CN112402488A - Compound red sage root concentrated pill and its preparing method - Google Patents
Compound red sage root concentrated pill and its preparing method Download PDFInfo
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- CN112402488A CN112402488A CN202011495838.4A CN202011495838A CN112402488A CN 112402488 A CN112402488 A CN 112402488A CN 202011495838 A CN202011495838 A CN 202011495838A CN 112402488 A CN112402488 A CN 112402488A
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
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- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract
The invention discloses a compound red sage root concentrated pill and a preparation method thereof, relating to the technical field of traditional Chinese medicines, wherein the compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 140 parts of salvia miltiorrhiza bunge, 40-45 parts of pseudo-ginseng and 2-3 parts of borneol; the preparation method of the compound red sage root concentrated pill comprises the following steps: weighing the raw materials for later use; extracting Saviae Miltiorrhizae radix with ethanol, and concentrating to obtain Saviae Miltiorrhizae radix soft extract; pulverizing cleaned and dried Notoginseng radix into fine powder, and mixing with the above Saviae Miltiorrhizae radix soft extract; grinding Borneolum Syntheticum, dissolving with ethanol, mixing with Notoginseng radix fine powder and Saviae Miltiorrhizae radix soft extract, making pill, drying at low temperature, and coating with film to obtain compound Saviae Miltiorrhizae radix concentrated pill. The preparation method of the compound salvia miltiorrhiza concentrated pill reduces the drying process in the mixing stage of the raw materials, reduces the process, reduces the loss of effective components and has better drug effect.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a compound salvia miltiorrhiza concentrated pill and a preparation method thereof.
Background
Compound red sage pills (concentrated pills) are a famous Chinese patent medicine for treating cardiovascular diseases. It is prepared from red sage root, notoginseng, borneol, etc. The compound red sage root pill (concentrated pill) has the functions of promoting blood circulation to disperse blood clots, inducing resuscitation, regulating vital energy and relieving pain, is used mainly in treating coronary heart disease caused chest distress, vexation, angina pectoris, insomnia, etc. and has similar recipe and different preparation process.
In the preparation process of the compound salvia miltiorrhiza pill, the setting of each process condition, the specific operation steps and the detailed parameters are very important, and the quality and the clinical effect of the final medicine can be influenced unpredictably by changing any process condition and deleting any operation steps. The existing process for preparing the compound salvia miltiorrhiza pill is complicated in steps and serious in loss of effective ingredients.
Disclosure of Invention
Therefore, the invention provides a compound salvia miltiorrhiza concentrated pill and a preparation method thereof, and aims to solve the problems of complicated process steps and serious loss of effective components in the existing preparation of the compound salvia miltiorrhiza pill.
In order to achieve the above purpose, the invention provides the following technical scheme:
according to the first aspect of the invention, the compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 140 parts of salvia miltiorrhiza bunge, 40-45 parts of pseudo-ginseng and 2-3 parts of borneol;
the preparation method of the compound red sage root concentrated pill comprises the following steps:
weighing the raw materials for later use;
extracting Saviae Miltiorrhizae radix with ethanol, and concentrating to obtain Saviae Miltiorrhizae radix soft extract;
pulverizing cleaned and dried Notoginseng radix into fine powder, and mixing with the above Saviae Miltiorrhizae radix soft extract;
grinding Borneolum Syntheticum, dissolving with ethanol, mixing with Notoginseng radix fine powder and Saviae Miltiorrhizae radix soft extract, making pill, drying at low temperature, and coating with film to obtain compound Saviae Miltiorrhizae radix concentrated pill.
Further, the compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 135 parts of salvia miltiorrhiza, 42.3 parts of pseudo-ginseng and 2.4 parts of borneol.
Further, the specific process of extracting and concentrating the salvia miltiorrhiza by adopting an ethanol extraction method is as follows: adding ethanol into Saviae Miltiorrhizae radix, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; adding 50% ethanol into the residue, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; decocting the residue in water for 2 hr, filtering the decoction, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, and concentrating to obtain soft extract.
Further, the pseudo-ginseng is prepared into 400-1200-mesh ultrafine powder by an ultrafine pulverizer after being pulverized.
Further, the fineness of the ground borneol is 100 meshes.
The invention has the following advantages:
compared with the existing preparation process of the compound red sage root concentrated pill, the preparation method of the compound red sage root concentrated pill reduces the drying process in the mixing stage of the raw materials, thus shortening the process flow and simplifying the preparation process. The appearance and the water content of the prepared compound red sage root concentrated pill conform to the standard of Chinese pharmacopoeia, and the prepared compound red sage root concentrated pill is superior to the existing compound red sage root concentrated pill in the aspects of effective components, dissolving time limit and stability.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It should be apparent that the drawings in the following description are merely exemplary, and that other embodiments can be derived from the drawings provided by those of ordinary skill in the art without inventive effort.
