CN109620872B - Granules of traditional Chinese medicine composition for reducing blood fat and softening blood vessels and granulation method thereof - Google Patents
Granules of traditional Chinese medicine composition for reducing blood fat and softening blood vessels and granulation method thereof Download PDFInfo
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract
The invention discloses granules of a traditional Chinese medicine composition for reducing blood fat and softening blood vessels and a granulating method thereof, belongs to the technical field of processing of traditional Chinese medicines and natural medicines, and solves the problems of difficult forming, long production period, large loss of effective components and poor dissolubility of the preparation in the prior art. The granulation method comprises the following steps: step a: concentrating the water extract of semen Cassiae and fructus crataegi to fluid extract; step b: concentrating the alcohol extract of the lotus leaf and the prepared fleece-flower root into clear paste; step c: and (b) mixing the clear paste obtained in the step (a) and the clear paste obtained in the step (b) with sugar powder, performing combined granulation of two granules of spray granulation and swing granulation, and drying to prepare the granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels. Compared with the original granulation method, the granulation method provided by the invention has the advantages of strong operability, short production period and suitability for industrial mass production, the prepared granules have good dissolubility, the clarity of the solution is improved after dissolution, the loss of active ingredients of the granules is small, and the yield is high.
Description
Technical Field
The invention relates to the technical field of processing of traditional Chinese medicines and natural medicines, in particular to a granule of a traditional Chinese medicine composition for reducing blood fat and softening blood vessels and a granulation method thereof.
Background
The Jiangzhining granules are composed of four traditional Chinese medicines of cassia seed, lotus leaf, prepared fleece-flower root and hawthorn fruit, and have the functions of reducing blood fat and softening blood vessels. It is used clinically in strengthening coronary blood circulation, resisting arrhythmia, hyperlipemia, etc.
The original preparation process of the Jiangzhining granules adopts swing granulation, because the amount of the traditional Chinese medicine paste in the prescription is large, the granulation cannot be finished at one time, the traditional Chinese medicine paste needs to be added in several times, the technological processes of granulation, drying, crushing and then paste adding granulation are carried out for 4-5 times, and the whole preparation process is about 12-15 hours. Therefore, the original production process has the problems of difficult preparation forming, long production period, large loss of effective components and poor dissolubility.
Disclosure of Invention
Aiming at the problems that the soluble granules of the traditional Chinese medicine composition are difficult to granulate, the production period is long, and the industrialized production of the traditional Chinese medicine is greatly limited, the invention provides a granulation method combining spray granulation and swing granulation of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels.
In order to achieve the above purpose, the invention provides the following technical scheme:
a granulation method of a traditional Chinese medicine composition for reducing blood fat and softening blood vessels comprises the following raw materials in parts by weight: 25 parts of cassia seed, 75 parts of lotus leaf, 25 parts of prepared fleece-flower root and 500 parts of pitted hawthorn, and the granulation method comprises the following steps:
step a: concentrating the water extract of semen Cassiae and fructus crataegi to fluid extract;
step b: concentrating the alcohol extract of the lotus leaf and the prepared fleece-flower root into clear paste;
step c: and (b) mixing the clear paste obtained in the step (a) and the clear paste obtained in the step (b) with sugar powder, performing combined granulation of two granules of spray granulation and swing granulation, and drying to prepare the granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels.
Preferably, the relative density of the clear paste of the water extract in the step a is 1.15-1.25 at 50 ℃.
Preferably, the relative density of the ethanol extract fluid paste in the step b is 1.15-1.25 at 50 ℃.
Preferably, in the step c, the clear paste in the steps a and b is sprayed by sugar powder to obtain paste by a spray granulation method, the paste is crushed, ethanol is added, and the mixture is dried and granulated by a swing granulation method to prepare the granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels.
Preferably, the sugar powder spraying method in the step c comprises the following steps:
100 parts by weight of sugar powder is taken and put into a spray granulator, the air inlet temperature is set to be 90-120 ℃, and the sugar powder is boiled for 15 minutes; and when the air outlet temperature is 50 ℃, starting a peristaltic pump, adjusting the atomization pressure to 0.2-0.4 Mpa, spraying 55-65 parts by weight of ointment to start granulation, closing the peristaltic pump after all the ointment is sprayed, starting a drying program to continuously send hot air to dry the formed particles in a bed layer for 8-12 minutes, stopping drying when no moisture is sensed, and crushing the particles into fine powder.
Preferably, the sugar powder in step c is fine powder obtained by drying and pulverizing sucrose or granulated sugar.
