g, Alpinia oxyphylla 10.86g, Alisma orientalis 21.71g, vinegar-fried lotus leaf 16.28g, Gentiana macrophylla 21.71g, Rehmannia root bark 21.71g, Bletilla striata 43.43g, Chinese toon bark 32.57g, amber 5.43g, wine-fried Scutellaria baicalensis 32.57g, Ziziphus jujuba seed 10.86g, processed Polygala tenuifolia 16.28g, dried tangerine peel 32.57g, and liquorice 21.71g.

[0024] Preparation method of Fuke Zaizao Pills: (1) Extraction and concentration: according to the prescription ratio, weigh Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Cortex Lycii, add water and decoct twice. The first time, add 8 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine; add water to the residue and continue to decoct. The second time, add 5 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine, discard the residue, combine the two decoctions, filter, and concentrate the filtrate to obtain the concentrated solution; (2) Preparation of clear paste: Add 5 times the amount of boiling water to the prescribed proportion of donkey-hide gelatin, continue heating, and stir constantly until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin solution. Combine the melted donkey-hide gelatin solution with the concentrated solution prepared in step (1) and concentrate into a clear paste to obtain the Fuke Zaizao Pill extract, which is set aside. (3) Grinding and mixing: Grinding and mixing: After drying the 33 ingredients including wine angelica for 20 minutes at 110°C for the first time and drying them for 6 hours at 80°C for the second time, the ingredients are ground into fine powder, and then mixed to obtain the mixed powder of Fuke Zaozao Wan. (4) Preparation of sucrose syrup: 3.57% of the total weight of sucrose in the total mixed powder of Fuke Zaizao Pills was taken, and sucrose and water were stirred and dissolved in a weight ratio of 2.5:1 to obtain sucrose syrup; (5) Pill making: Mix the extract of Fuke Zaizao Pills, the total mixed powder of Fuke Zaizao Pills and sucrose syrup for 30 minutes, refine the medicine 4 times, and make wet pills weighing 3.4-3.7g / 10 pills. Dry at 70℃ until the moisture content of the pills is within the range of 3.0-6.0%, and the weight difference is controlled within 2.418-2.782g / 10 pills. The Fuke Zaizao Pills are obtained.

[0025] Example 2: Preparation of Fuke Zaizaowansu Pills Prescription: Wine-soaked Angelica 65.14g, Vinegar-soaked Cyperus 66.14g, White Peony Root 43.43g, Rehmannia Glutinosa 21.71g, Donkey-hide Gelatin 10.86g, Poria 65.14g, Codonopsis pilosula 21.71g, Astragalus 21.71g, Chinese Yam 32.57g, Atractylodes macrocephala 16.28g, Wine-soaked Ligustrum lucidum 43.43g, Vinegar-soaked Tortoise Shell 32.57g, Cornus officinalis 21.71g, Dipsacus asper 21.71g, Salt-soaked Eucommia ulmoides 21.71g, Cistanche deserticola 10.86g, Rubus idaeus 16.28g, Deer Antler Powder 5.43g, Chuanxiong 43.43g, Salvia miltiorrhiza 21.71g, Achyranthes bidentata 16.28g, Motherwort 21.71g, Corydalis 16.28g, Panax notoginseng 5.43g, vinegar-fried mugwort 43.43g, fennel 21.71g, Ligusticum 21.71g, cuttlebone 32.57g, wine-fried Sanguisorba officinalis 32.57g, Alpinia oxyphylla 10.86g, Alisma orientalis 21.71g, vinegar-fried lotus leaf 16.28g, Gentiana macrophylla 21.71g, Rehmannia root bark 21.71g, Bletilla striata 43.43g, Chinese toon bark 32.57g, amber 5.43g, wine-fried Scutellaria baicalensis 32.57g, Ziziphus jujuba seed 10.86g, processed Polygala tenuifolia 16.28g, dried tangerine peel 32.57g, and liquorice 21.71g.

[0026] Preparation method of Fuke Zaizao Pills: (1) Extraction and concentration: According to the prescription ratio, weigh Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Lycium bark, add water and decoct twice. The first time, add 8 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine; add water to the residue and continue to decoct. The second time, add 5 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine, discard the residue, combine the two decoctions, filter, and concentrate the filtrate to obtain a concentrated solution; (2) Preparation of clear paste: Add 5 times the amount of boiling water to the prescribed proportion of donkey-hide gelatin, continue heating, and stir constantly until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin solution. Combine the melted donkey-hide gelatin solution with the concentrated solution prepared in step (1) and concentrate into a clear paste to obtain the Fuke Zaizao Pill extract, which is set aside. (3) Grinding and mixing: Dry the 33 ingredients including wine angelica for 20 min at 110°C for the first time and 6 h at 80°C for the second time, grind them into fine powder, and then mix them together to obtain the mixed powder of Fuke Zaizao Pills; (4) Preparation of sucrose syrup: Take 3.5% of the total weight of sucrose in the total mixed powder of Fuke Zaizao Pills, stir and dissolve the sucrose and water in a weight ratio of 3:1 to obtain sucrose syrup; (5) Pill making: Mix the extract of Fuke Zaizao Pills, the total mixed powder of Fuke Zaizao Pills and sucrose syrup for 20 minutes, refine the medicine 4 times, and make wet pills weighing 3.4-3.7g / 10 pills. Dry at 60℃ until the moisture content of the pills is within 3.0% and the weight difference is controlled within 2.418-2.782g / 10 pills.