The structures, ratios, sizes, and the like shown in the present specification are only used for matching with the contents disclosed in the specification, so that those skilled in the art can understand and read the present invention, and do not limit the conditions for implementing the present invention, so that the present invention has no technical significance, and any structural modifications, changes in the ratio relationship, or adjustments of the sizes, without affecting the functions and purposes of the present invention, should still fall within the scope of the present invention.
FIG. 1 is a comparison chart of a sample chromatogram, a tanshinone IIA reference chromatogram and a borneol reference chromatogram provided by an experimental example of the present invention;
FIG. 2 is a comparison chart of the chromatogram of a test sample of the compound red sage root concentrated pill, the chromatogram of a panax notoginseng reference drug, the chromatogram of a panax notoginseng saponin reference, and the chromatogram of a ginsenoside reference, which are provided by the experimental example of the invention;
fig. 3 is a comparison chart of the chromatogram of the test sample of the compound red sage root concentrated pill, the chromatogram of the pseudo-ginseng control drug, the chromatogram of the pseudo-ginseng saponin control and the chromatogram of the ginsenoside control provided by the embodiment of the invention.
Detailed Description
The present invention is described in terms of particular embodiments, other advantages and features of the invention will become apparent to those skilled in the art from the following disclosure, and it is to be understood that the described embodiments are merely exemplary of the invention and that it is not intended to limit the invention to the particular embodiments disclosed. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Examples
A compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 1350g of salvia miltiorrhiza, 423g of pseudo-ginseng and 24g of borneol;
the preparation method of the compound red sage root concentrated pill comprises the following steps:
weighing the raw materials for later use;
adding ethanol into Saviae Miltiorrhizae radix, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; adding 50% ethanol into the residue, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; decocting the residue in water for 2 hr, filtering the decoction, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, and concentrating to obtain soft extract.
Pulverizing cleaned and dried Notoginseng radix, micronizing into superfine powder of 400-1200 meshes, and mixing with the above Saviae Miltiorrhizae radix soft extract;
mixing the superfine powder with the Saviae Miltiorrhizae radix fluid extract;
grinding Borneolum Syntheticum into 100 mesh, dissolving with ethanol, mixing with Notoginseng radix fine powder and Saviae Miltiorrhizae radix soft extract, making pill, drying at low temperature, and coating with film to obtain compound Saviae Miltiorrhizae radix concentrated pill. The compound Saviae Miltiorrhizae radix concentrated pill is coated concentrated pill, and appears brown to brown after removing coating, and has aromatic gas and slightly bitter taste.
Comparative example
A compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 1350g of salvia miltiorrhiza, 423g of pseudo-ginseng and 24g of borneol;
the preparation method of the compound red sage root concentrated pill comprises the following steps:
weighing the raw materials for later use;
adding ethanol into Saviae Miltiorrhizae radix, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; adding 50% ethanol into the residue, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; decocting the residue in water for 2 hr, filtering the decoction, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, and concentrating to obtain soft extract.
Pulverizing cleaned and dried Notoginseng radix, micronizing into superfine powder of 400-1200 meshes, and mixing with the above Saviae Miltiorrhizae radix soft extract;
mixing the superfine powder with the Saviae Miltiorrhizae radix fluid extract, drying, and pulverizing into 60-80 mesh coarse powder; the drying conditions were: the temperature is 100-120 ℃, and the time is 40-60 min.
Grinding Borneolum Syntheticum into 100 mesh, dissolving with ethanol, mixing with the above coarse powder, making pill, drying at low temperature, and coating with film to obtain compound Saviae Miltiorrhizae radix concentrated pill.