Preferably, the swing granulation method in step c is specifically: putting 100 parts by weight of the fine powder after spray granulation in a groove type mixer, adding 8-12 parts by weight of 95% ethanol, stirring for 5-10 minutes, uniformly mixing, quantitatively transferring to a swing granulator, making into wet granules by using a 14-mesh sieve, drying for 40-60 minutes at the temperature of 75 +/-5 ℃, and finishing granules by using a 16-mesh sieve to obtain the granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels.
The invention also provides the blood fat reducing and blood vessel softening traditional Chinese medicine composition granules prepared by the granulation method of the blood fat reducing and blood vessel softening traditional Chinese medicine composition.
Compared with the prior art, the invention has the beneficial effects that:
the granulating method of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels provided by the invention is characterized in that the original preparation method is combined by two granulating methods of spray granulation and swing granulation which are convenient to operate, so that the feasibility and the applicability of the preparation method in production are met, and the granulating method is a feasible, effective and quality-controllable granulating method of the traditional Chinese medicine composition.
Compared with the original granulation method, the granulation method provided by the invention has the advantages that two granulation modes are combined, the operability is strong, the granulation method is suitable for industrial mass production, main process test comparison experiments prove that the combined granulation method is superior to the traditional granulation method, the granulation, drying and crushing time is saved, the production period is shortened by 50%, and the problem of operability of industrial production is solved.
The soluble traditional Chinese medicine granules prepared by the method have good dissolubility, improve the clarity of the solution after dissolution, further improve the medication compliance of patients, have uniform granularity and accurate subpackage dosage, and ensure the medication safety. In addition, the method overcomes the defects of difficult one-time forming, complex and time-consuming multiple granulation and unstable production, and the obtained granules have low loss of effective components and high yield, and compared with the prior art, the yield is improved by more than 18 percent.
Drawings
In order to more clearly illustrate the embodiments of the present application or technical solutions in the prior art, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present invention, and other drawings can be obtained by those skilled in the art according to the drawings.
FIG. 1 is a sample chromatogram provided in example 1 of the present invention;
FIG. 2 is a sample chromatogram provided in example 2 of the present invention;
FIG. 3 is a sample chromatogram provided in example 3 of the present invention;
FIG. 4 is a chromatogram of a control of examples 1-3 of the present invention;
FIG. 5 is a sample chromatogram provided in comparative example 1 of the present invention;
FIG. 6 is a sample chromatogram provided in comparative example 2 of the present invention;
FIG. 7 is a sample chromatogram provided in comparative example 3 of the present invention;
FIG. 8 is a chromatogram of a control of comparative examples 1-3 of the present invention.
Detailed Description
In order to make those skilled in the art better understand the technical solution of the present invention, the present invention will be further described in detail with reference to the following embodiments.
EXAMPLE 1 preparation of granules of the blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition of the present invention
The preparation of the Chinese medicinal composition clear paste for reducing blood fat and softening blood vessels comprises the following steps:
25 parts of semen cassiae, 75 parts of lotus leaves, 25 parts of prepared fleece-flower roots and 500 parts of hawthorn (pitted);
concentrating the water extracts of the cassia seeds and the hawthorn to clear paste with relative densities of 1.05-1.15, 1.15-1.25 and 1.25-1.30 (50 ℃) respectively by adopting the prior art;
concentrating the alcohol extract of the lotus leaf and the prepared fleece-flower root to clear paste with relative density of 1.05-1.15, 1.15-1.25 and 1.25-1.30 (50 ℃) respectively by adopting the prior art;
mixing the three kinds of fluid extract samples with relative density, which are prepared by concentrating the ethanol extract and the water extract, with the density similar to each other, stirring uniformly, and measuring the relative density of the concentration.
The observation results of the above-mentioned concentrated solution mixing selectivity experiments show that the two solutions with relative densities of 1.05-1.15 (50 ℃) are mixed, the mixed solution amount is relatively large, the operation is inconvenient, and the two solutions with relative densities of 1.25-1.30 (50 ℃) are mixed, and the two solutions are viscous and are not easy to mix, so that the relative densities of the two solutions are determined to be 1.15-1.25 (50 ℃).
Preparing granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels:
preparation of powdered sugar: drying sucrose or granulated sugar at low temperature, and pulverizing into fine powder.
Preparation of spray granulation: 100kg of sugar powder is taken and put into a spray granulator, the air inlet temperature is set to be 90 ℃, and the sugar powder is boiled for 15 minutes; when the air outlet temperature is 50 ℃ (namely the temperature in the fluidized bed is kept to be more than or equal to 50 ℃), the peristaltic pump is started, and the atomization pressure is adjusted to be 0.2 Mpa. Spraying 60kg of ointment (batch number 20180501) to start granulation, closing the peristaltic pump after the ointment is completely sprayed, and starting a drying program to continuously send hot air to dry the formed granules in the bed layer. The drying time is 8 minutes, and the drying is stopped when no moisture is sensed.
