Preparation method of prepared kusnezoff monkshood root decoction pieces and product thereof

Abstract

The invention provides a preparation method of prepared kusnezoff monkshood root decoction pieces. The preparation method comprises the following steps: (1) dividing kusnezoff monkshood roots into large kusnezoff monkshood roots which are larger than or equal to a cm and small kusnezoff monkshood roots which are smaller than a cm according to the Dividing the kusnezoff monkshood root into a grade I of less than b, a grade II of more than or equal to b and less than or equal to c and a grade III of more than c according to the mass percentage content of the total amount of the monoester alkaloid; obtaining a small radix aconiti agrestis file I, a large radix aconiti agrestis file I, a small radix aconiti agrestis file II, a large radix aconiti agrestis file II, a small radix aconiti agrestis file III and a large radix aconiti agrestis file III; (2) respectively adding water into the small radix aconiti agrestis file I, the large radix aconiti agrestis file I, the small radix aconiti agrestis file II, the large radix aconiti agrestis file II, the small radix aconiti agrestis file III and the large radix aconiti agrestis file III for soaking; (3) boiling the soaked radix aconiti kusnezoffii; and (4) drying to obtain the prepared kusnezoff monkshood root Wherein in the step (1), a ranges from 1 to 1.5, b ranges from 0.015% to 0.025%, and c ranges from 0.035% to 0.045%. The radix aconiti kusnezoffii is graded according to the size and the content of the monoester alkaloids, so that the content of the monoester alkaloids in the prepared radix aconiti kusnezoffii decoction pieces is increased while the low toxicity of the radix aconiti kusnezoffii is

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine preparations, and in particular to a preparation method of prepared Aconitum kusnezoffii decoction pieces and a product thereof. Background Art

[0002] Aconitum kusnezoffii Reichb. is a dried root tuber of the Ranunculaceae plant. The original plant belongs to a perennial herb. Aconitum kusnezoffii Reichb. has a long history of medicinal use in my country and is a commonly used bulk medicinal material. This product is hot in nature, pungent and bitter in taste, highly toxic, and enters the heart, liver, kidney, and spleen meridians. It belongs to the rheumatism-removing Chinese herbal medicine, and its effects are to dispel wind and dampness, warm the meridians and relieve pain. Modern pharmacodynamics results show that Aconitum kusnezoffii has multiple pharmacological effects such as analgesia, anti-inflammatory, cardiotonic, local anesthesia, hypoglycemic, tumor inhibition, laxative, and so on.

[0003] Diester alkaloids and monoester alkaloids are important components of Aconitum kusnezoffii, and are also toxic components. The 2020 edition of the Chinese Pharmacopoeia (Part I) stipulates that the total content of three diester alkaloids, namely aconitine, mesaconitine and mesaconitine, shall not exceed 0.040% under the item of processed Aconitum kusnezoffii; the total content of three monoester alkaloids, namely benzoylaconitine, benzoylhysaconitine and benzoylmeaconitine, shall be 0.020% to 0.070%. However, the current processing technology of Aconitum kusnezoffii excessively pursues the reduction of toxic components, and there is a problem of over-processing, which not only wastes medicinal resources, but also reduces the medicinal properties of the effective ingredients in processed Aconitum kusnezoffii.

[0004] There are many methods for processing Aconitum kusnezoffii. The 2020 edition of the Chinese Pharmacopoeia states under the item "Processing Aconitum kusnezoffii": Take Aconitum kusnezoffii, separate the large and small ones, soak them in water until there is no dry core inside, take them out, add water and boil until the large ones are cut open and there is no white core inside, and the tongue feels slightly numb when tasted, take them out, dry them until 60% dry, cut them into thin slices, and dry them.