[0027] Example 3: Preparation of Fuke Zaozao Pills Prescription: Wine-soaked Angelica 65.14g, Vinegar-soaked Cyperus 66.14g, White Peony Root 43.43g, Rehmannia Glutinosa 21.71g, Donkey-hide Gelatin 10.86g, Poria 65.14g, Codonopsis pilosula 21.71g, Astragalus 21.71g, Chinese Yam 32.57g, Atractylodes macrocephala 16.28g, Wine-soaked Ligustrum lucidum 43.43g, Vinegar-soaked Tortoise Shell 32.57g, Cornus officinalis 21.71g, Dipsacus asper 21.71g, Salt-soaked Eucommia ulmoides 21.71g, Cistanche deserticola 10.86g, Rubus idaeus 16.28g, Deer Antler Powder 5.43g, Chuanxiong 43.43g, Salvia miltiorrhiza 21.71g, Achyranthes bidentata 16.28g, Motherwort 21.71g, Corydalis 16.28g, Panax notoginseng 5.43g, vinegar-fried mugwort 43.43g, fennel 21.71g, Ligusticum 21.71g, cuttlebone 32.57g, wine-fried Sanguisorba officinalis 32.57g, Alpinia oxyphylla 10.86g, Alisma orientalis 21.71g, vinegar-fried lotus leaf 16.28g, Gentiana macrophylla 21.71g, Rehmannia root bark 21.71g, Bletilla striata 43.43g, Chinese toon bark 32.57g, amber 5.43g, wine-fried Scutellaria baicalensis 32.57g, Ziziphus jujuba seed 10.86g, processed Polygala tenuifolia 16.28g, dried tangerine peel 32.57g, and liquorice 21.71g.

[0028] Preparation method of Fuke Zaizao Pills: (1) Extraction and concentration: according to the prescription ratio, weigh Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Cortex Lycii, add water and decoct twice. The first time, add 8 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine; add water to the residue and continue to decoct. The second time, add 5 times the amount of the net material to decoct for 2 hours, filter and collect the liquid medicine, discard the residue, combine the two decoctions, filter, and concentrate the filtrate to obtain the concentrated solution; (2) Preparation of clear paste: Add 5 times the amount of boiling water to the prescribed proportion of donkey-hide gelatin, continue heating, and stir constantly until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin solution. Combine the melted donkey-hide gelatin solution with the concentrated solution prepared in step (1) and concentrate into a clear paste to obtain the Fuke Zaizao Pill extract, which is set aside. (3) Grinding and mixing: After drying the 33 ingredients including wine angelica for 20 min and 6 h at 110°C for the first time and at 80°C for the second time, the ingredients are ground into fine powder and then mixed to obtain the mixed powder of Fuke Zaozao Wan. (4) Preparation of sucrose syrup: Take 3.6% sucrose from the total mixed powder of Fuke Zaizao Pills, stir and dissolve sucrose and water in a weight ratio of 2:1 to obtain sucrose syrup; (5) Pill making: Mix the extract of Fuke Zaizao Pills, the total mixed powder of Fuke Zaizao Pills and sucrose syrup for 40 minutes, refine the medicine three times, and make wet pills weighing 3.4-3.7g / 10 pills. Dry at 80℃ until the moisture content of the pills is within 6.0% and the weight difference is controlled within 2.418-2.782g / 10 pills.

[0029] Example 4: Film coating process of gynecological regeneration pills film-coated pills (1) Preparation of coating solution: Divide the coating powder into 6 equal parts, add them into purified water in batches, stir and dissolve completely. The dissolution and mixing time is 50-70 minutes, and the concentration of the coating solution is 12.5%.

[0030] Coating liquid concentration (%) = coating powder amount ÷ (coating powder amount + purified water amount) × 100%. Calculate the amount of purified water added according to the formula.

[0031] (2) Preparation of polishing solution: Divide the polishing powder into 6 equal parts, add them into purified water in batches, stir and dissolve them completely. The dissolution and mixing time is 20 to 40 minutes, and the concentration of the polishing solution is 8.0%.

[0032] Polishing liquid concentration (%) = polishing powder amount ÷ (polishing powder amount + purified water amount) × 100%. Calculate the amount of purified water to be added according to the formula.

