阅读说明：本技术 一种山莨菪碱及其纯化工艺 (Anisodamine and purification process thereof ) 是由 于喜洋 刘东滨 刘千驰 于 2021-08-28 设计创作，主要内容包括：本发明提供一种山莨菪碱及其纯化工艺,涉及医药技术领域。该山莨菪碱的纯化工艺包括以下步骤：将0.05-0.15wt％复合酶溶液加入华山参酶解处理后过滤分离得到山莨菪浸膏和一次滤液；向一次滤液中加入乙醇一进行一次萃取得到萃取液；将萃取液减压蒸馏得到粗提取液；向粗提取液与山莨菪浸膏的混合物中加入乙醇一进行二次萃取过滤后得到二次滤液；将二次滤液于50-60℃的温度下减压蒸馏至无乙醇得到纯化的山莨菪碱。前述操作不仅对山莨菪碱进行了纯化,而且还能最大程度地保留山莨菪碱的生理活性。另一方面,本发明还提出了一种山莨菪碱,其由上述山莨菪碱的纯化工艺制成。该山莨菪碱的纯度较高,生理活性较为优异,且稳定性较好。(The invention provides anisodamine and a purification process thereof, relating to the technical field of medicines. The purification process of anisodamine comprises the following steps: adding 0.05-0.15 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol to the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain crude extract; adding ethanol into the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 50-60 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine. The above operation not only purifies anisodamine, but also retains the physiological activity of anisodamine to the maximum extent. On the other hand, the invention also provides anisodamine which is prepared by the purification process of the anisodamine. The anisodamine has high purity, excellent physiological activity, and good stability.)

1. A process for purifying anisodamine is characterized by comprising the following steps:

adding 0.05-0.15 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol I into the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain a crude extract; adding ethanol to the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 50-60 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

2. The process of claim 1, wherein the complex enzyme is at least two of cellulase, hemicellulase and pectinase.

3. The process for purifying anisodamine according to claim 1, wherein the temperature of the enzymatic treatment is 35-40 ℃ and the enzymatic time is 2-3 hours.

4. The process for purifying anisodamine according to claim 1, wherein in the step of enzymatic hydrolysis, the ratio of the materials of the composite enzyme solution and the Chinese hawthorn is 1: (15-20).

5. The process for purifying anisodamine according to claim 1, wherein the first step of ethanol comprises 70-85 vol% ethanol solution.

6. The process for purifying anisodamine according to claim 1, wherein the radix physochlainae is ground and sieved to obtain fine particles, the mesh number of the fine particles is 20-80 meshes, and the fine particles are added with the complex enzyme solution for enzymolysis.

7. The process for purifying anisodamine according to claim 1, wherein the temperature of the first extraction and the second extraction is 60-70 ℃ and the time of each extraction is 40-60 minutes.

8. The process for purifying anisodamine according to claim 1, wherein before the step of distilling the secondary filtrate under reduced pressure, the secondary filtrate is treated with macroporous adsorbent resin, and then eluted with ethanol to obtain a crude purified solution, and the crude purified solution is distilled under reduced pressure at a temperature of 50-60 ℃ until ethanol is removed to obtain the purified anisodamine.

9. The process for purifying anisodamine according to claim 8, wherein the second ethanol is 50-60 vol% ethanol solution.

10. A anisodamine characterized by being prepared by the process for purifying anisodamine according to any one of claims 1 to 9.

Technical Field

The invention relates to the technical field of medicines, and particularly relates to anisodamine and a purification process thereof.

Background

The anisodamine is an alkaloid extracted from radix Ginseng Indici of Solanaceae, and is prepared from anisodamine hydrobromide as natural product and racanisodamine as artificial synthetic product, which are M choline receptor blocking agents. It has effects in relieving vasospasm (especially capillary), improving microcirculation, relaxing smooth muscle, inhibiting glandular secretion, resisting shock, dilating pupil, and relieving pain, and can be used for treating vertigo, peripheral vascular diseases, eyeground diseases, and sudden deafness. Anisodamine is one of the most commonly used drugs in the primary medical institutions at present as a national basic drug. In recent years, with the progress of research, anisodamine has been used not only for the treatment of general diseases but also for the treatment of many patients in critical conditions and after cardiac surgery, and the application range thereof has been gradually expanded.

However, the primary extract of anisodamine has the disadvantages of low content of effective components, more impurities, unstable quality and the like, which results in poor absorption and utilization by human body. Therefore, in order to improve the utilization rate of the active substances, the anisodamine extract is often purified to improve the purity of the active substances and further improve the drug effect of the anisodamine.

