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Chinese medicine dispensing granules, the result of the efforts to transform Chinese medicinal decoction pieces in China, features portability and ease of storage. Thus, it is destined to be an indispensible dosage form in the modernization drive of Chinese medicine. The Announcement on Ending the Pilot Project of Chinese Medicine Dispensing Granules was released in February 2021 and relevant regulations went into force in November 2021, which marks the a new journey for the development of Chinese medicine dispensing granules and the beginning of the "post-pilot era". However, it faces the challenges in quality and standard. This study reviewed the history of Chinese medicine dispensing granules, analyzed the technical progress, market, and main problems in development, and proposed suggestions and prospects for its development in the "post-pilot era", which is expected to serve as a reference for its industry development and rational use.
Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Industrial Development , Medicine, Chinese Traditional , Pilot ProjectsABSTRACT
Objective:To study the regulative effect of Rhubarb dispensing granule on autophagy and gastrointestinal motility of Cajal interstitial cells in rats with chronic transit constipation (STC).Methods:A total of 75 rats were randomly divided into control group, model group, low, medium and high dose groups with 15 rats in each group. Except for the control group, the STC rat models were established by intragastric administration of compound diphenoxylate suspension. Rats in low, medium and high dose groups were given Rhubarb dispensing granule of 1, 2 and 4 g/kg by gavage respectively, while rats in control group and model group were given normal saline with the same volume by gavage, once a day for 14 consecutive days. Fecal moisture content and intestinal propulsion rate were measured. The serum levels of substance P (SP), vasoactive intestinal peptide (VIP), NO and NOS were detected by ELISA. The pathological changes of colon tissue were observed by HE staining. The c-kit level in colon tissue was detected by immunohistochemistry. The mRNA and protein levels of c-kit and Beclin1 in colon tissue were detected by PCR and Western blot.Results:Compared with the model group, the fecal moisture content, the carbon pushing distance and the intestinal pushing rate of the low, medium and high dose groups were significantly increased ( P<0.05), the serum SP level was increased ( P<0.05), the serum VIP, NO and NOS levels of the low, medium and high dose groups were decreased ( P<0.05), and the average expression score of c-kit in colon tissue of the low, medium and high dose groups was significantly increased ( P<0.05). The levels of c-kit mRNA (2.33 ± 0.35, 3.04 ± 0.17, 3.83 ± 0.23 vs. 0.61 ± 0.07) and protein (0.42 ± 0.06, 0.60 ± 0.07, 0.79 ± 0.08 vs. 0.22 ± 0.04)in colon tissue of rats in low, medium and high dose groups were increased ( P<0.05), and Beclin1 mRNA (4.17 ± 0.37, 3.35 ± 0.44, 1.05 ± 0.28 vs. 6.04 ± 0.31) and protein (0.76 ± 0.11, 0.57 ± 0.08, 0.43 ± 0.05 vs. 0.91 ± 0.06) were decreased ( P<0.05). Conclusion:Rhubarb dispensing granule could significantly increase the fecal moisture, intestinal motility rate, serum SP level and colonic tissue c-kit level, decrease serum VIP, NO, NOS level and colonic tissue Beclin1 level in rats with chronic transit constipation, and then inhibit autophagy of Cajal interstitial cells and regulate gastrointestinal motility in rats with chronic transit constipation.