[0033] (3) Place the Fuke Zaizao Pills (prepared in Example 1) into a high-efficiency intelligent coating machine for coating (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 100-115°C, the exhaust air temperature to 57-67°C, the tablet bed temperature to 38-44°C, the distance between the spray gun and the tablet bed to 20 cm, and the rotation speed to 4-9 rpm. The amount of coating liquid added is controlled to be 0.25 kg to 0.30 kg per 1 kg of the tablets. The coating liquid spraying time is 100-170 min / pot to obtain the film-coated pills after the first film coating. (4) Place the film-coated pills into a high-efficiency intelligent coating machine for polishing (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 95-105°C, the exhaust air temperature to 53-63°C, the tablet bed temperature to 36-42°C, the distance from the spray gun to the tablet bed to 20 cm, and the rotation speed to 4-9 r / m. The amount of polishing liquid added is controlled to be 0.02 kg to 0.03 kg per 1 kg of raw pills. The polishing liquid spraying time is 15-35 min / pot. Turn off the heating and blow cold air. After the pills cool down, take them out and put them into a clean container or large plastic bag and transfer them to the next process. Test the moisture content (3.0-7.0%), dissolution time (should be within 20-100 minutes), and weight difference (2.7 g / 10 pills ± 7%, i.e. 2.511-2.889 g / 10 pills). Calculate the coating weight gain (2.00%-4.00%).

[0034] Coating weight gain % = (total weight of pills after coating - total weight of pills before coating) ÷ total weight of pills before coating × 100%.

[0035] Example 5: Film coating process of gynecological regeneration pills (1) Preparation of coating solution: Divide the coating powder into 5 equal parts, add them into purified water in batches, stir and dissolve completely. The dissolution and mixing time is 50-70 minutes, and the concentration of the coating solution is 12%.

[0036] Coating liquid concentration (%) = coating powder amount ÷ (coating powder amount + purified water amount) × 100%. Calculate the amount of purified water added according to the formula.

[0037] (2) Preparation of polishing solution: Divide the polishing powder into 5 equal parts, add them into purified water in batches, stir and dissolve them completely. The dissolution and mixing time is 20 to 40 minutes, and the concentration of the polishing solution is 7.0%.

[0038] Polishing liquid concentration (%) = polishing powder amount ÷ (polishing powder amount + purified water amount) × 100%. Calculate the amount of purified water to be added according to the formula.

[0039] (3) Place the Fuke Zaizao Pills (prepared in Example 1) into a high-efficiency intelligent coating machine for coating (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 100-115°C, the exhaust air temperature to 57-67°C, the tablet bed temperature to 38-44°C, the distance between the spray gun and the tablet bed to 20 cm, and the rotation speed to 4-9 rpm. The amount of coating liquid added is controlled to be 0.25 kg to 0.30 kg per 1 kg of the tablets. The coating liquid spraying time is 100-170 min / pot to obtain the film-coated pills after the first film coating. (4) Place the film-coated pills into a high-efficiency intelligent coating machine for polishing (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 95-105°C, the exhaust air temperature to 53-63°C, the tablet bed temperature to 36-42°C, the distance from the spray gun to the tablet bed to 20 cm, and the rotation speed to 4-9 r / m. The amount of polishing liquid added is controlled to be 0.02 kg to 0.03 kg per 1 kg of raw pills. The polishing liquid spraying time is 15-35 min / pot. Turn off the heating and blow cold air. After the pills cool down, take them out and put them into a clean container or large plastic bag and transfer them to the next process. Test the moisture content (3.0-7.0%), dissolution time (should be within 20-100 minutes), and weight difference (2.7 g / 10 pills ± 7%, i.e. 2.511-2.889 g / 10 pills). Calculate the coating weight gain (2.00%-4.00%).

[0040] Coating weight gain % = (total weight of pills after coating - total weight of pills before coating) ÷ total weight of pills before coating × 100%.

[0041] Example 6: Film coating process of gynecological regeneration pills (1) Preparation of coating solution: Divide the coating powder into 7 equal parts, add them into purified water in batches, stir and dissolve completely. The dissolution and mixing time is 50 to 70 minutes, and the concentration of the coating solution is 13%.

[0042] Coating liquid concentration (%) = coating powder amount ÷ (coating powder amount + purified water amount) × 100%. Calculate the amount of purified water added according to the formula.

[0043] (2) Preparation of polishing solution: Divide the polishing powder into 7 equal parts, add them into purified water in batches, stir and dissolve them completely. The dissolution and mixing time is 20 to 40 minutes, and the concentration of the polishing solution is 9.0%.

[0044] Polishing liquid concentration (%) = polishing powder amount ÷ (polishing powder amount + purified water amount) × 100%. Calculate the amount of purified water to be added according to the formula.

[0045] (3) Place the Fuke Zaizao Pills (prepared in Example 1) into a high-efficiency intelligent coating machine for coating (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 100-115°C, the exhaust air temperature to 57-67°C, the tablet bed temperature to 38-44°C, the distance between the spray gun and the tablet bed to 20 cm, and the rotation speed to 4-9 rpm. The amount of coating liquid added is controlled to be 0.25 kg to 0.30 kg per 1 kg of the tablets. The coating liquid spraying time is 100-170 min / pot to obtain the film-coated pills after the first film coating. (4) Place the film-coated pills into a high-efficiency intelligent coating machine for polishing (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coating machine to 95-105°C, the exhaust air temperature to 53-63°C, the tablet bed temperature to 36-42°C, the distance from the spray gun to the tablet bed to 20 cm, and the rotation speed to 4-9 r / m. The amount of polishing liquid added is controlled to be 0.02 kg to 0.03 kg per 1 kg of raw pills. The polishing liquid spraying time is 15-35 min / pot. Turn off the heating and blow cold air. After the pills cool down, take them out and put them into a clean container or large plastic bag and transfer them to the next process. Test the moisture content (3.0-7.0%), dissolution time (should be within 20-100 minutes), and weight difference (2.7 g / 10 pills ± 7%, i.e. 2.511-2.889 g / 10 pills). Calculate the coating weight gain (2.00%-4.00%).