[0005] CN105708913A discloses a method for preparing Aconitum kusnezoffii, including cleaning, grading, soaking, steaming, slicing, and drying. Aconitum kusnezoffii is separated into large and small, and the weights are weighed respectively. The large Aconitum kusnezoffii is 1.5 cm or more in diameter, and the small Aconitum kusnezoffii is less than 1.5 cm in diameter; the graded Aconitum kusnezoffii is put into a clean water tank with a constant temperature water bath device, and the temperature is controlled to be 30-35°C. The large one is soaked for 3 days, and the water is changed twice a day until there is no dry core inside; the small one is soaked for 2 days, and the water is changed twice a day until there is no dry core inside, and then taken out and drained. However, this method only distinguishes the soaking time according to the size of Aconitum kusnezoffii, and still cannot solve the problem of reduced content of effective ingredients in some Aconitum kusnezoffii due to too long soaking time.

[0006] Therefore, how to reduce the toxicity of Aconitum kusnezoffii and reasonably increase the content of effective ingredients has become a technical problem that needs to be solved urgently. Summary of the invention

[0007] In view of the shortcomings of the prior art, the object of the present invention is to provide a method for preparing aconite slices and a product thereof. The method for preparing aconite slices of the present invention not only classifies aconite by size, but also classifies aconite by the total amount of monoester alkaloids, thereby further increasing the content of monoester alkaloids in the aconite slices while ensuring the low toxicity of aconite.

[0008] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a method for preparing processed Aconiti Kusnezoffii slices, the method comprising the following steps:

[0010] (1) According to the diameter, Aconitum kusnezoffii is divided into large Aconitum kusnezoffii with a diameter of ≥a cm and small Aconitum kusnezoffii with a diameter of <a cm; according to the mass percentage of the total amount of monoester alkaloids, Aconitum kusnezoffii is divided into Group I (<b), Group II (≥b and ≤c), and Group III (>c); and small Aconitum kusnezoffii Group I, large Aconitum kusnezoffii Group I, small Aconitum kusnezoffii Group II, large Aconitum kusnezoffii Group II, small Aconitum kusnezoffii Group III, and large Aconitum kusnezoffii Group III are obtained.

[0011] (2) Soak the small Aconitum grade I, large Aconitum grade I, small Aconitum grade II, large Aconitum grade II, small Aconitum grade III and large Aconitum grade III in water respectively.

[0012] (3) Boil the soaked Radix Aconitum.

[0013] (4) drying to obtain the prepared Radix Aconiti Kusnezoffii decoction pieces.

[0014] Wherein, in step (1), a=1-1.5, b=0.015%-0.025%, and c=0.035%-0.045%.

[0015] The specific point values ​​in the range of 1 to 1.5 can be selected from 1, 1.05, 1.1, 1.15, 1.2, 1.25, 1.3, 1.35, 1.4, 1.45, 1.5, etc. The specific point values ​​in the range of 0.015% to 0.025% can be selected from 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.0 21%, 0.022%, 0.023%, 0.024%, 0.025%, etc. The specific point values ​​between 0.035% and 0.045% can be selected as 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.04%, 0.041%, 0.042%, 0.043%, 0.044%, 0.045%, etc.

[0016] In the present invention, the Radix Aconiti Kusnezoffii is divided into 6 grades according to the size and the mass percentage of the total amount of monoester alkaloids, and each grade is soaked in water, thereby further increasing the content of monoester alkaloids in the prepared Radix Aconiti Kusnezoffii decoction pieces while ensuring the low toxicity of the Radix Aconiti Kusnezoffii.

[0017] Preferably, the soaking time of the small Aconitum grade I, large Aconitum grade I, small Aconitum grade II, large Aconitum grade II, small Aconitum grade III and large Aconitum grade III in step (2) are 60-84h, 84-108h, 108-132h, 132h-156h, 156h-180h, 180h-216h respectively.

