CN107823230B - Hainan holly leaf hard capsule for reducing blood pressure and preparation method thereof - Google Patents
Hainan holly leaf hard capsule for reducing blood pressure and preparation method thereof Download PDFInfo
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- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a folium ilicis hainanensis hard capsule for reducing blood pressure and a preparation method thereof, wherein the folium ilicis hainanensis hard capsule comprises a capsule shell and contents, the contents comprise folium ilicis hainanensis extracts and magnesium stearate, and the content of the magnesium stearate is 0.1-0.2 wt%. The invention adopts a new preparation process to synthesize the antihypertensive capsule of the hainan holly leaf with low magnesium stearate content (0.1-0.2 wt%), stable loading amount and good dissolution rate, obtains unexpected technical effects and is particularly suitable for treating hypertension.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a Hainan holly leaf hard capsule for reducing blood pressure and a preparation method thereof.
Background
Hainanensis Merr (Ilex hainanensis Merr) is leaf of Ilex hainanensis of Aquifoliaceae, and mainly contains flavone compounds such as rutin and hainanensis glucoside. More and more researches show that the Hainan holly has obvious curative effect on hypertension. For example, Liuyuan, Wahuanjin, Longjie super and the like observe the treatment effect of the mountain green tea antihypertensive tablets on hypertension in the pharmacodynamics research on the treatment of hypertension of the mountain green tea antihypertensive tablets, and the result shows that the mountain green tea antihypertensive tablets can obviously reduce the spontaneous activity of mice, have the tendency of inducing the sleep of the mice by cooperating with the subthreshold dose of sodium pentobarbital, and have obvious effects of reducing blood pressure and blood fat; zhao Tieliang and Huwen Zhong, etc. in the observation of the curative effect of mountain green tea hypertension treating tablet, the clinical curative effect of mountain green tea hypertension treating tablet is observed, and the mountain green tea hypertension treating tablet is proved to have obvious blood pressure lowering effect.
The dosage form of the hainan holly leaf is also developed from the initial tablet to the present hard capsule, and compared with the tablet, the capsule has the advantages of high bioavailability, capability of covering the unpleasant odor of the medicine, improvement of the stability of the medicine, prevention of medicine solidification and the like. However, capsules present a general problem: the filling amount is very unstable. In response to this drawback, the prior art generally considers increasing the amount of magnesium stearate to 1%, but increasing the amount of magnesium stearate causes problems of unacceptable dissolution. Therefore, how to stabilize the filling amount of the hainan holly leaf hard capsules without affecting the dissolution rate is a technical problem which needs to be solved at present.
Disclosure of Invention
The invention aims to provide a hainan holly leaf hard capsule which is low in magnesium stearate content, stable in filling amount and qualified in dissolution and a preparation method thereof.
In order to achieve the purpose, the invention adopts the following technical scheme: the pressure-reducing hard capsule of the Hainan holly leaf comprises a capsule shell and contents, wherein the contents comprise Hainan holly leaf extracts and magnesium stearate, and the content of the magnesium stearate is 0.1-0.2 wt%.
Further, the content of magnesium stearate is 0.15 wt%.
Further, the hainan holly leaf extract is prepared by the following steps:
s1, washing Hainan holly leaf, drying in the air, crushing into coarse powder, adding water in an amount which is 3-8 times the weight of the coarse powder, decocting for 1-3 times and 1-3 hours each time, combining decoction, filtering, concentrating filtrate into thick paste, drying, and crushing into fine powder for later use;
and S2, treating the fine powder in a forward direct current electric field for 10-18S, and then treating the fine powder in a reverse direct current electric field for 5-10S, wherein the voltage of forward current and reverse current is 10-22V, and the electric field intensity is 6-10V/m.
Further, in the step S2, the fine powder is firstly treated in a forward direct current electric field for 16S, and then treated in a reverse direct current electric field for 8S, wherein the voltage of the forward current and the reverse current is 10-20V, and the electric field intensity is 8-10V/m.
Accordingly, the method for preparing the camellia sinensis blood pressure reducing hard capsule comprises the following steps:
A) preparation of hainan holly leaf extract: the method comprises the following steps of S1-S2:
s1, washing Hainan holly leaf, drying in the air, crushing into coarse powder, adding water in an amount which is 3-8 times the weight of the coarse powder, decocting for 1-3 times and 1-3 hours each time, combining decoction, filtering, concentrating filtrate into thick paste, drying, and crushing into fine powder for later use;
and S2, treating the fine powder in a forward direct current electric field for 10-18S, and then treating the fine powder in a reverse direct current electric field for 5-10S, wherein the voltage of forward current and reverse current is 10-22V, and the electric field intensity is 6-10V/m.