[0046] Coating weight gain % = (total weight of pills after coating - total weight of pills before coating) ÷ total weight of pills before coating × 100%.

[0047] In order to prove the technical effect of the present invention, the inventors conducted a large number of experiments. The following is the research on the film coating process of the film-coated pills of the present invention: 1 Film coating process design of Fuke Zaizaowan film-coated pills 1.1 Calculate the amount of coating powder based on the number of pellets. Add the coating powder in small amounts to purified water and stir to dissolve completely. The dissolution and mixing time is 50-70 minutes. This is equivalent to a coating solution concentration of 12.5%.

[0048] Coating solution concentration % = coating powder amount ÷ (coating powder amount + purified water amount) × 100%, calculate the amount of purified water added according to the formula 1.2 Calculate the amount of polishing powder based on the amount of pellets. Add the polishing powder to purified water in small amounts and multiple times, stirring to dissolve completely. The dissolution mixing time is 20 to 40 minutes. This is equivalent to a polishing solution concentration of 8.0%. Polishing liquid concentration (%) = polishing powder amount ÷ (polishing powder amount + purified water amount) × 100%. Calculate the amount of purified water to be added according to the formula.

[0049] 1.3 Place Fuke Zaizao Pills (prepared as in Example 1) in a high-efficiency intelligent coating machine for coating (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coater to 100-115°C, the exhaust air temperature to 57-67°C, and the tablet bed temperature to 38-44°C. The spray gun should be 20 cm from the tablet bed and the rotation speed should be 4-9 rpm. The amount of coating solution added should be controlled at 0.25-0.30 kg per 1 kg of the tablets. The coating solution spraying time should be 100-170 min / pot.

[0050] 1.4 Place the film-coated pills in a high-efficiency intelligent coating machine for polishing (75.0-125.0 kg / pot). Adjust the hot air temperature of the film coater to 95-105°C, the exhaust air temperature to 53-63°C, and the tablet bed temperature to 36-42°C. The distance between the spray gun and the tablet bed should be 20 cm, and the speed should be 4-9 rpm. The amount of polishing liquid added should be controlled at 0.02-0.03 kg per 1 kg of raw pills. The polishing liquid spraying time should be 15-35 minutes per pot. Turn off the heat and apply cold air. After the pills have cooled, remove them and place them in a clean container or large plastic bag before proceeding to the next step. Test for moisture (3.0-7.0%), dissolution time (should be within 20-100 minutes), and weight variation (2.7 g / 10 pills ± 7%, i.e., 2.511-2.889 g / 10 pills). Calculate the coating weight gain (2.00-4.00%).

[0051] Coating weight gain % = (total weight of pills after coating - total weight of pills before coating) ÷ total weight of pills before coating × 100% Six samples were prepared by secondary coating of Fuke Zaizao Wansu pills using coating liquid and polishing liquid. The dosage of coating powder and polishing powder and related process parameters are shown in Table 1 and Table 2: Table 1: Samples 1-3 with different dosages of coating powder and polishing liquid and different coating parameters Table 2: Samples 4-6 different dosages of coating powder and polishing liquid and different coating parameters The dosages of coating powder were 8.24 kg, 8.60 kg, 8.60 kg, 8.60 kg, and 8.60 kg, respectively, and the dosages of purified water were 57.68 kg, 60.20 kg, 60.20 kg, 60.20 kg, 60.20 kg, and 60.20 kg, respectively, to prepare coating solutions with a concentration of 12.5%. The coating solutions were stirred for 60 minutes.

[0052] The amount of polishing powder used was 0.48 kg, and the amount of purified water used was 5.52 kg, to prepare a polishing solution with a concentration of 8.0%. The polishing solution was stirred for 30 minutes.

[0053] The maximum amount of vegetarian pills in each pot is 124.00kg and the minimum is 77.56kg.

[0054] The maximum value of the coating hot air temperature was 110.2℃ and the minimum value was 103.6℃.

[0055] The maximum exhaust temperature of coating was 65.4℃ and the minimum was 59.5℃.

[0056] The maximum temperature of the tablet coating bed was 43.2°C and the minimum temperature was 38.7°C.

[0057] The distance between the spray gun and the tablet bed is 20 cm.

[0058] The coating speed is 6r / m at the maximum and 5r / m at the minimum.

[0059] The maximum value of coating liquid spraying time is 165min and the minimum value is 110min.