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OBJECTIVE: To prepare Cinnamomi Ramulus standard decoction according to the traditional decoction method, and study the preparation process and quality control of Cinnamomi Ramulus formula granules. METHODS: The standard decoctions of 16 batches of Cinnamomi Ramulus were prepared using decocting pot. The extracting rate, contents and transfer rates of cinnamic acid and cinnamaldehyde were calculated. The preparation process of Cinnamomi Ramulus dispensing granules was improved based on the parameters of standard decoction. The volatile oil was collected while extracting, and the β-cyclodextrin inclusion technology was applied in the granulation process. Based on the parameters of standard decoction, the quality standard of Cinnamomi Ramulus formula granules was established. RESULTS: The extracting rate of Cinnamomi Ramulus standard decoction was 3.58%-6.10%; the cinnamic acid content was 0.99%-2.59% and the transfer rate was 39.56%-62.28%; while the cinnamaldehyde content was 1.95%-4.69% and the transfer rate was 4.76%-7.85%. According to the standard decoction, 1 g of Cinnamomi Ramulus formula granules was equivalent to 14 g of pieces, containing cinnamic acid (0.50%-1.43%) and cinnamaldehyde (0.98%-3.50%). Six characteristic peaks in specific spectra were confirmed, including protocatechuic acid (1), coumarin (2), cinnamic acid (3), 2-methoxycinnamic acid (4), cinnamaldehyde (5) and 2-methoxycinnamaldehyde (6). CONCLUSION: In this study, the quality parameters of Cinnamomi Ramulus standard decoction are determined by traditional decocting pot. The strategy of establishing the preparation process and quality standard of Cinnamomi Ramulus formula granules based on standard decoction is proposed. It can provide reference for the research of Cinnamomi Ramulus dispensing granules and other Chinese medicine preparations containing volatile oil.
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Objective: Comparing the differences between dispensing granule decoction (DGD), standard decoction (SD) and traditional decoction (TD) of Phellodendri Chinensis Cortex (PCC) prescription to evaluate the quality of commercially available dispensing granule (DG), and establish the relevant standards for SD, TD and evaluative methods for DG. Methods: Fingerprint was established by HPLC. A comprehensive comparative study was conducted on 35 samples of DGD (three batches from each of the five A-E manufacturers), SD (10 batches) and TD (10 batches) in seven categories from five aspects of chemical composition type, representative index component content, fingerprint similarity, total peak area sum and principal component analysis (PCA); Clinically recommended equivalent corrections were performed for DGD. Results: ① Twenty-one common peaks in SD and TD were preserved in the DGD fingerprint. ② The content of magnoflorine in manufacturer A of DGD was 34.3% lower than that of SD (P < 0.05); The content of magnoflorine in manufacturer C was 35.6% lower than SD (P < 0.01), and 37.0% lower than TD (P < 0.05); The content of phellodendrine hydrochloride in D manufacturer was 22.0% lower than SD (P < 0.05), and 27.5% lower than TD (P < 0.05), The content of berberine hydrochloride in D manufacturer was 20.8% lower than SD (P < 0.05), and 23.8% lower than TD (P < 0.05). There were no significant differences between the other manufacturers' components. ③ The average similarity of each DGD and SD was greater than 0.992 6, and the average similarity of each DGD and TD was greater than 0.991 2, with high component similarity. Using the normalization method, the total peak area of the 21 common peaks of SD was 1 unit, and the ratios of the seven types of samples were 0.90, 1.03, 0.69, 0.77, 0.73, 1.00, and 1.06. ⑤ PCA showed that the distance between the B manufacturer and SD and TD was close, and the difference was small. Using the 21 common peak information of SD as the standard, the peak area plus method was used to correct the clinical recommended equivalent of DG. It was recommended that manufacturers A, C, D, and E could be reduced from 1 g equivalent to 12 g of the original decoction pieces to 10.7, 8.3, 9.2, and 8.8 g, respectively. B manufacturer was not needed to be corrected, and still 1 g was equivalent to 10 g of the original decoction pieces. Conclusion: There are differences in the content of components between DGD, SD, and TD in the real world. There is no significant difference in the proportion of components and components. These overall basically consistent differences can be adjusted by correcting the clinical recommended equivalent, thus promoting clinical rational drug use.
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Consistency in quality of traditional Chinese medicine granules is an important factor to ensure reproducible clinical efficacy. In this study rhubarb dispensing granules were utilized to construct an efficacious near-infrared spectroscopy (eNIRS) assay by combining NIRS and biopotency. A NIR method for assaying rhubarb dispensing particles was established, and information on different batches was collected. The diarrhea-inducing biopotency of rhubarb dispensing granules was determined based on a constipation model induced by diphenoxylate in mice. The animal protocol was approved by the Animal Ethic Committee of 302 Hospital of Chinese PLA People's Liberation Army (ID: IACUC-2019-0010). Ten anthraquinones were determined in rhubarb dispensing granules by UPLC. The correlation between NIR and biopotency was analyzed and five characteristic bands that correlated highly with bioactivity were identified, including 4 011-4 390, 4 859-5 461, 7 012-7 493, 10 992-11 312 and 11 871-12 489 cm-1. There were some differences in the main bands of different chemical constituents. In summary, five active bands based on NIRS were identified and found to be able to achieve rapid on-line detection of rhubarb dispensing granule quality. This research model may also provide reference for quality control of other Chinese medicine dispensing granules.
