Mechanical production method of auxiliary-material-free traditional Chinese medicine temporary prescription watered pills

Abstract

The invention provides a mechanical production method of an auxiliary-material-free traditional Chinese medicine temporary prescription watered pill, which comprises the following steps of: weighing various medicines according to a prescription, mixing, crushing and sieving to obtain a compound powder mixture; determining the water adding amount required for pelleting according to the compound powder water adding amount prediction model; and mixing the compound powder mixture with required water to prepare a soft material, rounding the soft material to obtain wet pills, and drying the wet pills to obtain the pills. According to the method, accurate process prediction can be performed on the prescription of any temporary traditional Chinese medicine full-powder watered pill through the model, the qualified temporary traditional Chinese medicine full-powder watered pill can be prepared only with water without adding any adhesive, the limitation that the existing temporary traditional Chinese medicine full-powder watered pill needs to be added with the adhesive is broken through, and the production efficiency is improved. Prediction of the preparation process of the traditional Chinese medicine temporary prescription watered pills with water as the adhesive is achieved, and the defects of large dosage, long dissolution time limit and the like caused by addition of the adhesive are overcome.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine prescription preparations, and in particular to a mechanical production method for zero-excipient traditional Chinese medicine prescription water pills. Background Art

[0002] Traditional Chinese medicine prescription preparation technology has the characteristics of different prescription flavors, small production batches, the need to complete all processes temporarily, one-time molding without pre-experiment, and short storage time. At present, the dosage forms suitable for prescription preparation technology include traditional dosage forms such as pills, powders, and plasters. Among them, pills have become one of the most widely used prescription dosage forms in clinical applications. For prescription full-powder water pills, the concentration and dosage of the binder used in preparing the soft material determine the forming quality of the pills, and the concentration and dosage of the binder depend on the flavor composition of the entire prescription. How to predict the concentration and dosage of the binder used in pill making according to the prescription flavor composition is the most important link in the whole process. Patent CN111728873B discloses a mechanical production method for full-powder water pills of traditional Chinese medicine prescription preparations, which can quickly and accurately predict the concentration and dosage of the binder required for full-powder water pills of traditional Chinese medicine prescription preparations. However, this patent realizes pill making by adding binder excipients, and has defects such as large dosage and long dissolution time limit, and still needs further improvement. Summary of the Invention

[0003] The purpose of the present invention is to solve the above problems and provide a mechanical production method for zero-excipient traditional Chinese medicine prescription water pills, and provide a method for quickly and accurately predicting the water absorption rate of the powder of traditional Chinese medicine prescription and predicting the amount of water required for full-powder water pills of traditional Chinese medicine prescription preparations, which can accurately guide the mechanical production of full-powder water pills of zero-excipient traditional Chinese medicine prescription preparations.

[0004] The purpose of the present invention is achieved through the following technical solutions:

[0005] A mechanical production method for zero-excipient traditional Chinese medicine prescription water pills includes the following steps:

[0006] (1) Weigh each flavor of medicine according to the prescription, mix, crush, and sieve to obtain a compound powder mixture;

[0007] (2) Determine the amount of water to be added for pill making according to the compound powder water addition prediction model;

[0008] (3) Mix the compound powder mixture with the required amount of water, prepare to obtain a soft material, roll it into a round shape to obtain wet pills, and obtain pills after drying;

[0009] The compound powder water addition prediction model in step (2) is:

[0010] Y = 142.39 - 1.94X D + 191.37X E + 0.033X A2 -0.019X C 2 -0.030X D 2 -1.97X E 2 +0.0

[0011] 098X FP 2 -1.99X A X E -0.045X A X FP -0.064X B X C -1.98X B X E +0.023X C X D -1.86X C X E -1.91X D X E +0.014X D X FP +0.046X E X FP ;

[0012] X FP = 0.8812X FT + 5.3325;

[0013] In the formula,

[0014] Y represents the amount of water added, g water / 100 g compound powder;

[0015] X A 、X B 、X C 、X D and X E respectively represent the mass percentages of powdery materials, fibrous materials, sugary materials, oily materials and brittle materials in the whole prescription, %;

[0016] X FP represents the predicted water absorption rate of the compound powder, %;

[0017] X FT represents the theoretical water absorption rate of the compound powder, %.

