CN112618627A - Improved Chinese mahonia stem internal heat-reducing medicine composition preparation method - Google Patents
Improved Chinese mahonia stem internal heat-reducing medicine composition preparation method Download PDFInfo
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- 239000003814 drug Substances 0.000 title description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 112
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
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Abstract
The invention relates to a method for preparing improved Chinese mahonia stem internal heat-reducing pharmaceutical composition, which comprises the steps of pulverizing phellodendron into fine powder for standby; decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 13-17 times of water for the first time and 8-12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation. The preparation method improves the content of baicalin and berberine hydrochloride in the product, has short drying time, energy saving, continuous operation, high product quality and low production cost, and is suitable for large-scale production of the product.
Description
Technical Field
The invention relates to the field of medicine preparation, in particular to a preparation method of an improved Chinese mahonia internal heat-reducing medicine composition.
Background
The Chinese holly leaf capsule for clearing away heat and toxic matter is prepared with Chinese herbal medicine materials and through the processes of crushing, mixing, crushing, sieving, packing, etc. it is used in treating acute laryngopharyngitis, acute cholecystitis, etc. The analysis of the detection data is groped and combined in the long-term production process, and the following problems are found: the extraction process has the disadvantages of more thick paste and less fine powder, so the water content in the thick paste absorbed by the fine powder is limited, the drying time is longer, the effective components are easy to lose in the drying process, and the deterioration of the medicine is easy to occur.
According to the specification of Chinese pharmacopoeia, the prescription of the mahonia stem internal heat-reducing tablet comprises 604g of mahonia stem, 302g of phellodendron bark, 302g of scutellaria root and 302g of gardenia, and the preparation method comprises the following steps: taking 100g of phellodendron, crushing into fine powder, adding water into the rest of phellodendron and mahonia stem, decocting for three times, adding 7 times of water for the first time, adding 6 times of water for the second time and the third time respectively, each time for 2 hours, combining decoctions, filtering, and concentrating the filtrate into thick paste. Decocting Scutellariae radix and fructus Gardeniae in water twice, adding 7 times of water for the first time and 6 times of water for the second time, each for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract. Adding cortex Phellodendri powder into the above two soft extracts, mixing, drying, pulverizing into fine powder, mixing, granulating, tabletting into 1000 tablets, and coating with sugar; or pressing into 600 tablets, and coating with film.
Application No. CN200910307617.7, a Mahonia fortunei capsule for treating various inflammations and clearing away heat and toxic materials and a preparation method thereof, the applicant, Guizhou Jianxing pharmaceutical industry Co., Ltd, discloses a preparation method as follows: (1) pulverizing 100 parts of cortex Phellodendri into fine powder; (2) adding 8-12 times of water into the rest of golden cypress and Chinese mahonia stem, decocting for 3 times, each time for 2 hours, combining the decoctions, filtering, and concentrating the filtrate into thick paste; (3) adding 8-12 times of water into the scutellaria baicalensis and the gardenia, decocting for 2 times, each time for 2 hours, mixing decoctions, filtering, and concentrating the filtrate into thick paste; (4) adding cortex Phellodendri fine powder into the above two soft extracts, mixing, drying, pulverizing, sieving, mixing, and making into capsule.
The pharmacopoeia preparation method and the scheme of application number CN200910307617.7 have the following technical problems: 1) because the amount of the fine powder of the amur corktree bark is less and the amount of the total thick paste is larger, the drying time is longer, the energy consumption is high, and the deterioration of the medicine is easily caused in the drying process; 2) influence the baicalin content and berberine hydrochloride content of the effective components; 3) the thick paste has large amount and uneven drying, which causes uneven moisture of dry paste powder, and the thick paste is easy to mildew in the drying process, thereby influencing the production process and quality of later processes.
Aiming at the problems, the inventor improves the original production process by a series of production process groping tests and combining the quality detection data analysis results, and extracts a part of phellodendron amurense and leatherleaf mahonia of the original extraction method into thick paste; the preparation method comprises the steps of extracting thick paste from scutellaria and gardenia, mixing the thick paste and adding phellodendron fine powder, optimizing into the preparation method of extracting thick paste from mahonia stem, scutellaria and gardenia and adding phellodendron fine powder, and solves the technical problems of large thick paste amount, less fine powder, difficulty in drying, easiness in mildew during drying, long drying time, influence on medicine quality, high drying energy consumption, low production efficiency and the like.
Disclosure of Invention
The invention aims to provide an improved preparation method of a Chinese mahonia stem internal heat-reducing pharmaceutical composition.