[0018] Among them, the specific point values ​​in 60~84h can be selected from 60h, 63h, 66h, 69h, 72h, 75h, 78h, 81h, 84h, etc., the specific point values ​​in 84~108h can be selected from 84h, 87h, 90h, 93h, 96h, 99h, 102h, 105h, 108h, etc., the specific point values ​​in 108~132h can be selected from 108h, 111h, 114h, 117h, 120h, 123h, 126h, 129h, 132h, etc., and the specific point values ​​in 132h~156h can be selected from 132h, 135h, 138h, 141h, 144h, 147h, 150h, 153h, 156h, etc. The specific point values ​​in 156h~180h can be selected as 156h, 159h, 162h, 165h, 168h, 171h, 174h, 177h, 180h, etc. The specific point values ​​in 180h~216h can be selected as 180h, 183h, 186h, 189h, 192h, 195h, 198h, 201h, 204h, 207h, 210h, 213h, 216h, etc.

[0019] In the present invention, different soaking times are set for different grades of Aconitum kusnezoffii, and the soaking time is reasonably shortened for samples with low monoester alkaloid content in the medicinal materials, which ensures that the contents of diester alkaloids and monoester alkaloids are within a reasonable range and the low toxicity of Aconitum kusnezoffii is ensured. At the same time, the loss of effective ingredients is reduced, and the content of monoester alkaloids is greatly improved within the compliance range.

[0020] Preferably, the soaking temperatures of the small Aconitum kusnezoffii grade I, large Aconitum kusnezoffii grade I, small Aconitum kusnezoffii grade II, large Aconitum kusnezoffii grade II, small Aconitum kusnezoffii grade III and large Aconitum kusnezoffii grade III are all 10-25°C, for example, 10°C, 15°C, 20°C, 25°C, etc.

[0021] In the present invention, the soaking temperature is controlled at 10-25° C., which can further reduce the loss of effective ingredients in the Aconitum kusnezoffii slices while ensuring the low toxicity of the Aconitum kusnezoffii slices, thereby improving the product quality of the Aconitum kusnezoffii slices.

[0022] Preferably, the mass ratio of the material to liquid for soaking in step (2) is 1:(6-8).

[0023] Among them, the specific point values ​​from 6 to 8 can be selected as 6, 6.5, 7, 7.5, 8, etc.

[0024] In the present invention, the material-liquid ratio of water for soaking is controlled at 1:(6-8), so that the contents of monoester alkaloids and diester alkaloids can be controlled within a regulatory range while fully soaking the Aconitum kusnezoffii.

[0025] Preferably, the soaking process in step (2) also includes changing water, and the number of times of changing water is 2 to 4 times a day, for example, 2 times, 3 times, or 4 times.

[0026] In the present invention, changing water too frequently during the soaking process will further reduce the content of effective ingredients in the prepared Radix Aconiti Kusnezoffii slices, and insufficient water changes will cause the medicinal materials to deteriorate. Controlling the number of water changes per day to 2 to 4 times can further improve the product quality and effective ingredient content of the prepared Radix Aconiti Kusnezoffii slices.

[0027] Preferably, the cooking method in step (3) includes boiling with water.

[0028] Preferably, the mass of water added in the decoction is 6 to 8 times the mass of Aconitum kusnezoffii, for example, it can be 6 times, 6.5 times, 7 times, 7.5 times, 8 times, etc.

[0029] Preferably, the temperature for decocting with water is 90-100° C., and the time for decocting with water is 1-3 hours.

[0030] Among them, the specific point values ​​in 90-100°C can be selected from 90°C, 92°C, 94°C, 96°C, 98°C, 100°C, etc., and the specific point values ​​in 1-3h can be selected from 1h, 1.5h, 2h, 2.5h, 3h, etc.

[0031] In the present invention, the temperature of decocting with water is controlled at 90-100° C., and the time is controlled at 1-3 hours, so that the content of monoester alkaloids and diester alkaloids can be better controlled within the compliance range.

[0032] Preferably, step (3) further comprises slicing after cooking.

[0033] Preferably, the drying temperature in step (4) is 50-70° C., and the drying time is 300-600 min.