B) And adding starch in an amount which is 1-2 times the weight of the hainan holly leaf extract into the hainan holly leaf extract, mixing uniformly, granulating with 90% ethanol, drying, adding 0.1-0.2 wt% of magnesium stearate, mixing uniformly, and filling into a capsule shell to obtain the Chinese medicinal capsule.
Further, in the step S2, the fine powder is firstly treated in a forward direct current electric field for 16S, and then treated in a reverse direct current electric field for 8S, wherein the voltage of the forward current and the reverse current is 10-20V, and the electric field intensity is 8-10V/m.
When the hard capsules are produced according to the traditional process, the filling amount is difficult to keep stable during medicine filling, for example, the filling amount ranges from 0.324 to 0.375g, 5 capsules with unqualified filling amount can exist in every 20 capsules by spot check of samples, some capsules with the filling amount as high as 0.378g, and some capsules with the filling amount as low as 0.321 g. In contrast, the inventors have conducted extensive experimental studies and have considered that the poor flowability of the drug is caused. Thus, the inventors first tried to granulate a powdery drug, but the problem of unstable loading was not solved. Secondly, the inventors tried to increase the amount of magnesium stearate to 1wt% and found that the stability of the filled amount was improved, but increasing the amount of magnesium stearate easily resulted in defective dissolution of the capsule, and the dissolution percentage was 66.1%. The inventor finds out whether a method exists, which can improve the fluidity of the medicine on one hand and is beneficial to filling, and on the other hand, does not influence the dissolution rate of the capsule.
The inventor finds that the flowability of the traditional Chinese medicine fine powder can be improved to a certain extent after the traditional Chinese medicine fine powder is subjected to electric field treatment, more preferably the traditional Chinese medicine fine powder is subjected to electric field treatment with periodically changed directions, and specifically the traditional Chinese medicine fine powder is firstly placed in a forward direct current electric field for treatment for 10-18 s and then is placed in a reverse direct current electric field for treatment for 5-10 s. Surprisingly, the content of magnesium stearate in the processed traditional Chinese medicine fine powder is about 0.1-0.2 wt% when the traditional Chinese medicine fine powder is prepared into hard capsules, so that the filling stability can be greatly improved, the dissolution rate of the capsules is not influenced by the content of magnesium stearate due to the low content of magnesium stearate in the capsules, the dissolution percentage can reach more than 80%, and unexpected technical effects are achieved.
The invention has the following advantages:
the invention adopts a new preparation process to synthesize the Hainan holly leaf blood pressure reducing capsule which has low magnesium stearate content, stable filling amount and good dissolution rate, obtains unexpected technical effects and is particularly suitable for treating hypertension.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
Example 1 raw material formulation of Hainan holly leaf blood pressure lowering capsule of the present invention
Formula 1: 99.85wt% of Hainan holly leaf extract and 0.15wt% of magnesium stearate;
and (2) formula: 99.8wt% of Hainan holly leaf extract and 0.2wt% of magnesium stearate;
and (3) formula: 99.9wt% of Hainan holly leaf extract and 0.1wt% of magnesium stearate.
Example 2 preparation of Hainan holly leaf antihypertensive capsules
A) Preparation of hainan holly leaf extract:
s1, washing Hainan holly leaf, drying in the air, crushing into coarse powder, adding water with the weight 6 times of that of the coarse powder, decocting for 2 times, 2 hours each time, combining decoction, filtering, concentrating filtrate into thick paste, drying, and crushing into fine powder for later use;
and S2, treating the fine powder in a forward direct current electric field for 16S, and then treating the fine powder in a reverse direct current electric field for 8S, wherein the voltage of the forward current and the reverse current is 15V, and the electric field intensity is 8V/m.
B) Adding starch 2 times the weight of folium Ilicis Hainanensis extract into the obtained folium Ilicis Hainanensis extract, mixing, granulating with 90% ethanol, drying, adding 0.15wt% magnesium stearate, mixing, and making into capsule shell with a weight of 0.35 g/capsule.
Example 3 preparation of Hainan holly leaf antihypertensive capsules
The difference between the embodiment 3 and the embodiment 2 is that the forward dc electric field processing time is 10S and the reverse dc electric field processing time is 5S in the step S2, and the rest parameters and operations are as in the embodiment 2.
Example 4 preparation of Hainan holly leaf antihypertensive capsules
The difference between the embodiment 4 and the embodiment 2 is that the forward dc electric field processing time in the step S2 is 18S, the reverse dc electric field processing time is 10S, and the rest parameters and operations are the same as those in the embodiment 2.
Comparative example 1 preparation of Hainan tea antihypertensive capsule of the present invention
Comparative example 1 differs from example 2 in that step S2 is omitted and the remaining parameters and operation are as in example 2.