Examples of the experiments
1. The effective components are measured by adopting an HPLC-DAD method to prepare the compound red sage root concentrate obtained in the examples and the comparative examplesTanshinone II as main effective component in shrinkage pillAThe contents of salvianolic acid B and panax notoginsenosides are measured, and the main instruments adopted in the experiment comprise a Waters e2695 type high performance liquid chromatograph (USA), a Waters2695 type high performance liquid chromatograph (USA) and an Shimadzu LC-2030 (Japan), wherein the contents of the effective components are shown in Table 1:
TABLE 1 comparison table of the effective components in the concentrated pill of compound radix Salviae Miltiorrhizae obtained in the examples and comparative examples
| Tanshinone IIA | Salvianolic acid B | Notoginseng radix total saponin | |
| Example Compound Danshen root concentrated pill | 1.67mg/g | 26.5mg/g | 47.1mg/g |
| Comparative example compound red sage root concentrated pill | 1.64mg/g | 26.1mg/g | 46.5mg/g |
2. Comparison of thin layer chromatography
(1) Thin layer chromatography
And (3) checking date:2020.03.14temperature:17humidity of ° c:46％
scale model:SL-N/BT25Snumbering:AM-HS-003/004
tanshinone IIASources of the reference substances: intermediate inspection lot number:110766-201721
the borneol reference substance is from the following sources: intermediate inspection lot number:110747-201008
taking the product1g, grinding, adding diethyl ether15ml, ultrasonic treatment for 5 minutes, filtration, evaporation of the filtrate, addition of ethyl acetate to the residue1ml is dissolved to prepare a test solution. Taking another tanshinone IIAReference substance2.18mg, adding ethyl acetate to make into 1ml per1mg of the solution, and taking the reference substance of the ice flakes2.31mg, adding ethyl acetate to make into 1ml per1mg solution as control solution. Testing the operating procedures by thin layer chromatography, and sucking the sample solution4μ l, control solution2Mu.l of the solution is respectively spotted on the same silica gel G thin layer plate, and is developed by taking toluene-ethyl acetate (19: 1) as a developing agent, taken out and dried. In the test chromatogram, the sample is mixed with tanshinone IIAAt the corresponding position of the chromatogram of the reference substance, showingAre identical to each otherA spot of color; spraying 2% vanillin-sulfuric acid solution as developer, heating at 110 deg.C to develop color of spot, and developing at the position corresponding to the color spectrum of Borneolum Syntheticum control in the sample color spectrumAre identical to each otherSpots of color.
As shown in fig. 1, the left 1 is a tanshinone 2A control, the left 2 is a borneol control, the left 3-5 samples are comparative example compound red sage root concentrated pills, and the left 6-8 samples are example compound red sage root concentrated pills, as can be seen from fig. 1, spots of the same color appear at the positions corresponding to the color spectrums of the sample, the tanshinone iia control and the borneol control, the color of the compound red sage root concentrated pill in the example is obviously darker than that of the compound red sage root concentrated pill in the comparative example, which indicates that the contents of tanshinone 2A and borneol in the compound red sage root concentrated pill in the example are more than that of the compound red sage root concentrated pill in the comparative example.
(2) Thin layer chromatography
And (3) checking date:2020.03.14temperature:17humidity of ° c:46％
scale model:SL-N/BT25Snumbering:AM-HS-003/004
the sources of the pseudo-ginseng reference medicinal materials are as follows: intermediate inspection lot number:120941-201409
notoginseng radix saponin R1Sources of the reference substances: intermediate inspection lot number:110745-201318
ginsenoside Rb1Sources of the reference substances: intermediate inspection lot number:110704-201726
ginsenoside Rg1Sources of the reference substances: intermediate inspection lot number:110703-201731
the ginsenoside Re reference substance source is as follows: intermediate inspection lot number:110754-201525
taking the product0.5g, grinding, adding 25ml of water saturation n-butanol, performing ultrasonic treatment for 20 min, filtering, washing the filtrate with ammonia solution for 2 times, each time 20ml, discarding the ammonia solution layer, recovering solvent from n-butanol solution to dryness, adding methanol into the residue0.5ml is dissolved to prepare a test solution. Taking Notoginseng radix as reference material0.53gAdding methanol5ml, ultrasonic treatment for 15min, and supernatant as control solution. Collecting notoginsenoside R1Reference substance2.26mg, ginsenoside Rb1 2.11mg, ginsenoside Rg1 2.04mg, ginsenoside Re2.21mg, adding methanol to each 1ml solution to obtain control solution containing 1 mg. Extracting each of the above six solutions by thin layer chromatography2Mu l of the solution is respectively spotted on the same high-efficiency silica gel G thin layer plate, methylene dichloride-absolute ethyl alcohol-water (70: 45: 6.5) is used as a developing agent, and the solution is developed, taken out and dried in the air. Is sprayed with10% sulphuric acid ethanol solution color developing agent, heating at 105 deg.C until the color development of spots is clear, and inspecting under sunlight and ultraviolet light (365 nm). The chromatogram of the test solution is shown at the corresponding position of the chromatogram of the reference solution and the chromatogram of the reference solutionAre identical to each otherSpots of color or spots of fluorescence.
In FIG. 2, the left 1 is Notoginseng radix control material, and the left 2 is ginsenoside Rb1The left 3 is ginsenoside R1, the left 4 is ginsenoside Re, the left 5 is ginsenoside Rg1The left 6-8 is a test sample of the compound salvia miltiorrhiza concentrated pill in the comparative example; in fig. 3, the left 1 is Notoginseng radix control material, and the left 2 is ginsenoside Rb1The left 3 is ginsenoside R1, the left 4 is ginsenoside Re, the left 5 is ginsenoside Rg1And the left 6-8 are the test samples of the compound salvia miltiorrhiza concentrated pills in the embodiment. As can be seen from fig. 2-3, the same color spots appear in the corresponding positions of the chromatogram of the test sample, the chromatogram of the notoginsenoside reference substance and the chromatogram of the ginsenoside reference substance, and the color of the compound red-rooted salvia concentrated pill in the embodiment is obviously darker than that of the compound red-rooted salvia concentrated pill in the comparative example, which indicates that the contents of notoginsenoside and ginsenoside in the compound red-rooted salvia concentrated pill in the embodiment are higher than those in the compound red-rooted salvia concentrated pill in the comparative example.