[0018] Furthermore, the sieving in step (1) is sieving through a No. 5 sieve.

[0019] Furthermore, the powdery materials, fibrous materials, sugary materials, oily materials and brittle materials in step (2) are classified for the prescription flavors based on a semantic prediction model for material classification or material classification rules.

[0020] Further, the water absorption rate X of the single Chinese medicine powder in step (2) FP is determined by the water absorption rate database of the single Chinese medicine powder, and is specifically obtained by the measurement method of the water absorption rate of the single Chinese medicine powder.

[0021] Further, the temperature of the water added in step (3) is controlled at 60-100°C, preferably 80-100°C.

[0022] Further, after the soft material is prepared in step (3), it is extruded and rounded in an extrusion and rounding machine to obtain wet pills.

[0023] Further, it is dried in an oven in step (3), the temperature is 60-80°C, and the time is 2-6h. Preferably, the temperature is 70°C and the time is 4h.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] Compared with Patent CN111728873B, the present invention has made a breakthrough, overcome the problem of adding binder excipients in this patent, and realized a zero-excipient preparation formula that can make pills only with water. The pills prepared by the present invention dissolve and disperse faster and better, greatly reducing the dissolution rate of making pills by adding binders. The present invention proposes to replace the addition of excipients in the existing traditional Chinese medicine prescription powder water pills with water, overcomes the defects such as large dosage and long dissolution time limit caused by adding binders, provides a method for quickly and accurately predicting the water absorption rate of the traditional Chinese medicine prescription powder and predicting the amount of water required for the traditional Chinese medicine prescription powder water pills, and further guides the mechanical production of the zero-excipient traditional Chinese medicine prescription powder water pills. Specific embodiments

[0026] The present invention will be described in detail below with reference to specific embodiments, but it is by no means a limitation to the present invention.

[0027] The present invention first established a measurement method for the water absorption rate of single Chinese medicine powder (X Fi , i = A, B, C..., representing different single Chinese medicines) and the actual water absorption rate of the compound powder (X F ). The specific measurement method is as follows: Weigh 1.00 g of single Chinese medicine or compound powder, place it in an expansion degree measuring tube, add 25 mL of water at 80°C under room temperature conditions, tightly seal it, shake vigorously until the powder is evenly suspended, let it stand for 10 min, place a filter paper in a Buchner funnel and moisten it, pour the suspension in the expansion degree measuring tube into the Buchner funnel and filter it until there is no obvious flowing liquid on the surface of the powder and the funnel does not drip water within 5 s, and then weigh it.

[0028] X Fi and X FThe calculation is shown in formula (1), where m1 is the mass of single-herb Chinese medicine or compound powder, in g; m2 is the mass of the filter paper after being wetted and drained until no water drips from the funnel within 5 s, in g; m3 is the mass of the filter paper and the medicinal powder after suction filtration, in g.

[0029] X Fi or X F =(m3 - m2 - m1)×100% (1)

[0030] The theoretical water absorption rate of compound powder (X FT ): The result of the sum of the products of the water absorption rates of single-herb Chinese medicine powders in the compound (X FA , X FB , X FC ...) and the weight percentages of the herbs. The weight percentages of each single-herb Chinese medicine powder in the prescription are respectively denoted as A%, B%, C%... The calculation formula for the theoretical water absorption rate of compound powder is shown in (2).

[0031] X FT =X FA ×A% + X FB ×B% + X FC ×C% +... (2)

[0032] Construct a database of the water absorption rates of single-herb Chinese medicine powders. According to the additivity of the physical properties of Chinese medicine powders, construct a prediction model for the water addition amount of compound powder. The equation for the predicted water absorption rate of compound powder (X FP ) is: X FP =0.8812X FT +5.3325 (r = 0.91), where X FT represents the theoretical water absorption rate of compound powder (%), and X FP represents the predicted water absorption rate of compound powder (%).