[0060] The total amount of coating liquid used was 65.55kg, 65.30kg, 68.00kg, 67.80kg, 65.70kg, and 66.15kg, respectively. Calculations indicate that 0.27kg, 0.27kg, 0.28kg, 0.27kg, 0.28kg, and 0.28kg of coating liquid were used per kg of vegetarian pills, respectively. Calculations indicate that the actual amount of coating powder used was 8.19kg, 8.16kg, 8.50kg, 8.48kg, 8.21kg, and 8.27kg, respectively. Calculations indicate that 3.42%, 3.43%, 3.44%, 3.44%, 3.44%, and 3.44% of coating powder were used per kg of vegetarian pills, respectively.

[0061] The maximum value of the polishing hot air temperature is 102.1℃ and the minimum value is 100.1℃.

[0062] The maximum polishing exhaust temperature is 62.0℃ and the minimum is 38.4℃.

[0063] The maximum temperature of the polishing bed was 40.9°C and the minimum temperature was 38.7°C.

[0064] The distance between the spray gun and the tablet bed is 20 cm.

[0065] Polishing speed, maximum value is 7r / m, minimum value is 6r / m.

[0066] The maximum value of polishing liquid spraying time is 32 minutes and the minimum value is 25 minutes.

[0067] The total amount of polishing liquid used was 6.00kg, 5.95kg, 5.68kg, 6.00kg, 6.00kg, and 6.00kg, respectively. According to calculations, the polishing liquid used per kg of raw pills was 0.025kg, 0.025kg, 0.023kg, 0.024kg, 0.025kg, and 0.025kg, respectively. According to calculations, the actual amount of polishing powder used was 0.48kg, 0.476kg, 0.45kg, 0.48kg, 0.48kg, and 0.48kg, respectively. According to calculations, the polishing powder used per kg of raw pills was 0.20%, 0.20%, 0.18%, 0.19%, 0.20%, and 0.20%, respectively.

[0068] The weight difference of each batch of coated pills was tested, and the test results met the quality standard requirement of "2.7g / 10 pills ± 7%, i.e. 2.511~2.889g / 10 pills".

[0069] The moisture content of each batch of polished pellets was tested, and the test results met the quality standard requirement of "3.0% to 7.0%".

[0070] The dissolution time of each pot of polishing pills was tested, and the test results met the quality standard requirement of "20 to 100 minutes".

[0071] According to calculations, the weight gains of film coating were 3.51%, 3.47%, 3.43%, 3.57%, 3.54% and 2.79% respectively.

[0072] 2 Comparison of the effects of Fuke Zaizaowan film-coated pills and Fuke Zaizaowan sugar-coated pills 2.1 Traditional preparation process of Fuke Zaizaowan sugar-coated pills Prescription: It consists of 42 medicinal ingredients: angelica sinensis with wine, cyperus rotundus with vinegar, white peony root, rehmannia root, donkey-hide gelatin, poria, codonopsis pilosula, astragalus root, yam, atractylodes macrocephala, glossy privet fruit with wine, tortoise shell (fried with vinegar), cornus officinalis, dipsaccharin, eucommia bark with salt, cistanche deserticola, raspberry, antler frost, ligusticum chuanxiong, salvia miltiorrhiza, achyranthes bidentata, motherwort, yanhusuo, panax notoginseng (fried with oil), mugwort leaf (fried with vinegar), fennel, ligusticum chuanxiong, cuttlebone, sanguisorba officinalis (fried with wine), alpinia oxyphylla, oriental medicine, lotus leaf (fried with vinegar), gentiana macrophylla, rehmannia root bark, iris pulcherrima, toon bark, amber, scutellaria baicalensis with wine, jujube seed, processed polygala tenuifolia, tangerine peel, and licorice.

[0073] Preparation: First, decoct Astragalus, Eucommia ulmoides, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata, and Lycium bark in water twice for 2 hours each time. Combine the decoctions, filter, and concentrate the filtrate. Dissolve donkey-hide gelatin in an appropriate amount of water and combine with the concentrated solution to a clear paste with a relative density of 1.10 (80°C). Grind the remaining 33 ingredients, including Angelica sinensis, into a fine powder, sieve, and mix thoroughly. Use the clear paste to make pills, resulting in 1000g of concentrated pills. Dry at 60-80°C, coat with sugar, and polish.

[0074] Specific operation method: Extraction: Add 5 times the amount of purified water as the amount of donkey-hide gelatin to a double-layered kettle. Bring the water to a boil, then add the donkey-hide gelatin to the boiling water. Continue heating and stirring until the gelatin is completely dissolved. Place the purified ingredients, including the astragalus root (clean), into the extraction tank. Add 8 times the amount of drinking water to the first batch of purified ingredients and decoct for 2 hours. Collect the liquid, then add water to the residue and continue decoction. Add 5 times the amount of drinking water to the second batch of purified ingredients and proceed in the same manner. After extraction, transfer the liquid to a concentrator and concentrate until all the liquid from the second decoction has entered the concentrator. Add dissolved donkey-hide gelatin through the paste collection pipe and concentrate to a relative density of approximately 1.10 (approximately 80°C). Transfer the concentrated liquid to the paste collection chamber via a pipe. Collect the filtered clear paste in a clean container in the collection chamber. This is the Fuke Zaizao Pill extract. Seal the container with a lid, let cool, and set aside.