Disclosure of Invention

The invention aims to provide a purification process of anisodamine, which not only gradually purifies the anisodamine, but also can furthest retain the physiological activity of the anisodamine, and concentrates the anisodamine, thereby improving the content of active substances in unit volume and further improving the physiological performance of the anisodamine.

Another object of the present invention is to provide a scopolamine with high purity, excellent physiological activity and good stability.

The technical problem to be solved by the invention is realized by adopting the following technical scheme.

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps: adding 0.05-0.15 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol to the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain crude extract; adding ethanol into the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 50-60 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

The embodiment of the invention also provides anisodamine which is prepared by utilizing the purification process of the anisodamine.

The anisodamine and the purification process of the anisodamine in the embodiment of the invention have at least the following beneficial effects:

on one hand, the embodiment of the invention provides a purification process of anisodamine, which utilizes complex enzyme to act on plant cells in the purification process of the anisodamine to degrade substances such as cellulose, hemicellulose, pectin and the like in plant cell walls and intercellular substances of the radix physochlainae, destroy compact structures of the cell walls, and be beneficial to reducing mass transfer resistance of effective active ingredients in anisodamine cells from diffusion from the cells to an extraction medium, thereby improving the extraction rate of the effective active ingredients. Moreover, the synergistic effect of the complex enzyme can accelerate the dissolution of anisodamine cell walls, thereby improving the extraction rate of anisodamine in the later period. After enzymolysis, the active substance of anisodamine is dissolved out, and after filtration, the impurities and the active substance are separated to obtain primary filtrate containing anisodamine. The anisodamine is easily dissolved in ethanol, and can be extracted by adding ethanol into the primary filtrate, and the obtained extractive solution can be subjected to reduced pressure distillation to obtain crude extractive solution, and remove some soluble impurities. Then, ethanol is added into the mixture of the crude extraction liquid and the anisodamine extract for the first time for the second extraction, and the residual anisodamine in the anisodamine extract is dissolved out according to the principle of similarity and compatibility, so that the obtained secondary filtrate is most similar to the components of the anisodamine in the natural radix physochlainae, and the extraction rate of the anisodamine is also improved. Finally, distilling the secondary filtrate at 50-60 deg.C under reduced pressure until no ethanol is obtained to obtain purified anisodamine. The reduced pressure distillation at the temperature can further purify the anisodamine, the operations not only gradually purify the anisodamine, but also maximally retain the physiological activity of the anisodamine, and the anisodamine is concentrated, so that the content of active substances in unit volume is increased, and the physiological performance of the anisodamine is further improved.

The invention also provides anisodamine which is prepared by the purification process of the anisodamine. The anisodamine has high purity, excellent physiological activity, and good stability.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to specific examples.

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps: adding 0.05-0.15 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol to the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain crude extract; adding ethanol into the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 50-60 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

The physochlaina is a herbaceous plant, plant cells of the physochlaina consist of cell walls and protoplasts, and the cell walls consist of cellulose, hemicellulose, pectin, lignin and other substances. During the extraction process of anisodamine, the above-mentioned substances constituting the cell wall hinder the diffusion of the active ingredients of the protoplast into the extraction medium. Therefore, in the embodiment of the invention, 0.05-0.15% of complex enzyme solution is added into the radix physochlainae for enzymolysis treatment, the complex enzyme acts on plant cells to degrade cellulose, hemicellulose, pectin and other substances in cell walls and intercellular substances of the plant cells, destroy compact structures of the cell walls, reduce mass transfer resistance of effective active ingredients in the anisodus tanguticus from the intracellular direction to an extraction medium, and improve the extraction rate of the effective active ingredients. Moreover, the synergistic effect of the complex enzyme can accelerate the dissolution of anisodamine cell walls, thereby improving the extraction rate of anisodamine in the later period. In detail, the complex enzyme is at least two of cellulase, hemicellulase and pectinase.

Further, in order to improve the dissolution rate of anisodamine, in the embodiment of the invention, the radix physochlainae is ground and sieved to obtain fine particles, the number of the sieved particles is 20-80 meshes, and the fine particles are added with a complex enzyme solution for enzymolysis treatment. The radix Physochlainae is pulverized into small granules, which can increase the contact area between ethanol and radix Physochlainae granules, thereby increasing the dissolution rate of anisodamine, shortening the extraction time, and improving the extraction rate of anisodamine.