Comparative example 2 preparation of Hainan tea antihypertensive capsule of the present invention
Comparative example 2 differs from example 2 in that step S2 eliminates the operation of applying reverse dc treatment, and the remaining parameters and operation are as in example 2.
Comparative example 3 preparation of Hainan tea antihypertensive capsule of the present invention
Comparative example 3 differs from example 2 in that step S2 is omitted, step B) is added with 1wt% magnesium stearate, and the remaining parameters and operation are as in example 2.
Test example I, Loading stability test
Taking the hard capsules prepared in the example 2 and the comparative examples 1 to 3, respectively weighing 20 hard capsule samples prepared in the groups, respectively, precisely weighing the weights, pouring out the contents (without losing the capsule shells), wiping the hard capsule shells by using a small brush or other suitable tools (such as cotton swabs and the like), precisely weighing the capsule shells respectively, obtaining the content of each content, recording the measured content data (tables 2 to 5) of the samples in the groups, and obtaining the average content (m) of each group of samples and reserving 3 effective figures. The loading range (granule weight range = m ± m × weight difference limit) was determined based on the loading difference limit specified in table 1, and if the loading of each capsule in each group was within the allowable loading range, it was judged as being in compliance with the regulation, and if not, it was judged as being out of compliance.
TABLE 1 Loading Difference limits
Limit of mean weight (m) loading difference
Less than 0.30g plus or minus 10 percent
0.30g or more than 0.30g plus or minus 7.5 percent
Table 2 example 2 hard capsule preparation each granule content (n =20, g)
Serial number 12345
Loading 0.3500.3500.3500.3500.350
Serial number 678910
Loading 0.3490.3500.3500.3500.352
Serial number 1112131415
Loading 0.3500.3500.3510.3500.349
Serial number 1617181920
Loading 0.3500.3500.3500.3500.350
The average loading is calculated as: 0.3505 ≈ 0.351g, allowable loading range: 0.351 +/-0.351 multiplied by 7.5% = 0.325-0.377 g, and the filling amount of each capsule in the embodiment 2 is within the allowable filling amount range, thereby meeting the regulation.
Table 3 content of each granule of the hard capsule of comparative example 1 (n =20, g)
Serial number 12345
Loading 0.3520.3560.3350.3230.350
Serial number 678910
Loading 0.3650.3780.3520.3510.350
Serial number 1112131415
Loading 0.3770.3450.3490.3520.349
Serial number 1617181920
Loading 0.3500.3480.3210.3550.323
The average loading is calculated as: 0.349g, allowable loading range: 0.349 +/-0.349 multiplied by 7.5% = 0.324-0.375 g. Compared with the example 2, the periodic positive and negative direct current electric field treatment is omitted in the comparative example 1, and the examination shows that 5 hard capsules of the 20 comparative examples 1 exceed the filling range, are respectively numbered 4, 6, 11, 18 and 20 and are not in compliance. This shows that the periodic positive and negative DC electric field treatment is favorable for improving the stability of the hard capsule filling amount and is favorable for filling the medicine.
Table 4 content of each granule of the hard capsule of comparative example 2 (n =20, g)
Serial number 12345
Loading 0.3510.3570.3340.3240.350
Serial number 678910
Loading 0.3650.3770.3530.3520.351
Serial number 1112131415
Loading 0.3760.3440.3480.3530.350
Serial number 1617181920
Loading 0.3490.3490.3240.3520.325
The average loading is calculated as: 0.3492 ≈ 0.349g, allowed loading range: 0.349 +/-0.349 multiplied by 7.5% = 0.324-0.375 g. Compared with the example 2, the comparative example 2 does not need the treatment of introducing the reverse direct current, and 2 hard capsules out of 20 hard capsules are detected to be out of the filling range and not meet the requirements.
TABLE 5 filling of each granule of the hard capsule of comparative example 3 (n =20, g)
Serial number 12345
Loading 0.3500.3520.3490.3520.350
Serial number 678910
Loading 0.3650.3500.3520.3520.351
Serial number 1112131415
Loading 0.3620.3450.3480.3500.350
Serial number 1617181920
Loading 0.3500.3480.3500.3510.349
The average loading is calculated as: 0.3513 ≈ 0.351g, allowable loading range: 0.351 +/-0.351 multiplied by 7.5% = 0.324-0.377 g. Compared with the embodiment 2, the comparative example 3 omits the electrifying treatment, but increases the content of magnesium stearate and improves the fluidity of the medicine, so that the prepared hard capsule has better filling stability and meets the requirement.
Test example two measurement of dissolution
2.1 hard capsule test sample liquid preparation: taking 20 hard capsules prepared in example 2 and comparative example 3, pouring out the contents, uniformly mixing, taking about 0.2g, precisely weighing, placing in a 50ml measuring flask, adding about 15% ml of 60% ethanol, dissolving by ultrasonic, cooling to room temperature, fixing the volume to the scale by using 60% ethanol, and shaking up to obtain the hard capsule.