[0075] Crushing: Pour 33 kinds of clean materials including wine angelica into the material hopper, mix them appropriately, put them into a clean baking tray, load them onto a drying cart, and push them into a multifunctional Chinese patent medicine sterilizer, and dry them at 110℃ for 20 minutes. Push the once dried clean materials into a hot air circulation oven and dry them at 80℃ until the moisture content is ≤8.0%. Add the dried clean materials into the crushing unit and crush them into fine powder. Pour the crushed powder into the powder sifter and sieve it. Pour it into the two-dimensional motion mixer and mix it for 80 minutes. Obtain the mixed powder of gynecological regeneration pills. Seal and set aside. Pour the mixed powder of gynecological regeneration pills into the two-dimensional motion mixer and mix it for 25 minutes. Obtain the total mixed powder of gynecological regeneration pills. Seal and set aside Pill preparation: Dissolve sucrose in a mixture of 2.5:1 in a jacketed kettle to obtain sucrose syrup. Mix the Fuke Zaizao Pill extract, the Fuke Zaizao Pill mixed powder, and the sucrose syrup for 20-40 minutes, and refine the mixture 3-4 times to produce wet pills weighing 3.4-3.7g / 10 pills. Dry the pellets at 60-80°C using a pellet dryer until the moisture content is within the range of 3.0%-6.0%, and the weight difference is controlled within 2.6g / 10 pills ± 7% (2.418-2.782g / 10 pills). This yields the Fuke Zaizao Pills.

[0076] Sugar coating: Isolation layer: Preparation of Hydroxypropyl Methylcellulose Solution: According to the ratio of Hydroxypropyl Methylcellulose to Water (1:13), weigh Hydroxypropyl Methylcellulose (0.10% to 0.20% of the amount of the pellets), add it to water, mix and stir evenly, and set aside.

[0077] Isolation layer coating: Weigh the Fuke Zaizao Pills and place them in a coating machine. Spray the prepared hydroxypropyl methylcellulose solution evenly into each pot and set aside.

[0078] Pigment preparation: According to the ratio of carmine and tartrazine (4:1.1), weigh carmine and tartrazine and add them to a little purified water, stir and mix until they are completely dissolved, then set aside.

[0079] Preparation of sugar coating layer glue syrup: according to the ratio of sucrose: water: gelatin (10:7.5:1), soak the gelatin in purified water, heat it in a double-layer pot to dissolve the gelatin completely, then add sucrose and heat it to dissolve the sucrose completely, and set aside.

[0080] Preparation of sugar coating powder mixture: According to the ratio of talcum powder to corn starch (3:1), weigh talcum powder and corn starch, mix well and set aside.

[0081] Preparation of sugar coating slurry: According to the ratio of sugar coating glue syrup and sugar coating mixed powder (3:1), weigh the sugar coating mixed powder, sugar coating glue syrup and 1 / 2 pigment solution, put them into a stainless steel stirring bucket and mix them evenly.

[0082] Preparation of color coating layer gelatin syrup: according to the ratio of sucrose: water: gelatin (2:1:0.05), soak the gelatin in purified water, heat it in a double-layer pot to dissolve the gelatin completely, then add sucrose and heat it to dissolve the sucrose completely, and set aside.

[0083] Preparation of color coating layer syrup: Place the color coating layer gum syrup and 1 / 2 pigment solution in a stainless steel mixing bucket and mix evenly.

[0084] Sugar coating: Place the gynecological regeneration pills wrapped with the isolation layer into a stainless steel sugar coating machine, add the prepared sugar coating slurry, blow hot air, and operate in batches.

[0085] Color coating layer: Take the color coating layer gum syrup, add the color coating layer gum syrup to each pot, blow with cold air, for 10 to 25 minutes, and operate in batches.

[0086] Polishing layer coating: Take the color syrup for the color coating layer and add it to each pot. Cover the pot and stir for a few minutes. Then add the paraffin wax. When the pills are slightly shiny, cover the pot and blow with cold air until the pills are round, smooth, delicate, and shiny. Then add the paraffin wax and dimethicone. Turn on the air supply and blow with cold air until the paraffin wax and dimethicone on the pills are dissolved. This is the result of the Fuke Zaizao Pills sugar-coated pills.

[0087] Six samples were prepared using the traditional preparation process of Fuke Zaizao Pills sugar-coated pills, and their effects were compared with those of Fuke Zaizao Pills film-coated pills. The comparative effects of the prepared Fuke Zaizao Pills film-coated pills and the traditional Fuke Zaizao Pills sugar-coated pills are shown in Table 3: Content determination method: Each 1g of this product contains white peony root and paeoniflorin (C 23 H 28 O 11 ) shall not be less than 0.50mg.

[0088] How to do it: Chromatographic conditions and system suitability test: Use cyano-bonded silica gel as the filler; methanol-water (11:89) as the mobile phase; and a detection wavelength of 230 nm. The theoretical plate number calculated based on the paeoniflorin peak should be no less than 4000.