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OBJECTIVE:To establish a method for the contents determination of emodin,rhein,aloe-emodin,chrysophanol, physcion,geniposide,chlorogenic acid in Yinchenhao decoction and its dispensing granule,and to compare the difference among the above-mentioned ingredients. METHODS:HPLC was adopted to determine the contents of emodin, rhein, aloe-emodin, chrysophanol and physcion:the column was Ecosil C18 with mobile phase of acetonitrile-0.5% phosphoric acid(gradient elution)at a flow rate of 1 ml/min,the detection wavelength was 254 nm,column temperature was 35 ℃,and injection volume was 20 μl. When determining the content of geniposide by HPLC,the column was Ecosil C18 with mobile phase of acetonitrile-water(13∶87, V/V)at a flow rate of 1 ml/min,the detection wavelength was 238 nm,column temperature was 35 ℃,and injection volume was 20 μl. When determining the content of chlorogenic acid by HPLC,the column was Ecosil C18 with mobile phase of acetonitrile-0.5% phosphoric acid (10∶90,V/V) at a flow rate of 1 ml/min,the detection wavelength was 327 nm,column temperature was 35 ℃,and injection volume was 20 μl. RESULTS:The linear range was 2-20 μg/ml for emodin(r=0.996 5),5.2-52.0 μg/ml for rhein(r=0.998 5),2.6-26.0 μg/ml for aloe-emodin(r=0.999 9),1.0-10.4 μg/ml for chrysophanol(r=0.999 9),1.0-10.0 μg/ml for physcion(r=0.999 8),20-200 μg/ml for geniposide(r=0.999 9),20-200 μg/ml for chlorogenic acid(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 3%;recoveries were 91.1%-96.9%(RSD=2.0%,n=6)for emodin、93.9%-96.1%(RSD=0.8%,n=6)for rhein、90.9%-93.4%(RSD=1.2%,n=6)for aloe-emodin、88.5%-92.7%(RSD=1.8%,n=6) for chrysophanol、82.1% -87.9%(RSD=2.5% ,n=6)for physcion,100.4% -102.0%(RSD=0.7% ,n=6)for geniposide、101.1%-102.2%(RSD=0.4%,n=6) for chlorogenic acid. CONCLUSIONS:The method is simple,stable and reproducible,and can be used for the simultaneous contents determination of active ingredients in Yinchenhao decoction and its dispensing granule. The contents of active ingredients in Yinchenhao dispensing granule are obviously higher than those in its decoction.
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The aim of this study was to the prepare the standard decoction of paeoniae radix rubra for its investigation of quality standard.The standard decoction of paeoniae radix rubra was dissolved by water using standardization method and the content of peoniflorin was determined by UPLC-DAD.Then the transfer rate and the rate of extractum were calculated,and the fingerprint analysis was carried out.As a result,the content of the standard decoction of paeonia lactiflora ranged from 3.79 to 5.68 mg·mL-1 from 15 paeoniflorin batches,while the transfer rate ranged from 56.58％ to 90.14％,and the average transfer rate was 73.97％ and the standard deviation was 10.91％.The rate of extractum ranged from 16.74％ to 29.24％,the average yield was 21.82％ and the standard deviation was 3.55％.There were eleven common peaks,four of which were identified,including oxypaeoniflorin,albiflorin,paeoniflorin and benzoylpaeoniflorin.In conclusion,it was demonstrated that the method was simple with good repeatability for the preparation and quality standard studies of the standard decoction of paeoniae radix rubra.