[0033] Use Data Processing System (DPS) 7.05 software to analyze the pill-making results of the model prescriptions. With the material classification (X A powdery material; X B fibrous material; X C sugary material; X D oily material; X E brittle material) and the predicted water absorption rate of compound powder (X FP ) as independent variables and the water addition amount (Y) as the dependent variable, perform a quadratic polynomial stepwise backward regression. Finally, the obtained prediction equation for the water addition amount (the predicted water absorption rate model of compound powder) is as follows:

[0034] Y = 142.39 - 1.94X D +191.37X E +0.033X A2 -0.019X C 2 -0.030X D 2 -1.97X E 2 +0.00

[0035] 98X FP 2 -1.99X A X E -0.045X A X FP -0.064X B X C -1.98X B X E +0.023X C X D -1.86X C X E -1.91X D X E +0.014X D X FP +0.046X E X FP (R 2 =0.96)

[0036] The regression model is extremely significant (P = 0.0001 < 0.001), and the fitting of the equation is generally good.

[0037]

Verification of the Deviation between the Predicted Value and the Actual Value of the Water Addition Amount

[0038] According to the above regression equation, the predicted value of the water addition amount and the percentage of the predicted deviation are calculated. The results are shown in Table 1. The results show that the percentage of the deviation between the predicted value and the actual value of the water addition amount in the model prescription is less than 15%. The predicted water addition amount by the model equation is very close to the actual water addition amount, indicating that the prediction ability of this model is good and can be used for predicting the water addition amount in the process of preparing traditional Chinese medicine temporary water pills with water as the binder.

[0039] Table 1 Water Addition Amount Predicted by the Regression Equation for the Model Prescription

[0040]

[0041]

[0042]

Application of the Prediction Model for the Water Addition Amount of Temporary Water Pills

[0043] Verify the classification and water absorption rate of the cut crude drugs in the verification prescription

[0044] For the semantic prediction model of the classification of cut medicine materials established according to the present invention, 20 prescriptions including 14 ready-made prescriptions and 6 ad hoc prescriptions specified in the pharmacopoeia for powder-based medicines are selected as verification prescriptions. The traditional Chinese medicines involved in the prescriptions are classified by materials, and the proportion of the prescription materials is calculated. The water absorption rate of 20 verification prescriptions is calculated according to the compound powder water addition prediction model, and the water addition amount is calculated through the compound powder water addition prediction model. The results of the material proportion, powder predicted water absorption rate and predicted water addition amount of 20 verification prescriptions are shown in Table 2.

[0045] Table 2 Classification of cut medicine materials and powder water absorption rate of verification prescriptions

[0046]

[0047]

[0048] Note: X A Proportion of powdery materials; X B Proportion of fibrous materials; X C Proportion of sugary materials; X D Proportion of oily materials; X E Proportion of brittle materials; X FP Theoretical water absorption rate of compound powder; Predicted water addition amount of M2.

[0049] Taking Ad Hoc Prescription 1 to Ad Hoc Prescription 6 as examples, the present invention will be further described.

[0050] Example 1

[0051] A mechanical production method for zero-excipient traditional Chinese medicine ad hoc water pills is as follows:

[0052] The prescription of the traditional Chinese medicine ad hoc preparation is as follows: Astragalus membranaceus 30g, Ligusticum chuanxiong 24g, Angelica sinensis 24g, stir-fried Atractylodes macrocephala 30g, Achyranthes bidentata 30g, Paeonia lactiflora 24g, Saposhnikovia divaricata 24g, Cinnamomum cassia 24g, Notopterygium incisum 24g, Panax ginseng 9g, Eucommia ulmoides Oliv. var. wupinensis 12g, Viscum coloratum 12g, Heracleum hemsleyanum 12g, Gentiana macrophylla 9g (total prescription: 288g)

[0053] Step 1 After weighing each medicine according to the prescription of the ad hoc preparation and mixing them, they are pulverized to pass through a No. 5 sieve.