The invention provides a preparation method of an improved mahonia stem internal heat-reducing pharmaceutical composition, which comprises 604 parts of mahonia stem, 302 parts of phellodendron, 302 parts of scutellaria baicalensis and 302 parts of gardenia.
The preparation method of the composition comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 13-17 times of water for the first time and 8-12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
Preferably, the preparation method of the composition comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 14-16 times of water for the first time and 9-11 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
Further preferably, the preparation method of the composition comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
The drying is low-temperature vacuum belt drying.
The low-temperature vacuum belt type drying specifically comprises the following steps: the drying temperature is 80-150 ℃, the vacuum degree is-0.085 Mpa, the track speed is 120-.
Preferably, the low-temperature vacuum belt drying specifically comprises: the drying temperature is 130 ℃, the vacuum degree is-0.085 Mpa, the crawler speed is 150mm/min, the feeding speed is 25Hz, and the crushing frequency is 50 Hz. The drying time was 6 hours.
The crawler belt is divided into 1 section, 2 sections, 3 sections and 4 sections.
The heating temperatures of the sections 1, 2, 3 and 4 are respectively as follows: the sections 1, 2 and 3 are all 120-140 ℃ and the section 4 is 80-100 ℃.
Preferably, the heating temperatures of the sections 1, 2, 3 and 4 are respectively as follows: the 1 section, the 2 section and the 3 section are all 130 ℃; the temperature of 4 sections is 90 ℃.
The pharmaceutically acceptable formulation is a solid formulation; the solid preparation is capsule, tablet, granule, powder, or pill.
The weight parts may be those known in the medical field such as μ g, mg, g, kg, etc.
The term "times" means the weight ratio of the medicinal materials.
Has the advantages that:
1. the inventor carries out a series of production process groping tests, combines the quality detection data analysis results, improves the original production process, and extracts a part of phellodendron amurense and Chinese mahonia stem into thick paste by the original extraction method; the preparation method comprises the steps of extracting thick paste from scutellaria and gardenia, mixing the thick paste and adding phellodendron fine powder, optimizing into the preparation method of extracting thick paste from mahonia stem, scutellaria and gardenia and adding phellodendron fine powder, and solves the technical problems of large thick paste amount, less fine powder, difficulty in drying, easiness in mildew during drying, long drying time, influence on medicine quality, high drying energy consumption, low production efficiency and the like.
2. The invention takes the baicalin content in the thick paste as a main index, and considers the times of the reflux extraction solvent, so as to obtain the optimal water extraction scheme as follows: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 15 times of water for the first time and 10 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; the result shows that the extraction method can completely extract the effective components and ensure the quality of the extract.
3. The invention adopts an orthogonal design method, takes the water content as a main index, researches the drying process conditions of the vacuum belt drying method on the mahonia stem extract for reducing internal heat, and obtains the optimal drying scheme as follows: the results of the drying process parameters that the crawler speed is 150mm/min, the heating temperature of the 1 section is 130 ℃, the heating temperature of the 2 section is 130 ℃, the heating temperature of the 3 section is 130 ℃, the heating temperature of the 4 section is 90 ℃ and the feeding speed is 25Hz show that the vacuum belt type drying time is short, the energy is saved, the continuous operation is realized, the product quality is high, the production cost is low, and the method is suitable for the large-scale production of products.
4. The invention carries out quality detection on 9 finished products of 3 batches produced by the preparation method, and the inspection result shows that the appearance, the loading capacity, the disintegration time limit and the content measurement all accord with the quality detection standard of the Mahonia fortunei capsule, thereby further verifying the feasibility and the reproducibility of the preparation method.
5. According to the invention, the quality detection is carried out on the product prepared by the new and old production preparation methods, and the result shows that the detection indexes of 3 batches of samples in the application are superior to those of 3 batches of samples in the comparative example, which proves that the medicine preparation method is feasible and reliable.
Drawings
FIG. 1 comparison graph of baicalin content
The technical solution of the present invention will be further specifically described below by way of specific examples.
Example 1
The formula is as follows: 604kg of mahonia stem, 302kg of phellodendron, 302kg of scutellaria baicalensis and 302kg of gardenia.
Example 2
The formula is as follows: 6040kg of leatherleaf mahonia, 3020kg of golden cypress, 3020kg of baical skullcap root and 3020kg of cape jasmine fruit.
Example 3
The formula is as follows: 60.4kg of leatherleaf mahonia, 30.2kg of amur corktree bark, 30.2kg of baical skullcap root and 30.2kg of cape jasmine fruit.