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Objective:To compare the pharmacokinetics consistence of baicalin between traditional slice decoction and dispensing granule decoction of Huanglianjiedu decoction. Methods:After the gastric administration of the two decoctions at low, middle and high dose in rats, an HPLC method was used to detect the content of baicalin in the plasma, and then DASS 2. 1. 1 software was used to cal-culate the pharmacokinetic parameters. Results:After the administration of the two decoctions at low, middle and high dose, the phar-macokinetic parameters were as follows:Cmax of 0. 25 and 0. 27μg·ml-1 ,0. 30 and 0. 31 μg·ml-1 ,0. 40 and 0. 45 μg·ml-1;AUC of 2. 48 and 2. 59μg·ml-1 ·h,3. 59 and 3. 71μg·ml-1 ·h,5. 71 and 6. 16μg·ml-1 ·h;Tmax of 3. 0 and 3. 0 h,3. 0 and 3. 0 h, 4.0 and 4.0 h;Vd of (2 822.4 ±118.2) and (2 998.9 ±255.6) L·kg-1,(3 102.6 ±176.3) and (3 405.3 ±213.8) L·kg-1, (4 231.2 ±155.4) and (4 486.0 ±187.0) L·kg-1;CL of (2 923.3 ±215.6) and (2 767.5 ±184.6)L·h-1·kg-1,(4 921.7 ± 225.4) and (4 040.8 ±246.7)L·h-1·kg-1,(5 255.9 ±189.7) and (4 868.7 ±260.4)L·h-1·kg-1;and t1/2 of (3.88 ± 0.41) and (3.71 ±0.37)h,(4.19 ±0.36) and (3.73 ±0.51)h, (5.54 ±0.38) and (5.80 ±0.54)h. Conclusion: The pharma-cokinetic parameters of baicalin have no significant difference between traditional slice decoction and dispensing granule decoction of Huanglianjiedu decoction.
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OBJECTIVE:To establish the quality standard for Gentiana scabra dispensing granule. METHODS:TLC was ad-opted to identify G. scabra in the preparation;HPLC was adopted to determine the content of gentiopicroside in the preparation:the column was Dionex C18 with mobile phase of methanol- water(25∶75,V/V)at a flow rate of 1.0 ml/min,the detection wave-length was 270 nm,column temperature was 30 ℃,the injection volume was 10 μl. RESULTS:TLC showed clear spots and good separation. The linear range of gentiopicroside injection volume was 0.302 6-3.026 μg (r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 98.27%-99.56%(RSD=0.68%,n=6). CONCLUSIONS:The estab-lished standard can be used for the quality control of Gentiana scabra dispensing granule.
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Objective To establish the fingerprint of Forsythia suspensa dispensing granule by HPLC. Methods The total of 10 samples of Forsythia suspensa were analyzed by HPLC on a Waters SunFire C18 column(4. 6 mm×250 mm,5 μm) with mobile phase of A:acetonitrile and mobile phase B:0. 4% acetic acid solution as gradient elution, with flow rate at 1. 0 mL·min-1 , wavelength at 277 nm and column temperature at 30 ℃. Results There were 13 characteristic common peaks in the Forsythia suspensa dispensing granule, in which two peaks identified as forsythoside A and forsythin, the similarities were more than 0. 999. Conclusion The HPLC fingerprint of Forsythia suspensa dispensing granule is stable, and is easy to manipulate, which can provide more information for the quality control of Forsythia suspensa dispensing granule.
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Chinese medicine dispensing granule is made by qualified decoction pieces with modern pharmaceutical technology, which has the characteristics of flexible prescription, flexible dose, fast onset and easy absorption. However, there is great controversy in whether it has curative effects, also there are problems with non-conformant standard of prescription, high price, and incomplete varieties. In this case, advantages and disadvantages of present Chinese medicine dispensing granule are analyzed and discussed thoroughly in this article so that we can provide references for the benign development of Chinese medicine dispensing granule industry.