[0054] Step 2 Based on the single traditional Chinese medicine powder water absorption rate database, according to the compound powder water addition prediction model and the semantic prediction model based on the classification of cut medicine materials, the mass percentage of each type of material in the whole prescription and the predicted water absorption rate of the compound powder are calculated, which are: powdery materials 20.92%, fibrous materials 48.72%, sugary materials 18.57%, oily materials 10.63%, brittle materials 1.16%, predicted water absorption rate of compound powder 64.08%, that is, X A 、X B 、X C 、X D, X E and X FP They are 20.92, 48.72, 18.57, 10.63, 1.16, and 64.08 respectively. Substitute the above calculation results into the water addition prediction model for traditional Chinese medicine prescription water pills with water as the binder to obtain the prediction result that the water addition for 100 g of fine powder is 61 g;

[0055] Step 3-1: Take 200 g of fine powder and mix it with 122 g of hot water at 80 °C to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-1.

[0056] Step 3-2: Take another 200 g of fine powder and mix it with 110 g of hot water at 80 °C to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-2.

[0057] Step 3-3: Take another 200 g of fine powder and mix it with 160 g of hot water at 80 °C to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-3.

[0058] Step 3-4: Take another 200 g of fine powder and mix it with 122 g of hot water at 60 °C to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-4.

[0059] Step 3-5: Take another 200 g of fine powder and mix it with 122 g of hot water at 100 °C to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-5.

[0060] Preparation method of pills 1-6: Take another 200 g of fine powder, and prepare pills by the method of invention patent CN111728873B. Add 56.7 g of 20 wt% HPMC E5 to prepare a soft material. Extrude and round it in an extrusion spheronizer to obtain wet pills, and dry them in an oven (70 °C, 4 h) to obtain pills 1-6.

[0061] Calculate the extrusion process yield (I1) and pill making qualification rate (I2) of the prepared pills, and measure the dissolution time limit (T) and friability of the pills. The specific method is as follows, and the results are shown in Table 3

[0062] Extrusion process yield and qualified rate of pill making: The extrusion process yield can evaluate the loss degree of the soft material during the extrusion and spheronization process. The higher I1 is, the smaller the loss of the soft material, indicating that the soft material is suitable for pill making, as shown in formula (3); The qualified rate of pill making is an important index to evaluate the quality of the overall preparation process for the formation of pills. The higher I2 is, the better the formation quality of the pills, as shown in formula (4); Where M1 is the mass of traditional Chinese medicine powder, in g; M2 is the amount of water at 80 °C, in g; M3 is the mass of wet pills, in g; M4 is the mass of dry pills, in g; M5 is the mass of screened pills, in g.

[0063]

[0064] Dissolution time limit (T): The same as the disintegration time limit inspection method for pills in Part IV of the Chinese Pharmacopoeia (2020 Edition). Take 6 pills of the test sample, select a hanging basket with an appropriate aperture sieve mesh (use a sieve mesh with an aperture of about 2.0 mm for those above 3.5 mm), and conduct the inspection with a baffle according to the disintegration time limit inspection method. During the operation, if the test sample adheres to the baffle and hinders the inspection, another 6 pills of the test sample should be taken and inspected without a baffle. Record the duration for all the pills to completely dissolve, measure 3 times in parallel, and take the average value, which is the dissolution time limit of the pills.

[0065] Friability: The same as the friability inspection method for tablets in the Chinese Pharmacopoeia (2020 Edition). For tablets with a tablet weight of 0.65 g or less, take several tablets to make the total weight approximately 6.5 g; for tablets with a tablet weight greater than 0.65 g, take 10 tablets. Use a hair dryer to blow off the powder shed from the tablets, accurately weigh (G1), place them in a cylinder, and rotate 100 times. Take out, remove the powder in the same way, accurately weigh (G2), calculate the friability, as shown in formula (5). The weight loss shall not exceed 1%, and no broken, cracked, or pulverized tablets shall be detected. This test is generally only conducted once. If the weight loss exceeds 1%, it should be retested 2 times, and the average weight loss of the 3 times shall not exceed 1%, and no broken, cracked, or pulverized tablets shall be detected.