The formulations of examples 1-3 were prepared according to any of the following preparative methods of examples 4-21, respectively.
Example 4
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 5
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 6
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 7
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 8
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 9
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 10
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 180mm/min, the 1-section heating temperature of 140 ℃, the 2-section heating temperature of 140 ℃, the 3-section heating temperature of 140 ℃, the 4-section heating temperature of 100 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 30Hz and the crushing frequency of 60Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 11
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 180mm/min, the 1-section heating temperature of 140 ℃, the 2-section heating temperature of 140 ℃, the 3-section heating temperature of 140 ℃, the 4-section heating temperature of 100 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 30Hz and the crushing frequency of 60Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 12
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 180mm/min, the 1-section heating temperature of 140 ℃, the 2-section heating temperature of 140 ℃, the 3-section heating temperature of 140 ℃, the 4-section heating temperature of 100 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 30Hz and the crushing frequency of 60Hz, drying for 6 hours, crushing again, sieving and preparing into capsules.
Example 13
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 4 hours, crushing again, sieving and preparing into tablets.
Example 14
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type drying machine with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 8 hours, crushing again, sieving and preparing into granules.
Example 15
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into powder.
Example 16
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 4 hours, crushing again, sieving and preparing into capsules.
Example 17
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 8 hours, crushing again, sieving and preparing into capsules.
Example 18
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 120mm/min, the 1-section heating temperature of 120 ℃, the 2-section heating temperature of 120 ℃, the 3-section heating temperature of 120 ℃, the 4-section heating temperature of 80 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 20Hz and the crushing frequency of 40Hz, drying for 4 hours, crushing again, sieving and preparing into pills.
Example 19
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into tablets.
Example 20
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 13 times of water for the first time and 8 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type drying machine with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 6 hours, crushing again, sieving and preparing into granules.
Example 21
Preparation method
1) Pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 17 times of water for the first time and 12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) respectively adding the soft extracts into cortex Phellodendri fine powder, and mixing; then putting into a low-temperature vacuum belt type dryer with the track speed of 150mm/min, the 1-section heating temperature of 130 ℃, the 2-section heating temperature of 130 ℃, the 3-section heating temperature of 130 ℃, the 4-section heating temperature of 90 ℃, the vacuum degree of-0.085 Mpa, the feeding speed of 25Hz and the crushing frequency of 50Hz, drying for 4 hours, crushing again, sieving and preparing into powder.
To further verify the effectiveness of the present invention, the inventors performed a series of validation tests, excerpting the following:
1. investigation of amount of reflux extraction solvent
1.1 formula: 604g of mahonia stem, 302g of phellodendron bark, 302g of scutellaria root and 302g of gardenia.
1.2 investigation criteria: baicalin content.
The method comprises the following steps: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 15 times of water for the first time and 10 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
the second method comprises the following steps: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 10 times of water for the first time and 6 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
the third method comprises the following steps: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 13 times of water for the first time and 8 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
the method four comprises the following steps: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 17 times of water for the first time and 12 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
the baicalin content was determined by taking 3 parts each of the 1.2 'methods one to four' thick pastes, and the results are shown in Table 1.
TABLE 1 baicalin content determination and comparison table
As a result: as can be seen from table 1, the average content of baicalin is equivalent to that of baicalin in "method one" and "method four", the average content of berberine hydrochloride in "method two" is relatively low, and in order to save cost, the solvent volume of "method one" is preferably doubled, that is, the "first time: 15 times of the amount of the raw materials; second, third: 10 times the amount of the raw material.
1.3 verification of solvent times by contrast test
1.3.1 extraction method
Method one (application): decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for three times (each for 2 hr), adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
method II (comparative example), application No. CN200910307617.7, decocting cortex Phellodendri and caulis Mahoniae with 10 times of water for 3 times, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; decocting Scutellariae radix and fructus Gardeniae with 10 times of water for 2 times (each time for 2 hr), mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract;
1.3.2 results of the experiment
The baicalin content was measured by taking 3 parts of each of the 1.3.1 "method one" and "method two" thick pastes, and the results are shown in table 2 and fig. 1.
TABLE 2 comparative table for content measurement
As a result: as can be seen from Table 2 and FIG. 1, the baicalin content of the soft extract obtained by the method I (the application) is higher than that of the soft extract obtained by the method II (the comparative example), which indicates that the effective components are extracted more completely by the extraction method.