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Objective To compare the contents of forsythoside A and forsythin in Fructus Forsythia and its dispensing granule. Methods HPLC-gradient elution method was used with SunFire C18 column (4.6 mm×250 mm, 5μm), mobile phase A of acetonitrile and B of acetic acid, flow rate of 1.0 mL/min, detection wavelength of 277 nm, and column temperature at 30 ℃. HPLC was used to determine the contents of forsythoside A and forsythin in Fructus Forsythia and its dispensing granule, and compare the difference between the two contents. Results The content of forsythoside A in dispensing granule was less than that of raw material of Fructus Forsythia, and the concentration of the major components in the commercial Lianqiao Granule were not equivalent to that in the decoction of Fructus Forsythia. The content of forsythin in dispensing granule was equivalent with that of raw material of Fructus Forsythia. Conclusion The original formula granule production process needs to be improved, and the standardized criteria for the quality control and reasonable quality standard of granule should be established.
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OBJECTIVE: To study and compare the compositions of traditional decoction and compatible granules of Duhuo Jisheng Tang and reveal their differences in inner quality. METHODS: The compositions of eight medicines, i.e., duhuo, sangjisheng, danggui, chuangxiong, fuling, baishao, qinjiao and gancao in traditional decoction and dispensing granule decoction, were identified by TLC. And the contents of paeoniflorin were determined by HPLC. RESULTS: There were more spots of the eight than dispensing granules. The content of peaoniflorin of the traditional decoction was 29.37mg·g-1. The content of peaoniflorin of the dispensing granule decoction is 2.59 mg·g-1. CONCLUSION: Composition contents in traditional decoction from Duhuo Jisheng Tang is higher than that of dispensing granule decoction.
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Objective To compare the chemical constituents between the dispensing granules and the decoction of Buyanghuanwutang. Methods TLC and HPLC methods were carried out for comparative analysis. Results TLC indicated the chemical constituents were similar between the dispensing granule and the decoction. The HPLC method was successfully established,and used for taking the contents of paeoniflorin in dispensing granule and the decoction of Buyanghuanwutang. The contents of paeoniflorin in dispensing granule were only one sixth of that in the decoction. Conclusion The chemical constituents of the two preparations are similar,but the contents of paeoniflorin are different.
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Objective To compare the contents of berberine,palmatine,jatrorrhizine,baicalin and geniposide between traditional decoction and dispensing granule decoction of Huanglian Jiedu Decoction.Methods A HPLC method was carried out on Diamonsil C18 column(250 ? 4.6 mm,5 ?m).The mixture of H2O(A),CH3OH(B)and 0.05 % H3PO4 solution(C)was used as the mobile phase for gradient elution.The column temperature was set up at 35 ℃ and the flow rate was l mL/min.The detection wavelength was 345nm for berberine,palmtine and jatrorrhizine,280 nm for baicalin,and 238 nm for geniposide.Results This method can be used to determine 5 components in Huanglian Jiedu Decoction at the same time and the method was rapid,sensitive and accurate.Conclusion The HPLC chromatograms of traditional sliced decoction of Huanglian Jiedu Decoction are similar to the dispensing granule decoction.The contents of 5 main components in dispensing granule decoction are higher than those in traditional sliced decoction.
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AIM: To study the difference in main chemical composition and content between Mahuangtang Herb Ephedrae;Radix et Rhizoma Gly Cyrrhizae;Ramulus Cinnamoni;Semen Armeniacea Amarum;dispensing granule and its standard decoction. METHODS: RP-HPLC was used to create fingerprinits with MeOH-0.01 mol/L KH_2PO_4(H_3PO_4 adjusted pH=3),a gradient eluting agent. RESULTS: 26 co-possessing peaks were indicated,the retention time and relative peak area were obtained. CONCLUSION: The difference between Mahuangtang dispensing granule and standard decoction is not obvious,the former is rational.
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Objective: To study the quality standard for Puhuang Dispensing Granule (Pollen Typhae). Methods : Puhuang Dispensing Granule was identified by TLC and isorhamnetin-3-O-neohesperidoside and typhaneoside in Puhuang Dispensing Granule were determined by HPLC. Results : The linear relationship was at the range of 0.4～1.21?g for isorhamnetin-3-O-neohesperidoside and 0.42～1.25?g for typhaneoside, respectively. The average recovery was 98.88% for isorhamnetin-3-O-neohesperidoside and 99.68% for typhaneoside, respectively. Conclusion : The method is available with a good reproducibility and can control the quailty of Puhuang Dispensing Granule.