[0089] Preparation of reference solution: Take 10 mg of paeoniflorin reference substance, accurately weigh it, place it in a 20 ml volumetric flask, add methanol to dissolve and dilute to the scale, shake well, accurately measure 1 ml, transfer it to a 20 ml volumetric flask, add methanol to the scale, shake well, and the reference solution is obtained.

[0090] Preparation of test solution: Take an appropriate amount of this product (remove the sugar coating for sugar-coated pills and no need to remove the film-coated pills), grind finely, take 1g, accurately weigh, place in a stoppered conical flask, accurately add 25ml of 50% methanol solution, stopper, weigh the weight, ultrasonically treat (power 250W, frequency 35kHz) for 1 hour, let cool, weigh the weight again, make up the lost weight with 50% methanol solution, shake well, filter, accurately measure 10ml of the filtrate, place in a water bath and evaporate to about 0.5ml, then dissolve with methanol, transfer to a 10ml volumetric flask, add methanol to the scale, shake well, filter, and take the filtrate to obtain the test solution.

[0091] Table 3: Comparative effect test structure of Fuke Zaizao Wan film-coated pills and Fuke Zaizao Wan sugar-coated pills in conclusion: 1. The use of large amounts of sugar-coated excipients can increase the weight of the pills, and patients will take a large amount of excipients that are irrelevant to the drug ingredients.

[0092] 2. Since the sugar coating contains sucrose and talcum powder, middle-aged and elderly people and diabetic patients should not take it for a long time.

[0093] 3. The sugar coating layer is unstable and it is easy to have quality problems such as pill cracking, moisture absorption, and discoloration.

[0094] 4. The sugar coating process is complicated and the coating time is long.

[0095] 5. Due to the excessive number of coating layers, the drug effect is slow to be exerted; 6. Fuke Zaizao Wan film-coated pills and Fuke Zaizao Wan sugar-coated pills were tested separately, and the test parameters (moisture content, dissolution time, and assay) were compared. It was clearly shown that the moisture content, dissolution time, and assay of Fuke Zaizao Wan film-coated pills were more stable than those of Fuke Zaizao Wan sugar-coated pills.

[0096] In summary, the coating method for the gynecological regeneration pills prepared by the present invention is not only moisture-proof, light-proof, odor-masking, and wear-resistant, but also prevents pill cracking, flower spots, and mold spots, and is easy to disintegrate, significantly improving the drug's dissolution rate, bioavailability, and shelf life. The film-coated pills are compact and smooth, making them easier and more convenient for children and women to swallow. They also have no restrictions on use for diabetics and those avoiding sugar, expanding their range of patients.

[0097] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A method for preparing film-coated gynecological regeneration pills, characterized by: The medicinal active ingredients of the Fuke Zaizao Pills are calculated by weight as follows: 65.14 parts of wine-soaked angelica, 66.14 parts of vinegar-soaked cyperus, 43.43 parts of white peony root, 21.71 parts of prepared rehmannia root, 10.86 parts of donkey-hide gelatin, 65.14 parts of poria, 21.71 parts of codonopsis pilosula, 21.71 parts of astragalus, 32.57 parts of yam, 16.28 parts of atractylodes, 43.43 parts of wine-soaked privet fruit, 32.57 parts of vinegar-soaked tortoise shell, 21.71 parts of cornus officinalis, 21.71 parts of dipsaci, 21.71 parts of salted eucommia, 10.86 parts of cistanche, 16.28 parts of raspberry, 5.43 parts of antler frost, 43.43 parts of ligusticum chuanxiong, and 21.71 parts of salvia miltiorrhiza. , 16.28 parts of Achyranthes bidentata, 21.71 parts of Leonurus japonicus, 16.28 parts of Corydalis yanhusuo, 5.43 parts of fried Panax notoginseng, 43.43 parts of vinegar-fried Artemisia argyi, 21.71 parts of fennel, 21.71 parts of Ligusticum chuanxiong, 32.57 parts of cuttlebone, 32.57 parts of wine-fried Sanguisorba officinalis, 10.86 parts of Alpinia oxyphylla, 21.71 parts of Alisma orientalis, 16.28 parts of vinegar-fried lotus leaf, 21.71 parts of Gentiana macrophylla, 21.71 parts of Rehmannia root bark, 43.43 parts of Bletilla striata, 32.57 parts of Toona bark, 5.43 parts of amber, 32.57 parts of wine-fried Scutellaria baicalensis, 10.86 parts of Ziziphus jujuba seeds, 16.28 parts of processed Polygala tenuifolia, 32.57 parts of dried tangerine peel, and 21.71 parts of Licorice root; The preparation method comprises the following steps: (1) Extraction and concentration: according to the prescription ratio, weigh Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Lycium bark, add water and boil twice, each time for 2 hours, combine the two decoctions, filter, and concentrate the filtrate to obtain a concentrated solution; (2) Preparation of clear paste: Add the prescribed proportion of donkey-hide gelatin into boiling water, continue heating, and stir continuously until the donkey-hide gelatin is completely dissolved to obtain a melted donkey-hide gelatin solution. Combine the melted donkey-hide gelatin solution with the concentrated solution prepared in step (1) and concentrate into a clear paste, i.e., the Fuke Zaizao Pill extract, which is set aside. (3) Grinding and mixing: After primary and secondary drying, the 33 ingredients including wine angelica root are ground into fine powder, and then mixed to obtain the mixed powder of Fuke Zaozao Pills; (4) Preparation of sucrose syrup: Take 3.5-3.6% of sucrose in the total mixed powder of Fuke Zaizao Pills, stir and dissolve sucrose and water in a weight ratio of 2-3:1 to obtain sucrose syrup; (5) Pill making: Mix the Fuke Zaizao Pill extract, the Fuke Zaizao Pill mixed powder and the sucrose syrup for 20-40 min, and refine the medicine 3-4 times to make wet pills weighing 3.4-3.7 g / 10 pills. Dry at 60-80°C until the moisture content of the pills is within the range of 3.0-6.0%, and the weight difference is controlled within 2.418-2.782 g / 10 pills. Thus, the Fuke Zaizao Pills are obtained. (6) First film coating: Divide the coating powder into 5-7 equal parts, add them into purified water in batches, stir and dissolve for 50-70 minutes to obtain a coating solution, the concentration of which is 12-13%; coat the Fuke Zaizao Wansu pills with the above coating solution for the first time, the mass ratio of the Fuke Zaizao Wansu pills to the coating solution is 1:0.25-0.30 kg, the coating solution spraying time is 100-170 minutes / pot, and the first coating is stopped after the weight gain is 1.50-3.00%, thereby obtaining film-coated pills with the first film coating; (7) Second film coating: Divide the polishing powder into 5-7 equal parts, add them into purified water in batches, stir and dissolve for 20-40 minutes to obtain a polishing liquid, the concentration of which is 7.0-9.0%; the film-coated pills that have been film-coated for the first time are coated with the above-mentioned polishing liquid for the second time, the mass ratio of the gynecological regeneration pills to the polishing liquid is 1:0.25-0.30 kg, the polishing liquid spraying time is 15-35 minutes, and the second coating is stopped after the weight gain is 2.00%-4.00%, the heating is turned off, and cold air is blown. After the pills are cooled, they are taken out to obtain the gynecological regeneration pills film-coated pills.

2. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (1), extraction and concentration are as follows: according to the prescription ratio, Astragalus membranaceus, Eucommia bark, Rehmannia root, Dipsacus root, Gentiana macrophylla, Cistanche deserticola, Achyranthes bidentata and Cortex Lycii are weighed and decocted twice with water, the first time decocting with 8 times the amount of the net material for 2 hours, filtering and collecting the medicinal liquid; adding water to the medicinal residue and continuing to decoct, the second time decocting with 5 times the amount of the net material for 2 hours, filtering and collecting the medicinal liquid, discarding the medicinal residue, combining the two decoctions, filtering, and concentrating the filtrate to obtain a concentrated solution.

3. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (2), a clear paste is prepared by adding 5 times the amount of boiling water to the prescribed proportion of donkey-hide gelatin, and continuing to heat and stir until the donkey-hide gelatin is completely dissolved to obtain a dissolved donkey-hide gelatin liquid. The dissolved donkey-hide gelatin liquid is combined with the concentrated liquid prepared in step (1) and concentrated into a clear paste, i.e., the Fuke Zaizao Pill extract is obtained and set aside.

4. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (3), the pulverization and mixing is as follows: the 33 clean ingredients such as the wine angelica are dried at 110°C for 20 minutes and at 80°C for 6 hours, and then pulverized into fine powder, and then mixed to obtain the gynecological regeneration pills mixed powder.

5. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (4), sucrose syrup is prepared by taking 3.57% sucrose from the total mixed powder of the gynecological regeneration pills, stirring and dissolving the sucrose and water in a weight ratio of 2.5:1 to obtain sucrose syrup.

6. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (5), the pills are prepared by mixing the Fuke Zaizao Pill extract, the Fuke Zaizao Pill mixed powder and the sucrose syrup for 30 minutes, refining the medicine for 3 to 4 times to prepare wet pills weighing 3.4 to 3.7 g / 10 pills, and drying at 70°C until the moisture content of the pills is within the range of 3.0 to 6.0%, and the weight difference is controlled within the range of 2.418 to 2.782 g / 10 pills, thereby obtaining the Fuke Zaizao Pills.

7. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In step (6), the main component of the coating powder is hydroxypropyl methylcellulose, and the concentration of the coating solution is 12.5%.

8. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In step (6), the hot air temperature of the first film coating is 100-115°C, the exhaust air temperature is 57-67°C, the tablet bed temperature is controlled at 38-44°C, the distance from the spray gun to the tablet bed is 20 cm, and the rotation speed is 4-9 r / m.

9. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In step (7), the main component of the polishing powder is sodium carboxymethyl cellulose, and the concentration of the polishing liquid is 8.0%.

10. The method for preparing the film-coated pills of Fuke Zaizaowan according to claim 1, characterized in that: In the step (7), the hot air temperature in the second film coating is 95-105°C, the exhaust air temperature is 53-63°C, the tablet bed temperature is controlled at 36-42°C, the distance from the spray gun to the tablet bed is 20 cm, and the rotation speed is 4-9 r / m.

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