2.2 chromatographic conditions: column active ZORBAX SB-C18 (4.6 mm. times.250 mm, 5 μm); mobile phase: methanol-acetonitrile-0.6% phosphoric acid (15: 15: 70); detection wavelength: 355 nm; flow rate: 1.0 ml/min; column temperature: 45 ℃; sample introduction amount: 10 μ L.
2.3 inspection of Linear Range
Accurately weighing rutin 10.17mg, placing in 100m L measuring flask, dissolving with methanol, diluting to scale, and shaking to obtain rutin control solution. Taking a proper amount of the reference solution, centrifuging for 10min at 12000 r.min-1, precisely sucking 2, 4, 6, 8, 10 and 12 mu L of supernate, injecting into a high performance liquid chromatograph, measuring peak area, and drawing a standard curve by taking the peak area as a vertical coordinate and the sample amount as a horizontal coordinate to obtain a regression equation.
2.4 determination of rutin content of each group of capsule samples: accurately sucking 10 mu L of each group of liquid medicine prepared in the 3.1 items, adding 2ml of fresh medium with the same temperature immediately after each sampling in parallel, filtering the sample by a 0.8 mu m microporous filter membrane immediately, taking 50 mu L of filtrate, sampling in parallel in 2 parts, recording peak areas, calculating the rutin content in the sample according to an external standard peak area method, and determining that the hard capsules prepared in the example 2 and the comparative example 3 are 0.92 mg/capsule, 0.86 mg/capsule and 0.89 mg/capsule respectively and taking the values as reference values when 100% is dissolved out.
2.5 dissolution rate determination:
the method is carried out by adopting item 3 under the dissolution rate determination item of 2000 th edition of Chinese medicine pharmacopoeia, the rotating speed is 50r/min, 150ml of pure water is taken as a medium, the temperature is 37 ℃, the sampling time points are 10, 15, 30, 45, 60, 90, 120 and 150min, and the sampling amount is 2 ml. After each sampling, 2ml of fresh medium with the same temperature is immediately supplemented, the sample is immediately filtered by a 0.8-micron microporous filter membrane, 50 mu L of filtrate is taken, the rutin content of the liquid medicine of each group of samples is measured according to the method operation under 3.4, the cumulative dissolution percentage of each capsule is calculated, and the results are shown in Table 6.
Table 6 cumulative percent dissolution for example 2 and comparative example 3 capsules
Percent dissolution (min) for different sampling times of group
10 15 30 45 60 90 120 150
Example 223.5% 55.6% 62.7% 65.2% 66.8% 71.9% 80.5% 82.6%
Comparative example 315.3% 22.4% 35.9% 48.6% 52.3% 58.9% 65.3% 66.1%
As can be seen from table 6, the content of magnesium stearate in the hard capsule prepared by the preparation process of the present invention is only 0.15wt%, but the dissolution rate is good, and the dissolution percentage reaches 82.6%, so that unexpected technical effects are obtained. In contrast, in comparative example 3, compared to example 2, the energization treatment was omitted, the content of magnesium stearate was increased to 1wt%, and although the filling stability of the hard capsule was improved to some extent, the dissolution rate of the capsule was greatly affected, and the dissolution percentage was decreased from 82.6% to 66.1%.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (1)
1. The Hainan holly leaf hard capsule for reducing blood pressure is characterized by consisting of a capsule shell and contents, and the preparation method of the Hainan holly leaf hard capsule for reducing blood pressure comprises the following steps:
A) preparation of hainan holly leaf extract:
s1, washing Hainan holly leaf, drying in the air, crushing into coarse powder, adding water with the weight 6 times of that of the coarse powder, decocting for 2 times, 2 hours each time, combining decoction, filtering, concentrating filtrate into thick paste, drying, and crushing into fine powder for later use;
s2, placing the fine powder in a forward direct current electric field for treatment for 16S, and then placing the fine powder in a reverse direct current electric field for treatment for 8S, wherein the voltage of forward current and reverse current is 15V, and the electric field intensity is 8V/m;
B) adding starch 2 times the weight of the above folium Ilicis Hainanensis extract into the above obtained folium Ilicis Hainanensis extract, mixing, granulating with 90% ethanol, drying, adding magnesium stearate, mixing, and making into capsule shell with a weight of 0.35 g/capsule; wherein, the percentage content of the folium ilicis hainanensis extract and the magnesium stearate is respectively 99.85wt% and 0.15wt% based on the total amount of the folium ilicis hainanensis extract and the magnesium stearate as 100%.
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