[0066] Friability (%) = (G1 - G2) / G1 × 100% (5)

[0067] Table 3

[0068]

[0069]

[0070] Note: I1 represents the extrusion process yield; I2 represents the qualified rate of pill making; T represents the dissolution time limit.

[0071] As can be seen from Table 3, when water is used as the binder in the present invention and the water addition amount is added according to the prediction model of traditional Chinese medicine individualized water pills, pills can be successfully prepared without using other binders (Steps 3-1, 3-4, 3-5). This indicates that the prediction model of traditional Chinese medicine individualized water pills of the present invention is accurate and can use water as the binder to prepare pills. When the water addition amount is too small or too large (Steps 3-2, 3-3), pills cannot be successfully prepared. At the same time, the water temperature has a certain influence on the pill-making process. At a higher water temperature (80-100 °C), pill-making is smoother, the pill grains are round and smooth, the extrusion process yield and pill-making qualification rate are higher, and the dissolution time limit is shorter. When the water temperature is too low (such as below 60 °C), the pill strips are easy to break and the pill-making qualification rate decreases.

[0072] Example 2

[0073] A mechanical production method for traditional Chinese medicine individualized water pills without excipients, the steps of which are basically the same as those in Example 1, except for the prescription of the individualized preparation, the proportion of various materials in the whole prescription, the predicted water absorption rate of the prescription powder and the predicted results of the water addition amount and the final product, which are as follows:

[0074] Prescription: Platycodon grandiflorum 8g, Eriobotrya japonica 12g, Lonicera japonica 12g, Hedyotis diffusa 24g, Atractylodes macrocephala 12g, Prunus armeniaca var. ansu 8g, Citrus reticulata Blanco 4g, Scutellaria baicalensis 8g, Forsythia suspensa 12g, Imperata cylindrica var. major 24g (total prescription: 124g)

[0075] (1) The mass percentages of various materials in the whole prescription and the predicted water absorption rate of the compound powder are as follows: powdery materials 10.59%, fibrous materials 54.92%, sugary materials 11.15%, oily materials 11.48%, brittle materials 11.86% and the predicted water absorption rate of the compound powder 71.43% i.e. X A 、X B 、X C 、X D 、X E and X FP are 10.59, 54.92, 11.15, 11.48, 11.86 and 71.43 respectively.

[0076] (2) The predicted water addition amount of the traditional Chinese medicine individualized water pills with water as the binder is 106g (80 °C) by the water addition amount prediction model;

[0077] (3) Final product: Pills can be successfully prepared, the extrusion yield is 79.6%, the pill-making qualification rate is 98.9%, the dissolution time limit is 11.71±0.05 min, and the friability is 0.01%.

[0078] Example 3

[0079] A mechanical production method for Chinese medicine water pills with zero auxiliary materials, the steps of which are basically the same as those of Example 1, except for the prescription of the prescription preparation, the proportion of various materials in the entire prescription, the predicted water absorption rate of the prescription powder and the predicted results of the amount of water added, and the final product, which are specifically as follows:

[0080] Prescription: Chuanxiong 60g, Poria 60g, Red Peony Root 60g, Atractylodes 40g, Rehmannia Glutinosa 80g, Paeonia Suffruticosa 40g, Licorice 20g, Safflower 20g, Coix Seed 120g, Angelica 60g, Peach Kernel 40g (Total Prescription: 600g)

[0081] (1) The mass percentage of each material in the entire prescription and the predicted water absorption rate of the compound powder are: powdery material 46.71%, fiber material 19.42%, sugar material 19.47%, oily material 11.99%, brittle material 2.41% and the predicted water absorption rate of the compound powder is 77.11%, i.e., X A , X B , X C , X D , X E and X FP They are 46.71, 19.42, 19.47, 11.99, 2.41 and 77.11 respectively.