2. Investigation of drying Process
2.1 instruments, equipments and raw and auxiliary materials
2.1.1 instruments, devices: a 6m3 extraction concentration machine set, a DGJ90-100 low-temperature vacuum belt type dryer, an LG200D type extrusion crusher, an NJP3500 type capsule filling machine, a high-efficiency liquid phase chromatographic analyzer and a rapid moisture tester.
2.1.2 raw and auxiliary materials: the mahonia stem fire-reducing capsule thick paste (mahonia stem, scutellaria and gardenia), the phellodendron bark powder and the hollow capsule which are prepared according to the embodiment 1 are adopted.
2.2 methods and results
2.2.1 orthogonal experimental design
According to the empirical values, the higher the degree of vacuum, the easier the drying, so the vacuum degree near-0.1 MPa conditions for the test. 3 main factors affecting drying were selected: track speed (A), heating temperature (B) of each section and feeding speed (C). Each factor was selected at 3 levels and orthogonal experiments were performed using the L9(34) orthogonal table, see table 3 for factors and levels.
TABLE 3 factor level table
2.2.2 orthogonal Experimental design and results
9 tests are designed according to an orthogonal table L9(34), 150kg of materials are fed in each test, the Chinese mahonia stem fire-reducing capsule extract is subjected to vacuum belt drying to obtain dry paste powder, the water content, the baicalin content and the berberine hydrochloride content are measured, and orthogonal test results are shown in a table 4.
TABLE 4 orthogonal test Table
2.3 analysis of results
From table 4, in the vacuum belt drying process, the influence degree of each factor on the moisture content of the dry extract powder of the mahonia stem fire-reducing capsule is as follows: b > C > A, and the influence degree on the content of baicalin is in the following order: b > C > A, and the influence degree on the content of berberine hydrochloride is in the following order: c > A > B. Comprehensively considering, the final drying process parameters are A1B3C3, namely the track speed is 150mm/min, the heating temperature of 1 section is 130 ℃, the heating temperature of 2 sections is 130 ℃, the heating temperature of 3 sections is 130 ℃, the heating temperature of 4 sections is 90 ℃, and the feeding speed is 25 Hz.
2.4 drying method comparative test
2.4.1 sample: mixing the soft extract of example 1 with cortex Phellodendri powder, and mixing.
2.4.2 drying method: drying in a drying oven, and low-temperature vacuum belt drying.
2.4.3 results of the experiment: 6 parts of each of the 2.4.1 samples were taken, and 3 parts of each of the samples were dried by oven drying and low-temperature vacuum belt drying, and the results are shown in Table 5.
Table 5 comparative results of drying method table
As a result: the water content of the product obtained by vacuum belt drying according to the method is below 1.5 percent, the drying time is 6 hours, the contents of baicalin and berberine hydrochloride in the sample are higher than those of a drying oven drying method, and the feasibility and the reliability of low-temperature vacuum belt drying are further verified.
3. Sample quality detection
In order to further examine the reliability and stability of the process improvement of the invention, 3 batches of the samples of the Mahonia fortunei fire-reducing capsules are respectively produced according to the production processes of 'example 1', 'example 7' and 'example 11' of the invention; taking 3 parts of each batch of samples, detecting according to the quality standard of the Chinese mahonia capsules for reducing internal heat, and obtaining results shown in tables 6 and 7.
3.1 evaluation index of results
3.1.1 appearance quality: the surface is smooth and clean, and no concave bottom or fork is split.
3.1.2 load variation check: according to the general rule of capsule preparations, the filling amount of the capsules is controlled to be 0.3 g/granule +/-10%.
3.1.3 disintegration time limit: not exceeding 30 minutes.
3.1.4 content determination: each granule of the product contains caulis Mahoniae and cortex Phellodendri and berberine hydrochloride (C)20H18ClNO4) Calculated, not less than 2.5 mg; each granule of the product contains baicalin (C) extracted from Scutellariae radix21H18O11) Calculated, the content of the active ingredients should not be less than 9.0 mg.
TABLE 6 table of contents measurement results
Table 7 test results of other items table
As a result: as can be seen from the results in tables 6 and 7, the inspection results of 9 samples of 3 batches of samples produced by the preparation method of the invention show that the appearance, the loading capacity, the disintegration time limit and the content measurement all accord with the quality detection standards of the Mahonia fortunei Huo capsule. The feasibility and the reproducibility of the preparation method are further verified.
4. Comparison test of main items for quality detection of finished products
4.1 sample: 3 batches of finished products in 'example 1' of the invention; batch 3 of finished product from "comparative" application No. (CN 200910307617.7).
4.2 detection indexes: determining the quality standard of the Chinese mahonia capsule for removing internal heat;
4.3 the results of the assay are shown in Table 8.