[0034] Among them, the specific point value in 50-70°C can be selected from 50°C, 55°C, 60°C, 65°C, 70°C, etc., and the specific point value in 300-600min can be selected from 300min, 400min, 500min, 600min, etc.

[0035] In the present invention, the drying temperature is controlled at 50-70° C. and the drying time is controlled at 360-600 min, which can further increase the content of monoester alkaloids within the range specified in the pharmacopoeia.

[0036] In a second aspect, the present invention provides a prepared Aconiti Kusnezoffii decoction piece prepared by the preparation method of the prepared Aconiti Kusnezoffii decoction piece as described in the first aspect.

[0037] The numerical range described in the present invention not only includes the point values ​​listed above, but also includes any point values ​​between the above numerical ranges that are not listed. Due to space limitations and for the sake of simplicity, the present invention no longer exhaustively lists the specific point values ​​included in the range.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] The preparation method of the prepared Aconiti kusnezoffii slices provided by the present invention divides Aconiti kusnezoffii into 6 grades and soaks them in water respectively, thereby further increasing the content of monoester alkaloids in the prepared Aconiti kusnezoffii slices while ensuring the low toxicity of Aconiti kusnezoffii, and the prepared Aconiti kusnezoffii slices have excellent stability.

[0040] Furthermore, the present invention sets different soaking times for different grades of Aconitum kusnezoffii, and reasonably shortens the soaking time for samples with low monoester alkaloid content in the medicinal materials, thereby ensuring that the contents of diester alkaloids and monoester alkaloids are within a reasonable range and the low toxicity of Aconitum kusnezoffii is ensured, while reducing the loss of effective ingredients and greatly improving the content of monoester alkaloids within the compliance range. DETAILED DESCRIPTION

[0041] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0042] Example 1

[0043] This embodiment provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, and the specific steps are as follows:

[0044] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.2 cm and small Aconitum kusnezoffii with a diameter of <1.2 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.02%, Class II with a mass percentage of ≥0.02% and ≤0.04%, and Class III with a mass percentage of >0.04% according to the total amount of monoester alkaloids; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0045] (2) Soaking: Add 7 times the amount of water to the six grades of Aconitum kusnezoffii respectively, and soak them at below 20°C: soak the small Aconitum kusnezoffii grade I for 72 hours, soak the large Aconitum kusnezoffii grade I for 96 hours, soak the small Aconitum kusnezoffii grade II for 120 hours, soak the large Aconitum kusnezoffii grade II for 144 hours, soak the small Aconitum kusnezoffii grade III for 168 hours, and soak the large Aconitum kusnezoffii grade III for 192 hours; change the water twice a day during the soaking process and turn the tubers over frequently.

[0046] (3) Cooking: Take out the soaked Aconitum kusnezoffii, add 7 times the amount of water, and cook each batch of Aconitum kusnezoffii for 2 hours. After cooking, take out the Aconitum kusnezoffii;

[0047] (4) Drying: After the boiled Radix Aconiti Kusnezoffii is dried to 60%, sliced ​​into thin slices, and dried at 60°C for 480 min until the moisture content reaches a certain level (the moisture content shall not exceed 12.0%), thereby obtaining the processed Radix Aconiti Kusnezoffii decoction slices.

[0048] Example 2

[0049] This embodiment provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, and the specific steps are as follows:

[0050] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.3 cm and small Aconitum kusnezoffii with a diameter of <1.3 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.023%, Class II with a mass percentage of ≥0.023% and ≤0.043%, and Class III with a mass percentage of >0.043% according to the total amount of monoester alkaloids; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0051] (2) Soaking: Add 6 times the amount of water to the above 6 grades of Aconitum kusnezoffii respectively, and soak them at below 15°C: soak the small Aconitum kusnezoffii grade I for 84 hours, soak the large Aconitum kusnezoffii grade I for 108 hours, soak the small Aconitum kusnezoffii grade II for 132 hours, soak the large Aconitum kusnezoffii grade II for 156 hours, soak the small Aconitum kusnezoffii grade III for 180 hours, and soak the large Aconitum kusnezoffii grade III for 204 hours; change the water 3 times a day during the soaking process and turn the tubers frequently.