[0082] (2) The water addition prediction model for the traditional Chinese medicine Linfang Shuiwan, which uses water as a binder, predicts that the water addition amount is 373 g (80 °C);

[0083] (3) Final product: The pellets can be made smoothly, with an extrusion yield of 91.0%, a pellet qualification rate of 98.7%, a dissolution time of 7.04±0.08min, and a friability of 0.04%.

[0084] Example 4

[0085] A mechanical production method for Chinese medicine water pills with zero auxiliary materials, the steps of which are basically the same as those of Example 1, except for the prescription of the prescription preparation, the proportion of various materials in the entire prescription, the predicted water absorption rate of the prescription powder and the predicted results of the amount of water added, and the final product, which are specifically as follows:

[0086] Prescription: Astragalus 240g, Atractylodes 120g, Codonopsis 120g, Ephedra 90g, Acorus 90g, Curcuma 90g, Polygala 60g, Bupleurum 90g, Chuanxiong 90g, Peach Kernel 60g, Hedyotis Diffusa 120g (Total prescription: 1170g)

[0087] (1) The mass percentage of each material in the entire prescription and the predicted water absorption rate of the compound powder are: powdery material 18.51%, fiber material 50.55%, sugar material 20.49%, oily material 10.45%, brittle material 0.00% and the predicted water absorption rate of the compound powder is 74.48%, i.e. XA and X B and X C and X D and X E and X FP are 18.51, 50.55, 20.49, 10.45, 0.00, and 74.48 respectively.

[0088] (2) The predicted water addition amount of the traditional Chinese medicine prescription water pills with water as the binder is 674 g (80 °C) by the water addition prediction model;

[0089] (3) Final product: Can make pills smoothly, the extrusion yield is 94.0%, the pill-making qualification rate is 98.6%, the dissolution time limit is 6.19 ± 0.16 min, and the friability is 0.02%.

[0090] Example 5

[0091] A mechanical production method for traditional Chinese medicine prescription water pills without excipients, the steps of which are basically the same as those in Example 1, the differences lie in the prescription of the prescription preparation, the proportion of various materials in the whole prescription, the predicted water absorption rate of the prescription powder, the predicted results of the water addition amount, and the final product, which are specifically as follows:

[0092] Prescription: 60 g of Rhizoma Pinelliae Praeparatum, 60 g of Radix Paeoniae Alba, 60 g of Fructus Aurantii Immaturus Praeparatus, 60 g of Fructus Citri Sarcodactylis, 90 g of Radix Pseudostellariae, 60 g of Atractylodes Macrocephala Praeparata, 120 g of Poria, 30 g of Panax Notoginseng, 90 g of Salvia Miltiorrhiza, 90 g of Cortex Albiziae (total prescription: 720 g)

[0093] (1) The mass percentages of various materials in the whole prescription and the predicted water absorption rate of the compound powder are respectively: powdery material 44.90%, fibrous material 37.24%, sugary material 13.01%, oily material 4.84%, brittle material 0.00%, and the predicted water absorption rate of the compound powder is 90.89%, i.e., X A and X B and X C and X D and X E and X FP are 44.90, 37.24, 13.01, 4.84, 0.00, and 90.89 respectively.

[0094] (2) The predicted water addition amount of the traditional Chinese medicine prescription water pills with water as the binder is 447 g (80 °C) by the water addition prediction model;

[0095] (3) Final product: Can make pills smoothly, the extrusion yield is 91.4%, the pill-making qualification rate is 97.3%, the dissolution time limit is 4.56 ± 0.87 min, and the friability is 0.01%.