In order to improve the activity of the compound enzyme and accelerate the speed of enzymolysis treatment, in the embodiment of the invention, the temperature of the enzymolysis treatment is 35-40 ℃, and the enzymolysis time is 2-3 hours. The complex enzyme has higher activity, accelerated molecular motion and accelerated dissolution and diffusion rates at the temperature, is beneficial to the extraction of anisodamine, and can avoid the reduction of catalytic capability caused by the high-temperature inactivation of the complex enzyme. In addition, the low temperature is also beneficial to protecting the effective components of the anisodamine and avoiding the invalidation caused by the high temperature damage. The enzymolysis time can ensure that the cell wall enzymolysis of the physochlaina is more sufficient, and meanwhile, the phenomenon that the hydrolysate is corrupted due to overlong enzymolysis time can be avoided, and the cost of the heat preservation process is reduced.

Further, in the step of enzymolysis treatment, the feed-liquid ratio of the Huashan mountain participating in the complex enzyme solution is 1: (15-20). In the proportion, the contact area of the complex enzyme and the physochlaina is larger. The enzymolysis reaction rate is relatively high. If the concentration of the complex enzyme is too high, the complex enzyme can be inhibited, so that the complex enzyme is not fully utilized, the waste of resources is caused, and the economic cost is increased; if the concentration of the complex enzyme is too low, the complex enzyme cannot sufficiently hydrolyze the physochlaina huashanensis.

Filtering the suspension after the previous enzymolysis treatment, and separating to obtain anisodamine extract and primary filtrate. Because anisodamine is easily soluble in ethanol, ethanol is selected as the extractant in the embodiment of the invention. Adding ethanol into the primary filtrate, extracting to obtain extractive solution, extracting anisodamine and other substances soluble in ethanol, and distilling under reduced pressure to obtain crude extractive solution. The vacuum distillation can distill the crude product of anisodamine at a lower temperature, and the low-temperature treatment can not only avoid the decomposition of the effective components, but also reduce the cost and save the energy. According to the principle of similar phase dissolution, in the embodiment of the invention, 70-85 vol% ethanol solution is adopted as ethanol I. The ethanol solution with the concentration has high extraction rate of anisodamine, and if the concentration is exceeded, the water content in ethanol is low, the polarity of the solvent is weakened, the extraction of anisodamine is not facilitated, and the extraction rate is reduced.

In order to improve the bioavailability of the radix anisodamine, in the embodiment of the invention, ethanol is added into the mixture of the crude extraction liquid and the radix anisodamine extract for primary extraction, so that the residual radix anisodamine in the radix anisodamine extract is dissolved out according to the principle of similarity and compatibility, the secondary filtrate is closest to the components of the radix anisodamine in the natural radix anisodamine, and the extraction rate of the radix anisodamine is improved.

In detail, the temperature of the primary extraction and the secondary extraction is 60-70 ℃, and the extraction time is 40-60 minutes each time. The extraction temperature can not only accelerate the molecular movement rate and shorten the extraction time, but also avoid the failure of the anisodamine active ingredient caused by high temperature. The longer the extraction time, the more beneficial the extraction of the active substance. However, too long an extraction time causes excessive impurities to be dissolved out, resulting in a decrease in the extraction rate of anisodamine. Therefore, too long extraction time is not favorable for the extraction of anisodamine, so the extraction time is selected to be 40-60 minutes.

Then distilling the secondary filtrate at 50-60 deg.C under reduced pressure until no ethanol is obtained to obtain purified anisodamine. The reduced pressure distillation at the temperature can remove redundant impurities, further purify the anisodamine, maximally retain the physiological activity of the anisodamine, and concentrate the anisodamine, so that the content of active substances in unit volume is increased, and the physiological performance of the anisodamine is further improved.

Further, before the step of distilling the secondary filtrate under reduced pressure, treating the secondary filtrate by macroporous adsorbent resin, eluting by ethanol II to obtain a purified crude liquid, and distilling the purified crude liquid under reduced pressure at the temperature of 50-60 ℃ until no ethanol exists to obtain the purified anisodamine. And (3) treating the secondary filtrate by using ion exchange resin to remove salts and pigments in the secondary filtrate. When the physochlaina is extracted, a part of impurities such as pigment and salt are often mixed in the solution. Wherein the pigment is mainly derived from pigment contained in the cellulose raw material, and products generated by caramelization reaction, Maillard reaction and the like. During the extraction process of the physochlaina japonica, a large amount of sodium ions are often mixed into the extracting solution. The presence of pigments and salts can reduce the quality of the final product and limit the application of anisodamine, so that the anisodamine needs to be treated by macroporous adsorption resin. And (4) eluting and separating the macroporous adsorption resin by using ethanol to obtain a purified crude liquid, thereby achieving the purposes of purification and impurity removal. Then carrying out reduced pressure distillation treatment to obtain the purified anisodamine.