[0052] (3) Cooking: Take out the soaked Aconitum kusnezoffii, add 8 times the amount of water, and cook each batch of Aconitum kusnezoffii for 1.5 hours. After cooking, take out the Aconitum kusnezoffii;

[0053] (4) Drying: After the boiled Radix Aconiti Kusnezoffii is dried to 60%, the slices are cut into thin slices, and the slices are dried at 55°C for 540 min until the moisture content is within the acceptable range, thereby obtaining the processed Radix Aconiti Kusnezoffii decoction slices.

[0054] Example 3

[0055] This embodiment provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, and the specific steps are as follows:

[0056] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.1 cm and small Aconitum kusnezoffii with a diameter of <1.1 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.018%, Class II with a mass percentage of ≥0.018% and ≤0.037%, and Class III with a mass percentage of >0.037% according to the total amount of monoester alkaloids; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0057] (2) Soaking: Add 6 times the amount of water to the above 6 grades of Aconitum kusnezoffii respectively, and soak them at below 15°C: soak the small Aconitum kusnezoffii grade I for 60 hours, soak the large Aconitum kusnezoffii grade I for 84 hours, soak the small Aconitum kusnezoffii grade II for 108 hours, soak the large Aconitum kusnezoffii grade II for 132 hours, soak the small Aconitum kusnezoffii grade III for 156 hours, and soak the large Aconitum kusnezoffii grade III for 180 hours; change the water 4 times a day during the soaking process and turn the tubers over frequently.

[0058] (3) Cooking: Take out the soaked Aconitum kusnezoffii, add 6 times the amount of water, and cook each batch of Aconitum kusnezoffii for 3 hours. After cooking, take out the Aconitum kusnezoffii;

[0059] (4) Drying: After the boiled Radix Aconiti Kusnezoffii is dried to 60%, thin slices are cut and dried at 70°C for 420 min until the moisture content is within the acceptable range, thereby obtaining the processed Radix Aconiti Kusnezoffii decoction slices.

[0060] Example 4

[0061] This embodiment provides a method for preparing processed Aconitum carmichaelii decoction pieces, which is different from Embodiment 1 only in that the soaking temperature in step (2) is adjusted to 30°C.

[0062] Example 5

[0063] This embodiment provides a method for preparing processed Aconitum carmichaelii decoction pieces, which is different from Embodiment 1 only in that the soaking temperature in step (2) is adjusted to 7°C.

[0064] Example 6

[0065] The present embodiment provides a method for preparing prepared Aconitum kusnezoffii decoction pieces, which differs from the embodiment 1 only in that the soaking time in step (2) is adjusted to: soaking of small Aconitum kusnezoffii grade I for 96 hours, soaking of large Aconitum kusnezoffii grade I for 120 hours, soaking of small Aconitum kusnezoffii grade II for 144 hours, soaking of large Aconitum kusnezoffii grade II for 168 hours, soaking of small Aconitum kusnezoffii grade III for 192 hours, and soaking of large Aconitum kusnezoffii grade III for 216 hours.

[0066] Example 7

[0067] The present embodiment provides a method for preparing prepared Aconitum kusnezoffii decoction pieces, which differs from the embodiment 1 only in that the soaking time in step (2) is adjusted to: soaking the small Aconitum kusnezoffii grade I for 48 hours, soaking the large Aconitum kusnezoffii grade I for 72 hours, soaking the small Aconitum kusnezoffii grade II for 96 hours, soaking the large Aconitum kusnezoffii grade II for 120 hours, soaking the small Aconitum kusnezoffii grade III for 144 hours, and soaking the large Aconitum kusnezoffii grade III for 168 hours.

[0068] Example 8

[0069] This embodiment provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, which is different from Embodiment 1 only in that the decoction time in step (3) is adjusted to 5 hours.