Preparing medicinal powder: the granules after spray granulation are taken and crushed into fine powder, and 120.5kg of the fine powder is weighed for standby.
Preparation of wet granules: putting 120.5kg of the medicinal powder into a tank type mixer, adding 9.5kg of 95% ethanol, stirring for 5 minutes, mixing uniformly, transferring all the medicinal powder into a swing granulator, and preparing into wet granules by using a 14-mesh sieve.
Drying of the particles: a boiling drying bed is used, the drying temperature is 70 ℃, and the drying time is 60 minutes.
Finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing 120.1kg of the granules, and subpackaging 10g of the granules in each bag.
Comparative example 1 preparation of granules of the existing blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition
The preparation of the blood fat reducing and blood vessel softening traditional Chinese medicine composition clear paste and powdered sugar is the same as example 1.
Preparation of wet granules: taking 100kg of sugar powder, placing in a tank type mixer, adding 12.0kg of ointment (batch No. 20180501) at one time, stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granules;
drying and crushing the particles: using a boiling drying bed, drying at 70 ℃ for 60 minutes, and then crushing into fine powder.
And (3) re-granulation: placing all the above dried and pulverized medicinal powder in a tank type mixer, adding 12.0kg of unguent (batch No. 20180501), stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granule;
then according to the above operation method from preparation of wet granules to re-granulation, the rest 36kg of ointment (batch No. 20180501) is divided into 3 times, and 12kg of ointment is added each time for granulation;
finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing 117.3kg of the granules, and subpackaging 10g of the granules in each bag.
Example 2 preparation of granules of the blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition of the present invention
The preparation of the blood fat reducing and blood vessel softening traditional Chinese medicine composition clear paste and powdered sugar is the same as example 1.
Preparation of spray granulation: 100kg of sugar powder is taken and put into a spray granulator, the air inlet temperature is set to be 110 ℃, and the sugar powder is boiled for 15 minutes; when the air outlet temperature is 50 ℃ (namely the temperature in the fluidized bed is kept to be more than or equal to 50 ℃), the peristaltic pump is started, and the atomization pressure is adjusted to be 0.3 Mpa. Spraying 65.0kg of ointment (batch number 20180502) to start granulation, closing the peristaltic pump after the ointment is completely sprayed, and starting a drying program to continuously send hot air to dry the formed granules in the bed layer. The drying time is 10 minutes, and the drying is stopped when no moisture is sensed.
Preparing medicinal powder: the spray granulated granules were ground into fine powder and weighed 128.1kg for use.
Preparation of wet granules: putting 128.1kg of the medicinal powder into a tank type mixer, adding 12kg of 95% ethanol, stirring for 5 minutes, mixing uniformly, transferring all the materials into a swing granulator, and preparing into wet granules by using a 14-mesh sieve.
Drying of the particles: a boiling bed drier was used, the drying temperature was 75 ℃ and the drying time was 50 minutes.
Finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing 127.3kg of the finished granules, and subpackaging 10g of the granules in each bag.
Comparative example 2 preparation of granule of existing blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition
The preparation of the blood fat reducing and blood vessel softening traditional Chinese medicine composition clear paste and powdered sugar is the same as example 1.
Preparation of wet granules: taking 100kg of sugar powder, placing in a tank type mixer, adding 13.0kg of ointment (batch No. 20180502) at one time, stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granules;
drying and crushing the particles: using a boiling drying bed, drying at 75 ℃ for 50 minutes, and then crushing into fine powder.
And (3) re-granulation: placing the above dried and pulverized medicinal powder in a tank type mixer, adding 13.0kg of unguent (lot 20180502), stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granule;
then, according to the operation method from the preparation of the wet granules to the re-granulation, the rest 39kg of ointment (batch number 20180502) is divided into 3 times, and 13kg of ointment is added each time for granulation;
finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing the weighed granules to obtain 126.5kg of granules, and subpackaging 10g of granules in each bag.
Example 3 preparation of granules of the blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition of the present invention
The preparation of the blood fat reducing and blood vessel softening traditional Chinese medicine composition clear paste and powdered sugar is the same as example 1.