Specifically, the second ethanol is 50 to 60 vol% ethanol solution. The second ethanol is used as eluent, the volume fraction of the second ethanol is too low or too high, the polarity of the second ethanol is greatly different from that of a target compound, not only is the chemical bond formed by the resin and the active substance damaged, but also other adsorbed impurities compete for desorption, so that the elution rate is reduced, and therefore 50-60 vol% of ethanol is adopted.

The purification process of the anisodamine provided by the embodiment of the invention not only improves the dissolution rate of the anisodamine, but also purifies the anisodamine by a graded purification process, and retains the physiological activity to the maximum extent to ensure the drug effect.

The invention also provides anisodamine which is prepared by the purification process of the anisodamine. The anisodamine has high purity, excellent physiological activity, and good stability.

The features and properties of the present invention are described in further detail below with reference to examples.

Example 1

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

grinding radix Physochlainae, sieving, and sieving to obtain 20 mesh granules; adding 0.05 wt% of complex enzyme solution into the small granules, performing enzymolysis at 40 deg.C for 3 hr, filtering and separating to obtain anisodamine extract and primary filtrate; adding 70 vol% ethanol I into the primary filtrate for primary extraction to obtain extract liquor; distilling the extract under reduced pressure to obtain crude extract; adding 70 vol% ethanol into the mixture of the crude extraction liquid and the anisodamine extract, and performing secondary extraction and filtration to obtain secondary filtrate; treating the secondary filtrate with macroporous adsorbent resin, eluting with 50 vol% ethanol to obtain purified crude liquid, and distilling the purified crude liquid at 50 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

The complex enzyme is cellulase and hemicellulase, the mass ratio of the cellulase to the hemicellulase is 2:1, the feed-liquid ratio of the Huashan participating complex enzyme solution is 1:15, the temperature of the primary extraction and the secondary extraction is 60 ℃, and the extraction time is 60 minutes each time.

Example 2

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

grinding radix Physochlainae, sieving, and sieving to obtain 80 mesh granules; adding 0.15 wt% of complex enzyme solution into the small granules, performing enzymolysis at 35 deg.C for 2 hr, filtering and separating to obtain anisodamine extract and primary filtrate; adding 85 vol% of ethanol I into the primary filtrate for primary extraction to obtain extract liquor; distilling the extract under reduced pressure to obtain crude extract; adding 85 vol% ethanol I into the mixture of the crude extraction liquid and the anisodamine extract, and performing secondary extraction and filtration to obtain secondary filtrate; treating the secondary filtrate with macroporous adsorbent resin, eluting with 60 vol% ethanol to obtain purified crude liquid, and distilling the purified crude liquid at 60 deg.C under reduced pressure until no ethanol is contained to obtain purified anisodamine.

The complex enzyme is cellulase and pectinase, the mass ratio of the cellulase to the pectinase is 2.0:0.9, the feed-liquid ratio of the composite enzyme solution participating in the Huashan mountain is 1:20, the temperature of the primary extraction and the secondary extraction is 70 ℃, and the extraction time is 40 minutes each time.

Example 3

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

grinding the physochlaina huashanensis, sieving the ground physochlaina huashanensis, and screening 45-mesh small particles; adding 0.10 wt% of complex enzyme solution into the small granules, performing enzymolysis at 37 deg.C for 2.5 hr, filtering and separating to obtain anisodamine extract and primary filtrate; adding 80 vol% ethanol I into the primary filtrate for primary extraction to obtain extract liquor; distilling the extract under reduced pressure to obtain crude extract; adding 80 vol% ethanol into the mixture of the crude extraction liquid and the anisodamine extract, and performing secondary extraction and filtration to obtain secondary filtrate; treating the secondary filtrate with macroporous adsorbent resin, eluting with 55 vol% ethanol to obtain purified crude liquid, and distilling the purified crude liquid at 55 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

The complex enzyme is cellulase and pectinase, the feed-liquid ratio of the Huashan participating complex enzyme solution is 1:18, the temperature of the primary extraction and the temperature of the secondary extraction are both 65 ℃, and the extraction time is 50 minutes each time.