[0070] Example 9

[0071] This embodiment provides a method for preparing prepared Aconitum carmichaelii decoction pieces, which is different from Embodiment 1 only in that the decoction time in step (3) is adjusted to 0.5 h.

[0072] Example 10

[0073] This embodiment provides a method for preparing prepared Aconitum carmichaelii decoction pieces, which is different from Embodiment 1 only in that the drying temperature in step (4) is adjusted to 80°C.

[0074] Embodiment 11

[0075] This embodiment provides a method for preparing processed Aconitum carmichaelii decoction pieces, which is different from Embodiment 1 only in that the drying temperature in step (4) is adjusted to 40°C.

[0076] Comparative Example 1

[0077] This comparative example provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, which is different from Example 1 in that the Radix Aconiti Kusnezoffii is graded differently. The specific preparation method is as follows:

[0078] (1) Classification: According to the diameter, Aconitum kusnezoffii is divided into large Aconitum kusnezoffii ≥1.2 cm and small Aconitum kusnezoffii <1.2 cm;

[0079] (2) Soaking: Add 7 times the amount of water to each of the two grades of Aconitum kusnezoffii, and soak them at below 20°C: soak the small Aconitum kusnezoffii Grade I for 120 hours and the large Aconitum kusnezoffii for 144 hours; change the water twice a day during the soaking process and stir frequently.

[0080] (3) The cooking and drying methods are the same as those in Example 1.

[0081] Comparative Example 2

[0082] This comparative example provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, which is different from Example 1 in that the Radix Aconiti Kusnezoffii is graded differently. The specific preparation method is as follows:

[0083] (1) Classification: the Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.2 cm and small Aconitum kusnezoffii with a diameter of <1.2 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.03% and Class II with a mass percentage of ≥0.03%; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, and large Aconitum kusnezoffii Class II are obtained;

[0084] (2) Soaking: Add 7 times the amount of water to the four grades of Aconitum kusnezoffii respectively, and soak them at below 20°C: soak the small Aconitum kusnezoffii grade I for 96 hours, soak the large Aconitum kusnezoffii grade I for 120 hours, soak the small Aconitum kusnezoffii grade II for 144 hours, and soak the large Aconitum kusnezoffii grade II for 168 hours; change the water twice a day during the soaking process and turn the water over frequently.

[0085] (3) The cooking and drying methods are the same as those in Example 1.

[0086] Comparative Example 3

[0087] This comparative example provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, which differs from Example 1 only in that the size classification standard of Radix Aconiti Kusnezoffii is adjusted to 1.6 cm. The specific preparation method is as follows:

[0088] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.6 cm and small Aconitum kusnezoffii with a diameter of <1.6 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.02%, Class II with a mass percentage of ≥0.02% and ≤0.04%, and Class III with a mass percentage of >0.04% according to the total amount of monoester alkaloids; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0089] (2) The soaking, boiling and drying methods are the same as those in Example 1.

[0090] Comparative Example 4

[0091] This comparative example provides a method for preparing Radix Aconiti Kusnezoffii decoction pieces, which differs from Example 1 only in that the grading standard of Radix Aconiti Kusnezoffii size is adjusted to 0.9 cm. The specific preparation method is as follows:

[0092] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥0.9 cm and small Aconitum kusnezoffii with a diameter of <0.9 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.02%, Class II with a mass percentage of ≥0.02% and ≤0.04%, and Class III with a mass percentage of >0.04% according to the total amount of monoester alkaloids; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0093] (2) The soaking, boiling and drying methods are the same as those in Example 1.