Preparation of spray granulation: 100kg of sugar powder is taken and put into a spray granulator, the air inlet temperature is set to be 120 ℃, and the sugar powder is boiled for 15 minutes; when the air outlet temperature is 50 ℃ (namely the temperature in the fluidized bed is kept to be more than or equal to 50 ℃), the peristaltic pump is started, and the atomization pressure is adjusted to be 0.4 Mpa. Spraying 55.0kg of ointment (batch number 20180503) to start granulation, closing the peristaltic pump after the ointment is completely sprayed, and starting a drying program to continuously send hot air to dry the formed granules in the bed layer. The drying time is 12 minutes, and the drying is stopped when no moisture is sensed.
Preparing medicinal powder: the granules after spray granulation are taken and crushed into fine powder or superfine powder, and 111.0kg of the powder is weighed for standby.
Preparation of wet granules: putting 111.0kg of the medicinal powder into a tank type mixer, adding 14kg of 95% ethanol, stirring for 5 minutes, mixing uniformly, quantitatively transferring into a swing granulator, and sieving with a 14-mesh sieve to prepare wet granules.
Drying of the particles: a boiling drying bed is used, the drying temperature is 80 ℃, and the drying time is 40 minutes.
Finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing the weighed granules to obtain 110.3kg of granules, and subpackaging 10g of granules in each bag.
Comparative example 3 preparation of granule of existing blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition
The preparation of the blood fat reducing and blood vessel softening traditional Chinese medicine composition clear paste and powdered sugar is the same as example 1.
Preparation of wet granules: taking 100kg of sugar powder, placing in a tank type mixer, adding 11.0kg of ointment (batch No. 20180503) at one time, stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granules;
drying and crushing the particles: using a boiling drying bed, drying at 80 ℃ for 40 minutes, and then crushing into fine powder.
And (3) re-granulation: placing the above dried and pulverized medicinal powder in a tank type mixer, adding 11.0kg of unguent (lot 20180503), stirring for 5 min, mixing, transferring into a swing granulator, and sieving with 14 mesh sieve to obtain wet granule;
then, according to the operation method from the preparation of wet granules to the re-granulation, the rest 33kg of ointment (batch number 20180503) is divided into 3 times, and 11kg of ointment is added for granulation each time;
finishing and subpackaging: and (3) grading the dried granules by using a 16-mesh sieve, weighing 107.1kg of the granules, and subpackaging 10g of the granules in each bag.
Test examples measurement of particle content
The content of the granules prepared in the examples 1 to 3 of the invention and the granules prepared in the prior art of the comparative examples 1 to 3 were measured by the existing method for detecting Jiangzhining granules.
The detection method and the process are as follows:
octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; acetonitrile-water (17:83) is used as a mobile phase; the detection wavelength was 320 nm. The number of theoretical plates is not less than 2000 calculated according to the peak of 2,3,5, 4-tetrahydroxystilbene-2-0-beta-D-glucoside.
The operation method comprises the following steps: measuring by high performance liquid chromatography.
Preparation of control solution A suitable amount (about 10mg) of 2,3,5, 4-tetrahydroxystilbene-2-0-beta-D-glucoside control was taken, dissolved in 200ml of methanol and diluted to the scale, and shaken well to obtain a solution containing 50. mu.g of 2,3,5, 4-tetrahydroxystilbene-2-0-beta-D-glucoside per 1 ml.
Preparation of test solution samples of examples 1-3 and comparative examples 1-3 were respectively ground, about 5g was taken, precisely weighed, placed in a conical flask with a stopper, 50ml of methanol was added, ultrasonic treatment was performed for 30 minutes, cooling was allowed to stand, filtration was performed, the filtrate was evaporated to dryness, the residue was dissolved in 50% methanol, transferred to a 100ml volumetric flask and diluted to the scale, shaken up, filtered, and the subsequent filtrate was taken to obtain the final product.
The determination method comprises precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.
The standard stipulates that the content of prepared fleece flower root in each 10g of the product is 0.70mg-2.00mg calculated by 2,3,5, 4-tetrahydroxystilbene-2-0-beta-D-glucoside.
Calculating the formula: the content (mg/10g) is ASample (A)×WTo pairX the purity of the reference substance x the dilution multiple of the test substance x 10/(A)s×WSample (A)X control dilution factor)
Wherein A isSample (A)Is the peak area of the sample solution;
Aspeak area of the control solution;
Wto pairWeight of the reference substance;
Wsample (A)Is the sample weight.