3. Table for comparison of degree of pulverization (particle size) the second ultrafine powders prepared in examples and comparative examples were observed by an electron microscope and compared in degree of pulverization and particle size distribution, as shown in table 2.
TABLE 2 comparative table of the degree of pulverization (particle size) of the second ultrafine powder prepared in examples and comparative examples
4. Comparative table of dissolution time limit
TABLE 3 comparative table of the dissolution time period of the compound Saviae Miltiorrhizae radix concentrated pill prepared in the example and the comparative example
| Time limit of dissolution | |
| Example Compound Danshen root concentrated pill | 4 minutes |
| Comparative example compound red sage root concentrated pill | 5 minutes |
5. Appearance and moisture content evaluation the appearance and moisture content evaluation of the compound red sage root concentrated pills obtained in the examples and the comparative examples have round and uniform appearance and consistent color, and the moisture content is less than 9 percent.
6. The stability test was carried out at a temperature of 25 ℃. + -. 2 ℃ and a relative humidity of 60%. + -. 10%, based on the change in the content of borneol in the pellets, and the test results are shown in Table 4 below.
| Example Compound Danshen root concentrated pill | Comparative example compound red sage root concentrated pill | |
| 0 month | 20.08 | 19.03 |
| 6 month | 18.58 | 17.48 |
| 12 month | 17.35 | 16.12 |
| 18 months | 14.85 | 13.89 |
| 24 months | 12.00 | 10.82 |
| Rate of loss | 40.21％ | 43.1％ |
Compared with a comparative example, the preparation method of the compound red sage root concentrated pill in the embodiment of the invention directly mixes the superfine powder and the red sage root thick paste into pills without drying, thus reducing the process steps and simplifying the preparation process from the aspect of the preparation method. The experimental results show that the appearance and the water content of the compound red sage root concentrated pill prepared by the invention both accord with the standard of Chinese pharmacopoeia, and are superior to the compound red sage root concentrated pills of the prior comparative example in the aspects of effective components, dissolving time limit and stability.
Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (5)
1. The compound red sage root concentrated pill is characterized by being prepared from the following raw materials in parts by weight: 140 parts of salvia miltiorrhiza bunge, 40-45 parts of pseudo-ginseng and 2-3 parts of borneol;
the preparation method of the compound red sage root concentrated pill comprises the following steps:
weighing the raw materials for later use;
extracting Saviae Miltiorrhizae radix with ethanol, and concentrating to obtain Saviae Miltiorrhizae radix soft extract;
pulverizing cleaned and dried Notoginseng radix into fine powder, and mixing with the above Saviae Miltiorrhizae radix soft extract;
grinding Borneolum Syntheticum, dissolving with ethanol, mixing with Notoginseng radix fine powder and Saviae Miltiorrhizae radix soft extract, making pill, drying at low temperature, and coating with film to obtain compound Saviae Miltiorrhizae radix concentrated pill.
2. The compound red sage root concentrated pill according to claim 1, wherein the compound red sage root concentrated pill is prepared from the following raw materials in parts by weight: 135 parts of salvia miltiorrhiza, 42.3 parts of pseudo-ginseng and 2.4 parts of borneol.
3. The compound red sage root concentrated pill according to claim 1, wherein the red sage root is extracted and concentrated by ethanol extraction method as follows: adding ethanol into Saviae Miltiorrhizae radix, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; adding 50% ethanol into the residue, heating and refluxing for 1.5 hr, filtering the extractive solution, recovering ethanol from the filtrate, and concentrating to appropriate amount; decocting the residue in water for 2 hr, filtering the decoction, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, and concentrating to obtain soft extract.
4. The compound Danshen root concentrated pill as claimed in claim 1, wherein the Sanchi material is pulverized and made into 400-1200 mesh ultra-fine powder by an ultra-fine pulverizer.
5. The compound salvia miltiorrhiza pill as claimed in claim 1, wherein the fineness of the borneol powder is 100 meshes.
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| CN104622960A (en) * | 2015-01-23 | 2015-05-20 | 爱民药业集团股份有限公司 | Compound salviae miltiorrhizae condensed pill and preparation method thereof |
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| CN115429827A (en) * | 2022-09-14 | 2022-12-06 | 爱民药业集团股份有限公司 | Preparation method of compound salvia miltiorrhiza concentrated pill |
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