[0094] Comparative Example 5

[0095] This comparative example provides a method for preparing prepared Radix Aconiti Kusnezoffii slices, which differs from Example 1 only in that the grading standard of the total amount of Radix Aconiti Kusnezoffii monoester alkaloids is adjusted to grading I of <0.03%, grading II of ≥0.03% and ≤0.05%, and grading III of >0.05%. The specific preparation method is as follows:

[0096] (1) Classification: The Aconitum kusnezoffii is classified into large Aconitum kusnezoffii with a diameter of ≥1.2 cm and small Aconitum kusnezoffii with a diameter of <1.2 cm; the Aconitum kusnezoffii is classified into Class I with a mass percentage of the total amount of monoester alkaloids of <0.03%, Class II with a mass percentage of ≥0.03% and ≤0.05%, and Class III with a mass percentage of >0.05%; and small Aconitum kusnezoffii Class I, large Aconitum kusnezoffii Class I, small Aconitum kusnezoffii Class II, large Aconitum kusnezoffii Class II, small Aconitum kusnezoffii Class III and large Aconitum kusnezoffii Class III are obtained;

[0097] (2) The soaking, boiling and drying methods are the same as those in Example 1.

[0098] Test Example 1

[0099] The content of monoester alkaloids and diester alkaloids in the samples were determined according to the test conditions under the "Content Determination" item of the 2020 edition of the Chinese Pharmacopoeia. Among them, the total amount of monoester alkaloids includes the sum of benzoylmesaconitine, benzoylaconitine, and benzoylhypaconitine, and the total amount of diester alkaloids includes the sum of metaaconitine, hypoaconitine, and aconitine.

[0100] Five batches of Aconiti kusnezoffii were taken, and each batch of Aconiti kusnezoffii was used to prepare Aconiti kusnezoffii decoction pieces according to different grading, soaking, boiling and drying methods in different embodiments and comparative examples. The contents of monoester alkaloids and diester alkaloids in the Aconiti kusnezoffii decoction pieces prepared from different batches of Aconiti kusnezoffii were measured; at the same time, the Aconiti kusnezoffii was cut open to observe whether there was a dry core and a white core on its cross section. The results are shown in the following table:

[0101]

[0102]

[0103] It can be seen from the data of Example 1 and Comparative Examples 1 to 2 and Comparative Example 5 that when Aconitum kusnezoffii is not classified according to the content of monoester alkaloids, or when the standard for classification according to the content of monoester alkaloids is adjusted, it is impossible to take into account both the low toxicity and high efficacy of Aconitum kusnezoffii with different monoester alkaloid contents.

[0104] It can be seen from the data of Example 1 and Comparative Examples 3 to 4 that after adjusting the classification standard of the size of Aconitum kusnezoffii, the size of Aconitum kusnezoffii and the content of monoester alkaloids cannot be reasonably matched and classified, and the quality of the prepared Aconitum kusnezoffii slices is uneven, and the monoester and diester alkaloids will change to varying degrees. Some batches, especially those with low monoester alkaloid content in the medicinal materials, may not be properly prepared and do not meet the requirements of the pharmacopoeia.

[0105] It can be seen from the data of Examples 1 and 4 to 5 that when the soaking temperature is above 25°C, the content of monoester alkaloids decreases, and when the soaking temperature is below 10°C, the content of diester alkaloids in some batches and all batches of monoester alkaloids is too high, which cannot meet the requirements of the pharmacopoeia for monoesters and diesters in processed Aconitum kusnezoffii slices, and cannot better reduce the toxicity of Aconitum kusnezoffii.

[0106] It can be seen from the data of Examples 1 and 6 to 7 that if the soaking time is too long, the content of monoester alkaloids in the original medicinal material of Aconitum kusnezoffii, which is already low, will further decrease after soaking. If the soaking time is insufficient, the content of diester alkaloids in some batches of Aconitum kusnezoffii decoction pieces will be high, which does not meet the requirements of the pharmacopoeia.

[0107] From the data of Examples 1 and 8-9, it can be seen that the decoction time of more than 3 hours or less than 1 hour will cause the content of monoester alkaloids or diester alkaloids to exceed the provisions of the pharmacopoeia to varying degrees. In addition, some medicinal materials have white cores inside, indicating that the processing is not in place.