The test results are as follows:
combined granulation method (examples 1-3):
original granulation method (comparative examples 1-3):
content yield (%) comparison of the two methods:
wherein, the sample chromatogram of example 1 is shown in figure 1, the sample chromatogram of example 2 is shown in figure 2, the sample chromatogram of example 3 is shown in figure 3, the control chromatogram of examples 1-3 is shown in figure 4, the sample chromatogram of comparative example 1 is shown in figure 5, the sample chromatogram of comparative example 2 is shown in figure 6, the sample chromatogram of comparative example 3 is shown in figure 7, and the control chromatogram of comparative examples 1-3 is shown in figure 8.
After the process method is adopted, the comparison results of the working hours and the solubility tests are shown in the following table:
| serial number | Categories | Raw granulation method | Two granulation methods are combined |
| 1 | Number of pelletization | 4 to 5 times | 2 times (one time) |
| 2 | Number of pulverization | 4 to 5 times | 2 times (one time) |
| 3 | Production cycle | 12 to 15 hours | 6 to 8 hours |
| 4 | Solubility in water | Passed but slight cloudiness | Qualified and clarified solution |
While certain exemplary embodiments of the present invention have been described above by way of illustration only, it will be apparent to those of ordinary skill in the art that the described embodiments may be modified in various different ways without departing from the spirit and scope of the invention. Accordingly, the foregoing description is illustrative in nature and is not to be construed as limiting the scope of the invention as claimed.
Claims (3)
1. A granulation method of a traditional Chinese medicine composition for reducing blood fat and softening blood vessels comprises the following raw materials in parts by weight: 25 parts of cassia seed, 75 parts of lotus leaf, 25 parts of prepared fleece-flower root and 500 parts of denucleated hawthorn, and is characterized in that the granulation method comprises the following steps:
step a: concentrating the water extract of semen Cassiae and fructus crataegi to fluid extract; the relative density of the water extract clear paste is 1.15-1.25 at 50 ℃;
step b: concentrating the alcohol extract of the lotus leaf and the prepared fleece-flower root into clear paste; the relative density of the clear paste of the alcohol extract is 1.15 to 1.25 at 50 ℃;
step c: spraying the fluid extracts obtained in step a and b with sugar powder by spray granulation, pulverizing, adding ethanol, performing swing granulation, drying, grading, and making into granule;
the method for spraying the powdered sugar comprises the following steps:
100 parts by weight of sugar powder is taken and put into a spray granulator, the air inlet temperature is set to be 90-120 ℃, and the sugar powder is boiled for 15 minutes; when the air outlet temperature is 50 ℃, starting a peristaltic pump, adjusting the atomization pressure to 0.2-0.4 Mpa, spraying 55-65 parts by weight of ointment to start granulation, closing the peristaltic pump after all the ointment is sprayed, starting a drying program, continuously sending hot air to dry the formed particles in a bed layer for 8-12 minutes, stopping drying when no moisture is sensed, and crushing the particles into fine powder;
the swing granulation method comprises the following steps: putting 100 parts by weight of the fine powder after spray granulation in a groove type mixer, adding 8-12 parts by weight of 95% ethanol, stirring for 5-10 minutes, uniformly mixing, quantitatively transferring to a swing granulator, making into wet granules by using a 14-mesh sieve, drying for 40-60 minutes at the temperature of 75 +/-5 ℃, and finishing granules by using a 16-mesh sieve to obtain the granules of the traditional Chinese medicine composition for reducing blood fat and softening blood vessels.
2. The method for granulating a blood lipid-lowering and blood vessel-softening traditional Chinese medicine composition as claimed in claim 1, wherein the sugar powder in step c is fine powder obtained by drying and pulverizing sucrose or granulated sugar.
3. The granules of the blood-fat-reducing and blood-vessel-softening traditional Chinese medicine composition are prepared by adopting the granulation method of the blood-fat-reducing and blood-vessel-softening traditional Chinese medicine composition as claimed in claim 1 or 2.
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| Title |
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| 复方山楂颗粒两种生产工艺的比较;张朝绅等;《药学实践杂志》;20120525;第30卷(第3期);第220-221页，尤其是第220页左栏第1段，第221页右栏第2段 * |
| 无糖型降脂宁颗粒制备工艺研究;曲晶;《中国制药装备》;20170531(第14期);第30-31、46页 * |
| 降脂宁颗粒一步制粒工艺研究;徐云等;《长春师范大学学报》;20180630;第37卷(第6期);第131-134页 * |
| 降脂宁颗粒生产工艺规程;udoc008;《http://www.doc88.com/p-7197003516816.html》;20140714;第1-7页，尤其是第2-4页"产品概述"、"制剂生产处方"，第6页倒数第1-3行，第7页第1-6段，第8页第1-3段 * |
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