[0096] Example 6

[0097] A mechanical production method for zero-excipient traditional Chinese medicine ready-made pills according to a prescription, the steps of which are basically the same as those in Example 1, except for the prescription of the ready-made preparation, the proportion of various materials in the whole prescription, the predicted water absorption rate of the prescription powder and the predicted results of the water addition amount, and the final product, which are specifically as follows:

[0098] Prescription: Prepared Aconite Root 45g, Codonopsis Pilosula 90g, Stir-fried Atractylodes Macrocephala 45g, Dried Ginger 18g, Honey-fried Licorice Root 30g, Stir-fried White Peony Root 45g, Cistanche Deserticola 30g, Stir-fried Raphanus Sativus Seed 45g (Total prescription: 348g)

[0099] (1) The mass percentages of various materials in the whole prescription and the predicted water absorption rate of the compound powder are respectively: powdery materials 23.35%, fibrous materials 17.06%, sugary materials 41.74%, oily materials 12.93%, brittle materials 4.92% and the predicted water absorption rate of the compound powder 58.42% i.e. X A 、X B 、X C 、X D 、X E and X FP are 23.35, 17.06, 41.74, 12.93, 4.92 and 58.42 respectively.

[0100] (2) The predicted water addition amount of the traditional Chinese medicine ready-made pills with water as the binder is predicted to be 175g (80°C);

[0101] (3) Final product: Can make pills smoothly, the extrusion yield is 93.6%, the pill-making qualification rate is 98.6%, the dissolution time limit is 6.77±0.21 min, and the friability is 0.02%.

[0102] The above description of the embodiments is for the convenience of those of ordinary skill in the art to understand and use the invention. It is obvious that those who are familiar with the technology in this field can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative labor. Therefore, the present invention is not limited to the above embodiments, and the improvements and modifications made by those skilled in the art without departing from the scope of the present invention according to the disclosure of the present invention should be within the protection scope of the present invention.

Claims

1. A mechanical production method for Chinese medicine Linfangshui pills with zero auxiliary materials, characterized in that: The following steps are involved: (1) Weighing each medicine according to the prescription, mixing, crushing, and sieving to obtain a compound powder mixture; (2) Determine the amount of water required for pilling based on the compound powder water addition prediction model; (3) mixing the composite powder mixture with a required amount of water to prepare a soft material, rolling into rounds to obtain wet pills, and drying to obtain pills; The prediction model of the amount of water added to the compound powder in step (2) is: Y=142.39-1.94X D +191.37X E +0.033X A 2 -0.019X C 2 -0.030X D 2 -1.97X E 2 +0.0 098X FP 2 -1.99X A X E -0.045X A X FP -0.064X B X C -1.98X B X E +0.023X C X D -1.86X C X E -1.91X D X E +0.014X D X FP +0.046X E X FP ; X FP =0.8812X FT +5.3325; In the formula, Y represents the amount of water added, g water / 100g compound powder; X A , X B , X C , X D and X E Respectively represent the mass percentage of powdery material, fiber material, sugar material, oily material and brittle material in the whole prescription, %; X FP It indicates the predicted water absorption of the compound powder, %; X FT It indicates the theoretical water absorption rate of compound powder, %.

2. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: The sieving in step (1) is through a No. 5 sieve.

3. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: In step (2), the powdery material, fiber material, sugar material, oily material and brittle material are classified according to the flavor of the prescription medicine based on a semantic prediction model of material classification or a material classification rule.

4. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: The water absorption rate of the single Chinese medicine powder in step (2) is X FP It is determined by the water absorption rate database of single Chinese medicine powder and is specifically obtained through the determination method of water absorption rate of single Chinese medicine powder.

5. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: The temperature of water added in step (3) is controlled to be 60-100°C.

6. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 5 is characterized in that: The temperature of water added in step (3) is controlled to be 80-100°C.

7. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: After the soft material is prepared in step (3), it is extruded and spheronized in an extrusion spheronizer to obtain wet pills.

8. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 1 is characterized in that: Step (3) is drying in an oven at a temperature of 60 to 80° C. for 2 to 6 hours.

9. The mechanical production method of a zero-auxiliary Chinese medicine Linfangshui pill according to claim 8 is characterized in that: Step (3) is dried in an oven at 70°C for 4 hours.

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