[0108] It can be seen from the data of Examples 1 and 10-11 that when the drying temperature is above 70° C. or below 50° C., the content of monoester alkaloids will be reduced to varying degrees.

[0109] Test Example 2

[0110] In this test example, 15 batches of Radix Aconiti Kusnezoffii medicinal materials were randomly selected, and the preparation method of Example 1 was used for processing verification. The same detection method as in Test Example 1 was used to detect the content of monoester alkaloids and diester alkaloids in the prepared Radix Aconiti Kusnezoffii medicinal materials to verify the stability of the preparation method of Example 1. The results are shown in the following table:

[0111]

[0112] From the above results, it can be seen that the 15 batches of processed Aconitum kusnezoffii slices all meet the content limit requirements of monoester alkaloids and diester alkaloids under the processed Aconitum kusnezoffii item in the 2020 edition of the "Chinese Pharmacopoeia", and this processing process can be stably reproduced.

[0113] The applicant declares that the present invention illustrates the technical solution of the present invention through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of various raw materials of the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0114] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0115] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

Claims

1. A method for preparing Radix Aconiti Kusnezoffii decoction pieces, characterized in that: The preparation method comprises the following steps: (1) According to the diameter, the Aconitum kusnezoffii was divided into large Aconitum kusnezoffii with a diameter of ≥a cm and small Aconitum kusnezoffii with a diameter of <a cm; according to the mass percentage of the total amount of monoester alkaloids, the Aconitum kusnezoffii was divided into group I with a diameter of <b, group II with a diameter of ≥b and ≤c, and group III with a diameter of >c; Get small Aconitum file I, large Aconitum file I, small Aconitum file II, large Aconitum file II, small Aconitum file III and large Aconitum file III; (2) Soak the small Aconitum kusnezoffii grade I, large Aconitum kusnezoffii grade I, small Aconitum kusnezoffii grade II, large Aconitum kusnezoffii grade II, small Aconitum kusnezoffii grade III and large Aconitum kusnezoffii grade III in water respectively; (3) boiling the soaked Aconitum kusnezoffii; (4) drying to obtain the processed Aconiti Kusnezoffii decoction pieces; Wherein, in step (1), a=1-1.5, b=0.015%-0.025%, and c=0.035%-0.045%.

2. The preparation method according to claim 1, characterized in that: The soaking time of the small Aconitum grade I, large Aconitum grade I, small Aconitum grade II, large Aconitum grade II, small Aconitum grade III and large Aconitum grade III in step (2) is 60 to 84 hours, 84 to 108 hours, 108 to 132 hours, 132 hours to 156 hours, 156 hours to 180 hours, and 180 hours to 216 hours, respectively; The soaking temperatures of the small Aconitum grade I, large Aconitum grade I, small Aconitum grade II, large Aconitum grade II, small Aconitum grade III and large Aconitum grade III are all 10-25°C.

3. The preparation method according to claim 1 or 2, characterized in that: The mass ratio of the material to liquid for soaking in step (2) is 1:(6-8).

4. The preparation method according to any one of claims 1 to 3, characterized in that: The soaking process in step (2) also includes changing water, and the number of times of changing water is 2 to 4 times a day.

5. The preparation method according to any one of claims 1 to 4, characterized in that: The cooking method in step (3) includes boiling with water.

6. The preparation method according to claim 5, characterized in that: The mass of water added in the decoction is 6 to 8 times the mass of Aconitum kusnezoffii.

7. The preparation method according to claim 5 or 6, characterized in that: The temperature of the decoction is 90-100° C., and the time of the decoction is 1-3 hours.

8. The preparation method according to any one of claims 1 to 7, characterized in that: Step (3) further includes slicing after cooking.

9. The preparation method according to any one of claims 1 to 8, characterized in that: The drying temperature in step (4) is 50-70° C. and the drying time is 360-600 min.

10. A processed Aconiti Kusnezoffii decoction piece prepared by the method for preparing the processed Aconiti Kusnezoffii decoction piece as claimed in any one of claims 1 to 9.

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