TABLE 8 table of contents measurement results
As a result: as can be seen from Table 8, the detection indexes of the 3 samples of the present invention are superior to those of the 3 samples of the comparative example, which indicates that the pharmaceutical preparation method of the present invention is feasible and reliable.
And (4) conclusion:
1. the invention takes the baicalin content in the thick paste as a main index, and considers the times of the reflux extraction solvent, so as to obtain the optimal water extraction scheme as follows: decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water twice, adding 15 times of water for the first time and 10 times of water for the second time, each time for 2 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; the result shows that the extraction method can completely extract the effective components and ensure the quality of the extract.
2. The invention adopts an orthogonal design method, takes the water content as a main index, researches the drying process conditions of the vacuum belt drying method on the mahonia stem extract for reducing internal heat, and obtains the optimal drying scheme as follows: the results of the drying process parameters that the crawler speed is 150mm/min, the heating temperature of the 1 section is 130 ℃, the heating temperature of the 2 section is 130 ℃, the heating temperature of the 3 section is 130 ℃, the heating temperature of the 4 section is 90 ℃ and the feeding speed is 25Hz show that the vacuum belt type drying time is short, the energy is saved, the continuous operation is realized, the product quality is high, the production cost is low, and the method is suitable for the large-scale production of products.
3. The experimental comparison between the oven drying method and the vacuum belt drying method shows that the water content of the product is below 1.5%, the drying time is 6 hours, the contents of baicalin and berberine hydrochloride in the sample are higher than those of the oven drying method, and the feasibility and the reliability of the vacuum belt drying method in the process are further proved.
4. The invention carries out quality detection on 9 finished products of 3 batches produced by the preparation method, and the inspection result shows that the appearance, the loading capacity, the disintegration time limit and the content measurement all accord with the quality detection standard of the Mahonia fortunei capsule, thereby further verifying the feasibility and the reproducibility of the preparation method.
Although the invention has been described in detail in the foregoing by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that various modifications and improvements can be made thereto without departing from the spirit of the invention.
Claims (9)
1. An improved Chinese mahonia stem internal heat-reducing pharmaceutical composition preparation method, the composition is composed of 604 parts of Chinese mahonia stem, 302 parts of phellodendron, 302 parts of scutellaria baicalensis and 302 parts of gardenia, and the preparation method of the composition comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 13-17 times of water for the first time and 8-12 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
2. The method for preparing the composition according to claim 1, wherein the method comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 14-16 times of water for the first time and 9-11 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
3. The method for preparing the composition according to claim 2, wherein the method comprises the following steps: 1) pulverizing cortex Phellodendri into fine powder; 2) decocting caulis Mahoniae, Scutellariae radix and fructus Gardeniae in water for 2 hr for three times, adding 15 times of water for the first time and 10 times of water for the second and third times, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; 3) mixing cortex Phellodendri fine powder and soft extract, drying, pulverizing, sieving, and making into pharmaceutically acceptable preparation.
4. A method for preparing a composition according to any one of claims 1 to 3, wherein the drying in step 3) of the preparation method is low-temperature vacuum belt drying, in particular: the drying temperature is 80-150 ℃, the vacuum degree is-0.085 Mpa, the track speed is 120-.
5. The method for preparing the composition according to claim 4, wherein the low-temperature vacuum belt drying is carried out by: the drying temperature is 130 ℃, the vacuum degree is-0.085 Mpa, the crawler speed is 150mm/min, the feeding speed is 25Hz, and the crushing frequency is 50 Hz. The drying time was 6 hours.
6. The method for preparing the composition according to claim 5, wherein the caterpillar track is divided into 1, 2, 3 and 4 sections.
7. The method for preparing the composition according to claim 6, wherein the heating temperatures of the 1 st, 2 nd, 3 rd and 4 th stages are respectively: the sections 1, 2 and 3 are all 120-140 ℃ and the section 4 is 80-100 ℃.
8. The method for preparing the composition according to claim 7, wherein the heating temperatures of the 1 st, 2 nd, 3 rd and 4 th stages are respectively: the 1 section, the 2 section and the 3 section are all 130 ℃; the temperature of 4 sections is 90 ℃.
9. The method of preparing a composition according to claim 1, wherein the pharmaceutically acceptable formulation is a solid formulation; the solid preparation is capsule, tablet, granule, powder, or pill.
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| CN113552277A (en) * | 2021-07-12 | 2021-10-26 | 贵州健兴药业有限公司 | Detection method of Chinese mahonia capsules for reducing internal heat |
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