Example 4

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

grinding the physochlaina huashanensis, sieving the ground physochlaina huashanensis, and screening out 60-mesh small particles; adding 0.08 wt% of complex enzyme solution into small particles for enzymolysis, and filtering and separating to obtain anisodamine extract and primary filtrate; adding 75 vol% of ethanol I into the primary filtrate for primary extraction to obtain extract liquor; distilling the extract under reduced pressure to obtain crude extract; adding 75 vol% ethanol into the mixture of the crude extraction liquid and the anisodamine extract, and performing secondary extraction and filtration to obtain secondary filtrate; treating the secondary filtrate with macroporous adsorbent resin, eluting with 53 vol% ethanol to obtain purified crude liquid, and distilling the purified crude liquid at 52 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

It is to be noted that the complex enzyme is cellulase and hemicellulase, and the feed-liquid ratio of the Huashan participating complex enzyme solution is 1: 17.

Example 5

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

adding 0.12 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding 78 vol% ethanol I into the primary filtrate for primary extraction to obtain extract liquor; distilling the extract under reduced pressure to obtain crude extract; adding 78 vol% ethanol into the mixture of the crude extraction liquid and the anisodamine extract, and performing secondary extraction and filtration to obtain secondary filtrate; treating the secondary filtrate with macroporous adsorbent resin, eluting with ethanol to obtain a crude purified solution, and distilling the crude purified solution at 58 deg.C under reduced pressure until no ethanol is obtained to obtain purified anisodamine.

It is to be noted that the feed-liquid ratio of the Huashan participating in the complex enzyme solution is 1: 18.

Example 6

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

adding 0.09 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol to the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain crude extract; adding ethanol into the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 56 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

It is to be noted that the feed-liquid ratio of the Huashan participating in the complex enzyme solution is 1: 16.

Example 7

The embodiment of the invention provides a anisodamine purification process, which comprises the following steps:

adding 0.14 wt% of complex enzyme solution into radix Physochlainae for enzymolysis, filtering and separating to obtain anisodamine extract and primary filtrate; adding ethanol to the primary filtrate for primary extraction to obtain an extract; distilling the extract under reduced pressure to obtain crude extract; adding ethanol into the mixture of the crude extraction liquid and the anisodamine extract for secondary extraction and filtration to obtain secondary filtrate; distilling the secondary filtrate at 57 deg.C under reduced pressure until ethanol is removed to obtain purified anisodamine.

Test example 1

According to the guidelines for stability tests of raw materials and preparations (hereinafter referred to as "guidelines"), 1g of the purified scopolamine obtained in examples 1 to 7 was weighed, placed in a petri dish, spread in a thin layer of 5mm or less, and placed at a temperature of 25 deg.C and a relative humidity of 92.5% (KNO) in an open atmosphere₃Saturated solution) and the temperature of 25 ℃ and the relative humidity of 75 percent (NaCl saturated solution), sampling on the 0 th, 5 th and 10 th days after the placement, accurately weighing the quality of the test sample before and after the experiment, and the results are shown in table 1.

TABLE 1

As is clear from the data in Table 1, the purified anisodamine obtained in examples 1-7 has better moisture resistance, and the increased moisture absorption weight of anisodamine is less than 5% under two relative humidity conditions, which shows that the anisodamine purification process proposed in the examples of the present invention can improve the stability of anisodamine and reduce the moisture absorption under high humidity environment.

Test example 2

According to the guideline, 1g of the purified anisodamine obtained in examples 1-7 was weighed, spread in a petri dish, spread in a thin layer of not more than 5mm, placed at 60 ℃ in the open, sampled at 0, 5 and 10 days after placement, and the quality of anisodamine was determined, the results are shown in Table 2.

TABLE 2

As can be seen from the data in Table 2, the content of anisodamine at this temperature did not change significantly, indicating that it is stable at high temperature.

Test example 3

As is clear from the above 2 test examples, the stability of the purified anisodamine obtained in example 7 was relatively poor compared with that of examples 1 to 7, and therefore, the anisodamine of example 7 was selected as the subject of the test example, and the purity of the anisodamine of example 7 (prepared into 50mg/ml of anisodamine solution) was measured by the optical rotation measuring method in the pharmacopoeia.

Through the detection of the detection method, the specific rotation degree of the anisodamine in the embodiment 7 is-32.0 degrees, is close to the specific rotation degree of the anisodamine, is-32.5 degrees, meets the optical activity of the anisodamine, and has higher purity, so that the anisodamine purification process provided by the embodiment of the invention can improve the purity of the anisodamine.

In conclusion, the invention provides anisodamine and a purification process thereof, which not only purify the anisodamine, but also maximally retain the physiological activity of the anisodamine. On the other hand, the invention also provides anisodamine which is prepared by the purification process of the anisodamine. The anisodamine has high purity, excellent physiological activity, and good stability.

The embodiments described above are some, but not all embodiments of the invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be obtained by a person skilled in the art without inventive step based on the embodiments of the present invention, are within the scope of the present invention.